{ "meta": { "tracker_site_url": "https://psilocybin-research.com", "publication_tracker_url": "https://psilocybin-research.com/", "generated_at_utc": "2026-07-02 22:08:05", "record_count": 287 }, "papers": [ { "id": 3693, "title": "Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study", "normalized_title": "consciousness and psilocybin effects on well being the copewell study", "authors": "University of Wisconsin, Madison", "abstract": "This study is exploring how psilocybin (a psychedelic drug) may improve mood and wellbeing. Many people report feeling better after taking psilocybin, but it is not clear why. The CoPEWell study will test whether these improvements come from the psychedelic experience itself (the \"trip\") or from direct effects on the brain. To study this, up to 120 participants will be enrolled to receive psilocybin either while awake or asleep and can expect to be on study for up to 4 months. Primary Objectives: 1. To evaluate the effect of psilocybin on wellbeing when administered while awake vs. while asleep 2. To evaluate the effect of psilocybin on wellbeing administered while asleep vs. placebo administered while asleep Secondary Objectives: 3. To evaluate the effect of psilocybin on psychological flexibility when administered while awake vs. while asleep 4. To evaluate the effect of psilocybin on psychological flexibility administered while asleep vs. placebo administered while asleep 5. To evaluate the effect of psilocybin on social connectedness when administered while awake vs. while asleep 6. To evaluate the effect of psilocybin on social connectedness administered while asleep vs. placebo administered while asleep 7. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while awake vs. while asleep 8. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while asleep vs. saline placebo administered while asleep", "journal": "ClinicalTrials.gov", "publication_date": "2026-07-01", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07360301", "keywords": "Well-Being, Psychological, Psychedelic Experiences, Psilocybin, intravenous psilocybin, Saline Placebo, Clonidine, Clonidine ER, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT07360301\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Consciousness,Wellbeing,Psychological Flexibility", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3662, "title": "Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms", "normalized_title": "efficacy in relapse prevention psilocybin in alcohol use disorder with depressive symptoms", "authors": "Centre Hospitalier Universitaire de Nīmes", "abstract": "Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants. The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \\[0.16-1.65\\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-30", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07638553", "keywords": "Alcohol Use Disorder, Depressive Sympotoms, Psilocybin, Psilocybin (high dose), Psilocybin (low dose), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT07638553\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Addiction,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3547, "title": "A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)", "normalized_title": "a phase 2 open label study investigating the safety and efficacy of psilocybin assisted therapy for sexual assault related posttraumatic stress disorder ptsd", "authors": "Sunstone Medical", "abstract": "A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-30", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06902974", "keywords": "Post Traumatic Stress Disorder, PTSD, Psilocybin 25 mg, Psilocybin-assisted therapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT06902974\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3495, "title": "A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults", "normalized_title": "a multicenter phase 1 safety and tolerability trial of psilocybin in healthy older adults", "authors": "University of Colorado, Denver", "abstract": "This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85. The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing. * Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. * Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart. * Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults. * Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort. Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-29", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07516405", "keywords": "Healthy Volunteer, Older Adults (65-85 Years), Psilocybin (Usona Institute), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT07516405\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Pharmacology,Aging,Wellbeing,Clinical Trial,Observational Study,Healthy Volunteers,Older Adults,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3561, "title": "The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease", "normalized_title": "the efficacy of psilocybin therapy for depression in parkinson s disease", "authors": "Yale University", "abstract": "The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy. This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. Investigators will enroll participants with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an \"on\" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low (\"microdose\") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments will be used to quantify changes in depression as well as other relevant outcomes (non-motor and motor symptoms of PD, cognitive performance, quality of life). Follow-up will continue to 3 months after the second session. Endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at UCSF (NCT06455293) for publication purposes.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-28", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07610369", "keywords": "Depression, Parkinson's Disease (PD), Psilocybin (drug), 4-phosphoryloxy- N, N-dimethyltryptamine, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT07610369\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Microdosing,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3494, "title": "5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder", "normalized_title": "5 ht2a agonist psilocybin in the treatment of tobacco use disorder", "authors": "Johns Hopkins University", "abstract": "This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart. This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. The investigators previously conducted an open-label pilot trial (N = 15) of psilocybin paired with cognitive behavior therapy (CBT). Data showed a biologically-verified 7-day point-prevalence abstinence rate of 67% at 12 months and 60% at 2.5 years (continuous abstinence rates: 53% and 47%, respectively). The investigators are now conducting an open-label randomized comparative efficacy trial of psilocybin vs. nicotine patch, both in combination with CBT. Interim results (N = 44; 22 per group) show greater biologically-verified abstinence rates at 12 months for psilocybin: 7-day point-prevalence: 59% vs. 27%; continuous abstinence: 36% vs. 9%. Despite these promising findings, the investigators have yet to conduct a double-blind study of psilocybin for smoking cessation. Furthermore, previous psilocybin study samples have been largely White with higher socioeconomic status (SES). The current trial will address these issues across four sites with experience in conducting psilocybin research: Johns Hopkins, the University of Alabama at Birmingham (UAB), and New York University (NYU). A diverse sample with regard to ethno-racial identity and SES will be recruited at each site. The proposed double-blind study will treat 66 participants (22 at each site), randomized to receive either: 1) psilocybin; 30 mg in session 1 and either 30 or 40 mg in session 2, with sessions 1 week apart; or 2) niacin; 150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart. Niacin was selected because it has been used as an active placebo in two previous randomized therapeutic trials of psilocybin, and the FDA has informed the investigators that niacin is the FDA's preferred active placebo for psilocybin. CBT will be administered to both groups and will allow the investigators to test psilocybin's efficacy above and beyond an established treatment approach. Biochemically-confirmed 7-day point-prevalence abstinence will be assessed throughout for up to 12 months. The investigators hypothesize that psilocybin (compared to niacin) will cause increased biologically-confirmed 7-day point-prevalence abstinence at 12-month follow-up. Based on pilot data, the investigators will test cognitive/psychological mediators of treatment response. The investigators hypothesize that psilocybin will be associated with improved cognitive control and decreased anticipation of withdrawal relief (from smoking) 1 day after the target quit date, which will be associated with greater 7-day point-prevalence abstinence at 12- month follow-up. This trial will provide a rigorous test of efficacy in a diverse study sample, and test relevant mechanisms, for an innovative smoking cessation treatment showing potential for substantial efficacy.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-28", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05452772", "keywords": "Tobacco Use Disorder, Psilocybin, Active Experimental Group, Niacin, Active Comparator Group, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT05452772\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Mechanism of Action,Receptor Pharmacology,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3621, "title": "Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial", "normalized_title": "psilocybin assisted massed cognitive processing therapy for chronic posttraumatic stress disorder an open label trial", "authors": "Unity Health Toronto", "abstract": "This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD. Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-25", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06386003", "keywords": "Post Traumatic Stress Disorder, PTSD, Chronic PTSD, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT06386003\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3522, "title": "Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]", "normalized_title": "psilocybin assisted therapy for physician well being and burnout feasibility safety clinical effectiveness and biomarkers of response pat b psilocybin assisted therapy for physician well being and burnout", "authors": "University of California, San Diego", "abstract": "Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms. Physician burnout is a critical issue. Research shows that physician burnout is increasing, that physicians suffer higher rates of burnout than the general population, and that physician burnout is associated with poor mental health outcomes. Psilocybin is a naturally occurring alkaloid within certain fungi that elicits acute perceptual, cognitive, and emotional changes when ingested, due to action on neurotransmitter and neurocirculatory systems. The combination of psilocybin with psychological support, termed Psilocybin-Assisted Therapy (PAT), is a promising new mental health intervention shown to produce rapid and sustained improvements in psychological domains affected in burnout. PAT demonstrates preliminary efficacy as a treatment for depression and substance use disorders, is associated with brain changes measured with electroencephalography (EEG) and is a strong candidate treatment for physician burnout. The primary aim of this study is to investigate the safety, feasibility, and preliminary efficacy of PAT to enhance well-being in University of California, San Diego (UCSD) physicians experiencing burnout. A secondary aim is to identify neurophysiological changes associated with response to PAT. Physicians experiencing burnout will be recruited in an open-label trial involving preparatory therapy sessions, psilocybin treatment, and post-treatment integration. Burnout will be measured with the Stanford Professional Fulfillment Index (PFI).", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-25", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06814522", "keywords": "Burnout, Burnout, Healthcare Workers, Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-02 22:01:25", "raw_json": "{\"nct_id\":\"NCT06814522\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Addiction,Brain Imaging,Biomarkers,Wellbeing,Emotional Processing,Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3595, "title": "Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects", "normalized_title": "acute effects of mdma co administration on the response to psilocybin in healthy subjects", "authors": "University Hospital, Basel, Switzerland", "abstract": "The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA. Psilocybin is a classic serotonergic psychedelic. Clinically, the acute effects of psilocybin last shorter than those of lysergic acid diethylamide (LSD) but are qualitatively very similar. Currently, psilocybin is the most investigated psychedelic substance among the classic psychedelics including LSD, psilocybin, mescaline, and dimethyltryptamine (DMT). Psilocybin is capable of inducing exceptional subjective effects such as a dream-like alteration of consciousness, affective changes, psychological insight, visual imagery, pseudo-hallucinations and ego-dissolution. The acute subjective effects elicited by psilocybin are mostly positive in humans. However, psychedelic substances like psilocybin may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of psilocybin used, the personality traits of the person consuming it (i.e. 'set'), the environment in which it is consumed (i.e. 'setting'), and other factors. Acute negative psychological effects are considered the main risk of psychedelic substance use in humans. Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic. The present study uses 3,4-methylenedioxymethamphetamine (MDMA) as a pharmacological tool to optimize the effects of psilocybin by inducing positive mood. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the serotonin transporter (SERT). Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics. Due to its psychological profile, MDMA could be a reliable pharmacological tool to serve as an optimizer of a psychedelic experience by inducing positive emotions.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-24", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06884514", "keywords": "Healthy, Psilocybin, 3,4-Methylenedioxymethamphetamine, Psilocybin placebo, 3,4-Methylenedioxymethamphetamine placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 23:13:10", "raw_json": "{\"nct_id\":\"NCT06884514\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Addiction,Receptor Pharmacology,Consciousness,Wellbeing,Personality Change,Emotional Processing,Safety", "study_type": "Qualitative Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3560, "title": "A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)", "normalized_title": "a pilot mechanistic rct of psilocybin with mindfulness based therapy vs support for posttraumatic stress disorder ptsd", "authors": "Anthony P King", "abstract": "The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard \"psychological support\" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT). Many patients with PTSD do not respond or have an incomplete response to treatment with currently available medications that are FDA-approved for PTSD, and/or do not respond to psychotherapies for PTSD. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve symptoms in patients with PTSD and depression, however their mechanism of action is still not well understood. Furthermore, while psychedelics are usually administered in the context of psychological support (\"psychedelic assisted therapy\", PAT) the kinds of support therapy used and possible interactions with drug with therapy effects is not well understood. This study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity, assessed using electroencephalography (EEG) / electromyography (EMG) and functional magnetic resonance imaging (fMRI) /diffusion-weighted magnetic resonance imaging (DWI), after administration of one oral dose of 25 mg synthetic Psilocybin delivered in the context of either non-directive psychological support only (the most common approach for PAT) or in combination with psychological support plus an active form of psychotherapy called Mindfulness-based Cognitive Therapy (MBCT). Up to 30 participants will be enrolled altogether. The initial phase of this study will be an open label administration of 25 mg synthetic Psilocybin combined with standard \"PAT psychological support\" plus MBCT in ten participants with PTSD, to allow us to pilot this new intervention package. In the next phase of the study, we will randomly assign twenty participants with PTSD into two groups: one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard \"PAT support\" only, and one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard \"support\" plus active form MBCT psychotherapy. In both groups, psychological support will be provided before, during and after the administration session. The MBCT group will also receive bi-weekly individual MBCT sessions and will be invited to complete daily homework, as per the MBCT protocol. Assessments performed at Baseline and on Day 2 and Day 28 after administration will include EEG/EMG, MRI, clinician-administered scales (CAPS-5, MADRS, C-SSRS) and self-report questionnaires to assess PTSD, depression and anxiety symptoms, cognitive testing, self-report questionnaires to evaluate the psychedelic effects of synthetic Psilocybin administration, and blood collection for the Gsα-AC biomarker assay.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-24", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07104916", "keywords": "Post Traumatic Stress Disorder, Depression - Major Depressive Disorder, Psilocybin + MBCT therapy, Active Comparator: Psilocybin with Support Only, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 23:13:10", "raw_json": "{\"nct_id\":\"NCT07104916\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,PTSD,Neuroplasticity,Brain Imaging,Mechanism of Action,Biomarkers,Aging,Randomized Controlled Trial,Healthcare Workers,Drug Interactions", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3525, "title": "Psilocybin Administration With 5-HT1a Blockade", "normalized_title": "psilocybin administration with 5 ht1a blockade", "authors": "Johns Hopkins University", "abstract": "The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries. This double-blind, randomized, cross-over study (N = 18) will administer a moderate dose of psilocybin trihydrate (18 mg, equivalent to 15 mg psilocybin anhydrate), with pindolol (30 mg), or placebo to assess the effects of 5-HT1A receptor blockade on the acute subjective effects and the acute neurophysiological effects of psilocybin through the use of self-report measures and acute EEG. Participants will also complete sleep and dream diaries 10 days prior to and 10 days following each drug administration session as well as wear an at-home sleep EEG device for 5 days prior to and 5 days following each drug session. This study aims to understand the mechanistic basis of the perceptual changes in the altered state of consciousness induced by psilocybin as well as its effects on post-acute sleep and dreaming.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-24", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07565493", "keywords": "Psychedelic Effects in Healthy Volunteers, Pindolol, Placebo, Microcrystalline cellulose placebo, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 23:13:10", "raw_json": "{\"nct_id\":\"NCT07565493\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Receptor Pharmacology,Consciousness,Observational Study,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3684, "title": "TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy", "normalized_title": "trip treatment to improve depression and or anxiety using psilocybin assisted psychotherapy in patients with advanced cancer on maintenance therapy", "authors": "M.D. Anderson Cancer Center", "abstract": "To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer. Primary Objective To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for participants with depression and/or anxiety who are being actively treated for advanced cancer. Feasibility will be measured as: At least 20% of eligible participants consent and at least 60% of consented participants complete the two doses of treatment. Secondary Objectives 1. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, functional status) and psychosocial well-being (e.g., finding meaning and post-traumatic growth), as measured by the following: PHQ-9, GAD-7, PROMIS-10, PROMIS-A, PROMIS-D, MEQ30 (mystical experience), Flourishing scale, mDES, 5D-ASC (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. Assess the effects of psilocybin-assisted psychotherapy on cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies. 4. Measure the change in inflammatory markers (IL6, TNF, and CRP) and in frequency and activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry. 5. Examine changes in central nervous system plasticity through the use of fMRI, specifically changes in 5-HT2A-rich and higher-order functional networks, as well as a global increase in brain network integration. 6. Evaluate the Impact on MDASI measurements.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-23", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06200155", "keywords": "Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer, Psilocybin, Niacin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06200155\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Chronic Pain,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Wellbeing,Mystical Experience,Healthcare Workers,Safety,Inflammation,Immune Function", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3674, "title": "TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors", "normalized_title": "trips treatment to improve depression and or anxiety using psilocybin assisted psychotherapy in cancer survivors", "authors": "M.D. Anderson Cancer Center", "abstract": "This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety. Primary Objective: To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety. Feasibility will be measured as: At least 20% of eligible patients consent (inclusion rate), at least 60% of consented patients completing the two doses of treatment (treatment completion rate), and at least 80% and 65% consenting patients completing assessments at the 2- and 6-month follow-ups (adherence rates), respectively. Secondary Objectives: 1. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, functional status) and psychosocial well-being (e.g., finding meaning and post-traumatic growth), as measured by the following: PHQ-9, GAD-7, PROMIS-10, PROMIS-A, PROMIS-D, MEQ30 (mystical experience), Flourishing scale, mDES, PIQ (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. Measure the change in inflammatory markers (IL6, TNF, and CRP) and in frequency and activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry. 4. Examine changes in central nervous system plasticity through the use of fMRI, specifically changes in 5-HT2A-rich and higher-order functional networks, as well as a global increase in brain network integration. 5. Evaluate the Impact on MDASI measurements.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-23", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06801041", "keywords": "Depression, Anxiety, Cancer, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06801041\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Chronic Pain,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Wellbeing,Mystical Experience,Healthcare Workers,Safety,Inflammation,Immune Function", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3555, "title": "NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy", "normalized_title": "neuroguard psilocybin trial for preventing chemo induced neuropathy", "authors": "M.D. Anderson Cancer Center", "abstract": "To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo. Primary Objective 1\\. To assess the efficacy of psilocybin in the prevention or mitigation of chemotherapy-induced peripheral neuropathy (CIPN) in individuals undergoing adjuvant neurotoxic chemotherapy (i.e., taxanes, platinum-based compounds) for breast, colorectal, and head \\& neck cancers. The primary endpoint is the proportion of participants with a ≥25% increase (worsening) from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale. The primary comparison is 25 mg psilocybin vs pooled control (standard of care + 1 mg subperceptual psilocybin), tested two-sided at α=0.05. If significant, two confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) will be performed with Hochberg multiplicity control. Hypothesis: Prophylactic psilocybin administered in four doses (two pre-chemotherapy and two during chemotherapy) will reduce the severity of CIPN as measured by the proportion of participants reporting a 25% or greater increase in CIPN on the EORTC QLQ-CIPN20 sensory subscale compared to placebo or SOC. Secondary Objectives 1. Determine whether prophylactic psilocybin reduces rates of dose-liming modifications to chemotherapy as result of peripheral neurotoxicity. Dose modifications are defined by either a change in frequency or reduced chemotherapy dose during the 12-week study period. Dose modification decisions will be made by the participant's independent, primary clinician. 2. Determine whether prophylactic psilocybin decreases incidence and severity of CIPN as measured by the NCI-CTCAE criteria 3. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, fatigue, functional status) and psychosocial well-being (e.g., mental health, finding meaning, and post-traumatic growth), as measured by the following: PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 (mystical experience), Flourishing scale. 4. Determine whether psilocybin-assisted psychotherapy improves functional status per clinicianrated outcome measures. 5. Assess the effects of psilocybin-assisted psychotherapy on all-cause cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-23", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07227909", "keywords": "Psilocybin, Neuropathy, Psilocybin (drug), Standard of Care (SOC), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07227909\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Chronic Pain,Wellbeing,Mystical Experience,Healthcare Workers,Toxicity", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3705, "title": "Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study", "normalized_title": "effects of psilocybin microdosing on cognition mood and quality of life a pilot study", "authors": "Yale University", "abstract": "This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences. This study is being conducted to evaluate the effects of 30 days of intermittently microdosed psilocybin in a parallel arm double-blind manner on mood, cognition, subjective well-being and structural/functional MRI compared to placebo, using validated psychological assessments and cognitive tests. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences. Demonstrating significant results in a population of healthy psychedelic non-users will establish a strong precedent for studying the effects of microdosing psychedelics in patient populations, such as those with treatment-resistant depression. Showing that microdosing minimizes risk of adverse outcomes with psychedelic treatment while maintaining beneficial effects would provide useful information relevant to clinical research in psychedelic-assisted psychotherapy. In addition to investigating claims that microdosing psychedelics may improve cognition and mood, this study also aims to test the hypothesis that these effects including those measurable at a brain level may persist beyond the course of the 30 days of the study. There are few to no studies that assessed the longevity of psychedelic effects on the majority of the above measures, so the proposed study may further establish the longer-term benefits of microdosing. The use of structural and functional magnetic resonance imaging (fMRI) will elucidate the mechanisms by which microdosing may be exerting its effects on mood and cognition. Because this is a relatively understudied area, information gleaned from this study will provide service in informing the field in general.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07449351", "keywords": "Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI, Psliocybin, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07449351\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Brain Imaging,Mechanism of Action,Aging,Longevity,Microdosing,Wellbeing,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3650, "title": "Psilocybin-assisted Existential, Attachment and Relational (PEARL) Therapy for Caregivers of Patients With Advanced Cancer: A Phase II Open-Label Trial", "normalized_title": "psilocybin assisted existential attachment and relational pearl therapy for caregivers of patients with advanced cancer a phase ii open label trial", "authors": "University Health Network, Toronto", "abstract": "The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Caregivers of patients with advanced cancer often experience high levels of distress but there is currently little evidence-based guidance on how to help caregivers who experience depression, anxiety, anticipatory grief, spiritual suffering, caregiving burden and/or impaired quality of life. Over the past decade, research has shown that psychotherapies incorporating existential, attachment and relational approaches can address the specific needs and challenges of the advanced cancer population and thus help to reduce related distress. Simultaneously, recent research has shown that psilocybin-assisted psychotherapy, in which an individual ingests the psychoactive drug within a carefully monitored therapy, can reduce end-of-life distress and greatly benefit those with advanced disease. The multidisciplinary team has combined these two evidence-based approaches into Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted psychotherapy, including preparatory therapy sessions, a high-dose drug session, and integration sessions, with important elements from manualized individual psychotherapies designed for patients and their families facing advanced cancer. This study will assess the feasibility, acceptability, and safety of PEARL therapy among caregivers of patients with advanced cancer. This study will contribute to the growing research around the efficacy of psychedelic-assisted therapies for the psychological distress associated with advanced disease and mortality. This type of therapy has the potential to improve quality of life among caregivers of those with advanced disease, to build upon previous findings to help outline the necessary components of therapy, and to inform public policy and clinical guidelines.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07048743", "keywords": "Caregiver Distress, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07048743\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Spirituality,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3637, "title": "Psilocybin-Assisted Therapy for Prolonged Grief", "normalized_title": "psilocybin assisted therapy for prolonged grief", "authors": "University of Virginia", "abstract": "The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD). The study aims to investigate whether a single dose of 25 mg psilocybin can reduce the symptoms of grief and trauma associated with Prolonged Grief Disorder (PGD). It is hypothesized that psilocybin will significantly reduce the symptoms of PGD, and that the treatment will facilitate subjective mystical, spiritual, or insightful experiences, which in turn may contribute to the alleviation of grief and trauma symptoms. Neuroimaging will be used to help researchers better understand the relationship between grief and brain functions, comparing pre- and post-dose scans. Participants will undergo two MRI (magnetic resonance imaging) where they are asked to look at images (this is called a functional MRI or fMRI).", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06724289", "keywords": "Prolonged Grief Disorder, Psilocybin 25 mg, Functional Magnetic Resonance Imaging (fMRI), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06724289\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Aging,Spirituality,Mystical Experience,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3574, "title": "Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids", "normalized_title": "low dose psilocybin therapy for palliative care patients with chronic cancer pain requiring opioids", "authors": "Roswell Park Cancer Institute", "abstract": "This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's \"total pain\", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain. PRIMARY OBJECTIVE: I. To evaluate the safety, tolerability, and feasibility of low dose psilocybin therapy in patients with chronic cancer pain who require opioids. SECONDARY OBJECTIVE: I. To obtain preliminary evidence for efficacy of low dose psilocybin therapy in reducing pain and opioid requirement in participants with chronic cancer pain. EXPLORATORY OBJECTIVES: I. To evaluate potential mechanisms of action for psilocybin in pain control, including its effects on resting brain network activity, inflammation, and psychological changes processes. II. To obtain preliminary evidence for efficacy of psilocybin therapy on additional outcomes related to pain control, physical function, and opioid requirement in participants with chronic cancer pain. III. To obtain preliminary evidence for efficacy of low dose psilocybin therapy in alleviating psychological symptoms associated with chronic cancer pain. IV. To evaluate potential mechanisms of action for low dose psilocybin therapy in pain control, including its effects on the following: resting brain network activity, inflammation, psychological processes and psychedelic effects. OUTLINE: Patients attend two preparatory psychotherapy sessions. Patients then receive psilocybin orally (PO) twice a week (BIW) for 4 weeks (8 doses total) in the absence of unacceptable toxicity and attend three integration psychotherapy sessions over 1.5 hours each during psilocybin dosing sessions 2, 4, and 6. Patients may optionally attend additional psychotherapy sessions as needed during follow-up. Additionally, patients undergo functional magnetic resonance imaging (fMRI) and collection of blood and urine samples throughout the study. After completion of study intervention, patients are followed up at days 28-34, 56, and 84.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06827054", "keywords": "Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Functional Magnetic Resonance Imaging, fMRI, Functional MRI, Interview, Psilocybine, CY-39, Indocybin, Psilocybin, Psychotherapy, talk therapy, Questionnaire Administration, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06827054\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,End-of-Life Distress,Chronic Pain,Brain Imaging,Mechanism of Action,Aging,Spirituality,Clinical Trial,Cancer Patients,Safety,Toxicity,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3471, "title": "Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy", "normalized_title": "psilocybin for ptsd with or without psychotherapy a pilot study of safety and efficacy", "authors": "Johns Hopkins University", "abstract": "The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) will test the following primary hypotheses in adult patients with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy will be feasible and safe for participants, significantly remediate PTSD symptoms, and enhance wellbeing and quality of life. In addition, the study will examine whether elements of evidence-based trauma-focused psychotherapy enhance treatment response when paired with psilocybin. This study uses a randomized controlled design to compare the safety and efficacy of 2 doses of psilocybin for PTSD. In addition, it will investigate the effects of trauma-focused psychotherapy (which includes standard psychological support) versus standard psychological support alone. Twenty participants will be recruited. Following the first psilocybin session, participants will be randomized to either the trauma-focused psychotherapy (which includes standard psychological support) treatment condition or the standard psychological support treatment condition (the latter being typical for the experimental administration of psilocybin therapy). Both groups will receive identical treatment prior to receiving the first dose of psilocybin, with one group receiving procedures related to trauma-focused psychotherapy (combined with standard psychological support) beginning after receipt of psilocybin. The study will include clinician and participant ratings of PTSD and mood symptoms pre- and post-drug session and monitor and participant ratings of subjective drug effects during and after each drug session. The intervention for both groups will consist of about 8 hours of preparatory meetings (over approximately 2 weeks), followed by 2 psilocybin sessions separated by approximately 2 weeks. The initial psilocybin dose will be 25 mg. The dose for the second session may be increased conditional on the strength of subjective effects, as measured by the Mystical Experiences Questionnaire (MEQ30), taken at the end of participants' first psilocybin session. This allows a dose to increase if, for example, concomitant serotonin reuptake inhibitors reduce subjective effects. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 25 mg of psilocybin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 40 mg for the second session. Elevation of dose will also be based on the clinical judgment of the principal investigator, study physician, and study staff that a higher dose can be safely administered. In addition, participants who prefer to not elevate the dose will remain at 25 mg for the second session. To support the participant's therapeutic integration of psilocybin experiences, following each psilocybin session, participants will meet with the session facilitator(s) at multiple scheduled time points. Additional contact hours will be scheduled if it is judged that the participant would benefit from additional meetings to discuss experiences from the session(s) or to prepare for the next session. This study is supported in part by philanthropic contributions from private individuals. These donors are not involved in the design, conduct, or analysis of the research.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06407635", "keywords": "Post Traumatic Stress Disorder, Psilocybin, Trauma-focused psychotherapy, Standard psychological support, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06407635\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "PTSD,Receptor Pharmacology,Consciousness,Wellbeing,Mystical Experience,Randomized Controlled Trial,Healthcare Workers,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3460, "title": "Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Phase II Open-Label Trial", "normalized_title": "psilocybin assisted existential attachment and relational pearl therapy for patients with advanced cancer a phase ii open label trial", "authors": "University Health Network, Toronto", "abstract": "The PEARL Pilot is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Individuals with advanced cancer often experience high levels of distress due to physical suffering, difficult treatment decisions, social isolation, and fear of death. While there are many treatment options for the management of physical symptoms associated with cancer, there are relatively few standard treatment approaches to help patients deal with psychological and existential suffering. Over the past decade, research has shown that psychotherapies incorporating existential, attachment and relational approaches can address the specific needs and challenges of the advanced cancer population and thus help to reduce distress. Simultaneously, recent research has shown that psilocybin-assisted psychotherapy, in which, an individual ingests the psychoactive drug within the carefully monitored therapeutic setting, can reduce end-of-life distress and greatly benefit those with advanced disease. The multidisciplinary team has combined these two evidence-based approaches into what the team calls Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted psychotherapy, including preparatory therapy sessions, a high-dose drug session, and integration sessions, with important elements from manualized individual psychotherapies designed for patients with advanced cancer. This study will assess the feasibility, acceptability, and safety of PEARL therapy among patients with advanced cancer. This study will yield important information about the feasibility of this type of therapy and contribute to the growing research around the efficacy of psychedelic-assisted therapies. This type of therapy has the potential to improve quality of life among those with advanced disease and careful research is needed to build upon previous findings to outline the necessary components of therapy and guide public policy, legislation, and clinical guidelines.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06416085", "keywords": "Advanced Cancer, Stage IV Solid Tumor Cancer, Stage IV Sarcoma of Bone, Stage IV Lymphoma, Stage IV Melanoma, Endocrine Cancer, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06416085\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "End-of-Life Distress,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3589, "title": "The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function", "normalized_title": "the acute effects of psilocybin on cognition memory and brain function", "authors": "Manoj Doss", "abstract": "This study will test the effects of psilocybin on memory and cognition in healthy participants using computerized tasks and magnetic resonance imaging (MRI). In a double-blind, placebo-controlled, repeated measures design in healthy participants, this study will test the effects of psilocybin on memory and cognition in healthy individuals using computerized tasks and magnetic resonance imaging (MRI). A better understanding of the basic neurocognitive effects of psilocybin may allow for minimizing potential harms and maximizing potential benefits of psilocybin therapy.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-14", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07079852", "keywords": "Healthy, Placebo, Psilocybin 15mg, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07079852\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Brain Imaging,Aging,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3440, "title": "Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial", "normalized_title": "psilocybin assisted psychotherapy for the treatment of severe alcohol use disorder a double blind dose comparison concurrent control randomized trial", "authors": "Brigham and Women's Hospital", "abstract": "This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg). This study is a double-blind, dose-comparison concurrent control randomized trial designed to evaluate the effects of psilocybin-assisted psychotherapy on alcohol-related outcomes, neurocognitive processes related to craving and stress, and neural circuits involved in reward and regulation among adults with severe alcohol use disorder (AUD). Participants are recruited up to 3 months after completing inpatient alcohol withdrawal treatment to ensure medical stabilization prior to psilocybin administration. The study examines both preliminary efficacy and safety while also exploring mechanistic pathways through behavioral assessments and functional neuroimaging. Participants (N=36) are randomized in a 1:1 ratio to receive either a full-dose psilocybin (30 mg, with option to escalate to 40 mg on the second session) or a low-dose (10 mg, with option to escalate to 15 mg on the second session). All participants complete two dosing sessions spaced four weeks apart. The psychotherapy is delivered by a dyad of trained therapists before, during, and after the dosing sessions and is based on established therapeutic frameworks used in prior psilocybin-assisted therapy trials. The aim of the therapeutic support is to prepare participants for the psilocybin experience, facilitate psychological processing during and after dosing, and support integration of insights into daily life. A peer recovery coach is integrated into the study to support relapse prevention, enhance coping skills, and encourage engagement in ongoing addiction treatment. All participants are offered follow-up services at the institution's outpatient addiction treatment program (including the BWH Bridge Clinic), regardless of study arm. This combination of medical oversight, psychotherapy, and recovery support reflects an effort to embed the intervention within real-world addiction care settings. Alcohol-related outcomes are assessed repeatedly from baseline through 48 weeks after the second dosing session. The primary clinical outcome is the percentage of heavy drinking days during the 24-week follow-up period, measured using Timeline Follow-Back. Secondary alcohol outcomes include drinking quantity and frequency, relapse timing, direct alcohol biomarkers (phosphatidylethanol and ethylglucuronide), withdrawal symptoms, treatment expectancy, blinding integrity, and quality of life measures. Additional exploratory outcomes assess peer support engagement and 12-step attendance. Safety is evaluated throughout the study using structured assessments of adverse events, vital signs, and mood and anxiety symptoms. Because participants have severe AUD and recent withdrawal treatment, careful medical screening is conducted prior to each dosing session. The study includes multiple follow-up assessments up to 48 weeks after the second psilocybin dose, allowing characterization of both acute and longer-term safety. Two mechanistic components are incorporated. First, neurocognitive tasks assess cue-induced craving, attentional bias, stress reactivity, delayed discount, decision making, and distress tolerance. These measures evaluate whether psilocybin influences cognitive and affective processes known to contribute to alcohol use and relapse. Second, participants complete two fMRI scans-first within one week prior to the first dosing session and the second within one week after the second dosing session. The fMRI tasks evaluate neural response to alcohol-related cues and the ability to down-regulate craving, focusing on the nucleus accumbens (NAcc) and dorsolateral prefrontal cortex (DLPFC). Connectivity analyses examine changes in functional coupling between these regions during alcohol cue processing. Together, these approaches allow the study to evaluate whether full-dose psilocybin, compared to low-dose, produces greater reductions in heavy drinking and craving, whether the treatment is safe and tolerable for individuals with severe AUD, and whether changes in cognitive, emotional, and neural functioning help explain clinical outcomes. By recruiting individuals immediately following inpatient detoxification, the study also examines the feasibility of incorporating psilocybin-assisted therapy into a critical window of early recovery. Results will inform whether a larger, fully powered clinical trial is justified and will contribute to the broader understanding of psilocybin's therapeutic potential in alcohol use disorder.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-14", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07296094", "keywords": "Alcohol Use Disorder, Psilocybin, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07296094\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Addiction,Brain Imaging,Mechanism of Action,Biomarkers,Aging,Emotional Processing,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3565, "title": "Psilocybin as a Treatment for Chronic Pain in Smokers", "normalized_title": "psilocybin as a treatment for chronic pain in smokers", "authors": "Yale University", "abstract": "The purpose of this study is to understand whether psilocybin therapy is safe and well tolerated in improving chronic pain and increasing motivation to quit smoking for people who have chronic pain and smoke cigarettes. Psilocybin is a psychedelic drug and the active ingredient in \"magic mushrooms.\" Psilocybin is currently being studied in clinical trials but has no current medical use in the United States. Some studies have shown that a dose of psilocybin can help people quit smoking. Other studies have shown that a dose of psilocybin may improve certain chronic pain conditions, such as migraine headaches. We believe that it may also be helpful for people who smoke and have chronic pain, but this has not been tested yet. This will be an open-label pilot study examining the feasibility and potential efficacy of psilocybin in individuals who smoke and have chronic pain. Following the screening visit, the potential participants will have 1) an adaptation/preparation session, 2) a treatment session, and 3) two post-treatment follow-up sessions: 1 and 4 weeks after the treatment session. During study participation, participants will also complete surveys 4 times per day on a mobile device for 5 weeks (1 week before the treatment session and 4 weeks post-treatment session). General Procedures: Potential participants will undergo extensive medical and psychiatric screening to minimize the risk of study participation. Psilocybin will be administered as a 25 mg oral dose under close medical and psychiatric monitoring. For the 24 hours before the treatment session, subjects will be asked to abstain from consuming alcoholic beverages and any illicit drugs, verified by urine drug screening and breathalyzer. Non-compliant subjects will be rescheduled or discharged from the study if they are repeatedly non-compliant. Subjects will be instructed to drink their typical number of caffeinated beverages and smoke cigarettes as usual to minimize caffeine and tobacco withdrawal, which could confound the study measures. Subjects will be instructed not to eat for 4 hours before the treatment sessions because a light snack will be provided before the beginning of the session, and lunch will be provided at the end.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-08", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07118332", "keywords": "Smokers With Chronic Pain, Psilocybin (drug), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07118332\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Addiction,Chronic Pain,Headache / Migraine,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3686, "title": "PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment", "normalized_title": "prismatic a phase 1b randomized double armed parallel group placebo controlled trial of psilocybin efficacy with or without pimavanserin pretreatment", "authors": "Johns Hopkins University", "abstract": "Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-07", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07610135", "keywords": "Mood (Psychological Function), Well Being, Mood, Healthy, Psilocybin, Pimavanserin, Nuplazid, Inactive Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07610135\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Brain Imaging,Pharmacology,Mechanism of Action,Receptor Pharmacology,Biomarkers,Wellbeing,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3452, "title": "A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease", "normalized_title": "a double blind randomized trial investigating the safety feasibility and mechanisms of psychedelics in healthy older adults with low well being as moderated by biomarkers for preclinical alzheimer s disease", "authors": "Jennifer Mitchell", "abstract": "This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-07", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07386730", "keywords": "Anhedonia in Healthy Volunteers, Older Adults (50-90 Years), Psilocybin (drug), Dextromethorphan (DXM), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07386730\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Biomarkers,Aging,Wellbeing,Animal Study,Healthy Volunteers,Older Adults,Safety,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3702, "title": "Multivariate Neural and Physiological Correlates of Psychedelic Sub-states: a Within-subjects, Healthy Volunteer Study With Experience-sampling", "normalized_title": "multivariate neural and physiological correlates of psychedelic sub states a within subjects healthy volunteer study with experience sampling", "authors": "Robin Carhart-Harris, PhD, MA", "abstract": "The main purpose of this study is to gain a better understanding of the distinct mental states and physical reactions that can arise during a psychedelic experience. By repeatedly assessing the same participants in an MRI while under the effects of psilocybin, the investigators want to identify reliable brain and body reactions arising during these psychedelic experiences. It is hoped that this will provide an insight to inspire future research on psilocybin and related psychedelics as well as inform on their therapeutic action. This study will involve up to 12 healthy volunteers with previous psychedelic experience. Participants in this study will be given four doses of psilocybin, with breaks of at least seven days in between dosing visits. The first dosing visit will feature a 10 mg dose of psilocybin, which can be considerate a low to moderate dose, whereas the remaining three dosing visits will feature 25 mg psilocybin, a high dose that is consistent with the dosage chosen for several modern clinical trials with psilocybin. From the initial in-person screening visit to the final follow-up, participants will be in this study for approximately 6-12 weeks and visit the research site 5 times. The first visit will be an in-person screening visit, during which the investigators will assess participants' eligibility to be enrolled. There will be 4 subsequent visits to the scan center for dosing and magnetic resonance imaging (MRI) scanning, and there will be a final remote follow up. Each of the four dosing visits will include four periods of lying within the MRI scanner for scanning, each of these 'in-scanner' sessions will last for \\~ 45 minutes. Actual scans, which are also called 'runs' last for \\~ 12 mins. During these 'runs', the investigators will ask participants two brief questions about how positive or negative their current experience is every 100 seconds. They will be able to record their answers using a button box which they will be operating with their hand. One day after each dosing visit, the investigators will schedule a phone call with the participant to check how they are doing and perform an informal interview focused on their experience while under the effects of psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05698511", "keywords": "Psychedelic Experiences, Neuroimaging, Healthy Volunteers, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05698511\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Aging,Clinical Trial,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3472, "title": "A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans", "normalized_title": "a multi site randomized controlled trial of psilocybin for treatment resistant depression trd in veterans", "authors": "VA Office of Research and Development", "abstract": "The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder. Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic stress disorder (PTSD), and in need of novel and effective treatments. Clinical studies have revealed antidepressant effects of psilocybin for depression in civilians, but less is known about its efficacy and safety in Veterans. Very limited data is available on the effects of psilocybin in the treatment of PTSD. Thus, it is important to evaluate the safety and efficacy of psilocybin in the treatment of TRD with and without PTSD among Veterans. The purpose of this multi-site, double-blind, randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of TRD in U.S. military Veterans with and without (±) concurrent PTSD. Eligible and consenting Veterans will two psilocybin dosing sessions along with preparation, administration, and integration psychological support provided by a facilitator. For the 1st psilocybin administration, participants will be randomized to one of two doses under blinded conditions. One month later, all participants will receive a 25mg dose at their 2nd psilocybin visit. Outcomes will be measured by an independent evaluator masked from all treatments at 2 and 4 weeks after each dosing session. Longer-term follow-up will be conducted over 6 months. Both expected and unanticipated adverse events will be collected by type, severity and relatedness to the study drug.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07226232", "keywords": "Major Depression, Psilocybin, COMP360, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07226232\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,PTSD,Randomized Controlled Trial,Treatment-Resistant Depression,Veterans,Safety,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3664, "title": "Effects of Repeated Dosing of Psilocybin on Obsessive-Compulsive Disorder: A Randomized, Waitlist-Controlled Study", "normalized_title": "effects of repeated dosing of psilocybin on obsessive compulsive disorder a randomized waitlist controlled study", "authors": "Yale University", "abstract": "This study aims to investigate the effects of repeated dosing of oral psilocybin on obsessive-compulsive disorder (OCD) symptomatology in a randomized, waitlist-controlled design with blinded independent ratings, and assess psychological mechanisms that may mediate psilocybin's therapeutic effects on OCD. Aim 1: To examine the effects of two doses of psilocybin on OCD symptoms among participants in the immediate treatment condition, compared to participants in the waitlist control/delayed treatment condition. The investigators hypothesize that participants in the immediate treatment group will report statistically significantly greater symptom improvement from baseline 4 days post-second dose, compared to participants in the waitlist control/delayed treatment group at the same interval during their waitlist phase. Aim 2: To examine the effects of two doses of psilocybin on OCD symptoms, compared to one dose. The investigators hypothesize that two doses of oral psilocybin will reduce OCD symptoms to a statistically significantly greater extent than one dose. This study aims to investigate the effects of repeated dosing of oral psilocybin on OCD symptomatology and assess psychological mechanisms that may mediate psilocybin's therapeutic effects on OCD. This study will employ a randomized, waitlist-controlled design with blinded independent ratings, with participants randomized to receive either immediate treatment (two doses oral psilocybin separated by one week) or delayed treatment (7 weeks post-randomization). An adaptive dose selection strategy will be implemented, with the first dose being standardized at 25 mg of psilocybin, and the second dose being either the same or a higher dosage (i.e., 30 mg) on the basis of a clinically significant response from baseline or not, respectively, 4 days post-first dose. This study is conducted entirely on an outpatient basis with the possibility of remote/virtual follow-up visits after each dosing session. The dosing sessions last the entire day, and participants will be medically cleared prior to being permitted to return home with assistance (e.g., driven by a family member or friend, or ride share).", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05370911", "keywords": "Obsessive-Compulsive Disorder, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05370911\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "OCD,Mechanism of Action", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3483, "title": "2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers", "normalized_title": "2 x 2 factorial double blind randomized trial of set and setting a translational study in healthy volunteers", "authors": "Robin Carhart-Harris, PhD, MA", "abstract": "One hundred twenty healthy participants, ages 21 to 70, who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms, using a 2x2 factorial design. Depending on the study arm, participants will either receive an inactive placebo or up to 25mg psilocybin (oral dose), in one of two set and setting conditions; drug administration contexts that are predicted to modulate drug effects. The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context (set and setting). Recent research posits that psychedelic medicine is best employed as a combination treatment, i.e., as drug x psychological support or psychotherapy referred to for simplicity as 'psychedelic therapy'. It is assumed that positive outcomes via psychedelic therapy critically depend on a synergistic relationship between drug-induced brain and mind plasticity and supportive contextual factors (Carhart-Harris et al., 2018; Carhart-Harris and Friston, 2019). These contextual factors have been referred to as 'set and setting' (Leary et al., 1963) or 'extrapharmacological'- highlighting elements beyond the drug that contribute to relevant outcomes (Hartogsohn, 2016). The proposed experiment is a double-blind, randomized between-subjects 2 x 2 factorial study in 120 volunteers who experience low psychological well-being at baseline and have limited prior experience with psychedelics (1:1:1:1, n = 30 per condition). The main aim of the study is to assess the contribution of a select number of pre-defined contextual variables (both 'set' and 'setting') on the nature and trajectory of effects linked to a single dosing session with either psilocybin (oral, 25mg) or placebo (oral, inert). The study will have four primary outcomes, two pertaining to mental health, namely: changes in psychological well-being - as measured via the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), from baseline to 4 weeks post dosing session (primary endpoint) and changes in the Watts Connectedness Scale (WCS) at consistent timepoints. The two primary outcomes indexing the quality of the acute experience will be: Emotional Breakthrough - measured via mean scores on the Emotional Breakthrough Inventory (EBI), and Challenging experience (CE) - defined and measured here as scores on the following four sub-factors of the Challenging Experience Questionnaire (CEQ): fear, insanity, isolation, and paranoia.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06626139", "keywords": "Healthy Participants With Lower-than-average Mental Well-being, Psilocybin, Context 1, Context 2, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06626139\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Neuroplasticity,Wellbeing,Emotional Processing,Healthy Volunteers,Drug Interactions", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3558, "title": "The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults", "normalized_title": "the role of the subjective experience in supporting positive effects following psilocybin a randomized controlled clinical trial using risperidone in healthy adults", "authors": "University of Calgary", "abstract": "The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of \"magic mushrooms\") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin. The overall goal of this clinical trial is to systematically explore the relationship between the subjective psychedelic experience, improvements in well-being, and the stress response following psilocybin administration. The investigators aim to determine whether blocking the acute subjective effects (via risperidone) will influence the acute or protracted effects of psilocybin as measured via self-report, biochemical, or psychophysiological measures. The study also aims to determine if individual variability in stress reactivity or regulation predicts acute (day of dosing) or protracted (1-week later) effects of psilocybin. A single site will recruit 128 participants aged 18 to 65 who do not meet criteria for any psychiatric diagnoses. A series of questionnaires, blood labs, and medical exams including electrocardiogram will determine inclusion into the study. Once accepted into the study, participants will complete baseline measures assessing biomarkers such as cortisol and brain-derived neurotrophic factor (BDNF) levels, cognitive flexibility, mood, well-being, personality traits, and anxiety levels. Participants will then be randomly assigned into one of the following groups: i) high dose psilocybin in combination with placebo pretreatment ii) high dose psilocybin in combination with risperidone pretreatment iii) low dose psilocybin in combination with placebo pretreatment iv) low dose psilocybin in combination with risperidone pretreatment Outcome measures will be assessed at 1-week and 1-month after each dosing session.", "journal": "ClinicalTrials.gov", "publication_date": "2026-06-01", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06768944", "keywords": "Investigating the Importance of the Subjective Psychedelic Experience, Psilocybin high-dose, PEX010, high-dose psilocybin, Psilocybin low-dose, low-dose psilocybin, Risperidone 1 MG, Risperdal, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06768944\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Biomarkers,Wellbeing,Personality Change,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3647, "title": "Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)", "normalized_title": "imaging the effects of serotonin 2a receptor modulation on synaptic density in treatment resistant depression synvest", "authors": "Centre for Addiction and Mental Health", "abstract": "Limit: 5000 characters. Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone. The purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-31", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06512220", "keywords": "Treatment Resistant Depression, Psilocybin 25 mg, PEX010, Risperidone 1 MG, MAR-Risperidone, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06512220\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Aging,Clinical Trial,Randomized Controlled Trial,Healthy Volunteers,Treatment-Resistant Depression", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3615, "title": "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)", "normalized_title": "a phase 3 randomized double blind multicenter study to evaluate the efficacy safety and tolerability of psilocybin in adults with major depressive disorder mdd", "authors": "Usona Institute", "abstract": "Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period. Double-blind Period: Participants who show stable depression symptoms between Screening and Trial Baseline will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. Investigational Product (IP) will be administered in the context of a \"Set and Setting\" (SaS) Protocol for psychosocial support, comprised of 1) a period of preparation with Facilitators prior to dosing; 2) administration of IP in an aesthetically pleasing room under the supervision of two Facilitators; and 3) post-dose integration sessions during which participants will discuss their dosing experience with the Facilitators. Trial outcome measures will assess depressive symptoms, functional disability, health-related quality of life, and clinical global impression of disease severity. Long-term Follow-up Period: After the initial 6-week Double-blind Period and completion of the post-dosing Trial Day 43 assessments, all participants will proceed into a 1-year Follow-up Period. During the 1-year Follow-up Period, participants will be followed regularly by clinic staff to assess MDD symptom severity, functional disability, and health-related quality of life; long-term safety data will also be collected. In addition to scheduled clinic visits, clinic staff will contact participants by telephone every two weeks to assess for changes in MDD symptom severity, concomitant medications, adverse events (AEs), and suicidal ideation and behavior. Participants who meet the pre-defined MDD severity criteria and meet all re-administration eligibility criteria may be offered re-administration(s) of open-label Psilocybin 25 mg administered under a \"Set and Setting\" (SaS) Protocol. Psychosocial support, including psychoeducation, is also incorporated in the long-term Follow-up Period.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-31", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06308653", "keywords": "Depressive Disorder, Major, Psilocybin 25 mg, Psilocybine, Psilocibin, Indocybin, Inactive Placebo, Microcrystalline Cellulose (MCC), Placebo, Psilocybin 5 mg, Psilocybine, Psilocibin, Indocybin, Active Comparator, Psychosocial Support, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06308653\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3431, "title": "Psilocybin: Capturing Brain Mechanisms of Motivation and Neurocognition in Individuals With Opioid Use Disorder", "normalized_title": "psilocybin capturing brain mechanisms of motivation and neurocognition in individuals with opioid use disorder", "authors": "University of Pennsylvania", "abstract": "The goal of this study is to test addiction-related brain circuitry (motivation/reward and inhibition) as well as neurocognitive circuitry prior to and following low or high dose psilocybin (PEX010 from Filament). Using fMRI, we will examine brain circuits relevant to drug relapse as well as neurocognitive flexibility circuits in individuals with opioid use disorder. We will randomize 24 males and females, aged 18 - 60, in the greater Philadelphia area, to either 1mg or 25 mg of psilocybin. Participants will come to our offices for screening visits - these are assessments, interviews, and some medical tests (such as a history and physical, as well as a fasting blood draw) to help us determine eligibility for our study. If eligible, they will be brought to our offices at 3535 Market Street in Philadelphia for about 7 visits. These visits include pre-dose psilocybin preparation therapy, baseline assessments and neuropsychological testing, psilocybin dosing, post dose therapy visits, and post dose assessments.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-31", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06810310", "keywords": "Opioid Use Disorder, Psilocybin (high dose), psilocybin (low dose), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06810310\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Brain Imaging,Mechanism of Action", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3576, "title": "A Phase 2a Study of Group Retreat Psilocybin Therapy for Cancer-Related Anxiety and Depression", "normalized_title": "a phase 2a study of group retreat psilocybin therapy for cancer related anxiety and depression", "authors": "University of Washington", "abstract": "This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies. OUTLINE: Patients attend group preparation therapy sessions on days -14 (virtual), -7 (virtual) and -1 (in person), and also attend an individual preparation therapy session on day -1 (in person). Patients receive psilocybin orally (PO) on day 0. Patients may receive an additional \"booster\" dose 60-90 minutes after the initial dose based on their subjective report combined with the physician's clinical judgement. Patients attend group integration therapy sessions on days 1 (in person), 8 (virtual), 15 (virtual), and 22 (virtual), and attend individual integration therapy sessions on days 1 (in person) and 8 (virtual). After completion of study treatment, patients are followed up at 2 weeks and at 1, 2, 3, and 6 months.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-28", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07336238", "keywords": "Anxiety, Depression, Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm, Psychotherapy, therapy, talk therapy, Psilocybin, psilocybine, Survey Administration, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07336238\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Observational Study,Cancer Patients,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3607, "title": "Targeting Reward Circuits: Psilocybin as a Novel Therapy for Residual Anhedonia", "normalized_title": "targeting reward circuits psilocybin as a novel therapy for residual anhedonia", "authors": "NYU Langone Health", "abstract": "The primary objective is to evaluate whether a single dose of psilocybin (25 mg), compared to placebo, can restore fronto-striatal reward circuit function and thereby improve anhedonia and emotional blunting in individuals with residual symptoms despite ongoing SSRI or SNRI treatment. This will be assessed using precision functional mapping (PFM), task-based fMRI, and clinical rating scales (DARS).", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-26", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07607938", "keywords": "Anhedonia, Emotional Blunting, Psilocybin, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07607938\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Emotional Processing", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3660, "title": "The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD", "normalized_title": "the safety and acceptability of psilocybin with support and with massed prolonged exposure therapy for ptsd", "authors": "Emory University", "abstract": "This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy. The Primary objective is to pilot and investigate tolerability, safety, and acceptability of psilocybin-assisted supportive therapy and psilocybin-assisted massed prolonged exposure (PE) therapy and conduct exploratory analyses related to comparative effectiveness of these treatments, including preliminary outcomes from pre-treatment to 1-month follow-up on post-traumatic stress disorder (PTSD) symptoms. Safety and tolerability of the treatment will be assessed and evaluated using the Swiss Psychedelic Side Effects Inventory (SPSI), Psychedelic-assisted Therapy After Effects (PATAE), and the Accessibility Questionnaire (AQ). The study will also evaluate the effect of psilocybin and massed exposure therapy using Subjective Units of Distress (SUDS) during imaginal exposure sessions; to assess self-reported PTSD and depression symptoms across treatment and investigate effect on fear extinction learning and fear extinction recall as assessed via fear potentiated startle. Given that this is a pilot study with small sample, analyses will be preliminary.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-25", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07332143", "keywords": "PTSD, psilocybin, 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate, Supportive Therapy, Prolonged Exposure Therapy, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07332143\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,PTSD,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3661, "title": "Effects of Psilocybin With Psychological Support on Anhedonia in Treatment-resistant Depression: a Randomized Controlled Pilot Trial", "normalized_title": "effects of psilocybin with psychological support on anhedonia in treatment resistant depression a randomized controlled pilot trial", "authors": "University of Colorado, Denver", "abstract": "The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06230757", "keywords": "Major Depressive Disorder, Anhedonia, Treatment Resistant Depression, Psilocybin 25mg, Placebo (active placebo), Ultra Low Dose Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06230757\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Randomized Controlled Trial,Treatment-Resistant Depression", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3614, "title": "Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder", "normalized_title": "group psilocybin assisted therapy for post traumatic stress disorder", "authors": "University of New Mexico", "abstract": "This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity. This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity. These will be assessed by the following outcome measures: * Proportion of participants completing the study protocol * Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 * Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07506395", "keywords": "PTSD, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07506395\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "PTSD,Clinical Trial,Healthcare Workers,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3636, "title": "A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression", "normalized_title": "a pilot mechanistic study of psilocybin assisted therapy as a treatment for depression", "authors": "Washington University School of Medicine", "abstract": "Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants. In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits. This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-19", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07582120", "keywords": "Depression, Psilocybin (Usona Institute), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07582120\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Biomarkers,Psychological Flexibility,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3514, "title": "Psilocybin-assisted Cognitive Behavioral Therapy for Depression", "normalized_title": "psilocybin assisted cognitive behavioral therapy for depression", "authors": "University of California, Los Angeles", "abstract": "The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study will involve an open trial of PA-CBT where participants will receive two doses of psilocybin (10mg and then 25mg, separated by one month) plus 12 sessions of cognitive behavioral therapy.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-18", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05227612", "keywords": "Major Depressive Disorder, Psilocybin, Cognitive behavioral therapy, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05227612\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3580, "title": "Psilocybin-facilitated Treatment for Cocaine Use", "normalized_title": "psilocybin facilitated treatment for cocaine use", "authors": "University of Alabama at Birmingham", "abstract": "The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus. Individuals who are eligible to participate and provide informed consent will complete baseline questionnaires and be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group. The first MRI assessment will take place shortly thereafter using a 3T head-only Magnetic Resonance Imaging and Spectroscopy scanner (Magnetom Allegra, Siemens medial Solutions, Malvern, PA), optimized for neuroimaging applications. Preparation sessions (see below) and the drug administration session will take place in a room at the Clinical Research Unit designed to be as comfortable, aesthetically pleasing (i.e., living-room like), and safe (e.g., no furniture with sharp corners or glass objects) as possible, with a directly adjacent, private restroom. All participants will undergo four weekly preparation sessions of approximately 2 hours each. The purpose of these sessions is to: 1) develop strong therapeutic alliance between the participants and the primary therapist (Dr. Hendricks) and secondary therapist; 2) establish comfort and rapport between participants and the remainder of the research team; 3) discuss participants' aspirations with regard to their drug administration experience (e.g., What do participants hope to gain from their experience?); 4) discuss the treatment rationale and putative mechanisms of action of psilocybin; 5) obtain a detailed personal history of the participant, with a focus on those factors contributing to their current difficulties; 6) prepare participants for drug administration, including a detailed account of all potential effects of the drug; 7) discuss all aspects of the drug administration protocol (i.e., logistics and procedures), including plans of action in the event that participants experience acute distress; and 8) administer cognitive-behavioral treatment for cocaine use. Any participant who demonstrates significant anxiety, discomfort, or unease regarding drug administration at the conclusion of the four preparation sessions will be provided up to two additional preparation sessions. If these sessions are unsuccessful at mitigating the participant's anxiety, discomfort, or unease, the participant will be removed from the study. Approximately one week after their final preparation session, participants will be instructed to eat a low-fat breakfast prior to presenting for their drug administration session at 8:00 am, approximately 1 hour before drug administration. A urine sample will be collected to verify drug-free status and participants will be encouraged to relax and reflect before drug administration. The drug administration session will take place over the course of 8 hours. The primary and secondary therapists will be present with participants throughout this session (at least one individual will always be present with the participant, even during brief intervals when one of the two therapists may be using the restroom). During this time, participants will be encouraged to lie down, use an eye mask to block external visual distraction, and use headphones through which a supportive music program will be played. Participants will be instructed to focus their attention on their inner experiences throughout the session. Any participant reporting significant distress will be provided reassurance verbally or physically (e.g., with a supportive touch to the hand or shoulder). In the event that psychological distress is insufficiently managed with reassurance alone, medication will be administered under the guidance of the study physician. Blood pressure will be assessed at regular intervals via automatic blood pressure monitor (e.g., pre-administration, and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-administration), and medication for the treatment of acute hypertension will be administered should blood pressure remain elevated at \\>200 systolic or \\>110 diastolic. Seven hours after drug administration, when the major drug effects have subsided, participants will complete questionnaires assessing their experience. Participants will then be released into the care of a friend or family member (as arranged during preparation sessions) and instructed not to drive an automobile or engage in any other potentially dangerous activity for the remainder of the day. Participants will be provided with the primary therapist's pager number should they feel the need for support that evening. Within 2 days after the drug administration session, participants will meet with the therapists for approximately 1 hour to discuss and reflect on their experience. The therapists will assess for potential adverse effects at this time. The second MRI session will take place shortly thereafter. Participants will then meet with the guide once per week over the next 4 weeks with an emphasis on integration of their medication session experience in the context of achieving abstinence from cocaine; continued cognitive-behavioral treatment for cocaine use will be provided during these follow-up meetings. Long-term assessment visits will take place 3 and 6 months after the final therapy meeting. A battery of measures will be delivered at these times. At the conclusion of the 6-month assessment meeting, participants will be debriefed.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-17", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02037126", "keywords": "Cocaine-Related Disorders, Psilocybin, psychedelic compound, Diphenhydramine, Benadryl, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02037126\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Addiction,Brain Imaging,Mechanism of Action,Default Mode Network,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3529, "title": "Evaluating the Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant Obsessive-compulsive Disorder: An Open-label Clinical Trial", "normalized_title": "evaluating the feasibility clinical effects and safety of psilocybin assisted psychotherapy for treatment resistant obsessive compulsive disorder an open label clinical trial", "authors": "Centre for Addiction and Mental Health", "abstract": "Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms. Literature suggests that up to 40 percent of individuals with OCD do not respond to conventional treatment and experience treatment resistant OCD (TROCD) (1, 2). Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects (3). Results of these trials have led to growing calls for transition to clinical use, as well as increased research for other mental health disorders. It is presumed that psilocybin's therapeutic effects are induced by the psychedelic \"trip\", which is dependent on serotonin 2A receptor (5-HT2AR) activation (4, 5). All studies have used psilocybin in conjunction with psychotherapy involving two therapists present during full-day dosing sessions. There is a need for more data in the TROCD population as there is only one clinical trial published for this specific population, followed by various case reports. Using a proof-of-concept, open-label, clinical trial approach, 10 participants with TROCD will receive 2 doses of 25mg of psilocybin, with two weeks between each dosing day. The objectives of this study are as follows: 1. To assess the safety, and feasibility, of psilocybin, administered with psychological support to adult participants with TROCD. Hypothesis 1: The investigators will be able to recruit and retain ten participants with TROCD for the duration of the trial and that psychedelic-assisted psychotherapy for obsessive compulsive disorder (PAP-OCD) will be safe in those with TROCD, as measured by monitoring adverse events and using the Columbia Suicide Severity Rating Scale (C-SSRS). 2. To assess the clinical effects of PAP in those with TROCD. Hypothesis 2: Two sessions of psilocybin (25mg) administered under supportive conditions to participants with TROCD will lead to significant reductions in OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) when comparing baseline to Week 3. 3. Provide pilot data on the effect of psilocybin and supportive therapy on TROCD in preparation of a future larger RCT. Overview of Study Design: All 10 participants will follow the same study design. Each participant will undergo a screening assessment where they will complete lab tests, and clinical and psychiatric assessments to determine eligibility. Following the screening visit, participants will undergo a washout period where they will be tapered off concomitant medications over a medication the participant is being tapered off (based on the half-life of the medication) and the participant's preference for the length of the tapering period. All medications will require a minimum of a 2-week tapering period with the exception of fluoxetine which will require a minimum of 4-weeks. Additional time may be added at the discretion of the study investigator. During this period, there will be weekly check-ins with the study physician. At study Visit 2 (Baseline, V2), participants will complete a series of questionnaires and assessments, preparatory therapy with trained study therapists, and undergo a brain functional magnetic resonance imaging (fMRI). The preparatory therapy sessions will build a therapeutic alliance, and provide psychoeducation about, and set intentions for, the psilocybin session. To reduce participant burden, baseline can be broken up into multiple days, however all assessments must be completed within 7-days of the first dose. At study Visit 3 (V3), neurophysiological measurements will be performed. Upon completion of V2 and V3, participants will undergo the first psilocybin dosing session at Visit 4 (V4) where they will receive an active dose (25mg) of psilocybin in conjunction with supportive therapy. The psilocybin session will last 5 to 6 hours and will be conducted in the existing psychedelic treatment suite developed at the Centre for Addiction and Mental Health (CAMH). Two trained study therapists will be supporting each participant during the dosing session. After 5 hours of dose administration, participants will be evaluated for safety by the study psychiatrist and discharged home in the company of a caregiver or a family member. On the day after the dosing session (Visit 5, V5) and one-week after the dosing session (Visit 6, V6), participants will be asked to complete the same questionnaires that were done at Baseline (V2) and will undergo an integrative therapy session with the trained study therapist. Between Visit 5 (V5) and Visit 7 (V7), during study Visit 6 (V6), the same neurophysiological measurements will be performed as during Visit 3 (V3). Follow-up assessments will also occur at 3, 6, 9 and 12 weeks (Visit 7, 8, 9 and 10) after the second psilocybin dosing session. The same questionnaires administered at Baseline (V2) will be repeated at each of these study visits.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-17", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06299319", "keywords": "Obsessive-Compulsive Disorder, Psilocybin, PEX010, ENROLLING_BY_INVITATION", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06299319\",\"overall_status\":\"ENROLLING_BY_INVITATION\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Addiction,OCD,Brain Imaging,Receptor Pharmacology,Aging,Clinical Trial,Randomized Controlled Trial,Case Report,Safety,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3606, "title": "Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)", "normalized_title": "exploring the safety acceptability and efficacy of psilocybin among non small cell lung cancer patients with major depressive disorder a proof of concept trial dream lung study", "authors": "Alan Davis", "abstract": "This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer. PRIMARY OBJECTIVE: I. To determine the safety and acceptability of psilocybin-assisted psychotherapy with non-small cell lung cancer (NSCLC) patients. SECONDARY OBJECTIVE: I. To determine the efficacy of psilocybin-assisted therapy in the reduction of depression and the impact of treatment on quality of life, cancer-related stress, and existential distress. OUTLINE: Patients participate in two preparation therapy sessions over 4 hours each on days 7 and 14, then patients receive psilocybin orally (PO) on day 21 and participate in a single dosing therapy session for over 8-10 hours on study. Patients also complete two post-dosing therapy sessions over 2 hours each on days 22 and 28 on study. Patients additionally undergo blood and urine sample collection throughout the study. After completion of study treatment, patients are followed up at 4 and 12 weeks.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-13", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07216404", "keywords": "Lung Non-Small Cell Carcinoma, Unipolar Depression, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Counseling, Counseling Intervention, Interview, Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate, Survey Administration, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07216404\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Observational Study,Cancer Patients,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3511, "title": "Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence", "normalized_title": "psilocybin assisted therapy for post traumatic stress disorder in survivors of intimate partner violence", "authors": "University of Calgary", "abstract": "The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM1: To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \\[25mg\\] or low dose psilocybin \\[1mg\\]) * Complete 5-6 weekly sessions of ACT * Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration. The overall objective of this study is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM1: To compare the efficacy of a therapeutic psilocybin dose (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration). AIM2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration). The secondary efficacy outcomes will include measures of mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life. Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action. A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33. All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-13", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06885996", "keywords": "Post Traumatic Stress Disorder PTSD, Intimate Partner Violence (IPV), Psilocybin, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06885996\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,PTSD,Mechanism of Action,Biomarkers,Oxidative Stress,Emotional Processing,Randomized Controlled Trial,Inflammation", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3710, "title": "A Randomized Double-masked Dose-controlled Trial to Assess the Tolerability, Safety, Subjective Experience, and Efficacy of Repeated Administration of Three Different Doses of Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.", "normalized_title": "a randomized double masked dose controlled trial to assess the tolerability safety subjective experience and efficacy of repeated administration of three different doses of psilocybin whole mushroom for the treatment of obsessive compulsive disorder", "authors": "Francisco A Moreno", "abstract": "The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be assigned (by luck of the draw) to take a low, medium, or high dose whole psilocybin mushroom contained in three chocolate pieces, prepared for this study by the Scottsdale Research Institute. Participants will come to the University of Arizona CATS Research Unit in Tucson for assessment, if they are found to be fit for study participation, they will be scheduled for a preparation session with a study therapist and then will participate in a dosing session when they will ingest three pieces of chocolate containing psilocybin mushroom. They will answer questions of how they are feeling, and will be monitored for safety by two study staff members, and their vital signs will be checked every hour on the day they receive the study drug. The will be sent home with a responsible adult selected by the patient after they are felt to be safe once the effects of the drug have resolved. Participants will receive four different doses separated by about three weeks. After they complete the treatment phase, they will be contacted monthly for follow up assessment of efficacy, and safety.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07347405", "keywords": "Obsessive-Compulsive Disorder, Psilocybin 10 mg, Psilocybin 20 mg, Psilocybin 30 mg, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07347405\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "OCD,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3527, "title": "Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample", "normalized_title": "safety and feasibility of psilocybin in methamphetamine use disorder in a community based sample", "authors": "University of Wisconsin, Madison", "abstract": "The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral support for methamphetamine use disorder (MUD). Participants have a diagnosis of methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks. The objective of this study is to determine the safety of psilocybin in adult participants with MUD. Eligible participants will be adults with methamphetamine use disorder recruited from the community. After physical and psychological screening, and at least 6 hours of psychological support for the psilocybin dosing, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Session Room at the University of Wisconsin School of Pharmacy. After eight hours of observation in the dosing room, the participant will stay overnight in the hospital Clinical Research Unit, and complete an integration session with at least one of the session facilitators before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation. Participants who decide not to proceed to the second dose will complete two additional integration sessions and study measures through the two-month follow-up. If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the \"More Information\" section at the bottom of this record.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05322954", "keywords": "Methamphetamine Use Disorder, Substance-Related Disorders, Chemically-Induced Disorders, Substance Use Disorders, Stimulant-Use Disorder, Psilocybin, TERMINATED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05322954\",\"overall_status\":\"TERMINATED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Addiction,Observational Study,Safety", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3490, "title": "A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder", "normalized_title": "a phase 2b 3 multicentre randomised double blind controlled trial with an open label extension to investigate the efficacy safety and tolerability of comp360 in participants with post traumatic stress disorder", "authors": "COMPASS Pathways", "abstract": "The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07570654", "keywords": "PTSD - Post Traumatic Stress Disorder, PTSD, PTSD Symptoms, PTSD, Post Traumatic Stress Disorder, COMP360 psilocybin, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07570654\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\",\"PHASE3\"]}", "topic_tags": "PTSD,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3570, "title": "The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.", "normalized_title": "the safety and efficacy of psilocybin therapy compared to low dose control in reducing depressive symptoms in patients with copd als ms or apd", "authors": "University Medical Center Groningen", "abstract": "The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will the therapeutic effects be rapid and sustained over a 6-month period? Researchers will compare patients receiving two escalating doses of psilocybin (15mg followed by 25mg) against those receiving two low doses (1mg) to see if the higher doses lead to greater improvements in depression, anxiety, demoralization, and quality of life. Participants will: * Attend three preparation sessions with psychotherapists (1-2 hours each) * Undergo two supervised psilocybin dosing sessions (6-8 hours each) * Complete five integration therapy sessions following the dosing sessions * Participate in follow-up assessments at 6 weeks, 3 months, and 6 months * Have access to a digital care platform and peer support groups during the 6-month follow-up period * Optional: Control group participants may receive one high-dose psilocybin session (25mg) after the initial study period Rationale Patients with chronic obstructive pulmonary disorder (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), or atypical and advanced Parkinsonian disorder (APD) often suffer from severe psychological distress with demoralization and death anxiety, which may culminate in to depressive disorder. Treatments of depression in palliative care currently involves psychotherapy and/or the use of antidepressants. However, these treatments have shown limited efficacy which urgently calls for new and innovative approaches. In recent years, a number of studies have shown very promising results of psilocybin therapy in alleviating psychological distress in patients with advanced cancer. The current study (PsyPal) aims to evaluate whether psilocybin therapy can also lead to rapid and sustained decreases in depressive symptoms, demoralization and other facets of psychological distress in patients who suffer from COPD, ALS, MS and APD. Objective The primary objective of the PsyPal study is to assess the safety and efficacy of psilocybin therapy compared to low-dose control in reducing depressive symptoms in patients with COPD, ALS, MS, or APD. Secondary objectives of PsyPal are to assess change in clinical functioning, end-of-life anxiety, psychological/existential distress, health-related quality of life, and how it impacts caregiver 's health- and economic burden. The safety objective of PsyPal is to evaluate the difference in adverse events between high and low dose groups before, during and after the dosing session. Exploratory objectives include the investigation of psychological mechanism, subjective effects, biomarkers (EEG and blood-based), cost-effectiveness, and the usefulness of a digital care platform, with a mixed methods approach. Main trial endpoints The main trial endpoint for PsyPal is the change in depression severity from baseline to 6 weeks after the second dose of psilocybin (high dose session). Adverse events and change in depression symptoms will also be assessed at 3- and 6-month follow-up to determine the safety and sustained effects of psilocybin therapy. Secondary trial endpoints Secondary trial endpoints will be assessed at baseline and 6 weeks after the second dose of psilocybin. These include response rate, anxiety, demoralization, health-related quality of life, experiential avoidance, coping with illness, death anxiety, the wish to hasten death, self-compassion, spirituality, attachment, pain, healthcare resource use, blood-based biomarkers, and functional brain changes. Some secondary endpoints will also be assessed at the 3- and 6-month follow-up, including anxiety, demoralization, health-related quality of life, experiential avoidance, and coping with illness. These endpoints aim to improve our understanding of the effects of psilocybin therapy, how psilocybin therapy works, and to see which patients show the best response. Finally, changes in (religious/spiritual) beliefs/understandings and the experience(s) with psilocybin therapy will be assessed through in-depth qualitative interviews with patients that are conducted 6 weeks after the second dose of psilocybin. Trial design PsyPal trial consists of a double-blind randomized low-dose controlled clinical trial with long term follow-up. Patients who are enrolled in the trial will be actively participating for ten weeks. After the primary endpoint, patients who received a low dose of psilocybin (1 mg) will be offered an optional single open label high-dose of psilocybin (25mg) together with three integration sessions. During long-term follow-up, patients will have access to a digital care platform and peer support groups. Trial population The trial population in PsyPal consists of patients with COPD, ALS, MS, or APD and co-morbid depression. The main further inclusion criteria for participation are an age of 18 or higher, having an identified caregiver or support person, and a life expectancy of at least 6 months. The main exclusion criteria are current use of antipsychotic drugs, suicidal ideations, schizophrenia or other psychotic disorders, bipolar I/II disorder, other major neurological conditions, cardiovascular conditions, diabetes, and/or moderate to severe hepatic impairment (i.e., liver failure). Other exclusion criteria are a first-degree relative on the schizophrenia spectrum, other psychotic disorders, or bipolar I disorder. Interventions Patients will receive psilocybin therapy consisting of three phases; 1) preparation, 2) dosing, and 3) integration: Preparation - The preparation phase consists of three psychotherapy sessions of 1-2 hours each. The purpose of these sessions is threefold: to build a therapeutic alliance between the patient and the therapist, to make a psychotherapeutic treatment plan for the patient using a process-based approach, and to educate patients about psilocybin's acute effects and how patients and therapists together can handle difficult experiences during the dosing sessions. Dosing - The dosing phase of PsyPal starts 1-3 days after the last preparation session. It consists of two escalating dosing sessions of 6-8 hours each. The patient first receives a moderate dose of psilocybin (15mg). Two weeks later, the patient receives a high dose of psilocybin (25mg). Patients in the control group will receive two doses of psilocybin (1mg). All dosing sessions take place under supervision of two trained therapists within a treatment room specifically designed for psilocybin therapy and with a medical doctor on call. Integration - The integration phase consists of five psychotherapeutic sessions of 1-2 hours each. There are two integration sessions following the first dosing session and three integration sessions following the second dosing session. The integration sessions are intended for further psychotherapeutic work, including working with the experience(s) that may have emerged during dosing sessions, and clinical assessment of the patient. Central topics may include the relationship with their life-limiting illness, death, meaning, sense of purpose, personal (religious/spiritual) beliefs, (social) relationships, and conflict resolution. The patient can also share thoughts and feelings about the PsyPal trial. Long-term follow-up After the intervention, patients will be returned to regular care and followed for a period of 6 months, tracking usage of healthcare resources, the digital care platform, and peer support groups. Qualitative aspects of the intervention will be evaluated for patients, caregivers and therapists. Long-term safety data of psilocybin therapy will be collected for the four patient populations.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-07", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06782724", "keywords": "COPD (Chronic Obstructive Pulmonary Disease), ALS (Amyotrophic Lateral Sclerosis), MS (Multiple Sclerosis), Major Depressive Disorder (MDD), Atypical Parkinson Disease, Psilocybin therapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06782724\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Chronic Pain,Brain Imaging,Biomarkers,Spirituality,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3496, "title": "Does Psilocybin Require Psychedelic Effects to Treat Depression? A4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial", "normalized_title": "does psilocybin require psychedelic effects to treat depression a4 week double blind proof of concept randomized controlled trial", "authors": "Centre for Addiction and Mental Health", "abstract": "Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risperidone. The purpose of this \"double dummy\" proof-of-concept trial is to evaluate whether psilocybin's antidepressant effects are dependent on its psychedelic effects. Sixty participants with treatment-resistant depression will be randomly assigned to one of three groups: 1) Psilocybin 25 mg plus risperidone 1 mg; 2) Psilocybin 25 mg plus placebo; and 3) Placebo plus risperidone 1 mg. The investigator's hypothesize that the combination of psilocybin and risperidone will be well tolerated, safe, and will block the psychedelic effects of psilocybin in patients diagnosed with treatment-resistant depression. This study is a three-arm, 4-week, double blind, proof-of concept RCT for investigating psilocybin-assisted psychotherapy (PAP) administered with risperidone in treating TRD. This three-arm \"double dummy\" design allows for an assessment of risperidone's anti-psychedelic effects, while allowing for an assessment of psilocybin's antidepressant effects alone and combined with risperidone, compared to an \"active placebo\" (i.e. placebo plus risperidone 1 mg). Overview of Study Design: A study team member will obtain informed consent from interested participants prior to study activities being initiated. Following this, participants will undergo a screening assessment where they will complete lab tests, and clinical and psychiatric assessments to determine eligibility. Following the screening visit, eligible participants will undergo a washout period where they will be tapered off concomitant medication over a period of 4 to 6 weeks. The length of the tapering period will depend on the type of medication the participant is being tapered off (based on the half-life of the medication) and the participant's preference for the length of the tapering period. Most medications will require a minimum of a 2-week tapering period before the baseline, with the exception of fluoxetine, which will require a minimum of 4-weeks. Additional time may be added at the discretion of the study investigator. During the tapering period, the study psychiatrist will see participants weekly (V1a, V1b, etc.) for at least 4 weeks to monitor for withdrawal and worsening of depressive symptoms and suicidality. Suicidality will be closely monitored using the Columbia Suicide Severity Rating Scale (C-SSRS). Participants and their family members/carers will be educated on the signs and symptoms of worsening depression and suicidality and will be given contact details of the study team in case of major decline in mental state. At the Baseline visit (V2), which occurs the day before the dosing session, participants will complete clinical measures, and undergo a preparatory session (up to 4 hours) with the study therapists. These sessions will build a therapeutic alliance, provide psychoeducation about, and set intentions for, the psilocybin session. To reduce participant burden, baseline can be broken up into multiple days, however all assessments must be completed within 7-days of the intervention. Ideally, baseline occurs the day before the intervention is administered. The psilocybin session (Day 0 \\[V3\\]) will last 5 to 6 hours and will be conducted in the existing psychedelic treatment suite developed at the Centre for Addiction and Mental Health (CAMH) Mood Disorder Service by Dr. Husain (PI). Two trained study therapists will be supporting each participant during the dosing session. Participants will receive psilocybin 25 mg plus risperidone 1 mg, or psilocybin 25 mg plus placebo, or placebo plus risperidone 1 mg. All participants will receive 10 hours of manualized supportive psychotherapy (which includes the 5-6 hour dosing session). After 5 hours of dose administration, participants will be evaluated for safety by the study psychiatrist and discharged home in the company of a caregiver or a family member. After the dosing session, participants will be seen for two 1-hour integration sessions (Day 1 \\[V4\\], Week 1 \\[V5\\]). Thereafter, participants will be followed-up after 2 \\[V6\\], 3 \\[V7\\] and 4 weeks \\[V8\\] post-dosing (see Figure 1). A study psychiatrist will be available throughout the duration of the RCT to respond to any concerns or changes in mental/physical state. Participants will not start other interventions for MDD during the study.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-06", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05710237", "keywords": "Treatment-resistant Depression, Psilocybin 25 mg, Risperidone 1 MG, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05710237\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Addiction,Receptor Pharmacology,Clinical Trial,Randomized Controlled Trial,Healthy Volunteers,Treatment-Resistant Depression,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3620, "title": "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer", "normalized_title": "a phase 2 randomized double blind placebo controlled study to evaluate the efficacy and safety of up to two doses of psilocybin for the treatment of major depressive disorder in adults with cancer", "authors": "Sunstone Medical", "abstract": "This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \\< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called \"magic mushrooms\"; however, participants with prior recreational experience with psilocybin or \"magic mushrooms\" are eligible.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-05", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05947383", "keywords": "Cancer, Major Depressive Disorder, Psilocybin, Placebo, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05947383\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Observational Study,Cancer Patients,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3613, "title": "Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression (TRD): A Pilot Study", "normalized_title": "induction protocol for psilocybin assisted therapy in treatment resistant depression trd a pilot study", "authors": "University of North Carolina, Chapel Hill", "abstract": "The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants. Major depressive disorder (MDD) ranks fourth in global disease burden and has significant morbidity, mortality, societal and financial costs. However, few adequate and effective treatments exist with 60% of MDD patients not responding sufficiently to an initial oral antidepressant treatment. These patients who experience treatment resistant depression (TRD), defined as an intolerance or lack of response to two antidepressants of different classes, have limited treatment options beyond the antidepressant treatments that often yield insufficient results or relapse. Psilocybin, a novel treatment, has been found to relieve symptoms of TRD, but there are limited studies on specific dosing and long term treatment follow-up. In this study, the investigators will look closer at the effectiveness of one treatment with psilocybin versus two treatments with psilocybin, as well as the long term effectiveness over the first 12 months after treatment.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-05", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06303739", "keywords": "Refractory Depression, Treatment Resistant Depression, psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06303739\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Clinical Trial,Observational Study,Treatment-Resistant Depression", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3536, "title": "A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder", "normalized_title": "a phase 2 randomized study examining the safety feasibility and effectiveness of masking psilocybin therapy with general anesthesia in major depressive disorder", "authors": "Stanford University", "abstract": "Major depressive disorder (MDD) affects millions of Americans and remains difficult to treat. Psilocybin, a psychedelic compound, has shown promise for reducing depression symptoms, but a key challenge in psychedelic research is that participants can usually tell whether they received the active drug - making it hard to conduct fully blinded studies. This study (Studying Psilocybin with Anesthesia Controlled by EEG \\[SPACE\\]) tests a new approach: administering psilocybin while participants are under general anesthesia, so that the noticeable psychological effects of psilocybin are masked. This allows both participants and outcome assessors to remain unaware of whether psilocybin or placebo was given, improving the scientific rigor of the research. Participants with MDD will be randomly assigned to receive either psilocybin or placebo across four dosing sessions conducted under general anesthesia. The study will assess whether this approach is safe and feasible, and will collect early data on whether it may reduce depression symptoms. Participants will receive four dosing sessions spaced one week apart. Each session involves taking an oral capsule containing either psilocybin (10 mg or 25 mg) or placebo, followed by general anesthesia with propofol. All sessions take place at Stanford Hospital under the supervision of a board-certified anesthesiologist. Between and after sessions, participants complete questionnaires about mood, sleep, wellbeing, and anxiety. Participants may also wear a consumer-grade EEG headband at home to track sleep patterns. The total study duration per participant is approximately 7 weeks, across around 25 visits, most of which are conducted remotely. Psilocybin is not FDA-approved and is administered under an FDA Investigational New Drug (IND) authorization for research purposes only.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-05", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07479550", "keywords": "Major Depression, Psilocybin (Usona Institute), Propofol, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07479550\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Brain Imaging,Wellbeing,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3501, "title": "An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers", "normalized_title": "an exploratory pilot study of palliadelic treatment to reduce psychological distress in people with pancreatobiliary and other advanced gastrointestinal cancers", "authors": "University of Nebraska", "abstract": "The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm. Participants with stage IV or inoperable gastrointestinal cancers are eligible for intervention, paired family member recruited for observational arm. Following preparatory sessions in outpatient palliative care clinic or by telehealth (2-4 sessions lasting 60-90 minutes each), psilocybin will be administered as a 25mg capsule during an 8-hour monitored session. Integration sessions (2-3 sessions lasting up to 90 minutes each) will take place in the outpatient palliative care clinic or by phone or tele-heath. Primary and secondary objectives are complete at one-week post treatment, longitudinal exploratory measures collected up to 12 months post baseline. Parallel assessment of health care utilization, including choices regarding anti-cancer treatment and resource utilization, and family member distress, family communication, well-being and bereavement will be conducted at concurrent time points.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-05", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05220046", "keywords": "Pancreas Cancer, Biliary Tract Cancer, Psychological Distress, Gastrointestinal Cancer, Psilocybin, mushroom, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05220046\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "End-of-Life Distress,Wellbeing,Observational Study", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3577, "title": "A One-Year Observational Follow-up Study of Participants With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control", "normalized_title": "a one year observational follow up study of participants with major depressive disorder following a randomized double blind single dose of psilocybin or niacin control", "authors": "Usona Institute", "abstract": "This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3 and 6 (± 7 days for each assessment) and months 10 and 12 (± 14 days for each assessment).", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04353921", "keywords": "Major Depressive Disorder, No intervention will be administered as part of this study., TERMINATED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04353921\",\"overall_status\":\"TERMINATED\",\"phase\":[]}", "topic_tags": "Depression,Clinical Trial,Observational Study", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3559, "title": "A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression", "normalized_title": "a phase 2 sequential dose finding study of preparation for group retreat psilocybin therapy for healthcare clinicians with loss of meaning in their work and symptoms of depression", "authors": "University of Washington", "abstract": "In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes. This is a single-arm study that examines the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. Population: Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression (PHQ-9 ≥10) and loss of meaning during the past 5 years. Study Design: Phase 2, non-randomized, sequential cohort dose-escalation study examining the optimal number of preparation sessions for group retreat psilocybin therapy. Three cohorts will receive different \"doses\" of preparation: Cohort 1 receives 7 total preparation sessions (6 virtual + 1 in-person), Cohort 2 receives 4 total preparation sessions (3 virtual + 1 in-person), and Cohort 3 receives 2 total preparation sessions (1 virtual + 1 in-person). Each cohort includes 3 retreats with 8 participants per retreat. Sample Size: 72 participants total (24 per cohort, distributed across 3 retreats of 8 participants each) Study Duration: 18-24 months from enrollment of first participant to completion of final data analysis. Individual participant involvement spans approximately 8-10 months including 6-month post-retreat follow-up. Primary Objectives: (1) Safety: Assess incidence and severity of challenging experiences and adverse events across preparation dose levels using the Challenging Experience Questionnaire (CEQ), adverse event monitoring, and psychiatric symptom scales (PHQ-9, GAD-7, C-SSRS). (2) Feasibility: Determine completion rates for preparation sessions at each dose level. Secondary Objectives: (1) Mechanism Testing: Examine relationship between preparation dose, group cohesion, and challenging experiences. (2) Clinical Outcomes: Explore effects on depression and burnout for future power calculations. (3) Participant Preference: Assess participant-reported optimal preparation length. Summary: Psilocybin therapy has demonstrated promising efficacy for symptoms of depression related to frontline work during the COVID pandemic for clinicians. The group retreat format offers potential advantages over individual treatment, including enhanced accessibility, reduced cost per participant, and potential therapeutic benefits from group cohesion and shared experience. However, a critical unanswered question concerns the optimal number of preparation sessions. A sequential dose-finding design is appropriate because: (1) the dose-response curve for preparation sessions in group format is unknown; (2) attrition/completion rate is a critical feasibility outcome, particularly for time-constrained healthcare clinicians; (3) the design allows protocol refinement between cohorts based on emerging data; (4) this approach is more scientifically honest about genuine uncertainty regarding optimal preparation dose than premature randomization; and (5) it seeks to establish a minimum effective dose of preparation for practical feasibility and future scalability.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07565909", "keywords": "Depression, Anxiety, Psilocybin, Group Retreat Psilocybin Therapy, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07565909\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Observational Study,Healthcare Workers,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3531, "title": "Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury", "normalized_title": "safety tolerability outcomes of psilocybin for depression stop depression in veterans with spinal cord injury", "authors": "James J. Peters Veterans Affairs Medical Center", "abstract": "The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events. Background: Depression may be explained partly by decreased signaling of serotonin in the nervous system. Psilocybin, the active component of 'magic mushrooms', is a drug that activates serotonin pathways in the nervous system. Some scientists think psilocybin could help people with major depression, but it is not currently approved as a medicine in the United States. People with spinal cord injuries (SCI) often feel depressed, even more commonly than people without injuries. People with SCI have not been included in psilocybin studies. The goals of this study are first to see if psilocybin can be safely administered, and to determine if psilocybin can help improve symptoms of depression in people with SCI. Study Goals: The investigators will look at how safe psilocybin is for people with SCI, how people with SCI respond to different doses, and whether it helps reduce the severity of depression and other problems, like pain or muscle spasms. The study team will also check to see if psilocybin improves quality of life and wellbeing. The study will track these effects for a year after participants receive psilocybin. Study Plan: Thirty people with chronic SCI with a depressive disorder will be asked to join-15 with paraplegia and 15 with tetraplegia. They will be split into three groups to try different psilocybin doses: low (5mg), medium (10mg), and high (25mg). The study will take a stepwise approach to safety, but participants will not know the dose of psilocybin they receive. There will be at least 16 study visits, including medical and mental health check-ups, psilocybin assisted therapy, primary study endpoint and follow-up visits. What Will Be Measured: The study focus is to see if psilocybin is safe and tolerable in people with SCI. The study will track side effects, how people feel, and any changes in mood, pain, medication use, or body reactions. Doctors will check for problems like chest pain, high blood pressure, and changes in suicidal thoughts. The study team will also measure satisfaction with the therapy, experiences during the psilocybin sessions, and changes in depression. Why It Matters: Some people wrongly believe depression is just a normal part of living with SCI, so their depression may not be adequately treated. Also, people with SCI often can't join trials of new treatments because they have other health problems. Psilocybin could help treat depression and may improve many body functions affected by SCI if it is shown to be safe and effective.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07251491", "keywords": "Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran, Psilocybin (Usona Institute), Magic Mushrooms, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07251491\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Chronic Pain,Mechanism of Action,Receptor Pharmacology,Wellbeing,Veterans,Safety,Adverse Events", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3516, "title": "Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder", "normalized_title": "group psilocybin assisted cognitive behavioral therapy for major depressive disorder", "authors": "University of California, Los Angeles", "abstract": "This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.", "journal": "ClinicalTrials.gov", "publication_date": "2026-05-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07566104", "keywords": "Depression - Major Depressive Disorder, Psilocybin, Cognitive Behavioral Therapy, Psilocybin (drug), Group Cognitive Behavioral Therapy, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07566104\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3600, "title": "Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial", "normalized_title": "psilocybin assisted therapy for treatment resistant depression in bipolar ii disorder a randomized controlled trial", "authors": "Lakshmi N Yatham", "abstract": "This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists. Bipolar disorders (BD) are lifelong conditions characterized by recurrent episodes of depression and (hypo)mania. Statistics Canada data indicate over a million Canadians are affected by this illness. Bipolar II disorder is characterised by recurrent episodes of hypomania and depression and individuals with BD-II are symptomatic about 50% of the time despite treatment. The majority of this time is spent being depressed thus there is an urgent need to develop new treatments that are safe and effective. Psilocybin, a naturally occurring psychedelic compound found in mushrooms, has been noted to result in an increase in psychological well-being in healthy volunteers as well as have antidepressant effects when administered in conjunction with psychological support. Two recent open-label pilot trials of Psilocybin-Assisted Therapy (PAT) in treatment-resistant depression, including BD-II participants, demonstrated high response rates and excellent tolerability, thereby providing strong justification for the current study.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-30", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06943573", "keywords": "Bipolar II Depression, psilocybin (25 mg), psilocybin 1mg micro-dose, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06943573\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Wellbeing,Randomized Controlled Trial,Healthy Volunteers,Treatment-Resistant Depression,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3537, "title": "Computationally, Electrophysiologically, and Qualitatively Characterizing Serotonergic Psychedelics; Transdiagnostic Therapeutic and Pro-Psychotic Effects", "normalized_title": "computationally electrophysiologically and qualitatively characterizing serotonergic psychedelics transdiagnostic therapeutic and pro psychotic effects", "authors": "Yale University", "abstract": "This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom. Mounting evidence suggests that serotonergic psychedelics (SPs; eg. psilocybin, LSD) reduce symptoms across many mental illnesses with rapid, sustained effects from single interventions. They also cause persisting, positive effects in the general population and those without mental illness. This improved wellness comes at the cost of acute psychosis-like effects, that sometimes persist in weakened forms or, rarely, as prolonged episodes of psychosis. Understanding the mechanism underlying these dual effects may help maximize therapeutic effect and minimize unwanted outcomes. The reason SPs cause therapeutic change and also cause psychotic-like effects regardless of whether one has a mental illness may be because they alter the basic machinery that the brain uses to process all information. SPs seem to shift processing-in both how we perceive (seeing, hearing, etc.) and learn-to rely more on new, incoming information over previously learned information. Essentially, SPs shift the brain into an extreme learning mode that allows it to modify harmful thought patterns associated with many mental illnesses, but that may also be similar to the brain states of early psychosis. Participants in this study will opt-in to complete various measures to be completed before, during, and after being administered a serotonergic psychedelic through a clinical trial at Yale University. How participant's brains process information will be assessed by: 1. Playing 3-4 computer games that measure how people see, hear, and learn. These will be completed 1-30 days before receiving the serotonergic psychedelic, the day they receive the serotonergic psychedelic (once psychologically acceptable and permitted by relevant trial researchers), the day after, 5-14 days after, and 4-6 weeks after. 2. MEG or EEG to measure the brain activity responsible for representing new vs. old information-and structural MRI to determine where the activity is coming from. The MEG/EEG will be done the day before, day of, and day after administration of the serotonergic psychedelic. The MRI can be done before, after, or during the trial. They behaviors that accompany these changes will be assessed by: 1. Validated, online questionnaires at the same time points as the computer games. 2. Semi-structured interviews about what participants' day-to-day experiences are like and how they have changed after taking a serotonergic psychedelic. These may be done 2-5 days after using a psychedelic, or at the same time that clinical trial staff do their interviews. Participants participating in a trial with single-arm placebo-controlled study design that includes a placebo arm may only complete these measures around a placebo administration. Those in a trial with a crossover design may complete these measures twice (except for day 1-30 and 4-6 week time points). Those opting to complete open-label administrations after study completion may complete relevant time points. The primary objectives are to: 1. Investigate how serotonergic psychedelics change brain reliance on new vs. old information in perception and belief-updating while under the influence. 2. Investigate how serotonergic psychedelic change brain reliance on new vs. old information in perception and belief updating at short and long-term follow-up. 3. Investigate whether serotonergic psychedelics cause side effects in people's perception, attention, and belief updating that are both healthy and psychosis-like. 4. Investigate how serotonergic psychedelics acutely alter excitation/inhibition (E/I) balance in the brain. 5. Investigate whether there are any persisting changes in resting state EEG power or E/I balance. The secondary objectives are to: 1. Investigate whether changes in brain information processing can explain therapeutic effects of serotonergic psychedelics. 2. Investigate whether changes in brain information processing can predict who will respond positively to serotonergic psychedelics. 3. Investigate whether changes in brain information processing can explain psychotic-like side effects of serotonergic psychedelics. 4. Investigate whether changes in brain information processing can predict who will have stronger psychotic-like side effects from serotonergic psychedelics. 5. Investigate whether acute or persisting changes in E/I balance predict therapeutic or psychotic effects of serotonergic psychedelics.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-30", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06624137", "keywords": "OCD, Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD), Healthy Volunteer, Migraine, PTSD, PTSD - Post Traumatic Stress Disorder, Addiction, Tobacco Use Disorder, Obsessive Compulsive Disorder (OCD), Opioid Use Disorder, Serotonergic Psychedelic, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06624137\",\"overall_status\":\"RECRUITING\",\"phase\":[]}", "topic_tags": "Depression,PTSD,Addiction,OCD,Headache / Migraine,Brain Imaging,Aging,Wellbeing,Clinical Trial,Observational Study,Healthy Volunteers,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3509, "title": "Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)", "normalized_title": "lysergic acid diethylamide lsd in palliative care a randomised double blind active placebo controlled phase ii study lpc study", "authors": "University Hospital, Basel, Switzerland", "abstract": "Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects. Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-28", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05883540", "keywords": "Palliative Care, Pain, Anxiety, Depression, Demoralization, Psychological Distress, Quality of Life, Caregiver Burden, Fear of Death, Existential Distress, Lysergic Acid Diethylamide Tartrate, LSD, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05883540\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Chronic Pain,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3474, "title": "A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain", "normalized_title": "a double blind randomized trial examining the preliminary efficacy of psilocybin therapy for people with chronic low back pain", "authors": "Joshua Woolley, MD, PhD", "abstract": "This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions. Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-28", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05351541", "keywords": "Chronic Low-back Pain, Psilocybin therapy with Zolpidem and Modafinil, 4-phosphoryloxy- N,N-dimethyltryptamine, Psilocybin therapy with Zolpidem, Psilocybin therapy with Modafinil, Psilocybin therapy with Placebo, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05351541\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Chronic Pain,Emotional Processing", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3658, "title": "Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder", "normalized_title": "psilocybin enhanced psychotherapy for methamphetamine use disorder", "authors": "Portland VA Research Foundation, Inc", "abstract": "This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder. The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04982796", "keywords": "Amphetamine-Related Disorders, Psilocybin, Treatment-as-usual, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04982796\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3596, "title": "A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)", "normalized_title": "a randomized double blind study of single dose psilocybin for major depressive disorder mdd", "authors": "Usona Institute", "abstract": "One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo. The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose. Major depressive disorder (MDD) has become a health crisis of epidemic proportions in the modern world. One in six individuals in the United States will experience an episode of major depression in his or her lifetime, and it is estimated that major depression will rank second after cardiac disease as a cause of international medical morbidity by the year 2020. Depression is associated with greater disability than are most other chronic illnesses and is a risk factor for mortality. Additionally, depression predicts the later development of a number of medical conditions, including cardiac and cerebrovascular disease, hypertension, diabetes, obesity, metabolic syndrome, dementia, and cancer. Unfortunately, most patients with depression do not experience a complete resolution of symptoms with antidepressant treatment. Partial-but incomplete-response to antidepressants is associated with an increased risk of full symptomatic relapse (even when on therapy) and a worse long-term disease course. Combined with the high prevalence and significant disability associated with MDD, the fact that currently available treatments are not fully adequate highlights the tremendous need to identify novel treatment strategies. Data suggest that psilocybin may have behavioral effects relevant to the treatment of depression and recent studies also suggest that psilocybin may possess antidepressant properties. To further assess the effects of psilocybin on MDD signs and symptoms, this trial will enroll 100 participants, ages 21 to 65, who meet criteria for MDD. Participants will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo. To enhance participant safety, a Set and Setting (SaS) protocol will be utilized similar to the protocol that has been used in all modern studies of psilocybin. The SaS protocol for this study includes: 1) a period of preparation with session Facilitators prior to dosing; 2) administration of study medications in an aesthetically pleasing room under the supervision of two Facilitators who are present throughout the session; and 3) three post-dose integration sessions during which participants are encouraged to discuss their intervention experience with the Facilitators. The SaS protocol will be identical for those randomized to psilocybin or active placebo. The primary objective of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo (niacin), assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03866174", "keywords": "Depressive Disorder, Major, Psilocybin, Psilocybine, Psilocibin, Indocybin, Niacin, Vitamin B3, Set and Setting (SaS) Protocol, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03866174\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3567, "title": "Toward Patient-Tailored Care for Treatment-Resistant Depression: A Pilot Patient-Preference Clinical Trial of Music and Mindfulness in Psilocybin-Assisted Psychotherapy", "normalized_title": "toward patient tailored care for treatment resistant depression a pilot patient preference clinical trial of music and mindfulness in psilocybin assisted psychotherapy", "authors": "Kyle Greenway", "abstract": "The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how people respond to psilocybin treatment. The main questions it aims to answer are: * Is it feasible to conduct a patient-preference randomized trial of psilocybin-assisted psychotherapy? * Does receiving a preferred psychotherapy style improve treatment experiences or outcomes? * How do music-centered and mindfulness-centered PAP approaches compare in their effects on improving mood and well-being? Researchers will compare music-centered PAP to mindfulness-centered PAP to see if aligning psychotherapy with individual preferences is a practical and potentially beneficial approach for improving treatment efficacy and tolerability. Participants will: * Be adults with treatment-resistant depression * Receive two 25 mg psilocybin (PEX010, Filament Health) sessions, spaced four weeks apart * Experience one session with music-centered psychotherapy and one with mindfulness-centered psychotherapy * Before treatment, rate their preference for the two psychotherapy approaches * Be randomly assigned to receive their preferred or non-preferred approach first, followed by the other * Complete preparation and integration sessions before and after each psilocybin session This feasibility trial will also collect information on participants' cultural and personal factors influencing psychotherapy preferences using a modified Cultural Formulation Interview, and explore physiological measures of therapeutic alliance, an important factor in psychotherapy outcomes. Depression is one of the top causes of disability worldwide. Psilocybin-assisted psychotherapy (PAP) is an emerging treatment for Treatment-Resistant Depression (TRD) that pairs one or two doses of psilocybin, a serotonergic psychedelic, with a brief course of psychotherapy. While multiple studies of PAP have found safe, rapid, and lasting antidepressant effects, much remains unknown about how to optimize this promising intervention's psychotherapy component. This pilot study aims to explore a novel strategy for improving the efficacy and tolerability of PAP: individually-tailoring its psychotherapy based on patient preferences for two important nonpharmacological treatment elements: music and mindfulness. These core treatment components were selected based on their ubiquitousness in psilocybin studies and their potential for significant patient preference effects. The investigators will conduct a patient-preference randomized clinical trial where 16 patients with TRD will receive two doses of psilocybin (PEX010, Filament Health, 25mg). For each patient, one psilocybin dose will be administered with music-centered psychological support and the other with mindfulness-centered psychological support. In the first 4-week phase, patients will be asked to rate their preferences for these different psychotherapeutic approaches. Patients will then be 50:50 randomized to first receive either their preferred or their non-preferred treatment approach. In a second 4-week crossover phase, patients will receive the other treatment approach. All patients will thus undergo both music-centered and mindfulness-centered PAP interventions, but in an order dictated by their preferences and randomization. Each treatment phase entails pre-treatment and post-treatment psychotherapy following standard protocols. Similar patient-preference clinical trial designs have shown that preferences can significantly influence the efficacy and tolerability of existing psychiatric treatments. The primary aim of this pilot trial is to examine this design's feasibility for exploring such preference effects in PAP, which the investigators hypothesize will be substantial. As secondary aims, the trial will generate preliminary estimates about the magnitude of preference effects, compare the music- and mindfulness-centered approaches, and yield qualitative data about the diverse sociocultural factors that influence patient preferences, including with a modified Cultural Formulation Interview administered at baseline. An additional exploratory aim is to examine novel physiological measures of therapeutic alliance, a crucial factor in psychiatric care. Depression affects millions of Canadians and new treatments are sorely needed. This line of research seeks to produce systematic approaches to tailoring the psychotherapy of PAP for TRD. Its ultimate goal is to improve this promising intervention's efficacy, safety, and applicability to diverse populations.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07373535", "keywords": "Treatment-Resistant Major Depressive Disorder, Psilocybin 25mg, PEX010(25), Music-centered psilocybin-assisted therapy, Mindfulness-centered psilocybin-assisted therapy, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07373535\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Wellbeing,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3436, "title": "Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission", "normalized_title": "study of psilocybin assisted psychotherapy to address fear of recurrence in patients diagnosed with early stage breast cancer and ovarian cancer in remission", "authors": "University of Colorado, Denver", "abstract": "The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\\[s\\] it aims to answer \\[is/are\\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-20", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06430541", "keywords": "Breast Cancer, Ovarian Cancer, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06430541\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Observational Study", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3533, "title": "Open Label Psilocybin Brain Stimulation and Imaging Pilot Study", "normalized_title": "open label psilocybin brain stimulation and imaging pilot study", "authors": "Johns Hopkins University", "abstract": "This open-label pilot psilocybin administration study investigates the influence of psilocybin on brain function and cognitive control functions in clinically and psychiatrically healthy volunteers. Participants will undergo experimental drug administration sessions after careful screening and preparation. Participants will also have brain activity measured using electroencephalogram (EEG) also during non-invasive brain stimulation using Transcranial Magnetic Stimulation (TMS).", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-19", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06835699", "keywords": "Healthy Volunteers, Psilocybin 25 mgs, TMS, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06835699\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Aging,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3630, "title": "Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND)", "normalized_title": "probing the functional magnetic resonance imaging response to psilocybin in functional neurological disorder psifund", "authors": "King's College London", "abstract": "The goal of this study is to learn about the brain network response in people who have functional neurological disorder who are administered with a single dose of the psychedelic psilocybin with therapeutic support. The main question it aims to answer is: Can the default mode network, a brain network thought to be relevent in FND, be modified by the administration of psilocybin based on functional magnetic resonance imaging before and after the dose?", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-16", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05723276", "keywords": "Functional Neurological Disorder, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05723276\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"NA\"]}", "topic_tags": "Brain Imaging,Default Mode Network,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3578, "title": "CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial", "normalized_title": "capsi cancer related major depression treated with a single dose of psilocybin a multicenter randomized placebo controlled double blind clinical trial", "authors": "Section for Affective Disorders; Northern Stockholm Psychiatry", "abstract": "The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is: The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9) ≥10), \\>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-12", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06319378", "keywords": "MDD, psilocybin 25 mg sod, psilocybin 1 mg sod, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06319378\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3656, "title": "Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder", "normalized_title": "safety profile of 25 mg psilocybin in individuals with cocaine use disorder", "authors": "University of California, Los Angeles", "abstract": "The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-06", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06102434", "keywords": "Cocaine Use Disorder, Psilocybin, SUSPENDED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06102434\",\"overall_status\":\"SUSPENDED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Addiction,Brain Imaging,Aging,Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3678, "title": "Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)", "normalized_title": "role of experience conscious awareness and plasticity in psilocybin s behavioral effects follow up study the recap 2 study", "authors": "University of Wisconsin, Madison", "abstract": "The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing. Participants will: * Receive one of four possible combinations of medications * Undergo an MRI * Complete questionnaires * Undergo transcranial magnetic stimulation (TMS) and EEG The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-02", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06692192", "keywords": "Psilocybin, Psilocybine, Psilocibin, Midazolam, Saline, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06692192\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Neuroplasticity,Brain Imaging,Wellbeing,Emotional Processing,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3542, "title": "Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin", "normalized_title": "activating neuroplasticity to enhance the perception box expanding effects of psilocybin", "authors": "University of Wisconsin, Madison", "abstract": "This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS. One hundred and eight medically healthy adult volunteers with a modest decrement in wellbeing will receive a single open-label 25 mg dose of psilocybin administered within a \"set and setting\" (SaS) framework of psychological support provided by trained facilitators, such as has been successfully employed in prior psychedelic studies at UW-Madison. The SaS protocol will include 2-4 hours of preparation, a 6- to 8-hour psilocybin dosing session and an hour-long integration session 1 day and 9 days post dosing. All subjects will receive various combinations of active taVNS or sham taVNS prior to, or following, psilocybin dosing. Active and sham taVNS sessions will last 20 minutes and will occur twice daily (morning and afternoon/evening) for 7 consecutive days, using an \"at home\" protocol that has been used safely and effectively by study collaborators. taVNS is a non-invasive low-risk procedure. Subjects will be randomized with equal allocation to one of four conditions: 1) seven days of sham taVNS prior to psilocybin dosing and 7 days of active taVNS post- psilocybin dosing (Group 1: n=27); 2) seven days of sham taVNS prior to psilocybin dosing and 7 days of sham taVNS post- psilocybin dosing (Group 2: n=27); 3) seven days of sham taVNS prior to psilocybin dosing and psilocybin with psychosocial support post-dosing (Group 3: n=27); and 4) seven days of active taVNS prior to psilocybin dosing and 7 days of sham taVNS post- psilocybin dosing (Group 4: n=27). Importantly, participants in all groups will receive psychosocial support in addition to their randomization status (i.e., taVNS or sham taVNS prior to, or following psilocybin, or psychosocial support alone), as the provision of psychosocial support is the current standard of care for the use of psychedelics in FDA-regulated clinical trials (FDA2023). It is anticipated that a total sample of 108 subjects will be enrolled to provide 100 subjects who complete study activities/assessments sufficient to provide evaluable data for testing study primary and exploratory outcomes.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-02", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05866471", "keywords": "Healthy, Psychedelic Experiences, Vagus Nerve Stimulation, Psilocybin, Psilocybine, Psilocibin, Filament Health Psilocybin, PEX010, Transcutaneous auricular Vagus Nerve Stimulation (taVNS), Psychosocial Support Alone, Sham taVNS, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05866471\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Neuroplasticity,Wellbeing,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3670, "title": "Acute Analgesic Effects of DMT on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants", "normalized_title": "acute analgesic effects of dmt on experimentally induced acute nociceptive pain hyperalgesia and allodynia in healthy participants", "authors": "University Hospital, Basel, Switzerland", "abstract": "N,N-dimethyltryptamine (DMT) is a classical psychedelic with similar effects like LSD or psilocybin. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. Therefore, the investigators will evaluate the efficacy of DMT on different pain qualities within a model of electrically induced pain in healthy participants. The analgesic effects will be compared to racemic ketamine (active control) and placebo within a cross-over design. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. For instance, it is unclear whether psychedelics possess acute antinociceptive effects or if they rather modulate secondary pain phenomena such as hyperalgesia, allodynia, and/or functional pain. Here, the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia. The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds. Thus, the investigators will evaluate the efficacy of N,N-dimethyltryptamine (DMT), a classical and naturally-occurring psychedelic, on different pain qualities within this model. DMT differs from other classical psychedelics in its very short elimination half-life. Due to its rapid metabolization by monoaminoxidases (MAO), DMT is not orally bioavailable in the absence of MAO-inhibitors and thus has to be administered continuously and intravenously. Recently, the investigators tested several continuous intravenous administration regimes of DMT that lead to the induction of a constant and rapidly adaptable psychedelic state. The regime allows to induce stable DMT effect that can be terminated rapidly. Due to this controllability, a continuous infusion of intravenous DMT is most suitable to assess time and concentration-dependent analgesic effects within the used pain model. The analgesic efficacy of DMT will be compared to ketamine, a known analgesic (positive control), and placebo.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-01", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06180759", "keywords": "Healthy, Intravenous infusion of DMT, Intravenous infusion of ketamine, Intravenous infusion of placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06180759\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Chronic Pain,Headache / Migraine,Clinical Trial,Case Report,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3651, "title": "Effects of Psilocybin in Obsessive Compulsive Disorder", "normalized_title": "effects of psilocybin in obsessive compulsive disorder", "authors": "Johns Hopkins University", "abstract": "This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder (OCD). This will serve as a preliminary proof of concept study for future larger studies aimed to investigate the utility, cognitive mechanisms, and neural correlates of this intervention. Participants in this study will receive two doses of psilocybin approximately two weeks apart. Assessments will be conducted during screening visits, psilocybin sessions, and at follow up visits up to 6 months after the final psilocybin session. Thirty participants will complete all study visits including follow-up visits. Primary objectives: 1. Investigate the feasibility, safety, and acceptability of psilocybin for OCD. 2. Investigate the effect of psilocybin on OCD symptoms and concomitant depression and anxiety symptoms. 3. Investigate the effect of psilocybin on quality of life. Secondary objectives: 1. Investigate the effect of psilocybin on metacognition of episodic memory and decision-making. 2. Investigate the effect of psilocybin on model-based learning. 3. Investigate the effect of psilocybin on the ERN. 4. Investigate the effect of psilocybin on affect and social connection. 5. Investigate the effect of psilocybin on movement and communications.", "journal": "ClinicalTrials.gov", "publication_date": "2026-04-01", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05546658", "keywords": "Obsessive-Compulsive Disorder, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05546658\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Anxiety,OCD,Mechanism of Action,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3663, "title": "Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression", "normalized_title": "engaging mood brain circuits with psilocybin a randomized neuroimaging trial in depression", "authors": "Sunnybrook Health Sciences Centre", "abstract": "The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin: 1. Changes connectivity within brain networks associated with mood and depression 2. Changes blood flow in brain regions associated with mood and depression Participants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-29", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06072898", "keywords": "Depressive Disorder, Major Depressive Disorder, Psilocybin, Microcrystalline cellulose, MCC, Supportive psychotherapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06072898\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Brain Imaging,Aging,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3478, "title": "Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder", "normalized_title": "psilocybin assisted psychotherapy for treatment resistant depression and co occurring substance use disorder", "authors": "Indiana University", "abstract": "The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD) in veterans and first responders. We seek to answer: * Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with co-occurring TRD and SUD * Whether psilocybin assisted psychotherapy will reduce substance use severity and depression symptoms * What neurobiological processes are associated with the effects of psilocybin assisted psychotherapy. The researchers will compare the effects of a single dose of psilocybin (either 5mgs or 10mgs or 25mg) alongside psychotherapy on substance use severity and depression symptoms over six weeks in veterans and first responders with TRD and co-occurring SUD. In this 14-week study, participants will: * Visit the clinic for two intake sessions * Complete seven psychotherapy sessions. This will include three sessions before psilocybin administration, an 8 to 10 hour dosing session, and three sessions following psilocybin administration * Complete short, repeated daily assessments for six weeks, in total, before and after psilocybin administration * Complete two brain scans before and after psilocybin administration This is a double-blind randomized clinical trial to examine the safety and efficacy of a single dose of psilocybin (5mg or 10mg or 25mg) in reducing substance use severity and depression symptoms in N=50 veterans and first responders with treatment resistant depression (TRD) and co-occurring substance use disorder (SUD). The study will be conducted at Goodman Hall outpatient clinic located at Indiana University, Department of Psychiatry. All participants will take part in two intake visits (one to conduct safety tests and establish eligibility, and one to collect baseline and covariate data). They will then participate in three preparatory psychotherapy sessions with a certified psilocybin counselor before receiving one of three, randomly assigned, psilocybin doses during an 8 to 10 hour administration session. Following psilocybin administration, participants will participate in three weekly integrative psychotherapy sessions. We will also conduct three, two-week bursts of Ecological Momentary Assessment (EMA) during weeks 1 and 2, weeks 5 and 6 and weeks 10 and 11 of study participation, to measure daily substance use patterns and depression symptoms both during stressful and non-stressful situations. A pre- and post- fMRI paradigm will additionally be conducted to determine psilocybin-related changes within and between the default mode network, the salience mode network and the central executive network, during both resting state and stress. We will also explore the extent to which elevations in subjective mystical and existential experience contributes to psilocybin's therapeutic and mechanistic effects. It is anticipated that all three doses of psilocybin will be safe and well-tolerated in this sample of veterans and first responders. We additionally expect that 25mgs of psilocybin compared with 5mgs will attenuate substance use severity and depressive symptoms six weeks following administration, and during both stressful and non-stressful situations. In addition, we expect that 25mg Vs 5mg psilocybin will decrease resting state functional connectivity within the default mode network (DMN) and modulate connectivity between the DMN, salience network, central executive network, and the amygdala during stress exposure.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-29", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07499583", "keywords": "Treatment Resistant Depression, Substance Use Disorders, Psilocybin, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07499583\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Addiction,Brain Imaging,Default Mode Network,Mystical Experience,Clinical Trial,Treatment-Resistant Depression,Veterans,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3696, "title": "Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression", "normalized_title": "psilocybe cubensis mushrooms with or without fluoxetine for refractory depression", "authors": "Federal University of Latin American Integration", "abstract": "This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ages 25-64) have DSM-5-TR MDD, moderate-severe, MADRS ≥20, and partial response in the current episode (≥1 adequate antidepressant trial of 6-12 weeks with \\", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-26", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06898606", "keywords": "Depressive Disorder, Psilocybin and Psilocyn, Placebo, Psychotherapy-assisted session, Fluoxetine, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06898606\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3456, "title": "The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.", "normalized_title": "the quantum trip trial psilocybin assisted therapy for reducing alcohol intake in patients with alcohol use disorder a randomized double blinded placebo controlled clinical trial", "authors": "Anders Fink-Jensen, MD, DMSci", "abstract": "Note: The trial is only eligible for citizens of Denmark. The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD). To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagnosed with alcohol use disorder and treatment seeking will be recruited from the community via advertisement and referrals from general practitioners and hospital units. The psilocybin or placebo is administered within a protocol of psychological support before, during and after the dosing. Outcome assessments will be carried out one, four, eight- and 12 weeks post dosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes include 1) phosphatidyl-ethanol as an objective biomarker for alcohol consumption 2) plasma psilocin, the active metabolite, to establish a possible therapeutic range and 3) the acute subjective drug experience as a possible predictor of treatment outcome. Furthermore, we will investigate the neurobiological underpinnings of the possible treatment effects by use of functional magnetic resonance brain imaging one week post dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-23", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05416229", "keywords": "Alcohol Use Disorder, Psilocybin, Maltodextrin, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05416229\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Brain Imaging,Biomarkers,Aging,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3447, "title": "Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects: A Randomized, Open-Label, Cross-Over Functional Magnetic Resonance Imaging Trial", "normalized_title": "elucidating the relevance of the psychedelic experience to psilocybin s anti anhedonic effects a randomized open label cross over functional magnetic resonance imaging trial", "authors": "Medical University of Vienna", "abstract": "The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1. Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all participants). 2. Test effects of psilocybin on brain network complexity measures during the hedonic experience using fMRI as a correlate for prohedonic (anti-anhedonic and well-being increasing) effects. 3. Elucidate relevance of the psychedelic experience to these effects (clinical, behavioral, and imaging) in a pharmacological challenge using the 5-HT2A/D2 antagonist risperidone and extensive characterization of the psychedelic experience. Secondary Objectives 4. Test the differential effects of the psychedelic experience on fMRI paradigms measuring symptoms shown to be altered in anhedonia, more specifically reward processing and sexual arousal. 5. Test the relevance of neuroplasticity (BDNF) and inflammatory parameters to anti-anhedonic, well-being promoting, and brain network dynamic complexity effects. 6. Test the effects of the psychedelic experience on BDNF and inflammatory parameters. Researchers will compare the effects of psilocybin in two separate sessions (one with psilocybin alone, one with co-administration of risperidone) in both patients with depression and anhedonia and healthy control participants. Participants will: * Take 25 mg of psilocybin p.o. in two sessions, in one of the two sessions they will take 1 mg risperidone p.o. before ingestion of psilocybin, to block psilocybin's acute psychedelic effects. * Undergo 3 MRI sessions, one before the first psilocybin session ('baseline') and one session each on the day after each respective psilocybin session. * Perform a variety of tasks during each fMRI session to asses the treatment's effects on anhedonia.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-23", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07490353", "keywords": "Depression - Major Depressive Disorder, Anhedonia, Psilocybin (Usona Institute), Psilocybin, Risperidone 1 MG, Risperidone, Risperdal, MRI, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07490353\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Aging,Wellbeing,Clinical Trial,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3657, "title": "Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies", "normalized_title": "precision phenotyping of behavioral risk and response to electromagnetic and psychedelic therapies", "authors": "University of New Mexico", "abstract": "PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy. For U.S. Service Members, deployment and combat exposure can result in significant mental strain, with high rates of disability and suicide. Unfortunately our ability to predict and treat those at high risk of intentional self-harm is limited. PRE-EMPT (Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies) seeks to transform the assessment and treatment of the spectrum of depression, posttraumatic stress, and self-harm. PRE-EMPT will utilize multimodal neuroimaging, blood-based biomarkers, and predictive analytics to devise highly accurate models of behavioral risk, and to characterize response to three neuroplasticity-enhancing interventions. Background: Rates of suicide have increased 37% since the year 2000 despite concerted governmental and institutional programs to address root causes such as stigma and lack of access. Suicide was the number one cause of active-duty fatality from 2014 to 2019, highlighting the vulnerability of Service Members and Veterans. Suicide is a highly multifactorial event and may be conceptualized as a state in which individuals cannot come up with any other option to endure difficult circumstances or intense feelings, representing failures of cognitive control (CC) and emotion regulation (ER). Similarly, the heritability of suicide risk is well known, and transcriptomics, or the study of transcript molecules such as RNA that regulate gene expression, has potential to reveal mechanisms of risk not fully explained by DNA analysis. Better methods of classifying suicide risk according to objective and measurable factors are needed to proactively identify persons at risk and provide interventions tailored to risk. Research Plan: PRE-EMPT will assemble a cohort of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain baseline clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. In parallel, investigators will mine publicly available databases to identify network nodes and use deep learning techniques on multivariate patterns of brain activation, structural topography, and functional connectivity. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of risk prediction models. PRE-EMPT in three separate arms will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. Assessments will be repeated at post-treatment and at 1, 3, and 6 months after intervention. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects. Each clinical arm will contribute independent insights into mediators of efficacy for the specific interventions and risk groups, while pooling data to identify predictors across the risk spectrum. Specific Aim 1: To construct a neurobehavioral model from structural and functional MRI, clinical, and transcriptomic data that accurately predicts behavioral risk. Specific Aim 2: To test three potential rapid-acting therapies for suicidal ideation and identify mechanistic mediators of response.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-19", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07484906", "keywords": "Suicidal Ideation, fMRI Neurofeedback, Accelerated theta burst stimulation, Psilocybin assisted therapy, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07484906\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,PTSD,Neuroplasticity,Brain Imaging,Mechanism of Action,Biomarkers,Aging,Emotional Processing,Observational Study,Veterans,Safety,Transcriptomics", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3582, "title": "Psilocybin for Treatment-Resistant Depression in Autism: a Pilot Trial With Pre-Post Brain and Cognitive Measurement to Understand Mechanism", "normalized_title": "psilocybin for treatment resistant depression in autism a pilot trial with pre post brain and cognitive measurement to understand mechanism", "authors": "Centre for Addiction and Mental Health", "abstract": "We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized psychotherapy that has previously been used with psilocybin (Agin-Liebes et al., 2020). They will also receive psilocybin at 2 different time points, firstly a safety dose of 10mg, followed by a treatment dose of 25mg. This study design is in accordance with previous studies investigating the use of psilocybin with psilocybin-assisted therapy (PAT) to treat TRD (Carhart-Harris et al., 2016, 2018) Each participant will begin with a screening visit (V1), during which eligibility will be determined through clinical and psychiatric assessments of the participant's physical and mental health. Following confirmation of eligibility, the study procedures will begin. The participant will begin with a 2-4 week tapering period during which they will taper and discontinue any conventional antidepressants. Most conventional antidepressants will require a minimum 2-week tapering period, with the exception of fluoxetine, which will require a 4-week tapering period. Additional time may be added at the discretion of the study investigator. During the tapering period, there will be weekly check-ins with a study psychiatrist by in-person assessment or brief telephone calls to monitor for worsening depression and suicidality. Following the tapering period, participant eligibility will be re-assessed for the eligibility. At Study Visit 2 (Baseline, V2), participants will complete a series of questionnaires and assessments (Table 2) and preparatory therapy with trained study therapists. The participant will also receive a brain MRI scan lasting for about 45 minutes. At Study Visits 3 \\& 4 (V3/V4), participants will receive oral doses of psilocybin (safety dose of 10 mg at V3, treatment dose of 25 mg at V4), to assess the tolerability and efficacy of psilocybin. These sessions will be held one week apart and will last 6 to 8 hours each. These sessions will take place in a pre-decorated treatment room at CAMH. Throughout the entire duration of the dosing sessions, participants will be monitored by a minimum of two trained therapists. At the end of each session, participants will be evaluated for safety by a study psychiatrist before being discharged. Participants will also rate the 11-Dimension Altered States of Consciousness (11D-ASC) at the end of each dosing day when the subjective effects of psilocybin have subsided to a negligible level. In addition, the participant will also receive a second brain MRI scan lasting for about 30 minutes (V3a) following V3 Safety dosing. To reduce participant burden, MRI scan can be completed on the following day or within 1-3 days following safety dosing (V3). The participants will also be required to complete the self-rated questionnaires at this additional MRI assessment. Visit 5 (V5) will be held one day after administration of the treatment dose (V4). During V5 the participants will complete post-treatment clinical and cognitive assessments, alongside the third and final MRI scan (of the main clinical trial design). Participants will also undergo a 1-hour integration therapy session to debrief their experiences the day before. Visit 6 (V6) will be held one week following the treatment dose (V4). During V6 a second 1-hour integration therapy session takes place and all post-treatment clinical assessments will be repeated. Subsequent clinical progress will be evaluated virtually at V7, V8, V9, which will respectively be held 2, 4, and 12 weeks following the treatment session (V4). 10 participants out of 20 participants in the main clinical trial could opt to receive 7 additional brain MRI scans besides the MRI scans at V2, V3a and V5 required in the main clinical trial. These 7 additional scans will be assessed at V1, in the middle of medication washout/tapering period V6, V7, V8, 8 weeks following the treatment dose (V4), and V9, respectively. At each optional MRI visit, self-rated assessments will also be collected.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-19", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06731621", "keywords": "Treatment Resistant Depression, Autism Spectrum Disorder, Psilocybin, Psilocybin-Assisted Therapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06731621\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Consciousness,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3643, "title": "Pilot Study of Psilocybin-assisted Treatment for Cannabis Use Disorder", "normalized_title": "pilot study of psilocybin assisted treatment for cannabis use disorder", "authors": "Johns Hopkins University", "abstract": "This pilot study will evaluate the therapeutic potential of psilocybin in people with Cannabis Use Disorder (CUD). This study will examine the impact of psilocybin treatment on cannabis use and related variables in 12 people with CUD. This is an open-label proof-of-concept trial in which participants will complete a 12-week course of study treatment including two psilocybin sessions with psychological support, and follow-up assessments 3 and 6 months after the first psilocybin session. This pilot study will evaluate the therapeutic potential of psilocybin to produce significant reduction in cannabis use compared to pre-treatment in a sample of 12 treatment-seeking patients with Cannabis Use Disorder (CUD). Upon enrollment, participants will complete a 12-week course of study treatment including two psilocybin sessions, with follow-up assessment 3 and 6 months after the first psilocybin session. After 4 weekly preparatory meetings including a targeted cognitive behavioral therapy (CBT) intervention for CUD, participants will receive a moderately high dose (25mg) of psilocybin in week 5 of the 12-week counseling, and either another moderately high dose (25mg) or a high dose (35mg) in week 7. After each psilocybin session, participants will complete a follow-up meeting within 3 days (i.e. integration meeting), as well as continued weekly meetings through week 12. Participants will complete post-session assessments in approximately weeks 12 (End of Treatment), 17 (3 months after 1st psilocybin session, and 29 (6 months after 1st psilocybin session). Some study meetings may be held virtually via a secure web-based video conference platform (e.g., Zoom). Self-reported cannabis use and biomarkers of recent use will be assessed at baseline (screening), weekly throughout the 12-week intervention, and at approximately weeks 17 (3 months after 1st psilocybin session), and 29 (6 months after 1st psilocybin session).", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-17", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06660381", "keywords": "Cannabis Use Disorder, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06660381\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Biomarkers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3641, "title": "Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study", "normalized_title": "safety and efficacy of psilocybin assisted psychotherapy for demoralization syndrome in patients diagnosed with advanced stage cancer a pilot study", "authors": "Gustavo Vazquez", "abstract": "Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-17", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06818994", "keywords": "Demoralization, Safety, Psilocybin-assisted Psychotherapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06818994\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Aging,Clinical Trial,Cancer Patients,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3540, "title": "Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial", "normalized_title": "evaluating the role of psilocybin monitors in psilocybin therapy for treatment resistant depression a pilot randomized clinical trial", "authors": "Centre for Addiction and Mental Health", "abstract": "Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression. Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-17", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07211438", "keywords": "Treatment-Resistant Depression, Psilocybin, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07211438\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Randomized Controlled Trial,Treatment-Resistant Depression", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3604, "title": "Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease", "normalized_title": "pilot study of serotonin 2a receptor 5 ht2a agonist psilocybin for depression in patients with mild cognitive impairment or early alzheimer s disease", "authors": "Johns Hopkins University", "abstract": "This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quality of life in those individuals. This is a pilot study evaluating the potential efficacy of psilocybin to produce improvement in depression compared to pre-treatment in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD) and clinically significant symptoms of depression. The study will be an open-label trial in a sample of up to 20 treatment-seeking participants with a diagnosis of MCI or early AD. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg/70 kg in week 4 and 15 or 25 mg/70 kg in week 6), with follow-up assessments up to 6 months after the final psilocybin session. The study will assess changes in depressed mood at 1 week after the second psilocybin session compared to pre-treatment, and quality of life in participants from pre- to post-treatment.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-15", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04123314", "keywords": "Depressive Symptoms, Depression, Alzheimer Disease, Mild Cognitive Impairment, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04123314\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Receptor Pharmacology", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3493, "title": "Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder", "normalized_title": "psilocybin treatment of major depressive disorder with co occurring alcohol use disorder", "authors": "Johns Hopkins University", "abstract": "The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The objectives of this double-blind, placebo-controlled study are to test the hypotheses that a single high (25 mg) oral dose of psilocybin will lead to enduring reductions in depressive symptoms (as measured by the clinician-rated grid version of the Hamilton Depression Rating Scale, or GRID-HAMD) and amount of drinking (as measured using the Time Line Follow Back, or TLFB, procedure) compared to placebo in patients with co-occurring MDD and AUD. 90 male and female volunteers who are between the ages of 21 and 65 years old and who meet Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria for MDD and AUD will be recruited from the community and complete all study procedures. Volunteers will be randomized to one of two study arms (psilocybin \\[N=45\\] or placebo \\[N=45\\]), and will complete a drug administration session paired with a brief Motivational Interviewing intervention for alcohol use. Volunteers will undergo assessments of depression and alcohol use before and after treatment. After primary endpoints are measured, all volunteers will receive a second, unblinded intervention with a single high dose of psilocybin (25 mg) to test a secondary hypothesis that two doses of psilocybin are more effective in treating MDD with co-occurring AUD than a single dose.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-12", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04620759", "keywords": "Major Depressive Disorder, Alcohol Use Disorder, Psilocybin, 4-phosphoryloxy-N,N-dimethyltryptamine, Placebo, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04620759\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Addiction,Healthcare Workers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3599, "title": "Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health", "normalized_title": "exploratory study of the effects of low dose psilocybin on sensory processing neurophysiological arousal and emotional health", "authors": "University of Alabama at Birmingham", "abstract": "The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of \"microdoses\" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship). Individuals who call research staff will undergo an initial telephone screen that will determine eligibility. Week 1: Baseline Intake Appointment. Those who are eligible to participate on the basis of the telephone screen and provide informed consent will then complete a standard demographic questionnaire, a detailed psychiatric interview, and provide a urine sample for confirmation of substance abstinence and pregnancy status. Participants will then be administered a detailed medical history interview and physical examination including EKG and blood panel. Week 2: Orientation. Participants who are medically eligible to participate will be scheduled for a psychoeducational orientation session that further explains the rationale of the study, and summarizes the study logistics. Participants will complete a number of baseline questionnaires and neuropsychological assessments at this time. Week 3: Drug administration #1. In a between-groups design, participants will be randomized to receive 0 mg, 1 mg, 2.5 mg, or 5 mg of psilocybin at five weekly 6-hour long drug administration sessions. Dose will remain constant for each participant at each drug administration session. At Drug Administration #1 and all subsequent drug administration sessions, participants will complete visual analogue scale (VAS) questions drawn from different sources that include drug abuse liability measures. These VAS questions will be administered at drug administration baseline and every 30 minutes thereafter through the end of acute effects at 6-hrs post-baseline. Research staff will complete a number of observational assessments at similar intervals. Blood pressure will be assessed at regular intervals via automatic blood pressure monitor (i.e., at baseline and at 30, 60, 90, 120, 180, 240, and 360 min post-baseline), and medication for the treatment of acute hypertension will be administered should blood pressure exceed 200 systolic and/or 110 diastolic. At peak drug effects (2 hr post-baseline), a number of measures will be administered, each differing by drug administration session. At Drug Administration #1, participants will undergo two electroencephalogram (EEG) tasks (with assessments at baseline serving as pre-drug control values). At 6-hr post-baseline, participants will complete self-report measures assessing the subjective experience. These questionnaires will be administered at the conclusion of each drug administration session. Participants will then be administered a brief semi-structured qualitative interview designed to probe the nature of their experience. All participants will be required to arrange for transportation home from the CRU; participants will not be allowed to drive themselves after drug administration sessions. Week 4: Drug Administration #2. This session will be identical to Drug Administration #1, however, at peak drug effects, participants will complete two new EEG tasks (with assessments at baseline serving as pre-drug control values). Week 5: Drug Administration #3. This session will be identical to prior drug administration sessions, however, at peak drug effects, a neuropsychological measure will be administered. Week 6: Drug Administration #4. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure. Week 7: Drug Administration #5. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure. At the conclusion of this measure, subjects will undergo an EEG assessment (with an assessment at baseline serving as a pre-drug control value). Week 8: Study Termination. This session will comprise completion of the same questionnaires that were previously completed at baseline as well as a semi-structured qualitative interview. EKG will be repeated at study termination. It is noted that over the duration of the study, every day participants will be asked to complete some brief self-report measures and a resting state EEG via a smartphone app.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-10", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05227742", "keywords": "Demoralization, Psilocybin, Placebo, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05227742\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Microdosing,Emotional Processing,Mystical Experience,Observational Study,Abuse Liability", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3517, "title": "Psilocybin-facilitated Treatment for Chronic Pain", "normalized_title": "psilocybin facilitated treatment for chronic pain", "authors": "University of Alabama at Birmingham", "abstract": "The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients. Participants will be randomized to two groups: Psilocybin or Active Placebo. Those in the Psilocybin condition will receive.36 mg/kg of psilocybin. Based on previous research,.36 mg/kg of psilocybin is expected to balance the intention to increase the probability of having a full mystical-type experience against the odds of having a subjectively challenging psychological experience. Those in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). DXM was selected as the placebo drug in the current study because its subjective and behavioral effects at higher doses can resemble those of classical hallucinogens. Participants will be blinded to what drug they are administered. Participants will be unblinded at the end of the study. Participants will attend between 7 to 9 study sessions to complete the protocol. Interested individuals who call research staff will undergo an initial telephone prescreen by a trained member of the research staff: the study aims, protocol, and any possible risks will be described and a series of questions will be asked to determine interest and eligibility for screening for the study. Initial eligibility may also be assessed via an online questionnaire through Qualtrics. Qualified participants will be scheduled for an in-person screening. In-person screening sessions will be conducted by the PI or trained research staff. Individuals will first undergo informed consent; the consent form will describe the necessary eligibility confirmation that takes place before proceeding with the full study. A physical examination, a detailed psychiatric interview, several self-report questionnaires, and a detailed medical history will be completed at the screening session, which takes place at the UAB Clinical Research Unit. Participants will also have their blood drawn for screening tests. Study staff will provide participants with a hand-held tablet device and instructions on how to complete the daily symptom questionnaire via the tablet. They will be asked to begin reporting daily symptoms on their tablet from home that evening. Eligible participants will be contacted by study staff by phone to inform them of their eligibility. All participants will undergo at least 2 weekly preparation sessions of approximately 2 hours each, with the possibility of 1-2 additional weekly preparatory sessions per the discretion of the investigator. These sessions are to educate participants on the study protocol, psilocybin administration, and study treatment rationale. Participants will be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group following their final preparation session. One week after the final preparation session, participants will be instructed to eat a low-fat breakfast prior to presenting for their drug administration session at 8:00 am, approximately 1 hour before drug administration. A urine sample will be collected to verify drug-free and non-pregnant status and participants will be encouraged to relax and reflect before drug administration. The drug administration session will take place over the course of 8 hours. The guide and secondary monitor will be present with and monitor participants throughout this session (at least one individual will always be present with the participant, even during brief intervals when the guide or monitor may be using the restroom). Participants will be monitored for physical symptoms of distress and encouraged to report any symptoms experienced. Blood pressure will be assessed pre-administration via automatic blood pressure monitor, and will also be assessed at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-administration. Eight hours after drug administration, when the major drug effects have subsided, participants will complete questionnaires assessing their experience. Participants will then be released into the care of a friend or family member oriented to be emotionally supportive of the participant (as arranged during preparation sessions) and instructed not to drive an automobile or engage in any other potentially dangerous activity for the remainder of the day. Participants will be provided with the guide's contact information by phone should they feel the need for support that evening. An immediate post-session meeting will be held the day following the drug administration session. Participants will meet with the guide for approximately 2 hours to discuss and reflect on their experience. A final study visit will take place approximately 6 weeks later; some questionnaires that were administered at Visit 1 will be administered again at the final visit. At the conclusion of the final study visit, participants will be debriefed.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-10", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05068791", "keywords": "Fibromyalgia, Primary, Psilocybin, Dextromethorphan, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05068791\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Chronic Pain,Personality Change,Emotional Processing,Mystical Experience,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3473, "title": "Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study", "normalized_title": "safety feasibility and tolerability of psilocybin treatment for individuals with functional impairment related to mood anxiety trauma and or addiction symptoms an open label proof of concept study", "authors": "Yale University", "abstract": "The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months. In this Phase 1b proof-of-concept clinical trial, the investigators aim to investigate the safety, feasibility, and tolerability of treatment of oral psilocybin in participants with functional impairment due to depressive, anxiety, trauma addictive, or other psychiatric symptomatology, allowing for comorbidity and diagnostic complexity to mirror potential real-world clinical scenarios. Secondarily, The investigators will assess improvement in functional status and symptomatology. The investigators will employ an open-label study design, with participants receiving one dose of oral psilocybin. This is an open-label clinical trial with a single treatment arm and no blinding. All participants will receive 25 mg of oral psilocybin. All dosing will be accompanied by non-directive support before, during, and after treatment sessions.The rationale for conducting this study lies in recognizing that the narrow inclusion and exclusion criteria commonly employed in clinical trials may raise issues of external validity. While previous research has predominantly focused on specific diagnostic categories, our study aims to address these limitations by exploring the safety, feasibility, and tolerability of psilocybin in a heterogeneous population. This study also recognizes the importance of symptom-related functional impairment as a cross-cutting construct relevant to all diagnostic categories.This is a Phase 1b open-label clinical trial to determine the feasibility, tolerability and safety of psilocybin to reduce psychiatric symptoms in participants experiencing functional impairment. Participants will receive one dose of oral psilocybin (25mg). Follow-up visits for assessments and measures at 1-week, 4-week, and 6-week post psilocybin dosing. Long-term follow-up visits assessments and measures for participants who consent to long-term follow-up (reassessments of study measures) for 3-month, 6-month, and 12-month post dosing. Psilocybin (4-hydroxy-N,N-dimethyltryptamine) occurs in nature in many species of mushrooms, including the genera Psilocybe, Conocybe, Gymnopilus, Panaeolus, and Strophparia. Its chemical formula is C12H17N2O4P. Psilocybin is a potent agonist at 5-HT2A/C receptors; potency of binding by related compounds to these receptors correlates with human potency as hallucinogens. Psilocybin is currently a Schedule I substance. Psilocybin will be orally administered in this study. Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg. Descriptives for all safety measures (e.g., C-SSRS total and subscale scores, vitals, documented adverse events) will be compiled at all assessment intervals. Classification of adverse events will follow institute and regulatory body guidelines. Subsequent summary descriptives may focus on safety indices surrounding the dosing session and 1-week, 4 weeks, and 6-weeks after dosing. In addition, The investigators will perform descriptives and non-parametric analysis screen failure rates (including analysis of ineligibility), drop out rates pre and post dosing to determine feasibility and tolerability.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-10", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06442423", "keywords": "Transdiagnostic, Depression - Major Depressive Disorder, Anxiety, PTSD Symptoms, PTSD, Substance Use, Substance Use Disorder (SUD), OCD, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06442423\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,PTSD,Addiction,OCD,Receptor Pharmacology,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3654, "title": "An Open-Label, Phase 1 Study of the Safety Pharmacokinetic Profile, and Preliminary Efficacy, of Organic Whole Psilocybin-Containing Mushrooms in Patients Suffering From PTSD", "normalized_title": "an open label phase 1 study of the safety pharmacokinetic profile and preliminary efficacy of organic whole psilocybin containing mushrooms in patients suffering from ptsd", "authors": "Suzanne \"Sue\" Sisley MD", "abstract": "This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study. Each participant will ingest psilocybin from dried mushrooms in a chocolate formulation.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-08", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07275970", "keywords": "PTSD, Psychedelic, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07275970\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "PTSD,Pharmacology,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3626, "title": "The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults", "normalized_title": "the therapeutic potential of psilocybin in anorexia nervosa in young adults", "authors": "Region Skane", "abstract": "The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa. Background and Rationale Anorexia Nervosa (AN) is one of the most lethal psychiatric disorders, with mortality rates approximately five times higher than that of the general population. AN affects multiple organ systems due to severe weight loss and malnutrition and hence leads to a substantial decline in health-related quality of life. While psychotherapies have shown partial efficacy, data suggest that only 46% of patients recover within four years, and 20% remain chronically ill. Relapse rates exceed 50% among those who recover, underscoring the need for more effective treatments. Research suggests that several psychological factors, such as challenges in regulating emotions, black-and-white thinking, mental rigidity, and a limited capacity for mentalization may contribute to the persistence of severe, chronic anorexia nervosa. The age of onset for AN typically shows a bimodal distribution, peaking at 14 and 18 years of age, motivating the design of including patients as young as 16 years old in this study. Psilocybin, a serotonergic psychedelic compound, primarily acts as an agonist of the 5-HT2A receptor, inducing profound effects on cognition, emotion, perception, and self-awareness. Although research on psilocybin remains limited, clinical trials across psychiatric disorders suggest its potential therapeutic benefit. For example personality changes such as increased openness, have been observed to persist up to a year following a single high dose. The inclusion of 16-17-year-olds in this study is particularly novel, as research on psychedelic therapy in adolescents and young adults remains scarce. Emerging evidence highlights how psychedelics may benefit AN patients, such as enhanced serotonin signaling and cognitive flexibility. The ability of psychedelics to foster cognitive flexibility, a well-documented phenomenon, is considered a key factor in therapeutic processes. This is especially relevant for AN, where rigid thinking and behavior contribute to treatment resistance. One pilot study demonstrated that a 25 mg psilocybin dose, combined with psychological support, was well-tolerated by female AN patients with a body mass index (BMI) \\>16. The study reported significant reductions in eating disorder symptoms at one month post-treatment, with only mild and transient adverse events. Recent studies indicate that psilocybin induces significant changes in brain function and network organization across key regions. Notably, psilocybin disrupts connectivity in the default mode network by causing desynchronization across spatial scales. These findings suggest a neurobiological basis for psilocybin´s therapeutic effect. However, further research is needed to elucidate long-term effects, particularly in clinical context. Functional magnetic resonance imaging (fMRI) has demonstrated utility in detecting neuronal abnormalities in AN. This study's use of fMRI before and after psilocybin treatment will provide critical insights into the neurobiological impacts of psilocybin on AN. Brain-Derived Neurotrophic Factor (BDNF) is a protein that plays a crucial role in neuroplasticity. Preclinical studies show that psilocybin promotes neuritogenesis and synaptic plasticity, potentially via increased cortical BDNF expression. Given that individuals with AN exhibit reduced serum BDNF levels, this study will assess changes in BDNF pre- and post-treatment to elucidate psilocybin's impact on neurobiological mechanisms. These insights may advance treatment optimization and efficacy predictions for AN patients. Study Objectives Primary Objective is to assess the safety and tolerability of psilocybin 25 mg in young adults (16-35 years old) with anorexia nervosa. Secondary objectives include evaluating the efficacy of psilocybin with psychological support in reducing AN symptom compared to treatment as usual (TAU), investigate potential mechanisms of action through self-report questionnaires, neuroimaging and BDNF analysis, and conduct qualitative analysis of subjective experiences. Neuroimaging will investigate changes in brain resting state connectivity (measured by fMRI), and commonly used task-based fMRI paradigms. The task-based paradigms will involve food-related conditions, commonly used in the population (Celeghin et al., 2023; Bronleigh et al., 2022) as well as established paradigms involved in processing reward anticipation (Knutson et al., 2000; Ventorp et al 2022) Trial Design and Procedures This is a phase II, open-label, randomized controlled trial with two arms: 1. Active treatment arm; Two dosing sessions with psilocybin 25mg with psychological support alongside TAU. 2. Active comparator control arm; TAU only. The study will include 40 participants, 20 in each group. If the active treatment arm is determined to be safe, tolerable, and preliminarily effective during the follow-up assessment, participants in the control group will have the option to switch to the active treatment while maintaining their usual specialized care. The switch to psilocybin treatment will follow the same preparation, dosing, and integration protocols as outlined for the intervention group. This design minimizes ethical concerns regarding withholding a potentially effective treatment. Participants will be randomly assigned (1:1) to either the intervention or control group. Block randomization stratified by age group (16-18 and 19-35 years) will ensure balanced representation. Given the small sample size of 40 participants (20 per group), the statistical power to detect between-group differences is inherently limited, irrespective of blinding. As such, the trial is appropriately designed as a pilot study, with a primary focus on assessing safety, feasibility, and tolerability. To enhance interpretation, qualitative and neurobiological measures are also included. A formal power calculation was not conducted, in line with the exploratory nature of the study. The sample size was determined based on practical feasibility and aligns with current recommendations for early-phase trials of novel interventions. A post-hoc power analysis will be conducted to evaluate whether the sample size was sufficient to detect clinically meaningful changes in the primary outcomes. Details on location and Data Collection Methods All procedures will be conducted at the University Hospital for Psychiatry, Baravägen 1, Lund, except the fMRI assessments which are performed at the The National 7 Tesla (7T) Facility in Lund. All assessments will be carried out by qualified personnel appointed by the principal investigator, including medical doctors, nurses, and psychologists. The National 7T Facility will appoint qualified personnel for fMRI assessment. The duration of the entire trial is from the first screening of the first patient to the last follow up of the last patient. For each patient participant, the duration of the trial is from the screening to the last follow up at week 52 (12 month). Patient rehospitalization and additional interventions data are collected in patient journal registers. Pre-Study Activity Following ethical approval, a focus group will be conducted with patients with anorexia nervosa in two different groups, one aged 16-18 and one 19-35 years. The purpose is to provide study information, gather feedback on the clarity and ethical aspects of the protocol, and identify ways to improve potential benefit. Input from this focus group will inform study quality, recruitment materials, communication strategies and ethical aspects of psilocybin research experienced by the population. Any amendments based on this will be processed according to CTIS protocol. Screening Phase Screening includes psychiatric and medical history, inclusion/exclusion criteria assessment, safety blood tests (glucose, liver, kidney), electrocardiogram (ECG), informed consent (with a 2-week consideration period), pregnancy test and urine toxicology (U-tox). The time from screening to the first psilocybin dose must not exceed 8 weeks, regardless of washout status. Potential participants will be screened by a psychiatric clinician appointed by the principal investigator to ensure eligibility and understanding of the study requirements. Preparation Phase Preparation Session 1 \\& Baseline Assessment (Week -1): Psychoeducation about psilocybin, breathing and relaxation techniques, rapport-building with therapists, and discussion of expectations and concerns. Includes full baseline assessments (list provided as attachment to protocol: * Expectation of Treatment Scale (ETS-BF) * Readiness and Motivation Questionnaire (RMQ) * General Change Mechanisms Questionnaire (GCMQ) * Patient Health Questionnaire (PHQ-9) * Generalized Anxiety Disorder scale (GAD-7) * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * Life Satisfaction Scale (LS) * Positive and Negative Affect Schedule (PANAS) * Harmony in Life Scale (HILS) * Ten Item Personality Inventory (TIPI) * Honesty-Humility Scale (HH) Vital signs, ECG, fasting glucose, urine drug screening, fMRI, BMI, metric assessment of body size perception and blood sampling for BDNF and safety labs are also conducted. Preparation Session 2 (Week 0): 7-10 days after Preparation 1, and 2-3 days before psilocybin dosing. Dosing and Integration Phase Dosing Session 1 (Week 0): Psilocybin 25 mg under therapeutic support with ECG and blood pressure/pulse monitoring. Integration Session 1 (Day after Dosing 1): Reflection, fMRI, blood sampling (including glucose, liver, kidney, BDNF), and reassessments with RMQ, GCMQ, PHQ-9, GAD-7, C-SSRS, BPRS+, LS, PANAS, HILS, TIPI, ECG and blood pressure/pulse. Psychedelic Experience related scales; Altered States of Consciousness Rating Scale (5D-ASC), Mystical Experience Questionnaire (MEQ-4), Meaningful Life Experience Rating (MLE). Integration Session 2 (Week 1): Continued psychological integration support. Integration Session 3 (Week 2-3): Summary of first dosing experience and preparation for second dosing. Dosing Session 2 (Week 4): Second psilocybin 25 mg administration under identical conditions as first dosing session. Integration Session 4 (Day after Dosing 2): Reflection, blood sampling (including glucose, liver, kidney, BDNF), and reassessments with RMQ, GCMQ, PHQ-9, GAD-7, C-SSRS, BPRS+, LS, PANAS, HILS, TIPI, ECG and blood pressure/pulse. Psychedelic Experience related scales; Altered States of Consciousness Rating Scale (5D-ASC), Mystical Experience Questionnaire (MEQ-4), Meaningful Life Experience Rating (MLE). Integration Session 5 (Week 5-6): Final integration session and preparation for long-term follow-up. Primary Endpoint (Week 8) Includes full safety and outcome evaluations: * fMRI * blood sampling (including glucose, liver, kidney, glucose, BDNF) * Vital signs, ECG, U-tox * BMI * Metric assessment of body size perception * Adverse Event/Serious Adverse Event (AE/SAE) monitoring * Readiness and Motivation Questionnaire (RMQ) * General Change Mechanisms Questionnaire (GCMQ) * Patient Health Questionnaire (PHQ-9) * Generalized Anxiety Disorder scale (GAD-7) * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * Life Satisfaction Scale (LS) * Positive and Negative Affect Schedule (PANAS) * Harmony in Life Scale (HILS) * Ten Item Personality Inventory (TIPI) * Honesty-Humility Scale (HH) Intensive Follow-Up Phase (Week 8-24) Follow-up visits at Week 12, 16, and 20 include: * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * AE/SAE monitoring * BMI, blood pressure, ECG * Fasting glucose, U-tox 6-Month Follow-Up (Week 24) Same as primary endpoint assessments, including: * blood sampling (including glucose, liver, kidney, BDNF) * Vital signs, ECG, U-tox * BMI * Metric assessment of body size perception * AE/SAE monitoring * Readiness and Motivation Questionnaire (RMQ) * General Change Mechanisms Questionnaire (GCMQ) * Patient Health Questionnaire (PHQ-9) * Generalized Anxiety Disorder scale (GAD-7) * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * Life Satisfaction Scale (LS) * Positive and Negative Affect Schedule (PANAS) * Harmony in Life Scale (HILS) * Ten Item Personality Inventory (TIPI) * Honesty-Humility Scale (HH) Extended Follow-Up Phase (Week 24-52) 9-Month Follow-Up (Week 36) * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * AE/SAE monitoring * BMI, blood pressure, ECG * Fasting glucose, U-tox 12-Month Final Follow-Up (Week 52) * Eating Disorder Examination Questionnaire (EDE-Q ) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Brief Psychiatric Rating Scale - Extended (BPRS+) * Patient Health Questionnaire (PHQ-9) * Generalized Anxiety Disorder scale (GAD-7) * Ten Item Personality Inventory (TIPI) * Meaningful Life Experience Rating (MLE). * AE/SAE monitoring * BMI, blood pressure, ECG * Fasting glucose, U-tox Participants who show signs of psychological or physical deterioration at any point during the study between follow-ups are instructed to contact the research team at any time and will be offered additional assessment and support. Description of Psilocybin Administration and Psychological support Psychological support includes a non-directive preparation and integration pre- and post-dosing sessions according to protocol manual, alongside support for the patient on the dosing session day. The study follows the guidelines for safe research with psychedelics. Preparation session will include psychoeducation of the effects of psilocybin, breathing techniques, getting to know the two therapists (one male and one female). A standardized preparation script will ensure consistency across participants. The two integration sessions following each dosing session last 1-2 h and focus on exploring the session's effects and offer support in integrating the experience. Integration sessions will include structured discussions about insights gained, with therapists facilitating connections between the experience and the participant's therapeutic goals. The therapists couple will contain at least one licensed healthcare personnel (psychologist, nurse, physiotherapist or physician). The assistant therapist can be non-licensed healthcare personnel experienced with the anorexia nervosa population, such as a healthcare assistant. All psychological support therapists must have done all specific 5-day training in the psiAN manual. Dosing session day The dosing session, lasting 6-8 hours, is supported by the therapists introduced during preparation sessions. The psilocybin's acute effects persist for 4-6 hours, recorded via video and audio. Participants, lie down with an optional eye mask, experience the session in a comfortable room with a pre-selected music playlist, respecting individual preferences. Therapists provide support and guidance if requested but with minimal psychotherapeutic focus. Therapists will follow pre-established protocols for de-escalation and grounding in case of distressing experiences. Parents are introduced at the session's end with participant approval. During the dosing session, a medically trained study doctor will be available, equipped for emergencies in the unlikely event of serious adverse events related to psilocybin risks. Biological Sampling Procedures Blood samples will be collected for the analysis of Brain-Derived Neurotrophic Factor (BDNF) as the primary biomarker and for tolerance and safety measurements. Additionally, we aim to collect one tube of additional whole blood per occasion for future analysis. BDNF samples will be taken at five key time points: (1) before treatment (baseline), (2) and (3) at first integration session after Psilocybin 25mg dosing, (4) at 8 weeks, and (5) during the 6-month follow-up. This ensures comprehensive longitudinal data collection. Blood samples of glucose, kidney and liver status will be measured at the same time points as above for safety and tolerance reasons. None of these blood samples are collected or stored. All blood samples are done by a standard peripheral venous sampling method performed by a nurse at the research facility at the university hospital clinic for psychiatry at Baravägen 1, Lund. Procedures will be implemented to minimize discomfort during blood collection, such as using pediatric needles for younger participants when necessary. Blood collection and processing will follow standardized protocols to ensure sample integrity. Discontinuation from the Clinical Trial A participant will be discontinued entirely from the clinical trial (i.e., all further participation and follow-up will end) only under the following condition: Withdrawal of informed consent at any time, for any reason, without the need to justify. Discontinuation from the Intervention (Dosing) Participants may be discontinued from the intervention (i.e., psilocybin administration - first or second dose), without being excluded from the trial. Participants will be encouraged to continue with follow-up assessments unless they explicitly withdraw consent. This approach allows for continued safety and data collection in accordance with the intention-to-treat principle. Reasons for discontinuing intervention may include: * Development or discovery of exclusion criteria after inclusion (e.g. new psychiatric diagnosis, pregnancy). * Emergence of a serious adverse event (SAE) or medical condition that, in the investigator's judgment, makes continued treatment unsafe. * Initiation of treatment with prohibited medication according to protocol. * Failure to adhere to critical aspects of the study protocol (e.g. repeated missed visits, non-compliance with preparation or safety procedures). * Investigator decision in consultation with the medical monitor. The reason for discontinuation will be documented. Participants will be offered a final follow-up visit when appropriate. Non-compliance to fMRI will not lead to study exclusion nor discontinuation of the intervention. Methods for Measurement of Endpoints for Clinical Safety Continuous clinical safety monitoring will be performed by licensed healthcare professionals at Lund University Hospital throughout the trial, from baseline to the final 12-month follow-up. The safety evaluations cover physical, biochemical, and psychological parameters relevant to psilocybin administration. Measurements for assessing clinical safety will include blood samples of hepatic and renal function, glucose, urine toxicology, cardiovascular parameters, assessment of suicidality, assessment of mental health symptoms and and assessment of Adverse Events/Serious Adverse Events/Suspected Unexpected Serious Adverse Reactions (AE/SAE/SUSARs). Assessment of Adverse Events Participants are instructed to contact the research team during daytime hours for urgent concerns. Outside of study hours, they are directed to seek emergency services. Events will be assessed by the clinical team for causality, intensity, and seriousness and potential relationship to treatment (psilocybin 25mg). The investigator is responsible for determining whether there is a causal relationship between the AE/SAE and use of the investigational medicinal product. Consideration should be given to whether there is a reasonable possibility of establishing a causal relationship between the adverse event and the investigational medicinal product based on the analysis of the available evidence. All AE can be categorized as either likely related, possibly related, unlikely related or not related. Those AEs which are suspected of having a causal relationship to the investigational medicinal product will be followed up until the subject has recovered or is well taken care of and on the way to good recovery. Each adverse event shall be classified by an investigator as mild, moderate or severe. Follow-up of Adverse Events Follow-up visits will be scheduled for all participants experiencing AEs to ensure resolution and ongoing safety. Participants with unresolved AEs at the end of the trial will be monitored until resolution or stabilization. For SAEs, additional follow-ups will be scheduled at least every two weeks until resolution. The frequency can be changed by the Safety Review Committee or Principal Investigator. Procedures in Case of Emergencies and Overdose Emergency protocols are in place, including immediate medical care and monitoring. In case of an overdose, the participant will be transferred to an emergency facility. Emergency kits, including benzodiazepines for anxiety or seizures, will be available during all dosing sessions. Pregnancy Management Participants who can become pregnant must use a highly effective form of contraception during the study and for two months after the last psilocybin dose. Approved methods include hormonal contraception, IUDs, sterilization, vasectomized partner, or abstinence. Urine pregnancy tests will be done at screening, before each psilocybin session, and as needed during follow-up. Psilocybin's effects on pregnancy are unknown. To reduce possible risks, strict contraception and testing protocols are required. Interim Analysis Following two administration sessions of 25mg psilocybin, a panel of three senior psychiatrists, who are not part of the research team, will conduct an evaluation of the safety data and adherence to the protocol. This analysis will be repeated after a total of 20 psilocybin administrations have been completed. After 25 patients over 18 have been through dosing sessions, patients 16-17 will be recruited. Methods for Measurement of Endpoints for Clinical Efficacy Composite Relapse Endpoint: BMI Decrease: Measured at baseline, 8 weeks, and 6 months using calibrated equipment and standardized protocols. Hospitalization Data: Collected through patient reports and confirmed by medical records. Symptom Deterioration: Assessed using validated tools such as the EDE-Q6.0 and clinical interviews conducted by trained staff. Clinical Intervention Use: Recorded in patient files, including initiation of new treatments during follow-up. Statistics Analysis Population Both the Intention-to-treat (ITT) and per-protocol populations will be analyzed. ITT analysis will include all participants who are randomized, regardless of protocol adherence, to ensure generalizability. Per-protocol analysis will focus on participants who completed the study as planned, ensuring the assessment of efficacy under ideal conditions. Statistical Analyses Primary Baseline Analyses: The primary analyses will involve descriptive statistics for demographic and baseline characteristics, ensuring comparability across groups, and control for follow-up measurements. Primary Endpoints analysis We will analyze differences in the number of participants and severity experiencing adverse event/serious adverse event (AE/SAE) between the groups standardized forms for AE/SAE capturing: Event description, Start and end dates, Severity (e.g., mild, moderate, severe), Relatedness to intervention (assessed by safety review committee), Action taken. The primary statistical methods will be: Descriptive Frequencies and Percentages. Comparing Proportions (Most Common for \"Incidence\") (Chi-squared test (or Fisher's Exact Test): Fisher's exact test is preferred for small cell counts (\\ 1 would indicate a higher risk in the intervention group. Comparing Severity and Relatedness is assessed with Mann-Whitney U test or Student t-test to compare severity distributions between groups. Secondary Endpoints: For secondary endpoints (e.g., changes in fMRI connectivity, BDNF, rating scales), group comparisons, including t-test, Analysis of Variance (ANOVA), and Repeated Measures ANOVA will be utilized. When controlling for variables such as individual differences, ANCOVA or Multivariate Analysis of Covariance (MANCOVA) will be utilized. Principal component analysis (PCA) or independent component analysis (ICA) may be applied to identify patterns in fMRI data. Endpoints include longitudinal between- and within-person analyses. When dichotomous (binary) outcome variables: Binary outcomes (e.g., remission, response rates) will be analyzed using logistic regression models, adjusting for baseline characteristics such as age, baseline BMI, and symptom severity. The odds ratios and 95% confidence intervals will be reported. When continuous (dimensional) variables (e.g., BMI, BDNF levels, cognitive flexibility) will be analyzed using linear mixed-effects models, and regression models of various types. Other: Exploratory Subgroup Analyses: Exploratory subgroup analyses will assess treatment effects across different strata (e.g., age groups, baseline severity) using interaction terms in regression models or stratified analyses to explore heterogeneity in treatment responses. Other: Sensitivity Analyses: Sensitivity analyses will address missing data using methods such as multiple imputation or maximum likelihood estimation. These methods ensure robustness of the findings by accounting for the potential impact of missing data on primary and secondary outcomes. Adjustment of Significance and Confidence Interval A Bonferroni correction or false discovery rate (FDR) adjustment will be applied for multiple comparisons to control Type I error. Results will be presented with 95% confidence intervals, and significance will be set at a two-tailed p-value of \\", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-05", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07169747", "keywords": "Anorexia Nervosa, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07169747\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Eating Disorders,Neuroplasticity,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Default Mode Network,Consciousness,Biomarkers,Aging,Personality Change,Emotional Processing,Mystical Experience,Clinical Trial,Randomized Controlled Trial,Review Article,Animal Study,Adolescents,Healthcare Workers,Safety,Adverse Events,Toxicity,Drug Interactions", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3598, "title": "Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.", "normalized_title": "pilot proof of concept study evaluating the potential psilocybin assisted psychotherapy pap as a therapeutic tool for patients suffering from severe irritable bowel syndrome", "authors": "NYU Langone Health", "abstract": "This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session with single 25 mg oral \"high\" dose of psilocybin or a single 100 mg dose of niacin (active placebo) and attend 4 post-therapy integration sessions.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06760533", "keywords": "IBS - Irritable Bowel Syndrome, Psilocybin 25 mg, Psychotherapy Treatment Session, Niacin 100 mg, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06760533\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Randomized Controlled Trial", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3497, "title": "Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial", "normalized_title": "examining the safety and clinical efficacy of psilocybin therapy for veterans with ptsd an open label proof of concept trial", "authors": "Ohio State University", "abstract": "The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans. The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD. This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-03", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05554094", "keywords": "PTSD, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder, Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05554094\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Veterans,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3616, "title": "A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.", "normalized_title": "a phase 2b double blind randomized low dose comparator controlled clinical trial to assess the efficacy and safety of npx 5 in psilocybin assisted psychotherapy for the treatment of adjustment disorder associated with cancer", "authors": "Psyence Australia Pty Ltd", "abstract": "This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day). At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis. This is a randomized, double-blind, low-dose comparator-controlled Phase IIb study to investigate the efficacy and safety of PAP with 25 mg, 10 mg and 1 mg \\[low-dose comparator) NPX-5, for the treatment of adjustment disorder symptoms in participants diagnosed with cancer. The referring oncologist will indicate that the participant is physically capable of undergoing psychedelic encounter and is likely to have a minimum life expectancy of 6 months. At least 87 adult participants (age 18 to 80 at screening) with a diagnosis of AjD due to cancer diagnosis will be enrolled in this study. Participants will be randomly assigned with a ratio of 1:1:1 to receive Psilocybin-Assisted Psychotherapy (PAP) with either 25 mg, 10 mg or 1 mg NPX-5. Both the site staff treating participants and the participants themselves will be blinded to the treatments being administered. The study consists of a combination of clinic visits and telehealth phone calls to support this vulnerable participant population. The clinic will have experience with conducting PAP. All study visits be carried out by suitably qualified individuals and wherever possible, the same therapist will meet with study participants for in-person and telehealth appointments. Participants will undertake a screening visit between Day -45 and Day -2 to determine eligibility to participate in the study. Those participants that meet the eligibility criteria will attend the study site on Day 1 when continued eligibility will be assessed and baseline assessments performed. Participants must complete three preparation sessions with the therapist prior to dosing session. Two of these sessions can be completed remotely via telehealth and have flexible timing, provided there is at least one day between each session. One preparation session must be done in person in the dosing room, ideally during a site visit on Day 13. Additionally, at least one preparation session must include the sitter or secondary therapist. The primary therapist has the discretion to include the sitter or secondary therapist in more preparation or integration sessions based on their assessment. The clinic site visits will comprise Day 1, Day 13 (day prior dosing session), Day 14 (dosing session), Day 15 (integration session) and Day 70/Week 10 (follow-up) post-randomization. There will be ± 3 days for a dosing session allowed. Subsequently, all relevant visits will be adjusted accordingly. In addition, participants will be required to attend following telehealth appointments: * Two telehealth appointments for preparatory sessions within 2 weeks prior to dosing session. * One telehealth appointment for integration therapy session in the two weeks following the dosing session. * Follow up telehealth appointments on Day 28 (Week 4), Day 42 (Week 6). * Final study follow-up telehealth appointment at 3 months post the Day 70 (Week 10) visit of the final PAP cycle for final safety assessments. Non responders (for criteria see Section 5.5.2) at Day 70 (Week 10) that continue to meet the study eligibility criteria, may commence an additional PAP cycle (at 25 mg NPX-5). These participants will repeat the schedule described above, including the visit the day prior to dosing session, the actual dosing session, and the integration sessions. A maximum of 2 PAP cycles may be administered.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-02", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07072728", "keywords": "Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer of Endometrium, Cancer of Kidney, Cancer of Prostate, Cancer of the Breast, Cancer of Stomach, Cancer Melanoma Skin, Cancer Pancreas, Psilocybin therapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07072728\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3458, "title": "Study of Psilocybin for Anorexia in Young Adults", "normalized_title": "study of psilocybin for anorexia in young adults", "authors": "Marissa Raymond-Flesch, MD, MPH", "abstract": "This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be measured pre and post treatment. One to two family member(s) of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-02", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06399263", "keywords": "Anorexia Nervosa, Psilocybin, PEX010, Preparation and Integration Sessions, Psilocybin Therapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06399263\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Eating Disorders", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3707, "title": "Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought", "normalized_title": "effects of psilocybin on electrophysiology and the dynamic content of thought", "authors": "Johns Hopkins University", "abstract": "This research study will use computerized tasks, electroencephalography (EEG), and magnetic resonance imaging (MRI) to look at how the drug psilocybin, a naturally occurring compound contained in hundreds of species of psychoactive mushrooms, changes thoughts and brain activity. In this double-blind, placebo-controlled, within-subject, full cross-over study in healthy volunteers, computerized, electroencephalography (EEG), and magnetic resonance imaging (MRI) measures will be assessed to test the acute effects of a moderate dose of psilocybin (10 mg/70 kg) on creativity, the contents and dynamics of thought, memory, and shared vs individual brain response while viewing naturalistic stimuli. Understanding the acute psychological and neural effects of psychedelic drugs such as psilocybin may allow for future optimization of psychedelic medicine, as well as a deeper and more refined understanding of consciousness itself.", "journal": "ClinicalTrials.gov", "publication_date": "2026-03-01", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05301608", "keywords": "Healthy, Psilocybin, 4-phosphoryloxy-N,N-dimethyltryptamine, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05301608\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Brain Imaging,Consciousness,Aging,Creativity,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3608, "title": "Does Psilocybin Change Synaptic Density in the Brains of Patients With Amnestic Mild Cognitive Impairment", "normalized_title": "does psilocybin change synaptic density in the brains of patients with amnestic mild cognitive impairment", "authors": "Centre for Addiction and Mental Health", "abstract": "The goal of this pilot, exploratory, clinical trial is to investigate the effects of psilocybin on synaptic vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy participants. The investigators hypothesize that SVD levels in the brain will be higher following the ingestion of psilocybin in comparison to placebo, and that increases in SVD will be associated with improvements in cognition. 10 participants (6 with aMCI, and 4 sex and age matched healthy volunteers) will: * Be randomized to receive either: 1. Two 25 mg macrodoses of psilocybin separated by 1 week. 2. Two placebo doses separated by 1 week. * Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments. * Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment. * Depending on available funds, receive a third PET scan at any time within 4 weeks of the screening visit to quantify tauopathy with the \\[18F\\]T807 radiotracer. * Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last treatment. Researchers will compare placebo vs. experimental groups to see if psilocybin will increase SVD, and if increases in SVD are associated with cognitive improvements. The proposed study will investigate the effects of on synaptic vesicular density (SVD) levels as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, and cognition (i.e., global cognition, executive function, and memory domains) in amnestic Mild Cognitive Impairment (aMCI) and healthy participants. Participants will be randomized to receive either two 25mg doses of psilocybin separated by one week, or two placebo doses separated by one week. Brain scans, clinical, and cognitive assessments will be conducted one week before, and one week, four weeks, and 12 weeks post dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-24", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06041152", "keywords": "Amnestic Mild Cognitive Impairment, Psilocybin, Placebo, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06041152\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Neuroplasticity,Brain Imaging,Clinical Trial,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3439, "title": "The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.", "normalized_title": "the effects of psilocybin in healthy volunteers psychological biochemical and electrophysiological biomarkers", "authors": "Gabriella Gobbi", "abstract": "In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia). After psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor. This study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research. The goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-24", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07433452", "keywords": "Healthy Participants, Placebo - Control, Psilocybin, Psilocybin (drug), Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07433452\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Receptor Pharmacology,Biomarkers,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3675, "title": "Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial", "normalized_title": "inpatient buprenorphine induction with psilocybin for opioid use disorder a randomized double blind trial", "authors": "Johns Hopkins University", "abstract": "This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood. The proposed study is a double-blind, controlled investigation of the effect of 1 high-dose psilocybin (30 mg) session compared to a very low dose session (1 mg) following standard-of-care buprenorphine induction on drug abstinence, quality of life, craving, tobacco use, and treatment retention in healthy participants with an active OUD diagnosis. Use of buprenorphine follow standard of care, and the investigators are investigating the additive power of adjunctive psilocybin to enhance opioid abstinence, treatment adherence, quality of life, and mood. The study will consist of a brief (6-8 day) inpatient phase for standard buprenorphine induction as well as experimental psilocybin administration, an 8-week outpatient phase involving standard buprenorphine maintenance and experimental follow-up meetings, and long-term follow-up sessions for 4 months after. During the inpatient phase, participants will be inducted onto sublingual (SL) buprenorphine (using a buprenorphine/naloxone combination product) while admitted to the Bayview Clinical Research Unit. During this time, participants will also undergo 2-3 preparatory sessions, and will undergo an experimental drug administration session under supportive conditions, during which the participants will receive either a very low dose (1 mg) or a single high (30mg) oral dose of psilocybin under double-blind conditions. At the end of the inpatient phase, participants will be discharged to complete the 8-week outpatient phase, during which participants will undergo visits at 1, 2, 3, 4, 6, and 8 weeks post-dosing session for monitoring of adverse events, clinical status, treatment adherence, and to receive a weekly supply of buprenorphine. All buprenorphine procedures will be open label and will follow standard-of-care practices. This trial utilizes a Bayesian sequential methodology, employing a maximum sample size of 90 participants and calculating Bayes factors (starting at 20 participants and assessed after each 10) to assess evidence for the null and experimental hypotheses, enabling potential early stopping for efficacy or futility based on predetermined thresholds (Bayes factor of 6 and 1/6). This will be calculated for the primary outcome of opioid abstinence at 8-weeks", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06005662", "keywords": "Opioid Use Disorder, Psilocybin, Buprenorphine, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06005662\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Clinical Trial,Healthy Volunteers,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3602, "title": "Safety for Home Administration of Microdose Psilocybin Use", "normalized_title": "safety for home administration of microdose psilocybin use", "authors": "Johns Hopkins University", "abstract": "The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants. Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments. This study aims to enroll 20 healthy participants who will complete all study procedures. Participants will undergo a standard screening procedure. Baseline measures will be completed before the first dose. Participants will then be given ascending doses of psilocybin trihydrate (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg) and a single, interspersed, randomized placebo on separate days in double-blind fashion at the research site. A1 mg dose of psilocybin anhydrate is equivalent to a 1.19 mg dose of psilocybin trihydrate (used in this study). For each session, participants will be assessed with criteria for the safety of home dosing. If any dose meets criteria for at-home dosing, and a lower dose did not fail these criteria, that dose will be identified as the safe dose for the given participant. After administration of all doses of psilocybin to all participants, if a safe at-home dose was identified for all participants, that will be considered the highest safe dose for at-home administration to be used for future studies. Visit summary: Initial screening: Medical and psychological screening (Approx. 4 hours though portions of this may be completed remotely). Dosing sessions: There will be 5 double-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single, interspersed, randomized placebo dose. Baseline questionnaires will be completed on the day of the first dosing visit, and safety assessments will be administered during and at the end of each session.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06450210", "keywords": "Psychedelic Experiences, psilocybin trihydrate, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06450210\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Microdosing,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3551, "title": "Investigation of Psychedelic Effects in Psychoactive Substances", "normalized_title": "investigation of psychedelic effects in psychoactive substances", "authors": "Johns Hopkins University", "abstract": "The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06772753", "keywords": "Psychedelic Effects in Healthy Volunteers, Placebo, Psilocybin, Ketamine, Dextromethorphan (DXM), Dimethyltryptamine (DMT), Methylenedioxymethamphetamine (MDMA), Tetrahydrocannabinol (THC), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06772753\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3520, "title": "Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study", "normalized_title": "pilot study of psilocybin assisted therapy for demoralization in patients receiving hospice care path study", "authors": "Yvan Beaussant, MD, MSci", "abstract": "The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care. -The name of the study drug involved in this study is Psilocybin The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice care, in order to test its safety in people with terminal illness who experience demoralization, and to study how well it works to lessen symptoms of psychological and existential distress. * This research study involves a combined drug and psychotherapeutic (talk therapy) intervention. The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. * The treatment regimen consists of a single administration of psilocybin with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions * The name of the study drug involved in this study is Psilocybin. Psilocybin is a naturally occurring psychedelic drug produced by more than 200 species of mushrooms, which is manufactured for medical use to control potency and purity. * Participants will be followed for up to 24 weeks (approximately 6 months) after the study treatment. It is expected that about 15 people will take part in this research study. * This research study is a Feasibility Study, which mean it is the first time investigators are examining psilocybin-assisted therapy in the context of hospice care. Psilocybin is an \"Investigational\" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, the FDA has granted psilocybin the status of \"breakthrough therapy\" in the treatment of depression and the investigators have permission from the FDA to use this drug in this research study.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-16", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04950608", "keywords": "Hospice, Psilocybin, Demoralization, Terminal Illness, Cancer-related Problem/Condition, Psychotherapy, Terminal Cancer, Cancer Terminal, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04950608\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,End-of-Life Distress,Cancer Patients,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3541, "title": "A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers", "normalized_title": "a phase 1 translational study to assess brain activity using functional magnetic resonance imaging fmri and to evaluate the safety tolerability and pharmacokinetics of multiple doses of mls101 psilocybin in healthy volunteers", "authors": "MycoMedica Life Sciences PBC", "abstract": "MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants. In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited. The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-12", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07050368", "keywords": "Healthy Volunteer, Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07050368\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Addiction,Brain Imaging,Pharmacology,Aging,Clinical Trial,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3425, "title": "Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability", "normalized_title": "psychedelic healing adjunct therapy harnessing opened malleability", "authors": "Johns Hopkins University", "abstract": "The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke. Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a stroke recover completely, while 50 percent experience moderate to severe long-term disability, including significant impairment in language, cognition, motor, and sensory skills, which require special care or long-term care in a nursing home or other facility. Therefore, in the United States alone, nearly 400,000 people per year will suffer the lasting debilitating consequences of stroke. Previous studies have indicated that rehabilitation following stroke is constrained by a so-called 'critical' or 'sensitive' period. While this learning window can be extended or enhanced, once the post-stroke rehabilitation critical period has closed, clinically applicable manipulations that can reopen it are lacking. Recently the investigators have shown that the psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxmethamphetamine (MDMA) can reopen a novel critical period for social reward learning. The adage \"you can't teach an old dog new tricks\" captures a certain truth about the brain. Specifically, a young person's brain is much more malleable (e.g., able to make new motor-memories and store new motor-memories) compared to an adult's brain. Neuroscientists call these periods of heightened sensitivity to input \"critical periods.\" Based on these observations the investigators posit that psychedelic compounds serve as the long sought-after \"master key\" for unlocking critical periods across the brain. Ongoing preclinical studies are examining this possibility, with the goal of determining the therapeutic potential of psychedelics (including psilocybin) as adjunct therapies for any intervention whose clinical efficacy may be constrained by critical period closure, including post-stroke rehabilitation. The main purpose of the proposed studies is to evaluate the safety and tolerability of psilocybin in stroke patients (Phase 1). as a secondary aim the investigators will collect data on the efficacy of psilocybin in effecting motor recovery in post-stroke patients.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-12", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07053917", "keywords": "Stroke, Chronic Stroke, Intracerebral Haemorrhage, Intracerebral Haemorrhage (ICH), Intracerebral Hemorrhage Basal Ganglia, Ischemic Stroke, Ischemic Stroke and Hemorrhagic Stroke, Hemiparesis After Stroke, Hemiplegia Following Ischemic Stroke, Hemiplegia and Hemiparesis, Hemiplegia and/or Hemiparesis Following Stroke, Middle Cerebral Artery Stroke, Psilocybin (Usona Institute), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07053917\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Clinical Trial,Animal Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3704, "title": "Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder", "normalized_title": "single dose psilocybin for a post surgical trauma inpatient population for pain mood and opioid use disorder", "authors": "Trent Emerick", "abstract": "The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are: 1. Is a single psilocybin dose feasible to administer during postoperative hospitalization? 2. Is psilocybin safe in this patient population? 3. How does psilocybin affect postoperative pain, opioid use, anxiety, and depression after hospital discharge? Participants will: Receive one oral dose of psilocybin during their postoperative inpatient stay Complete assessments of pain, mood, and opioid use during recovery This is an open-label pilot feasibility trial conducted at a single academic medical center. Fourteen participants receive a single oral dose of psilocybin during inpatient hospitalization following trauma surgery. Outcomes in the psilocybin group are compared with a retrospectively identified standard-of-care cohort of 56 trauma surgery patients with opioid use disorder, identified through electronic medical record review. The standard-of-care cohort is selected using propensity score methods based on baseline characteristics, including age, sex, trauma diagnosis, psychiatric comorbidities, baseline medications, comorbid conditions, type of surgery, and baseline opioid consumption measured in morphine milligram equivalents. No interim efficacy analyses are planned. After the first three participants have received psilocybin and completed the one-week follow-up assessments, the Data and Safety Monitoring Board reviews safety data to assess ongoing risk and determine whether study procedures should continue unchanged.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07406828", "keywords": "Pain Management, Postoperative Pain, Psilocybin (Usona Institute), Postoperative analgesia, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07406828\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Addiction,Chronic Pain,Clinical Trial,Review Article,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3624, "title": "Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial", "normalized_title": "psilocybin assisted therapy for comorbid major depressive disorder and alcohol use disorder a pilot randomized clinical trial", "authors": "Centre for Addiction and Mental Health", "abstract": "The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \\- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety? Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events. Participants will: * be randomized to receive either psilocybin (25 mg) or placebo * visit the site (in-person and remotely) for a total of 14 times to complete study tasks * receive psilocybin-assisted therapy (PAT) at five various timepoints", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07405606", "keywords": "Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD), Psilocybin 25 mg, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07405606\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Addiction,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3690, "title": "Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers", "normalized_title": "safety and psychological effects of psilocybin and d serine formulation in healthy volunteers", "authors": "Hadassah Medical Organization", "abstract": "The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1. To assess the psychological and physiological effects of psilocybin administered with D-Serine in healthy adults. 2. To determine whether D-Serine modulates or attenuates the psychedelic effects of psilocybin. 3. To evaluate the safety and tolerability of psilocybin and D-Serine co-administration. Study population includes: 10 healthy male or female volunteers aged 25-60 years with no history of psychiatric or major medical disorders and no current evidence of such disorders. The study includes two cohorts. The first cohort of 5 participants will receive 15 mg of Psilocybin and 5 g of D-Serine. Safety data will be collected and submitted in an interim report to the Ethics Committee. If no safety concerns arise, the second cohort will receive an increased dose of 25 mg of Psilocybin and 7 g of D-Serine to help determine the optimal dose for a future Phase IIa clinical trial. This is a first-in-human, Phase I, exploratory clinical trial designed to evaluate the safety, tolerability, and initial psychological and physiological responses to a single administration of psilocybin in combination with D-Serine in healthy adult volunteers. The rationale for this combination stems from preclinical evidence indicating that D-Serine, a naturally occurring co-agonist at the NMDA receptor, may attenuate the acute psychedelic effects of psilocybin while preserving its neuroplastic and therapeutic properties. Preclinical studies demonstrated that D-Serine reduced the psilocybin-induced head-twitch response (HTR) in rodent models and enhanced the expression of synaptic plasticity markers (e.g., GAP43, PSD95, SV2A, synaptophysin) across multiple brain regions, with effects sustained up to 12 days post-treatment. These findings suggest that the combination may improve the safety and tolerability of psilocybin, particularly for populations sensitive to its psychoactive effects. The trial will consist of four sequential components: Screening Phase - to assess eligibility. Preparation Phase - to establish therapeutic rapport and baseline assessments. Administration Phase - involving a single oral administration of the investigational combination (psilocybin + D-Serine). Follow-up Phase - including in-person follow-up visits on Day 2, Day 7, Day 28, and Day 84 post-treatment to monitor safety outcomes, subjective responses, and potential delayed effects.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07079930", "keywords": "Healthy Volunteers, Psilocybin and D-Serine, Physical Examination, Vital signs, ECG test, Comprehensive Blood Panel, SMAC-20, Complete Blood Count, CBC, Urinalysis, Urine Toxicology Screen, A pregnancy Urine test, Electroencephalogram, EEG, Plasma Amino Acid Levels, Plasma Inflammation Markers, Plasma Brain-Derived Neurotrophic Facto, Plasma BDNF, Mini International Neuropsychiatric Interview, MINI, Family Psychiatric History Assessment, FPHA, Beck Depression Inventory, BDI, State-Trait Anxiety Inventory, STAI, Profile of Mood States, POMS, Subjective Units of Distress Scale, SUDS, Five-Dimensional Altered States of Consciousness questionnaire, 5D-ASC, Integration, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07079930\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Consciousness,Biomarkers,Clinical Trial,Observational Study,Animal Study,Healthy Volunteers,Safety,Toxicity,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3550, "title": "A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Oral Psilocybin (TRP-8802) Administration in Concert With Psychotherapy Among Adult Patients With Irritable Bowel Syndrome: A Randomized Delayed Treatment Control Design", "normalized_title": "a phase 2a open label pilot study to assess the safety and efficacy of oral psilocybin trp 8802 administration in concert with psychotherapy among adult patients with irritable bowel syndrome a randomized delayed treatment control design", "authors": "TRYP Therapeutics", "abstract": "Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS. The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session, monitor and participant ratings of subjective drug effects during and after each drug session. This study comprises approximately a 28-day screening period (Days 28 to 1). After screening and enrollment, participants will be randomized to an immediate treatment group or a delayed treatment group (\"waitlist control\" condition). Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37), integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments. As a safety precaution, participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3, 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed. At the end of the delay period, all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group. Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session. The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3-, 6, and 12- month follow-up visits (Days 120, 240, 365).", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06206265", "keywords": "Irritable Bowel Syndrome, TRYP-0082, Psychotherapy, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06206265\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Chronic Pain,Brain Imaging,Aging,Clinical Trial,Healthcare Workers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3486, "title": "Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER: a Pilot Study", "normalized_title": "psilocybin assisted psychotherapy for the treatment of gambling disorder a pilot study", "authors": "Nantes University Hospital", "abstract": "The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate preliminary efficacy data, identify clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect), and conduct a preliminary assessment of the safety of the treatment under study.", "journal": "ClinicalTrials.gov", "publication_date": "2026-02-04", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07391332", "keywords": "Gambling Disorder, Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07391332\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3502, "title": "PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial", "normalized_title": "psilocybin microdose for psychological and existential distress in palliative care psyched pal a multi site phase 3 double blind placebo controlled parallel arm clinical trial", "authors": "Bruyère Health Research Institute.", "abstract": "About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and can be available to all patients with advanced illness who have psychological distress. Psilocybin, a psychedelic medication (commonly called 'magic mushrooms') works well for improving psychological distress in people with cancer or chronic illness when given in high doses with specific forms of therapy. However, psilocybin has not been well-studied among people with advanced illness, and there are concerns about safety and side effects in people approaching the end of life. However, reports on psilocybin microdosing, which involves taking small doses that do not cause hallucinations and do not require therapy, suggest that this may be effective, safer, and more acceptable for people with advanced illness. We recently completed a small study of psilocybin microdosing. Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step is to do a randomized clinical trial where some patients receive psilocybin microdose and some receive placebo (a drug that contains no medicinal ingredients). By comparing these two groups, we can remove the possibility that improvements in symptoms are only because patients thought they were getting treatment. We will enroll 120 patients from inpatient, outpatient, and community care settings across seven sites. Participants in the microdose psilocybin group will receive 2 or 3 mg of psilocybin daily, 4 days per week, for two consecutive weeks. The placebo group will receive placebo with the same treatment schedule. All participants will be offered microdose psilocybin after 2-week follow-up. If this study is successful, we have the potential to change how psychological distress is managed in patients with advanced illness. Patients with advanced illness report feeling a sense of hopelessness, loss of autonomy and relationships, and a lack of purpose in life. These feelings of psychological suffering have been described as \"existential distress\" and are associated with poor outcomes, including decreased medication adherence and quality of life, increased desire for hastened death and rates of suicide, and has been identified as a primary reason why individuals pursue medical assistance in dying (MAiD). Current treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. Pharmacological approaches for treating psychological suffering may reduce symptoms of depression and anxiety, but evidence to support their efficacy in palliative care (PC) is underwhelming. Antidepressant and anxiolytic medications also take time to work and can cause serious side effects such as falls and confusion, which can be substantial deterrents for patients. Similarly, results from randomized controlled trials (RCTs) and meta-analyses have demonstrated psychotherapeutic interventions show limited benefit in a PC population. Further, psychotherapy can be time consuming and slow to work, which is not ideal for patients with limited life expectancy. Given the burden of psychological and existential distress among patients followed by PC providers, there is a need to develop scalable, brief, and rapidly effective therapeutic approaches to reduce this distress. Psychedelic medications offer an innovative, safe, complementary approach to address psychological and existential suffering in patients receiving PC. Studies from the 1950's showed serotonergic hallucinogens (\"psychedelics\") improved depression and anxiety symptoms in cancer patients. However, legislative changes restricted the use of these medications in clinical care and research. Interest in psychedelic medications has been rekindled by two recently published RCTs that studied the use of psilocybin (a mushroom-derived 5HT2A agonist) during a single psychotherapeutic session in cancer patients with anxiety and/or depression. These trials demonstrated rapid, clinically meaningful, and long-lasting reductions in depressed mood and/or anxiety symptoms and improvements in quality of life and death acceptance. Although the exact mechanism by which psilocybin affects mood symptoms is unclear, functional MRI studies of the brain show psilocybin disrupts the functional connectivity between anterior hippocampus (involved in memory and anticipation of future events) and the default mode network (associated with anhedonia and rumination on negative themes). There is also evidence suggesting psilocybin microdosing - taking sub-hallucinogenic doses continuously over longer time periods, rather than a one-time hallucinogenic dose - can improve mood and anxiety. The effects of microdosing, however, have not been rigorously evaluated, particularly in patients with life limiting illness. Results from recent trials are encouraging but knowledge gaps remain. First, studies to date primarily enrolled patients with localized disease who experience different distress than that of patients with advanced disease who are near the end of life. Second, it is unclear if Canadians would find psilocybin an attractive option in the context of MAiD legalization, which provides an alternative option for patients with severe psychological suffering. Third, there is no empirical research on the therapeutic effects of psilocybin microdosing, as most studies have followed macrodosing protocols. While preliminary efficacy of macrodosing has been demonstrated, there are important barriers to administering this therapy in a PC context. Previous trials had slow recruitment rates, suggesting there may be barriers related to the acceptability of psilocybin macrodosing from the perspectives of patients and families. Macrodosing requires the patient to dedicate an entire day to participating in a guided hallucinogenic experience and remain in an acute care setting where they can be closely monitored. It also requires patients to engage in preparatory sessions with monitors and a post-therapy session. In a PC context, this time commitment may not be acceptable or feasible for patients who are nearing the end of life. Macrodosing requires at least two trained moderators to guide the patient through their psychedelic experience and facilitate the pre- and post-dosing sessions. In most PC settings, it is not feasible to have clinicians dedicate two days to a single patient, thus limiting the scalability of this intervention. Anecdotally, concerns about the safety of high-dose psilocybin in the terminally ill, as well as access to psychotherapy, may also be substantial barriers in this population. Moreover, randomized trials of psychedelic medications are methodologically challenging because patients cannot be blinded to having a psychedelic experience. This \"functional unblinding\" was one major reason why the US FDA chose not to approve psychedelic medication for the treatment of post-traumatic stress disorder in August 2024, despite strongly positive trial results. Psilocybin microdosing may be safer and more feasible than psilocybin macrodosing in palliative setting. Psychedelic microdosing involves taking 5-10% of a psychedelic dose of a substance such as psilocybin on a regular basis (daily or several times per week). It does not produce a psychedelic experience, nor does it involve psychotherapy, but large surveys and anecdotal reports suggest that microdosing produces substantial and sustained improvements in mood and anxiety symptoms without any important side effects. By removing the requirement for trained moderators, minimizing the time commitment required of patients, eliminating the hallucinogenic effects of the therapy, and allowing patients to receive treatment either as an inpatient or in the community, microdosing may be a more acceptable option to patients and families and allow psychedelic therapy to be scalable across various PC settings. We have completed a phase 2 dose-finding and proof of concept study for microdosing psilocybin in people with advanced illness receiving PC. Using progressively increasing microdoses of psilocybin over a 3-week period (from 1 mg to 3 mg daily), we found that a large proportion of participants experienced dramatic improvements in their psychological distress, with minimal side effects. This effect was durable after stopping the medication but diminished after 4 weeks. Given the encouraging findings from our phase 2 study, and the potential feasibility, scalability, and safety of psilocybin microdosing for a population with few effective options, proceeding to a phase 3 placebo-controlled trial is warranted. Objectives Primary Objectives: To determine the efficacy of microdose psilocybin for improving psychological distress among patients with advanced illness followed by a palliative care provider. Secondary Objectives: 1. Assess whether microdose psilocybin improves quality of life and desire to die among patients with advanced illness followed by a palliative care provider. 2. Determine the safety of long-term (up to 1 year) use of psilocybin microdose to treat psychological distress among patients with advanced illness followed by a palliative care provider. Open-Label Access and Extension Phase Following the primary study 2-week follow-up completion, all participants will have the option to participate in an open-label access phase. In this phase, participants will be offered open-label psilocybin for two consecutive weeks (same dosing and schedule as the primary study). Two weeks after the access phase has been completed, all participants will have the option to participate in the open-label extension period for up to 1 year. The open-label extension will follow a three-week dosing cycle, where all participants will take psilocybin microdoses for two consecutive weeks, and then no doses on the third week, before starting the cycle again. The open-label and open-label extension phase include safety and primary and secondary outcomes (see Outcome Measures), in line with the primary study protocol. Sample Size We require a sample size of 60 patients per arm (120 patients in total). This assumes a 20% loss to attrition/deterioration and 10% withdrawal (based on our phase 2 study). This sample would have 80% power to detect a change of 0.30 from 30% PGIC response (control) to 60% PGIC response (intervention) at last treatment day, corresponding to an effect size (Cohen's d) of 0.61. Statistical Analysis We will follow an intent-to-treat approach. We will use chi-square tests to compare the proportion of participants in the microdose psilocybin vs. placebo arm with a PGIC score of ≥5 at the last day of treatment and at 2-week follow-up, and to compare the proportion of participants who demonstrate a minimal clinically important difference (MCID) in secondary efficacy outcomes. To minimize type I error, a correction will be performed on the multiple secondary endpoint analyses. Safety and feasibility outcomes will be analyzed using descriptive statistics with 95% confidence intervals.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-26", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07063862", "keywords": "Psychological Distress, Psilocybin, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07063862\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Anxiety,PTSD,End-of-Life Distress,Receptor Pharmacology,Default Mode Network,Aging,Microdosing,Clinical Trial,Randomized Controlled Trial,Observational Study,Cancer Patients,Healthcare Workers,Safety,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3673, "title": "A Phase 2 Trial of Psilocybin as an Adjunctive Treatment for OUD Patients Who Continue to Use Illicit Opioids Despite Adherence to Methadone Treatment", "normalized_title": "a phase 2 trial of psilocybin as an adjunctive treatment for oud patients who continue to use illicit opioids despite adherence to methadone treatment", "authors": "NYU Langone Health", "abstract": "This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be consented to yield 240 randomized participants. This study is part of the NIH HEAL Initiative (https://heal.nih.gov/). In Stage 1, subjects will be randomly assigned to one of three groups: psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), and psilocybin 1 mg (control condition). By the end of Stage 1, an interim statistical analysis will be performed. The study will proceed to Stage 2 if at least one of the active dosages of psilocybin demonstrates 1) acceptable safety, based on analysis of safety data from Stage 1; and 2) conditional power of at least 25%, based on effect size estimates for the primary opioid use outcome (weeks of biologically-verified abstinence during 24 weeks of follow-up). Using a priori decision rules, the interim analysis will determine which of the active treatment groups (30 mg, 20 mg, or both) will be retained in Stage 2 of the trial. Stage 2 will continue the study, using the same treatment and assessment protocols, but retaining only the active dosage or dosages with a high probability of demonstrating efficacy relative to the psilocybin 1 mg control condition. The primary aims are to 1) Evaluate safety and efficacy outcomes in Stage 1 subjects in order to optimize design of the Stage 2, 2) Determine whether treatment with a single high (30 mg) or medium (20 mg) dose of psilocybin improves OUD treatment outcomes, relative to psilocybin 1 mg (control condition), in patients who continue to use illicit opioids despite adherence to methadone treatment, 3) Evaluate the effects of high-dose psilocybin and medium dose psilocybin on self-reported OUD-related neuropsychopathology, and 4) Identify likely responders to psilocybin treatment by using machine learning to model post-treatment OUD outcomes, based on pretreatment characteristics including all relevant clinical data, evaluations, and questionnaires.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-22", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06796062", "keywords": "Opioid Use Disorder, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06796062\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3703, "title": "The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma", "normalized_title": "the starlight protocol state funded trial assessing recovery and long term impact of guided psilocybin for healing trauma", "authors": "Baylor College of Medicine", "abstract": "The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-21", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06888128", "keywords": "PTSD, Psilocybin 15mg, Psilocybin 25mg, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06888128\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Veterans,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3532, "title": "A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression", "normalized_title": "a phase iii multicentre randomised double blind controlled study to investigate the efficacy safety and tolerability of two administrations of comp360 in participants with treatment resistant depression", "authors": "COMPASS Pathways", "abstract": "Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg. The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week screening period. Part A will include a nine-week follow-up from initial investigational product (IP) administration. Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration. Part C will include a further 26 weeks follow-up out to 52 weeks from initial IP administration. In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05711940", "keywords": "Treatment Resistant Depression, Psilocybin, COMP360, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05711940\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3523, "title": "Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis", "normalized_title": "effects of psilocybin in patients with amyotrophic lateral sclerosis", "authors": "Johns Hopkins University", "abstract": "This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population. The proposed research's primary objective is to study the feasibility of psilocybin therapy for patients with ALS with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population. The proposed proof-of-concept interventional trial will use a single-arm design. The study will be an open-label trial in a sample of up to 24 treatment-seeking patients with a diagnosis of ALS and depressed mood. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments 1, 3, and 6 months after the final psilocybin session.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-11", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06656702", "keywords": "Amyotrophic Lateral Sclerosis, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06656702\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3645, "title": "Behavioral and Neural Mechanisms Supporting Psilocybin-assisted Therapy for Phantom Limb Pain", "normalized_title": "behavioral and neural mechanisms supporting psilocybin assisted therapy for phantom limb pain", "authors": "University of California, San Diego", "abstract": "This double-blind placebo-controlled pilot study seeks to investigate whether psilocybin can be safely administered to people with chronic phantom limb pain (PLP) in a supportive setting with close follow-up, and its effects on pain symptoms and other moods, attitudes, and behaviors. The investigators' primary hypotheses are that psilocybin is safe to administer in people with PLP and that it will reduce scores on measures of pain. The investigators will also assess a number of secondary measures related to the behavioral and neural responses to pain after psilocybin treatment.", "journal": "ClinicalTrials.gov", "publication_date": "2026-01-08", "publication_year": 2026, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05224336", "keywords": "Phantom Limb Pain, Psilocybin, Placebo Niacin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05224336\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Chronic Pain,Mechanism of Action", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3479, "title": "A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial", "normalized_title": "a randomized double blinded controlled trial for the treatment of persisting symptoms after concussion with psilocybin assisted therapy a safety and feasibility trial", "authors": "University of Calgary", "abstract": "The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC). This trail will test the following 2 aims: AIM1: To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PSaC. AIM2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC. Participants will be asked to: * Complete a 2-part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \\[25mg\\] or low dose psilocybin \\[1mg\\]) * Complete 5 weekly sessions of Acceptance and commitment therapy (ACT) * Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months). The overall objective of this study is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce symptom burden in patients with persisting symptoms after concussion (PSaC). This trail will test the following 2 aims: AIM1: To test the safety and feasibility of an active/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PSaC. Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months. Feasibility will be determined through recruitment, enrollment, and adherence rates. AIM2: To evaluate the efficacy of an active/high dose (25mg) psilocybin-assisted psychotherapy compared to an active control (1mg) as a treatment for PPCS at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration. The primary efficacy outcome will be the change in PSaC burden (RPQ). The secondary efficacy outcomes will include measures of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life. A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury (American College of Rehabilitation Medicine 2023 criteria) who meet criteria for persisting symptoms after concussion (ICD-10) within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community. All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (20 participants) or low dose (20 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures, followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months, and 6 months post-dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-29", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06615908", "keywords": "Persisting Symptoms After Concussion, Psilocybin, magic mushrooms, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06615908\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Anxiety,PTSD,Headache / Migraine,Emotional Processing,Randomized Controlled Trial,Safety,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3464, "title": "Microdosing Psychedelics to Improve Mood", "normalized_title": "microdosing psychedelics to improve mood", "authors": "Rotem Petranker", "abstract": "This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder. This protocol is for a University of Toronto - sponsored, randomized, placebo-controlled crossover phase 2 study of the safety and efficacy of low doses of psilocybin in subjects with depressive symptoms who meet Diagnostic and Statistical Manual 5 (DSM-5) criteria for diagnosis of a major depressive disorder (MDD) and who are either unwilling to pursue standard treatment (psychotherapy and/or pharmacotherapy) or have previously been non-responsive to standard treatment. This feasibility study will assess whether microdosing has a short-term impact on participant ratings of depressive symptoms. Participants will be administered one dose of either placebo or psilocybin once weekly for four weeks, and then all participants will be administered a dose of psilocybin once weekly for four additional weeks. Short surveys will be collected once weekly three days after the administration of psilocybin/placebo, and follow-ups will occur for up to two years following the beginning of the trial. Using this design will maximize the experimental power to detect an effect if one exists and would inform future research on microdosing in terms of duration, effect size, and expectancy bias.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-29", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05259943", "keywords": "Major Depressive Disorder, Psilocybin first, Placebo first, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05259943\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Microdosing,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3515, "title": "Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes", "normalized_title": "psilocybin in chronic low back pain an integrative study of lab based mechanisms and real world physical therapy outcomes", "authors": "Yale University", "abstract": "The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes. Preclinical and human studies suggest that psilocybin can temporarily disrupt rigid, maladaptive patterns of brain activity and promote longer-lasting changes in how the brain processes internal sensations. People with chronic pain who have used psilocybin qualitatively describe feeling more aware of their bodies, able to reinterpret pain sensations, and less distressed and disabled by their pain. Building on these mechanistic insights, this randomized, double-blind, placebo-controlled trial will evaluate a single dose of low- (10 mg), moderate-dose (25 mg), or placebo (niacin) administered prior to a standardized course of physical therapy (PT) in adults with chronic low back pain (CLBP). Participants in both treatment groups will receive a course of PT that is consistent with what would be delivered outside of involvement in the research study. That is, the study is evaluating psilocybin as an adjunct to PT delivered in a community outpatient PT clinic. By testing whether psilocybin-induced recalibration of brain networks can enhance engagement with and outcomes of PT, this study aims to establish a novel, non-opioid integrative strategy to relieve CLBP and restore functional recovery.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-28", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07306364", "keywords": "Chronic Low Back Pain (CLBP), Physical Therapy, Psilocybin, Psilocybin 10 mg, Psilocybin 25 mg, Niacin 100 mg, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07306364\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Chronic Pain,Mechanism of Action,Animal Study", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3701, "title": "The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation", "normalized_title": "the safety and efficacy of psilocybin in patients with treatment resistant depression and chronic suicidal ideation", "authors": "Sheppard Pratt Health System", "abstract": "This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-23", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05220410", "keywords": "Treatment Resistant Depression, Suicidal Ideation, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05220410\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3506, "title": "An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder", "normalized_title": "an open label study of single dose psilocybin for major depressive disorder with co occurring borderline personality disorder", "authors": "University of Chicago", "abstract": "The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). Ten subjects with MDD and BPD will receive a single 25 mg oral dose of psilocybin. The hypothesis to be tested is that psilocybin will result significant reduction in symptoms of both MDD and BPD after 1 week and sustained for 4 weeks compared to baseline (improvement in symptoms will be indicated by lower scores on established outcome measures of MDD and BPD symptoms that have been used in prior studies).", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-22", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05399498", "keywords": "Borderline Personality Disorder, Major Depressive Disorder, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05399498\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Personality Change,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3585, "title": "Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter", "normalized_title": "effects of psilocybin on speech fluency struggle and brain activity in people who stutter", "authors": "NYU Langone Health", "abstract": "This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical outcomes in individuals who stutter, is warranted. The aims of this study include: * Aim 1: Assess the safety and feasibility of psilocybin as a therapeutic agent for stuttering. * Aim 2: Evaluate the effects of psilocybin on objective and subjective measures of stuttering severity, struggle, and well-being. * Aim 3: Explore the therapeutic neural mechanisms of psilocybin in stuttering.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-21", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07296328", "keywords": "Stuttering, Psilocybin, Speech therapy, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07296328\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Mechanism of Action,Wellbeing,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3587, "title": "Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder", "normalized_title": "neurobehavioral mechanisms of psilocybin assisted treatment for alcohol use disorder", "authors": "NYU Langone Health", "abstract": "This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06349083", "keywords": "Alcohol Use Disorder, Psilocybin, Inactive Placebo, Supportive therapy sessions, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06349083\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Brain Imaging,Mechanism of Action,Biomarkers,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3521, "title": "A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression", "normalized_title": "a phase iii multicentre randomised double blind placebo controlled study to investigate the efficacy safety and tolerability of comp360 in participants with treatment resistant depression", "authors": "COMPASS Pathways", "abstract": "Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 255 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo. The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week Screening Period. Part A will include a six-week follow-up from initial investigational product (IP) administration. In this study, the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support. This will be assessed in a 6-week, single-dose, double-blind, placebo-controlled part of the study (Part A). Durability of efficacy and long-term safety, and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose, double-blind re-treatment part (Part B), and a 26-week open-label treatment part (Part C).", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-17", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05624268", "keywords": "Treatment Resistant Depression, Psilocybin, COMP360, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05624268\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3437, "title": "Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer", "normalized_title": "feasibility phase 2 study of psilocybin assisted therapy for opioid refractory pain in patients with advanced cancer", "authors": "Yvan Beaussant, MD, MSci", "abstract": "The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative) This study is a phase 2 open label, single center, concurrent mixed-methods trial to assess the feasibility of a novel palliative-care informed psilocybin-assisted psychotherapy regimen to alleviate opioid-refractory pain in patients with advanced-cancer. Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood, motivation and impulse control. Psilocybin is an \"Investigational\" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, investigators have permission from the FDA to use this drug in this research study. The research study procedures include screening for eligibility, an electrocardiogram, blood tests, and the study intervention includes preparation, evaluations, one psilocybin session and follow up visits. Participants will be followed for up to 12 weeks (approximately 3 months) after receiving the study treatment. It is expected that about 15 people will take part in this research study. Filament Health is supporting this research study by providing the study investigational medication, psilocybin. Cy Biopharma and Pancreatic Cancer North America are supporting this research study by providing funding.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-15", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06001749", "keywords": "Opioid-Related Disorders, Pain Management, Pain Management and Care, Advanced Cancer, Advanced Cancers, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06001749\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,End-of-Life Distress,Chronic Pain,Receptor Pharmacology,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3625, "title": "Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study", "normalized_title": "investigating the effects of a psychedelic augmented mental imagery based intervention for young people with self harm behaviour an experimental medicine study", "authors": "Imperial College London", "abstract": "Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs has recently been shown to be helpful in a variety of mental health disorders, including depression. This research project will explore the mechanisms by which combining a low dose of psychedelic psilocybin with a cognitive technique may target self-harm behaviour in young people (aged 16-25). Previous research has shown that mental images of self-harm are common among individuals who self-harm and can increase the urge to self-harm. Imagery Re-Scripting (ImRS) is a cognitive technique that guides an individual to replace mental imagery driving self-harm with an alternative image that will instead discourage self-harm and promote alternative coping strategies. However, during ImRS individuals may fear bringing negative mental images and emotions to mind, hindering the process. Psychedelic substances can increase the ability to tolerate difficult emotions, make thinking styles more flexible and individuals more open to change. Based on this, the aim is to test if enhancing a cognitive technique with a low dose psychedelic can modify the cognitive mechanisms maintaining self- harm behaviour. The aim is to examine the effect of a sub-hallucinogenic dose of psilocybin in combination with ImRS on cognitive processes, such as experiencing vivid mental images, and whether it can reduce these mental images and associated negative emotions in young people with recent self-harm behaviour above the effects of ImRS alone. The hypothesis is that psilocybin could facilitate confronting the emotions that arise during ImRS and make it easier to generate new helpful mental imagery. These experimental data could lay the foundation for future treatment development targeting self-harm in young people.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06798636", "keywords": "Self Harm, Psilocybin 5 mg with cognitive behavioural therapy intervention, Psilocybin, Placebo with cognitive behavioural therapy intervention, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06798636\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Mechanism of Action,Emotional Processing,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3692, "title": "Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study", "normalized_title": "standardized natural psilocybin assisted psychotherapy for tapering of opioid medication in patients with chronic pain an open label feasibility study", "authors": "University of British Columbia", "abstract": "This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psilocybin-assisted therapy sessions. The study will evaluate the incidence and severity of adverse events during and after treatment, the number of participants who drop out of the study for intervention-related reasons, and the self-reported benefits and harms of the intervention. The purpose of this pilot study is to establish the safety and tolerability of a therapeutic intervention using psilocybin-assisted psychotherapy as a novel treatment for opioid tapering in a sample of patients with chronic pain. Participants will be patients who have failed previous attempts to reduce their use of opioid medication and who have no medical or psychological contraindications for psilocybin administration. This pilot study involves an 8-week open-label, non-randomized therapeutic intervention and a 6-month follow-up period. To provide a supportive context for the drug experience, participants will receive preparatory and integrative sessions following an acceptance and commitment therapy model for psychedelic therapy. The physician-supervised opioid taper will begin following the first psilocybin dosing session (25mg) after an integration session with therapists, and a second optional psilocybin dosing session (37.5mg) will be facilitated one month later. Assessments will be completed at baseline, and at follow-up points at 1-month, 3-months and 6-months post-intervention to evaluate both acute and long-term effects of the intervention. Primary outcomes of interest are rates of adverse events, retention rates, and patient perceptions of intervention tolerability. Preliminary efficacy of the treatment will be evaluated by tracking opioid reduction rates and long-term maintenance of these reductions. Other measures of interest include qualities of the psychedelic experience, opioid cravings and withdrawal, chronic pain symptoms, and psychological mechanisms.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-03", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05585229", "keywords": "Opioid Dependence, Chronic Pain, Psilocybin-assisted Psychotherapy, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05585229\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Chronic Pain,Mechanism of Action,Safety,Adverse Events,Contraindications", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3513, "title": "A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer", "normalized_title": "a phase 2b randomized double blind placebo controlled multi center study of the effects of psilocybin assisted psychotherapy on psychiatric and existential distress in advanced cancer", "authors": "NYU Langone Health", "abstract": "The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer. This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral 'high' dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.", "journal": "ClinicalTrials.gov", "publication_date": "2025-12-03", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05398484", "keywords": "Advanced Cancer, Psilocybin 25 mgs, Niacin 100mg, Psychotherapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05398484\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\",\"PHASE3\"]}", "topic_tags": "Depression,Anxiety,Mechanism of Action,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3444, "title": "Psilocybin vs Ketamine for Alcohol Use Disorder", "normalized_title": "psilocybin vs ketamine for alcohol use disorder", "authors": "University of Iowa", "abstract": "This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-27", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06405607", "keywords": "Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse, Psilocybin, Ketamine, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06405607\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3698, "title": "Digital Intervention for Psychedelic Preparation (DIPP): A Randomised Controlled Feasibility Trial Comparing Meditation and Music-Based Programs in Healthy Volunteers.", "normalized_title": "digital intervention for psychedelic preparation dipp a randomised controlled feasibility trial comparing meditation and music based programs in healthy volunteers", "authors": "University College, London", "abstract": "This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will follow identical program structures, with the key distinction being their daily practice focus: meditation or music listening. Following the 21-day preparation period, participants will undergo a supervised 25 mg psilocybin session at University College London. Assessment visits include an in-person follow-up at 2 weeks post-session, followed by online assessments at 3, 6, and 9 months. The primary outcomes include operational feasibility (recruitment rates and participant retention) and intervention adherence (completion rates of DIPP program activities). Secondary outcomes include participant ratings of the platform's feasibility, acceptability, and usability, as well as changes in psychedelic preparedness, the quality of the psychedelic experience, and mental wellbeing over time. Growing evidence demonstrates the therapeutic potential of psychedelic substances, particularly psilocybin, in addressing mental health challenges and enhancing psychological well-being. While psychedelic experiences can catalyse profound positive changes, they can also be psychologically challenging and potentially destabilising, underscoring the need for thorough preparation. Studies consistently show that an individual's psychological state prior to psychedelic administration significantly influences both the acute experience and its lasting benefits. However, structured preparation protocols designed to optimise this pre-psychedelic state remain understudied despite their crucial role in therapeutic outcomes. Digital health interventions offer a promising solution for delivering standardised preparation protocols at scale. Meditation-based approaches warrant particular investigation, as they systematically cultivate both immediate psychological states and enduring traits (e.g. non-judgemental acceptance) beneficial for psychedelic experiences. Through regular practice, meditation promotes trait-like metacognitive awareness, emotional regulation, and tolerance of uncertainty - qualities particularly valuable for navigating altered states of consciousness. These benefits are supported by neuroscientific evidence showing that meditation and psychedelics influence similar brain networks and mechanisms. While traditional meditation training often requires substantial time investment and in-person instruction, digital platforms can provide efficient structured guidance without the need for face-to-face support from a trained instructor, while maintaining essential elements of practice. This combination of accessibility and evidence-based benefits makes digital meditation platforms particularly well-suited for preparing individuals for psychedelic experiences. This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day self-guided program. Forty healthy volunteers will be randomised 1:1 to either a meditation-based intervention or music-based control condition. Both groups will engage with identical program structures, differing only in their daily practice (meditation versus music listening). Following preparation, all participants will undergo a supervised 25 mg psilocybin session at University College London, with follow-up assessments conducted in person at 2 weeks and online at 3, 6, and 9 months post-intervention. The primary outcomes address two key aspects of feasibility: operational feasibility and intervention adherence. Operational feasibility evaluates study-wide metrics, including recruitment efficiency (target ≥1 participant per week) and participant retention (target ≥70% completion through the 2-week post-dose follow-up). Intervention adherence focuses on participant engagement with the DIPP activities (meditation or music listening), assessed through completion rates for daily sessions, mood check-ins, journal entries, and weekly tasks, with a target of ≥70% of participants achieving an average completion rate of 70% or higher. Secondary outcomes, reported descriptively for both conditions, include implementation measures such as subjective feasibility (SFIS), acceptability (TFA), and usability (SUS/MARS) ratings. Efficacy measures assess changes in psychedelic preparedness (PPS) from baseline to post-DIPP intervention, the qualities of the acute psychedelic experience (11-Dimensional Altered States of Consciousness Scale \\[11D-ASC\\] and Challenging Experience Questionnaire \\[CEQ\\]) following dosing, and changes in mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale \\[WEMWBS\\]) from baseline through the 2-week post-dose follow-up. As such, this study will investigate the feasibility of implementing a digital preparation protocol within a research setting, while gathering preliminary data on engagement, acceptability, and potential efficacy. The findings will inform refinements to the DIPP platform and protocol, supporting the development of accessible, standardised preparation methods for psychedelic research and therapy as the field continues to expand into diverse clinical and community-based settings.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-25", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06815653", "keywords": "Healthy, Psilocybin 25mg, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06815653\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Mechanism of Action,Consciousness,Wellbeing,Emotional Processing,Randomized Controlled Trial,Healthy Volunteers", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3681, "title": "Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder", "normalized_title": "assessing the safety tolerability and efficacy of psilocybin therapy followed by accelerated intermittent theta burst aitbs repetitive transcranial magnetic stimulation rtms for treatment resistant major depressive disorder", "authors": "University of Texas at Austin", "abstract": "The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participants, ages 22-76, with treatment-resistant MDD will be randomized to treatment with either: a) 25mg of COMP360 (N=50); or b) 1mg of COMP360 (low-dose comparator; N=50) with appropriate psychological preparation, support, and integration sessions with trained therapists. This will then be directly followed by one of two subsequent treatment conditions: i) the active accelerated intermittent theta burst (aiTBS) rTMS treatment known as Stanford Neuromodulation Therapy (SNT) and/or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) targeted to a functional magnetic resonance imaging (fMRI) functional connectivity-guided personalized left dorsolateral prefrontal cortex target using neuronavigation and delivered over 10 sessions daily for 5 consecutive days at 90% of coil-to-target depth-corrected resting motor threshold50,51; or ii) sham iTBS delivered in the same fashion. Individuals will undergo screening, a baseline clinical assessment and neurobiological assessment of functional magnetic resonance imaging (fMRI) and electroencephalographic (EEG) recordings. Individuals will then return on a subsequent day to begin the course of psilocybin therapy. Preparation sessions will occur on the first two out of five days (\\~1.5-2 hrs each day), psilocybin dosing will occur on the third day (\\~6-8 hours), integration session (\\~1 hour) and post-dosing assessments will occur on the fourth day, and a final integration session (\\~1 hour) and post-psilocybin clinical and neurobiological assessments will occur on the last of the five days. The following week, the individual will return to the lab to begin the course of active or sham SNT, for 10 hrs. a day (10 min once per 60 min, 50-minute inter-session interval, repeated 10 times daily) for 5 days. This is the protocol now FDA-cleared for treatment of treatment-resistant MDD, known as Stanford Neuromodulation Therapy and commercialized by Magnus Medical (see support letter from Magus Medical). In the third week, the individual will return to complete post-SNT clinical assessments and to complete a post-SNT neurobiological (fMRI and EEG) assessment. Individuals will complete long-term follow-up clinical assessments at 1 month, 2 months, 3 months, 4 months, 6 months, 9 months, and 12 months post-initiation of first treatment (psilocybin administration) to assess durability of clinical response and identify potential points of depression relapse over a sustained period of time. Aims: To determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. To determine if the combination of psilocybin therapy followed by SAINT demonstrates superior efficacy relative to either treatment alone acutely (primary acute endpoint will be \\~14 days after the initiation of the treatment sequence) and over time (additional endpoints at 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months following cessation of the treatment protocol). To determine the neurobiological changes following the combination treatment (assessment points at baseline, 2 days post-psilocybin, and \\~14 days post-psilocybin/2-4 days post cessation of accelerated theta burst), and if the magnitude or nature of such changes are different from those demonstrated in either treatment alone. Investigate how psychedelic treatment may impact blood biomarkers of inflammation (e.g., inflammatory cytokines) and how select functional genetic polymorphisms may moderate the effect of the psychedelic treatment on subsequent functional brain changes.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-25", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06132178", "keywords": "Treatment Resistant Depression, MDD, Major Depressive Disorder, Recurrent Depression, Depression, Psilocybin, COMP360, Accelerated intermittent theta burst (aiTBS) rTMS treatment, Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), Stanford Neuromodulation Therapy (SNT), Low-dose psilocybin, low-dose COMP360, Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment, Sham Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), Sham Stanford Neuromodulation Therapy (SNT), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06132178\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Brain Imaging,Biomarkers,Aging,Clinical Trial,Safety,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3700, "title": "Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life", "normalized_title": "pragmatic trial of psilocybin therapy in palliative care pt2pc a multicenter triple blind phase 2 randomized controlled trial of psilocybin therapy for demoralized adults near the end of life", "authors": "Charles S. Grob, M.D.", "abstract": "This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy). After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, \"unblinded\"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-24", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05403086", "keywords": "Demoralization, Psilocybin, Hallucinogen, Ketamine, Ketalar, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05403086\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3665, "title": "Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans", "normalized_title": "does serotonin system stimulation increase pro social behavior a comparative pharmacological neuroscientific study in healthy humans", "authors": "University of Zurich", "abstract": "The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy individuals. Psychedelic substances have been shown to be powerful modulators of social perception and behavior during the acute experience. This is of particular interest given that social relationships play a key role in the development and resolution of psychiatric symptoms. However, the neuropharmacological mechanism underlying pro-social effects and time-dependent changes currently remain unclear. This study therefore aims at answering two key questions: 1) Does stimulation of the serotonin system induce lasting effects on pro-social behavior? and 2) Are these effects specific to serotonergic stimulation? The following proposed study will assess these questions by investigating objective, ecologically valid measures of pro-social cognition four weeks after different pharmacological challenges (MDMA, an entactogen and releaser of serotonin, norepinephrine, and dopamine; psilocybin: a classical psychedelic and serotonin 2A receptor agonist, methylphenidate: an amphetamine and norepinephrine-dopamine re-uptake inhibitor) in healthy volunteers.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06081179", "keywords": "Healthy, Psilocybin, magic mushrooms, 3,4 Methylenedioxymethamphetamine, MDMA, Ecstasy, Methylphenidate, Ritalin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06081179\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Receptor Pharmacology,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3548, "title": "A Double-blind, Phase II Feasibility Study to Assess the Safety and Efficacy of Psilocybin Microdosing Combined With Psychotherapy in Treatment-resistant Depression", "normalized_title": "a double blind phase ii feasibility study to assess the safety and efficacy of psilocybin microdosing combined with psychotherapy in treatment resistant depression", "authors": "Beersheva Mental Health Center", "abstract": "Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to previous pharmacological or long-term psychological interventions. Hypothesis: Compared to baseline, the group that begins with psilocybin will exhibit a more rapid reduction in depressive symptoms after six weeks, compared to the group that begins with placebo and receives only psychotherapy. Following the crossover between conditions, the placebo-first group will also show an accelerated reduction in these measures after the subsequent six weeks. Alternative hypothesis: No difference will be observed between groups in the rate of symptom reduction. Objective: To examine biological markers that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo. Hypothesis: Compared to baseline, six weeks of active psilocybin dosing will result in decreased levels of cortisol and inflammatory markers, and increased levels of oxytocin and BDNF in saliva. Objective: To assess psychological factors that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo. Hypothesis: Compared to baseline, six weeks of active psilocybin dosing will lead to increased cognitive flexibility, greater self-compassion, and enhanced present-moment awareness. Objective: To explore a subpopulation of women experiencing premenstrual symptom exacerbation (PMS) and the potential for improvement in depressive symptoms in the days preceding menstruation, if any. Hypothesis: Among women with worsened premenstrual symptoms, psilocybin will reduce premenstrual symptoms, specifically depressive symptoms, compared to baseline.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07183748", "keywords": "Treatment Resistant Depression, Psilocybin (drug), Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07183748\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Biomarkers,Microdosing,Clinical Trial,Treatment-Resistant Depression,Safety,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3454, "title": "Open Label, Phase 2 Study for Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe Obsessive Compulsive Disorder (OCD) in Drug and/or Psychotherapy Resistant Patients.", "normalized_title": "open label phase 2 study for evaluating the feasibility safety and efficacy of psychotherapy assisted psilocybin for treatment of severe obsessive compulsive disorder ocd in drug and or psychotherapy resistant patients", "authors": "Beersheva Mental Health Center", "abstract": "Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current available treatments for OCD show moderate response rate and high rate of symptom relapse. The purpose of the current study is to explore new alternative options for the treatment of OCD that can widely and continuously benefit patients. Specifically, The aim of this study is to investigate the feasibility, safety and efficacy of psychotherapy assisted psilocybin for treatment of severe OCD. Previous research has shown safety of treatment and high efficacy in reduction of anxiety and depression symptoms. However, only one study has evaluated the use of psilocybin for OCD patients. The protocol includes 15 therapeutic sessions, of which 12 are one-hour sessions for psychological preparation and integration, and three are eight hours' experiential sessions under the influence of psilocybin. The research will include 15 participants diagnosed with severe OCD, with at least one treatment failure. Assessments will be based on comparing ratings of the main outcome measure (Y-BOCS), at baseline, at the middle and at end of treatment. Other assessments will include data on side effects- to evaluate safety, and possible spiritual variables underlying change in symptoms via standardized questionnaires. Background and research rationale: Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviours or mental rituals performed to control or alleviate this anxiety. Individuals with OCD often have diminished quality of life, functional impairment, and cause substantial caregiver burden and personal and societal economic costs. Lifetime prevalence of OCD ranges between 1.9%-2.5%, with patients often not responding to the offered pharmacological or psychological treatment, and in extreme cases may even undergo neurosurgical interventions. There are several possible physiological mechanisms leading to the development of OCD, which may indicate several possible effective treatment options. Nowadays there is a consensus that the dopaminergic and serotonergic pathways are central to the development of the disorder with the basal ganglia as the main area of its origin. Other brain areas involved in OCD are the orbitofrontal cortex and anterior cingulate cortex which are connected to the basal ganglia and are involved in regulating attention and awareness. Abnormal activity between these areas and other subcortical areas might explain why normally unconscious information processing, becomes consciousness, and requires additional resources for its regulation. It has also been suggested that the aversive emotional activity (anxiety, fear, disgust) experienced in OCD, relates to hyperactivity in the amygdala. The momentary relief brought on by the compulsive behaviour forms a positive feedback which perpetuate the disorder. The gold standard of care for OCD today is a combination of selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioural therapy (CBT). Most patients will experience at least some symptomatic relief with these interventions; however, relapse of symptoms occur in 40%-60% of patients and around 25% of patients are unresponsive to treatment. Other existing treatments (either pharmacological or neurosurgical) possess a higher risk for serious side effects. It is important to note that even for those patients who are responsive to treatment there are still significant residual, impairing symptoms. It thus seems that there is a real and immediate need to explore new alternative options for the treatment of OCD that can widely and continuously benefit patients, with lower risk and fewer side effects. A new and promising prospect of treatment in mental health is the use of psychedelic substances, which interact with the serotonergic pathways and induce a powerful subjective experience with the potential for psychological transformation. Specifically, psilocybin has received attention in research as a promising alternative in the treatment of severe mental illness. Psilocybin is a prodrug which is quickly converted by the body to psilocin (4-OH-dimethyltryptamine), a 5-HT2A receptor partial agonist. Both psilocybin and psilocin, which have psychoactive properties, are naturally occurring in Psilocybe mushrooms and are structurally similar to the endogenous neurotransmitter serotonin. As a direct 5-HT2A agonist, psilocybin has a unique therapeutic potential compared with other pharmacological treatment for OCD such as SSRIs. Animal studies have shown increased cognitive flexibility, associative learning, cortical plasticity, and anti-depressive effects in response to 5-HT2A activation. The first current clinical research with psilocybin examined the safety and efficacy of psilocybin in the treatment of psychological distress in patients with terminal advanced-stage cancer. The double-blind, placebo-controlled research was conducted in the Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center (Torrance, California). Researchers concluded that psilocybin is safe and well tolerated at 0.2 mg/kg dose. Following this research two different research groups, in Johns Hopkins University, and in New York University, have received FDA approval to administrate a higher dose of psilocybin in a similar clinical population. These trails have shown promising results for safety, psychological distress reduction, and significant improvement in anxiety and depression. In their research, Griffiths and colleagues, examined the efficacy of psilocybin in reducing anxiety and depression in 51 patients suffering from a terminal end-stage cancer and experiencing symptoms of anxiety and depression. This randomized, double-blind, cross-over trial investigated the effects of a very low (placebo-like) dose (1 or 3 mg/70 kg) vs. a high dose (22 or 30 mg/70 kg) of psilocybin. No serious adverse events attributed to psilocybin administration occurred. There were transient moderate increases in systolic and/or diastolic blood pressure after psilocybin (in 34% of participants in the high-dose session and 17% of participants in the low-dose session), none of these episodes met criteria for medical intervention. Nausea or vomiting occurred in 15% of participants in the high-dose session. An episode of physical discomfort (any type) occurred in 21% of participants in the high-dose session and 8% in the low-dose session. Psychological discomfort (any type) occurred in 32% of participants in the high-dose session and 12% in the low-dose session. An episode of anxiety occurred in 26% of participants in the high-dose session and 15% in the low-dose session. One participant had a transient episode of paranoid ideation (2% of high-dose sessions). There were no cases of hallucinogen persisting perception disorder (HPPD) or prolonged psychosis. Across the two dose sequence groups, the overall rate of clinical response at 6 months was 78% and 83% for depression and anxiety, respectively, and the overall rate of symptom remission at 6 months for all participants was 65% and 57%, respectively. Ross and colleagues conducted a double-blind, placebo-controlled, crossover trial, with 29 patients with cancer-related anxiety and depression that were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin (active placebo), both in conjunction with psychotherapy (before and after drug administration). The most common adverse effects were non-clinically significant elevations in blood pressure and heart rate (76%), headaches/migraines (28%), nausea (14%), transient anxiety (17%), and transient psychotic-like symptoms (7%). The medical and psychiatric adverse effects attributable to psilocybin are all known, were transient, and tolerable. There were no cases of prolonged psychosis or HPPD, and no participants required psychiatric hospitalization. Psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression, this effect was sustained at 6.5 months follow-up. These trails and others have shown safety of treatment and high efficacy in reduction of anxiety and depression symptoms with sustained effect at 6 months follow up. These findings taken together with the theoretical understanding of psilocybin mechanism of action and with the understanding of the neuro-psychological pathology of OCD, encourage investigating the potential of psilocybin as a novel significant treatment for this disorder. Research of beneficial effects of psilocybin for patients with OCD is in its infancy, but preliminary findings show potential efficacy in treatment of the disorder. Matsushima and colleagues, used a mice model for OCD and found that psilocybin (both syntactic and in mushroom form), significantly inhibited compulsive behaviour (marble burying) without affecting locomotor activity. In addition, several case reports showed beneficial effects of psilocybin for people with OCD. For example, Leonard and Rapoport (1987) and Moreno and Delgado (1997) reported that among drug-users with OCD, there was a worsening of symptoms under the influence of cocaine, but a remission of symptoms for hours/ days following psilocybin use. Wilcox (2014) described a case in which a patient with OCD self-medicated with psilocybin, once every three weeks, experienced a preserved effect of reduced anxiety, obsessive thoughts, and compulsive behaviour. In another case report, a patient suffering from a body dysmorphic disorder (spending about 4 hours a day examining himself in the mirror), has experienced a significant reduction in distress and a notable change in body perception following multiple dosing of psilocybin. Moreno et al. 2006 conducted a semi open-label trial examining the effect of psilocybin on nine participants with mild to severe OCD, which had at least one \"treatment failure\" defined as a lack of significant improvement after an adequate treatment. Doses were 25 (very low dose \\[VLD\\]), 100 (low dose \\[LD\\]), 200 (medium dose \\[MD\\]), and 300 (high dose \\[HD\\]) µg/kg. LD, MD, and HD were assigned in that order, and VLD was inserted randomly and in a double-blind fashion at any time after the first dose (LD). In measurements during the 24 hours after each dose all participants have experienced a significant relief in symptoms (23%-100% as measured by the Yale-Brown Obsessive-Compulsive Scale \\[YBOCS\\]) in at least one of the sessions. Two of the subjects reported that their symptomatic improvement lasted most of the following week after testing. One subject achieved long-term remission at the end of the 4 test sessions, as measured at 6-month follow-up. There was, however, no clear dose-response relationship to the change in YBOCS score and no correlation between YBOCS score reduction and the perceived intensity of the psychedelic experience. These preliminary findings stress the need for further research to examine the efficacy of psilocybin in the treatment of OCD. In addition, the only clinical trial to date did not include psychotherapy for patients while under the influence of psilocybin. Earlier studies have shown that a preliminary therapeutic relationship before psilocybin administration increases the probability for a \"peak experience\" during sessions. Furthermore, two more recent studies have emphasized the importance of psychotherapy during and before psilocybin sessions, touching on 'intent' and formulating an early and strong therapeutic relationship. There is also a reference to the, \"psychedelic afterglow\", an effect lasting for days and even weeks after a psychedelic session during which there is a unique window for a meaningful transformative psychotherapeutic intervention, most likely owing to the increased psychological plasticity following a psychedelic experience. The current study has two main goals: 1. Determine the safety and efficacy of psilocybin for patients suffering from OCD. 2. Elucidate the psychological mechanisms contributing to the beneficial effect of psilocybin on OCD symptoms. Research Plan: The current research aims to examine the feasibility, safety and efficacy of psychotherapy assisted psilocybin for treatment of severe OCD. The protocol includes 15 therapeutic sessions, of which 12 are one-hour sessions, and three are eight hours' experiential sessions (session 4,8,12) under the influence of psilocybin. In the first experiential session participants will receive a safety dose of 10mg/70kg. In the second and third sessions, participants will receive a therapeutic dose of 30mg/70kg. Three preparatory sessions will take place before the first experiential session, and three integration sessions will take place after each experiential session. The research will include 15 participants, and will include the following phases: Selection phase: Research team will screen participants via phone interviews. Participants answering the inclusion criteria will be invited to receive and sign consent forms. Research member will collect demographics and health status data and register the participants according to study protocol. Preparatory and final registration phase: It is known that SSRIs have a counter effect on psilocybin; therefore, to allow a full effect of psilocybin it is necessary to avoid drug interaction and discontinue previous treatment. In a period of 4 weeks participants will undergo medication withdrawal under psychiatric supervision. During the 4 weeks period each participant will have 2-4 sessions (as needed) with the research psychiatrist, to supervise their clinical state. At the end of 4 weeks, a psychiatric evaluation will take place to determine readiness to begin psilocybin treatment. Baseline assessment, and preparatory therapeutic sessions phase: During the 5-6 weeks from registration, participants will have three preparatory psychotherapy sessions with a couple of therapists assigned to their treatment. Prior to their first psychotherapy session, participants will complete the first-baseline assessment of research questionnaires. Treatment phase: The treatment phase includes three experiential sessions with psilocybin (sessions 4, 8, 12), and three integration sessions after each experiential session. During this phase participants will complete three assessments using research questionnaires (sessions 2, 10, 15). End of treatment and follow-up phase: Primary outcome assessment will take place at the end of the last therapeutic session (no.15). Additional assessments will take place at three months, and six months/one-year follow-up. Research procedure Participants will sign consent forms, before participating in the research treatment. The treatment is based on 15 therapy sessions: * Three preliminary sessions for establishing therapeutic alliance with the therapists and preparing the participant for the first experiential session. * An 8-hour experiential session with a safety dose of psilocybin (10mg/70 kg). (V4) * Participant will spend the night at the medical facility, under the supervision of a research member. * A1-hour session with the therapists, on the following morning (V5) * Two integration sessions, and preparation for the next experiential session. (V6, V7) * An 8-hour experiential session with a therapeutic dose of psilocybin (30mg/70 kg). (V8) * Participant will spend the night at the medical facility, under the supervision of a research member. * A1-hour session with the therapists, on the following morning (V9) * Two integration sessions, and preparation for the next experiential session. (V10, V11) * An 8-hour experiential session with a therapeutic dose of psilocybin (30mg/70 kg). (V12) * Participant will spend the night at the medical facility, under the supervision of a research member. * A1-hour session with the therapists, on the following morning (V13) * Two integration and summary sessions. (V14, V15) Possible discomfort: It is possible that psilocybin and the experience it induces will cause some emotional or physical discomfort. Investigators will address all possible discomforts and appropriate measures to contain them, in the research safety instructions. Research purpose: The main objective of this research is to use standardized measuring tools to explore the safety and efficacy of psilocybin assisted psychotherapy in treating severe OCD symptoms. A secondary aim is to explore possible variables underlying change in symptoms. Research objectives: The main objective is to assess efficacy of psilocybin assisted psychotherapy in treating severe OCD symptoms. This assessment will be based on comparing ratings of the main outcome measure (Y-BOCS), at baseline (session 2) at the middle and at end of treatment (session 10, 15 respectively). A score under 14 or a reduction of 35% in the overall score will be considered as remission (Lewin, Nadai, Park, Goodman, Murphy \\& Stroch, 2011). Secondary objectives: assessing safety by collecting data on side effects, and assessing possible spiritual variables underlying change in symptoms via standardized questionnaires and semi constructed interviews. Safety: The general safety goal is to assess occurrence and frequency of adverse events during treatment. This includes suicide ideation and/or behaviour, and adverse physiological or psychological responses. The safety of psilocybin use was previously proven in several clinical research. Potential adverse effects: In general, psychedelic drugs have low levels of physiological toxicity, and previous research indicate no evidence of toxicity, organ damage or neurophysiological disfunctions. Possible physiological effects experienced under the influence of psychedelic substances may include: dizziness, weakness, tremor, paresthesia, nausea, thirst, blurred vision, dilated pupils, and hyperreflexia. These somatic effects are dynamic and relatively minor, even when the psychological effect (sensory, perceptual, and cognitive) is strong/intense. The significant risk associated with psilocybin intake, is a subjective experience of fear and anxiety, panic, dysphoria and/or paranoia. Recent clinical studies report a high safety level with no adverse effects. The high safety levels can be attributed to several control parameters described below, and to complying with safety guidelines in clinical psychotherapy with psychedelics. The use of psilocybin requires a significant psychotherapeutic holding of the subjective experience, that will provide a safe and supportive environment during the psychedelic experience. The safety guidelines in clinical psychotherapy with psychedelics describe the therapeutic presence and processes, as well as the set and settings needed to provide a supportive emotional and external environment. Safety measures: 1. Controlling the quality of psilocybin and ensuring it is manufactured under GMP conditions. 2. Controlling for appropriate and adjusted dosage. 3. Controlling a strict protocol for screening eligible participants to the study (for details see inclusion-exclusion criteria section) 4. Recruiting professional and experienced psychotherapists with the appropriate training for clinical psychotherapy with psychedelics. Professionals will undergo a unique training to work with the psychotherapy protocol written for the current research. 5. Psychotherapists will work in pairs (a man and a woman), to provide an optimal holding space for each participant. 6. A proximity of a medical team for case of emergency. 7. Providing preparatory and integration sessions before and after the psilocybin sessions. 8. Preparing and using a comfortable and friendly room for the therapeutic session. The physical environment in which the treatment takes place should be suitable to the physical as well as the emotional safety of the participant. This means creating a lenient environment, which provides a pleasant and welcoming atmosphere, and may elicit a sense of intimacy and connection. As opposed to the environment of a hospital, a space like this supports and strengthens the participant's sense of safety and connectedness, thus helping him/her contain the intense psychedelic experience. 9. Guidelines for psychotherapy process: these guidelines are based on the humanistic perspective, and concern the characteristic of the therapeutic process: * A supportive, accepting, and non-judgmental presence of the therapist. * The importance of the therapeutic alliance and trust between participant and therapists. * A non-directive approach, supportive and gentle presence that stays with the participant's unfolding experience. * Viewing the mind as multi-dimensional, making space for the diverse dimensions of the internal experience: physical, emotional, and spiritual. 10. Maintaining a well-documented monitoring of the study and the participants status during the study period. 11. Monitoring physiological measure (blood pressure, heart rate and body temperature) during the psychedelic sessions with psilocybin: before taking the drug, an hour and a half after taking the drug, and 8 hours after. In case of anomalies physiological measures will be monitor more frequently. 12. Consulting and collaborating with other research teams with similar research interests, in NYU and Imperial College in London, UK.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04882839", "keywords": "Obsessive-compulsive Disorder, psychotherapy assisted psilocybin, RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04882839\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,OCD,End-of-Life Distress,Headache / Migraine,Neuroplasticity,Mechanism of Action,Receptor Pharmacology,Consciousness,Emotional Processing,Spirituality,Clinical Trial,Case Report,Animal Study,Cancer Patients,Safety,Adverse Events,Toxicity,Drug Interactions", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3443, "title": "Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder", "normalized_title": "psilocybin assisted vs ketamine assisted psychotherapy for alcohol use disorder", "authors": "Peggy C Nopoulos", "abstract": "This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use. This pilot study will be a double blind, randomized, active-comparator controlled trial with two study arms. Subjects randomized to Arm 1 (n=10) will receive individual psychotherapy sessions plus a 25mg dose of psilocybin, while Arm 2 subjects (n=10) will receive individual psychotherapy sessions and a 200mg dose of ketamine. Psychotherapy sessions will involve integrative psychotherapy modalities. At baseline, subjects will be consented, randomized into one of the two arms, complete psychiatric and medical evaluations, and will undergo an MRI scan. The first two therapy sessions (week 1 and week 2) will be used to learn about the participant's life story, engage the patient, and evoke their reasons for wanting to change their pattern of alcohol use. At week 3, participants will undergo a psilocybin-assisted therapy session or a ketamine-assisted therapy session. The last 2 psychotherapy sessions will be focused on integration of their experiences in the drug administration session and will include a second MRI scan and more assessments. Therefore, each arm receives 4 psychotherapy sessions, and the primary difference between the groups is which drug participants receive. After the psychotherapy sessions are completed at the end of week 4, subjects will be followed weekly for 4 weeks. At the last follow-up (week 8), they will undergo a third MRI scan and a final assessment. At the conclusion of the study, those randomized to the ketamine group will be offered a psilocybin-assisted therapy session, and two follow-up/integration sessions in an open-label extension. The open-label extension will also include an additional 4 weeks of follow-up.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-16", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05421065", "keywords": "Alcohol Use Disorder, Psilocybin, Ketamine, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05421065\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3510, "title": "Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder", "normalized_title": "psilocybin induced neuroplasticity in the treatment of major depressive disorder", "authors": "Yale University", "abstract": "The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression. In this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03554174", "keywords": "Major Depressive Disorder, Low Dose Psilocybin, Placebo, Medium Dose Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03554174\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Neuroplasticity", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3489, "title": "A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer", "normalized_title": "a phase 1 2 study of a group model of psilocybin assisted therapy for cancer related anxiety in patients with metastatic cancer", "authors": "University of Washington", "abstract": "This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin. Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety. OUTLINE: Patients receive psilocybin orally (PO) and participate in group and individual therapy sessions on trial.", "journal": "ClinicalTrials.gov", "publication_date": "2025-11-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05847686", "keywords": "Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm, Counseling, Counseling Intervention, Psilocybin, CY-39, Indocybin, psilocybine, Questionnaire Administration, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05847686\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Receptor Pharmacology,Clinical Trial,Cancer Patients,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3503, "title": "Precision Functional Brain Mapping to Understand the Mechanisms of Psilocybin", "normalized_title": "precision functional brain mapping to understand the mechanisms of psilocybin", "authors": "Washington University School of Medicine", "abstract": "This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain networks in healthy adults. Psilocybin shows promise as a safe, transformational therapeutic across several psychiatric conditions. However, little is know about its mechanism of action. This study aims to establish a neuroimaging paradigm for use in future clinical research testing the effectiveness of psilocybin in various clinical applications. In this study, we will assess both acute (during psilocybin exposure) and sustained (one week post-exposure) effects of 5-HT2A receptor agonism on brain circuits using resting state functional connectivity and precision functional mapping (PFM). Using a randomized, controlled crossover study design, a small number of healthy volunteers will receive either psilocybin or methylphenidate (MTP) and will undergo MRI (structural, task, blood flow, extended resting state). After two weeks, participants will return for a second exposure with the alternate of what they received in the first session. This study involves up to five separate imaging sessions. Functional connectivity will be measured using the following PFM approach: 1. Extended functional magnetic resonance imaging (fMRI) image acquisition 2. Aggressive data cleaning 3. Analysis designed to examine functional brain connectivity at the individual level This will allow us to map the effects of 5-HT2A receptor agonism on cortical and cortico-subcortical brain networks at the individual level with precision that is unparalleled in the current literature. This is the first step in developing a precision neuroimaging approach for mechanistic understanding of psilocybin's therapeutic effects. If successful, this pharmacoimaging paradigm will have potential utility across psychiatric conditions, allowing us to better understand whether and how psilocybin might \"bend the curve\" in treatment course, preventing persistent suffering, disability, and suicide.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-30", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04501653", "keywords": "Psilocybin, psilocin, Methylphenidate, Metadate, Methylin, Ritalin, Concerta, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04501653\",\"overall_status\":\"COMPLETED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Receptor Pharmacology,Aging,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3566, "title": "A Randomized, Double-Blind, Placebo-Controlled Mechanistic Study to Assess a Single Oral Dose of CYB003 in Participants With Major Depressive Disorder (MDD) and Moderate to Severe Anxiety", "normalized_title": "a randomized double blind placebo controlled mechanistic study to assess a single oral dose of cyb003 in participants with major depressive disorder mdd and moderate to severe anxiety", "authors": "Ohio State University", "abstract": "The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function. Many patients with MDD do not respond or have an incomplete response to treatment with currently available antidepressants. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve depressive symptomatology, however their mechanism of action is still not well understood. Psilocin is the active metabolite of psilocybin responsible for the psychedelic effects of the parent compound. CYB003 is a synthetic, deuterated isotopomer of psilocin, being developed by Cybin for the treatment of MDD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using electroencephalography (EEG)/electromyography (EMG) and functional magnetic resonance imaging (fMRI)/ diffusion-weighted magnetic resonance imaging (DWI) after administration of one oral dose of CYB003. Up to 40 participants will be enrolled and randomized into two groups: one receiving 16 mg of CYB003, and one group receiving placebo. Psychological support will be provided before, during and after the administration session. Assessments performed at Baseline and on Day 2 and Day 21 after administration will include EEG/EMG, MRI, clinician (MADRS, HAM-A, C-SSRS) scales and self-report questionnaires to assess depression and anxiety symptoms, cognitive testing, self-report questionnaires to evaluate the psychedelic effects of CYB003 administration, and blood draw of the Gsα-AC biomarker assay.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-29", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06820723", "keywords": "Depression, Anxiety, Major Depressive Disorder, CYB003, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06820723\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Neuroplasticity,Brain Imaging,Mechanism of Action,Biomarkers,Aging,Healthcare Workers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3597, "title": "A Wellcome Leap for the Opioid Crisis: Can the 5HT2A Agonist Psilocybin Improve Brain, Behavioral, and Clinical Outcomes in Opioid Use Disorder (OUD)?", "normalized_title": "a wellcome leap for the opioid crisis can the 5ht2a agonist psilocybin improve brain behavioral and clinical outcomes in opioid use disorder oud", "authors": "Anna Rose Childress, Ph.D.", "abstract": "Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose. The Opioid Crisis: Currently in its third wave, the opioid epidemic involves the prevalence of lethal levels of fentanyl in drugs, leading to a surge in opioid-related deaths. Reports indicate a record-breaking number of over 107,000 drug-related overdose deaths in 2021-2022, with opioids contributing to more than 75% of these fatalities. Beyond fatal overdoses, nearly 1 million non-fatal overdoses occurred in 2017, carrying significant, long-lasting consequences. Those who experience non-fatal overdoses are more prone to subsequent overdoses and have a higher likelihood of death within a year, primarily due to drug-related issues. The escalating cases of opioid use disorder (OUD) emphasize the critical need for innovative treatments to address the associated challenges, including neurocognitive difficulties and poor clinical outcomes. While medication-assisted treatment (MAT) like methadone or buprenorphine effectively alleviates withdrawal symptoms and reduces overdose risk, illicit drug use persists, and non-adherence to MAT remains a challenge. The opioid overdose crisis demands urgent attention and necessitates the development of treatments capable of making a significant impact. Psilocybin: In response to the need for improved treatments, there's a growing interest in psychedelic-assisted treatment (PAT), particularly involving psilocybin (PSI). Clinical trials support the use of PAT in controlled medical contexts, with 105 trials registered in the past 20 years covering various mental health and other conditions. PSI (at single doses in the proposed range) has shown preliminary promise for depression, alcohol use disorder, and tobacco-use disorder. However, its potential benefits for OUD remain unknown. This proposal aims to determine whether PSI enhances critical OUD clinical outcomes, such as relapse, overdose, and MAT adherence. Importantly, the investigators will test how PSI produces its benefits through its impact on brain and bio-behavioral targets, thus linking potential biomarkers to clinical outcomes. Cognitive Flexibility: The ability to change thoughts, emotions, and behaviors in response to changes in circumstance (to \"flex\") has strong survival value. When the brain cannot \"flex\", one can experience a range of mishaps, from small (turning left rather than right 'out of habit') to much larger ones. Being 'stuck' is a problem that appears in many disorders. For example, individuals with depression may get 'stuck' in dark ruminating thoughts; individuals with OCD may get 'stuck' in repetitive thoughts and behaviors; people with substance use disorders get 'stuck' over-responding to drug reward signals and pursue the drug despite negative consequences. Recent research shows that PSI facilitates intermediate and long-term improvements in cognitive flexibility, raising the hope that it can 're-set' the brain and enable new thoughts, emotions, and behaviors. Cognitive flexibility is often measured by tasks that quantify how successfully one can shift between changing mental rules to complete a task. Using such tasks, there is evidence of cognitive flexibility deficits in people with OUD, but research has not specifically examined the impact of improved cognitive flexibility on OUD clinical outcomes. To date, one study showed that neurocognitive training in executive function (EF), including cognitive flexibility, is associated with reduced opioid use, while a non-OUD study found that higher baseline cognitive flexibility was related to better substance use treatment retention. This proposal will be the first to test whether putative PSI-related improvements in cognitive flexibility will lead to more favorable OUD clinical outcomes. Other Executive Functions: Importantly, cognitive flexibility is a complex capability that depends on the integrated action of several other basic executive functions (EFs): attention, working memory, and inhibition of thoughts, feelings, or actions. Further, each of these basic EFs, together with cognitive flexibility, are needed for effective and efficient planning and decision-making. Individuals who use drugs demonstrate impairment in a variety of these fundamental EFs. In OUD populations, deficits are evident across most EF domains, including working memory, attention, inhibition, and decision-making, which may relate to or underly their cognitive inflexibility. Studies have found that performance on EF tasks (and the neural underpinnings of EF in the prefrontal cortex \\[PFC\\]) indeed correlate with clinical outcomes such as treatment non-adherence (e.g., working memory) and drug use/relapse (e.g., poor inhibition) in substance-use disorders generally, and with reduced abstinence in OUD. Whether these multiple EF deficits predate, or even predispose, drug use - they are likely compounded by drug exposure, including non-fatal opioid overdoses that produce hypoxic-related brain injuries, leading to further neurocognitive deficits. In sum, there is good preliminary evidence for deficits in the several component EFs underlying cognitive flexibility in OUD. By measuring these separately, the current proposal will be able to determine which of these targets are most impacted by PSI, and their relative importance for outcome prediction. What's \"special\" about psilocybin? PSI has likely been in use by humans for millennia, originally as a religious or spiritual agent due to its dramatic subjective effects, including hallucinations and mystical experiences. However, scientists have more recently understood that some of the effects - such as increased sense of connectedness, openness, and change in perspective - can produce long-lasting change and improved mental health. Indeed, psychometric instruments capturing non-ordinary states of consciousness and psychological constructs have reliably predicted clinical treatment outcomes, including substance use disorder outcomes. Some theorists have proposed that these dramatic drug effects may reflect a profound initial 'loosening' of top-down control over limbic and sensory regions, resulting in improved flexibility and adaptive behavior. Though the current proposal will not be able to test all features of this hypothesis, the investigators will capture the special acute phenomenology of the drug state and test for the fundamental feature of flexibility. Further, the investigators will determine the relative role of the basic EF components of flexibility and test the importance of all these factors (alone and in combination) for obtaining clinical benefit from the drug. This study will provide a critical foundation for understanding the potential of 5HT2A agonists in OUD, with treatment implications for several other disorders where cognitive inflexibility, 'getting stuck', is a core feature.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-28", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06786325", "keywords": "Opioid Use Disorder, Psilocybin, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06786325\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Addiction,OCD,Receptor Pharmacology,Consciousness,Biomarkers,Emotional Processing,Spirituality,Mystical Experience,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3688, "title": "Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults", "normalized_title": "investigating the persisting effects of a single dose of psilocybin on structural plasticity in healthy older adults", "authors": "University of California, Berkeley", "abstract": "Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. The investigators will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults (60-85 years old). The investigators will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose (1-30 milligrams). Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. The investigators will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-20", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06367738", "keywords": "Aging, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06367738\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Neuroplasticity,Brain Imaging,Aging,Microdosing,Wellbeing,Emotional Processing,Observational Study,Older Adults", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3432, "title": "Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain", "normalized_title": "investigating the mechanisms of the effects of psilocybin on visual perception and visual representations in the brain", "authors": "University of California, Berkeley", "abstract": "The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-20", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05265546", "keywords": "Perception Disorders, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05265546\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3652, "title": "Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation", "normalized_title": "phase i study of the safety and adjunctive effects of psilocybin in adults with opioid use disorder maintained on a buprenorphine naloxone formulation", "authors": "University of Wisconsin, Madison", "abstract": "Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain. The primary objective of this clinical trial is to determine the safety of psilocybin in adult patients with opioid use disorder concurrently taking buprenorphine-naloxone. Eligible participants will be adults with active opioid use disorder (OUD) who are willing to begin and maintain a daily dose of buprenorphine-naloxone throughout study participation. Initiation, stabilization, and maintenance of buprenorphine-naloxone will be overseen by a qualified study medical provider. After psychological screening and at least 6 hours of preparatory counseling and preparation for the psilocybin dosing, set, and setting, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Clinical Research Facility. After eight hours of observation in the dosing room, the participant will be kept overnight in the hospital Clinical Research Unit, and complete an integration session with a psychologist before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation. Participants who have been administered the first dose but decline to receive the second dose will remain evaluable. At study termination, their active study participation will end, but completion of the 28 day post-dose follow up will be requested. The primary endpoint is the assessment of the safety of concurrent administration of a buprenorphine-naloxone formulation and psilocybin as determined by physiological measures (ECG, respiratory rate, blood pressure, body temperature, and blood oxygen saturation) and validated clinical and self-report measures (Clinical Opiate Withdrawal Scale (COWS), Opioid Craving Scale (OCS), Timeline Follow-Back (TLFB)). If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the \"More Information\" section at the bottom of this record.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-14", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04161066", "keywords": "Opioid Use Disorder, Psilocybin with facilitated counseling, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04161066\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Addiction,Chronic Pain,Clinical Trial,Observational Study,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3640, "title": "A Phase 1 Study of a Second Psilocybin Group Retreat for Partial Responders With Anxiety Associated With Metastatic Cancer", "normalized_title": "a phase 1 study of a second psilocybin group retreat for partial responders with anxiety associated with metastatic cancer", "authors": "University of Washington", "abstract": "This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as \"magic mushrooms\". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer. OUTLINE: Patients receive psilocybin orally (PO) with optional booster dose on day 0. Patients attend an individual prep visit on day -1 and an individual integration visit on day 1. Patients also attend group preparation visits on days -14, -7 and -1 and group integration visits on days 1, 8, 22 and 36. After completion of study treatment, patients are followed up at 2, 3, and 6 months.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-13", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06644170", "keywords": "Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm, Behavioral Intervention, Psychedelic therapy, Group Therapy, Psilocybin, Questionnaire Administration, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06644170\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Anxiety,Receptor Pharmacology,Wellbeing,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3590, "title": "Psilocybin and Affective Function in Chronic Lower Back Pain Depression", "normalized_title": "psilocybin and affective function in chronic lower back pain depression", "authors": "Johns Hopkins University", "abstract": "This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects. This study will investigate the effects of a single experimental psilocybin (25 mg fixed dose) administration compared to a dose of methylphenidate (40 mg fixed dose). Assessments will be conducted during screening visits, before and after the drug session, at follow up visits up to 1-month after the drug session, as well as periodically throughout study participation via a multi-time-per-day survey application. Forty participants will complete all study visits including follow-up visits. Primary objectives: 1. Investigate the feasibility, safety, and acceptability of psilocybin for CLBP+D2. Investigate the effect of psilocybin on self-report of positive affect, negative affect, and pain catastrophizing 3. Investigate the effect of psilocybin on a behavioral task called positive affective pain inhibition Secondary objectives: 1. Investigate the durability (1-month follow-up) effects of psilocybin on self-report of positive affect, negative affect, and pain catastrophizing 2. Investigate the effect of psilocybin on dynamic associations between affective measures, pain, and function on a moment-to-moment basis.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-13", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06355414", "keywords": "Chronic Low-back Pain, Depression, Psilocybin, Methylphenidate, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06355414\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Chronic Pain,Mechanism of Action,Observational Study,Safety", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3455, "title": "Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study", "normalized_title": "psilocybin for chronic pelvic pain cpp in women a pilot feasibility study", "authors": "Oregon Health and Science University", "abstract": "The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions). Chronic pelvic pain (CPP) presents a significant challenge in healthcare, affecting approximately 15% of women in the United States and incurring annual healthcare costs upwards of $5.8 billion. This condition extends beyond persistent physical discomfort, profoundly impacting mental health and overall quality of life. Central to many chronic pain syndromes, CPP can lead to a heightened state of pain sensitivity known as central sensitization. This condition arises from neuroplastic changes within the central nervous system, leading to structural, functional, and chemical alterations in the brain that enhance neural reactivity, even in the absence of actual physical injuries. Central sensitization is characterized by widespread, multisite hyperalgesia and allodynia. These changes often co-occur with fatigue, mood and cognitive disturbances, sleep disruptions, and multisensory hypersensitivity, complicating the clinical picture and exacerbating the condition's impact on daily functioning. The use of psilocybin in chronic pain is a paradigm shift from conventional pain therapy where the goal is pain alleviation, to changing a person's relationship with pain, offering a re-alignment or 'reset' of one's view of their pain, this is an innovative approach. To date, there are no psilocybin studies evaluating CPP. This is a pilot feasibility and safety study to evaluate a single administration of psilocybin (25 mg) in women with CPP who have failed at least one conventional CPP therapy. The study will enroll 15 women, the primary aim is to assess feasibility that will be met when at least 80% of participants complete the study and attend 80% of 11 study visits (9/11 visits). Safety will be assessed by adverse event reports, safety labs, and vitals assessments.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-09", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06988319", "keywords": "Chronic Pelvic Pain, Psilocybin (Usona Institute), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06988319\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Chronic Pain,Safety,Adverse Events", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3668, "title": "A Pilot Study in North Louisiana to Assess the Tolerability of Psilocybin as Well as Its Capacity to Promote Abstinence From Methamphetamine", "normalized_title": "a pilot study in north louisiana to assess the tolerability of psilocybin as well as its capacity to promote abstinence from methamphetamine", "authors": "Kevin Murnane", "abstract": "The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive function and quality of life. Components of the psilocybin experience will also be measured (persisting effects, quality of life, challenging experiences, etc). Investigators will assess feasibility and tolerability as rates of retention and challenging experiences, among other factors. This is an open-label pilot study evaluating the feasibility and tolerability of a single 25 mg psilocybin dose in promoting abstinence from methamphetamine. Participants will attend 10 to 12 study visits over a period of up to six months. Participants will be recruited from a population receiving treatment for methamphetamine dependence at a local residential treatment facility. Recruitment will involve informative presentations to current clients and counselor-facilitated referrals based on provided inclusion criteria. Prescreening will utilize information collected by the treatment center during the client's admission process. Individuals who meet prescreening criteria will be invited to an in-person screening visit, conducted after obtaining informed consent. The screening visit will include a clinical review, a detailed psychiatric interview, self-report questionnaires, a comprehensive medical history, and safety laboratory testing, including blood draws. Once eligibility is confirmed, participants will proceed with study enrollment and complete baseline assessments, which will measure substance use, quality of life, and executive function. Three preparatory sessions will follow over a two-week period to establish trust and rapport between participants and session monitors, educate participants on the study protocol, and prepare them for the psilocybin session. Two preparatory sessions may be conducted via telehealth to enhance feasibility, while the third will be conducted in person with both the primary and secondary monitors present. A medical examination will be performed within the week preceding psilocybin administration. Within a week of the third preparatory session, participants will attend a psilocybin administration session. Participants will arrive at the study location by 9:30 AM and undergo safety screenings, including breathalyzer testing, before psilocybin administration at approximately 10:00 AM. Participants will have been instructed to consume a low-fat breakfast prior to arrival. During the session, cardiovascular measures (e.g., heart rate, blood pressure) will be monitored upon arrival, hourly throughout the session, and as clinically indicated. The psilocybin session, lasting approximately 6-8 hours, will be monitored by both the primary and secondary session monitors, ensuring that at least one individual is present with the participant at all times. At the conclusion of the session, participants will complete questionnaires assessing their subjective experiences. Participants will then be released into the care of treatment center staff, who will provide emotional support. Participants will also receive contact information for the primary monitor to access support if needed. Post-session integration will include two telehealth sessions: the first within one day of the psilocybin session and the second approximately 7 days later (±3 days). These sessions will provide opportunities to discuss insights or challenges arising from the psilocybin experience, with an emphasis on promoting adaptive cognitive and behavioral changes. Follow-up assessments will occur via telehealth at 30 and 60 days post-psilocybin, with an in-person assessment conducted at 120 days. The final visit will include a urine drug screen.", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-06", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06899594", "keywords": "Methamphetamine Use Disorder, Psilocybin 25 mg, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06899594\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Addiction,Emotional Processing,Review Article,Safety", "study_type": "Review Article", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3575, "title": "Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)", "normalized_title": "efficacy of psilocybin and trazodone combination in treatment resistant depression a randomized controlled proof of concept study psilotraz", "authors": "Centre Hospitalier St Anne", "abstract": "Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin. We hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects. Treatment-resistant depression (TRD) is a frequent and potentially severe psychiatric disorder characterized by specific neurocognitive impairments. It has previously been demonstrated that psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improved depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in TRD seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis in a randomized, double-blind, placebo-controlled phase II, monocentric, 4 parallel-group proof-of-concept study involving 112 adult subjects with a depressive episode who had failed to respond to at least two lines of antidepressant treatment. Patients will be randomized in a 1:1:1:1 ratio to one of the following treatment groups: * Group 1: Psilocybin PEX010 (25 mg) + trazodone placebo (pharmaceutical master preparation prepared according to GPP) * Group 2: Psilocybin PEX010 (25 mg) + trazodone 5 mg * Group 3: Psilocybin PEX010 (25 mg) + trazodone 30 mg * Group 4: PCB2 (Placebo of PEX010 (25)) + trazodone 30 mg Stratification factors: gender (M/F).", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-06", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07210112", "keywords": "Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD), Psilocybin 25 mg per os, Trazodone 5mg, Trazodone 30 mg, Placebo of psilocybin, Placebo of trazodone, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07210112\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Receptor Pharmacology,Clinical Trial,Randomized Controlled Trial,Treatment-Resistant Depression,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3677, "title": "Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment", "normalized_title": "retrospective observational study of intensity effects in psychedelic assisted treatment", "authors": "University Hospital, Geneva", "abstract": "This retrospective observational study examines the effects of psychedelic-assisted psychotherapy (PAP) with lysergic acid diethylamide (LSD) or psilocybin in patients with treatment-resistant depressive, anxiety, or addictive disorders. Data will be analyzed from patients treated at the University Hospitals of Geneva between June 2020 and April 2025 who obtained individual authorizations from the Swiss Federal Office of Public Health for use of LSD or psilocybin under compassionate use criteria. The main objective is to assess the effects of psychedelic-assisted psychotherapy with LSD or psilocybin on changes in depressive symptoms, anxiety symptoms. Secondary objectives include evaluating the association between psychedelic session intensity and the administered dose of LSD or psilocybin, changes in depressive symptoms, anxiety symptoms, and problematic substance use, as well as their association with intensity effects. Additionally physiological effects during session will be assessed. All data are retrospectively collected from clinical records with prior patient consent. This study aims to generate evidence on the feasibility, safety, and therapeutic potential of PAP in real-world clinical practice. The overall project is a retrospective observational study evaluating the effects of psychedelic-assisted psychotherapy (PAP) with LSD or psilocybin in treatment-resistant depressive, anxiety, and addictive disorders. Data from 200 patients treated at Geneva University Hospitals will be included, with the primary aim of assessing relationships between psychedelic dose, subjective intensity of experience, and clinical outcomes. Subset Analysis: Cardiovascular Outcomes In addition to the main objectives, a subset analysis will be conducted to evaluate cardiovascular effects of LSD and psilocybin. Routinely collected data from 30 patients with treatment-resistant depression or anxiety disorders will be included. Population: 30 patients who underwent their first psychedelic session (LSD100-200 µg or psilocybin 15-25 mg). Measurements: Heart rate and self-rated anxiety (visual analogue scale) recorded at seven time points between 30 and 300 minutes post-administration on the treatment day. A further subset analysis investigated the role of early maladaptive schemas (EMS) in psychedelic-assisted psychotherapy. Populations: 192 patients who routinely completed the Young Schema Questionnaire - Rasch version (YSQ-R) before treatment were included; of these, 97 initiated PAP with LSD or psilocybin and 74 contributed longitudinal outcomes. Measurements: Baseline EMS profiles (YSQ-R) measured at Baseline (screening or preparation visit, before first psychedelic session), immediately after each psychedelic session (sessions 1-3, up to 9 months) and 1 month after each psychedelic session (sessions 1-3, up to 12 months after baseline).", "journal": "ClinicalTrials.gov", "publication_date": "2025-10-01", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07164287", "keywords": "Major Depressive Disorder (MDD), Anxiety Disorders, Substance Use Disorder (SUD), PTSD - Post Traumatic Stress Disorder, Lysergic Acid Diethylamide (LSD) or psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07164287\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[]}", "topic_tags": "Depression,Anxiety,PTSD,Addiction,Observational Study,Treatment-Resistant Depression,Safety", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3552, "title": "Psilocybin and MDMA for Post-traumatic Stress Disorder (PTSD)", "normalized_title": "psilocybin and mdma for post traumatic stress disorder ptsd", "authors": "Johns Hopkins University", "abstract": "The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet The proposed randomized, double-blind, active control study will compare a single experimental dose of co-administered MDMA + psilocybin (exact dosages not disclosed) with a single comparator dose of co-administered MDMA + psilocybin (exact dosages not disclosed). For the co-administered dosing session, MDMA will be given initially, followed by psilocybin 30 minutes later. Approximately 1.5 months after the first dosing session, a second single-blind (participant masked) dosing session will occur. The study will recruit adult Veterans with PTSD for ≥ 6 months.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-30", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06989957", "keywords": "Posttraumatic Stress Disorder, Psilocybin, MDMA, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06989957\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "PTSD,Veterans,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3507, "title": "An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy", "normalized_title": "an exploratory study of feasibility efficacy and mechanisms of mindfulness assisted psychedelic therapy", "authors": "University of Southern California", "abstract": "The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is \"Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?\" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain). Both groups will also complete 2 follow-up surveys (at 8 weeks and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant. Psilocybin is a psychoactive compound found in a variety of mushrooms that has been used for centuries to facilitate spiritual experiences. Recent evidence suggests that the combination of psilocybin with mindfulness training may enhance the therapeutic effects of these interventions for mental health; however, to date, only few studies have investigated a combination approach, and no studies have yet investigated the effects of psilocybin in combination with a formal mindfulness training program in participants with little or no prior meditation experience. We propose here to conduct a pilot study to evaluate the efficacy of psilocybin administration in combination with 8 weeks of mindfulness training. Participants (N = 40) will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: psilocybin integrated with mindfulness training (MT) (Arm 1) and psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires and cognitive assessments. Both groups will also complete 2 brief follow-up surveys (at 8 weeks and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant. The primary feasibility outcome will be retention rate at the 8-week follow-up time point (percent of eligible enrolled participants who complete the 8-week follow-up). Secondary efficacy outcomes include change in psychological and mood measures, blood inflammatory \\& neurotrophic markers and neurocognitive measures (EEG outcomes) from baseline to post-treatment. Safety outcomes will include the number of participants reporting adverse events and the mean severity of events. Logistic regression models will be used to examine the relationships between intervention group and the primary and secondary outcome variables. The results of this pilot study will be used to support a larger NIH and other external grant application as well as the extension of this intervention to clinical populations.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-25", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06233344", "keywords": "Mental Health, Psilocybin plus mindfulness training, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06233344\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Biomarkers,Spirituality,Clinical Trial,Observational Study,Safety,Adverse Events,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3588, "title": "Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism", "normalized_title": "observational pilot study to explore the social and health impacts of a new model of care in oregon psilocybin services on alcoholism", "authors": "Healing Advocacy Fund", "abstract": "The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive psilocybin services at Oregon's Innertrek Patient Service Center (PSC) and who are willing to participate in the People Science pilot study to share their experience concurrently. Since the participant will be making the informed decision to voluntarily take part in this concurrent observational study, there will be no \"doctor-patient\" relationship between the participant and the People Science Study Investigator. Study participants will receive the standard of care and medical management from Oregon's Innertrek Patient Service Center facilitators as deemed appropriate per their existing guidelines and practices. People Science will solely be operating as an observer, using an agnostic research data capture system to collect outcomes and follow participant experiences throughout the course of their treatment journey. The study will incorporate participant-reported outcome measures, questionnaires and surveys. The primary endpoint in collecting study data will be to observe the impact of the Psilocybin-Assisted care model on the frequency of heavy drinking days through quantitative and qualitative data analysis for people who struggle with alcohol use. Non-quantitative narratives will also be captured. Throughout the People Science study observations, participants will be in the direct care of the Oregon Patient Service Center facilitators. Findings from this study will contribute knowledge toward the understanding of the use of psilocybin in individuals with self-described alcoholism (AUD). Alcoholism or Alcohol Use Disorder (AUD) is a chronic and relapsing condition characterized by an inability to control alcohol consumption, leading to significant health, social, and economic consequences. Despite the availability of various treatment modalities, including pharmacotherapies and behavioral interventions, relapse rates remain high, with many individuals failing to achieve long-term abstinence or control. This has spurred interest in exploring novel therapeutic approaches and care models, including the potential use of psychedelic compounds such as psilocybin used in a supportive care environment. Psilocybin, a naturally occurring psychoactive substance found in certain species of mushrooms, has garnered attention for its potential therapeutic effects in treating mental health disorders such as depression, anxiety, and post-traumatic stress disorder. More recently, research has suggested that psilocybin may be beneficial in addressing substance use disorders, including Alcohol Use Disorder. The mechanism by which psilocybin exerts its effects appears to involve the modulation of neural circuits related to mood regulation, behavior, and self-reflection, which can facilitate profound psychological experiences that may promote lasting changes in behavior and cognition. Early clinical trials have shown promising results, indicating that psilocybin, when administered in a therapeutic setting, can reduce alcohol consumption and cravings in individuals with Alcohol Use Disorder. In a study published in Journal of American Medical Association of Psychiatry, researchers from New York University Grossman School of Medicine found that heavy alcohol consumption among people with alcohol use disorders was 83 percent lower among participants who had received psilocybin over an 8-month period following the psilocybin administration and almost half of participants who received psilocybin stopped drinking alcohol altogether. These studies highlight the potential for psilocybin to act as a catalyst for psychological insights and behavioral change when combined with psychotherapy or a calming and supportive environment, offering a new avenue for treatment-resistant cases of Alcohol Use Disorder. In Oregon, excessive alcohol consumption causes 2,000 deaths each year, making it the third leading cause of preventable death in the state. There is a glaring need for support for Oregonians facing alcohol and substance use disorders. Alongside more traditional treatment and harm reduction models, Psilocybin shows promise for treating alcohol and substance disorders. Oregon's state-regulated psilocybin program offers an opportunity to advance real world research on Psilocybin for treating alcohol and substance use disorders. In 2020, Oregon voters approved a ballot measure (Measure 109) to create the world's first state-regulated psilocybin program to improve the physical, mental, and social well-being of all people. The measure required that the Oregon Health Authority (OHA) create a licensing and regulatory framework for a safe, accessible and equitable program. After a two-year rule making period, licensed service centers are now open and providing psilocybin services to clients in Oregon. Psilocybin services are only delivered in licensed service centers, under the supervision of a trained facilitator, and psilocybin can only be consumed in the service center during that supervised session. There are no retail sales, no off-site consumption, possession, or production of psilocybin (outside of licensed manufacturers). The sponsor of this pilot research project is the Healing Advocacy Fund (HAF). HAF is a 501c3 non-profit organization that advocates for safe, affordable state-regulated access to psychedelic services. The Healing Advocacy Fund promotes regulations that create a state psilocybin program that is of high quality, accessible, and maximizes safety; educates stakeholders, policymakers, regulators, and the general public on the Oregon psilocybin program; and serves as a convener for the Oregon psilocybin ecosystem to collaboratively address goals and challenges, organize around shared needs, and deliver services to high standards and best practices. InnerTrek will provide the psilocybin services to individuals who struggle with alcohol use for the pilot. InnerTrek is a psilocybin patient service center located in Portland, Oregon and licensed by the Oregon Health Authority to offer both individual and group psilocybin services, including preparation, administration, and integration sessions. The position of the People Science research team in this setting is to observe the practices and experiences already occurring in the context of the State of Oregon's Psilocybin Services program at the InnerTrek Patient Service Center. People Science will create the questionnaires to be offered to the participants, as well as analyze data on the observation of participants' perspectives.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-23", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07189988", "keywords": "Alcohol Use Disorder, psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT07189988\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[]}", "topic_tags": "Depression,Anxiety,PTSD,Addiction,Wellbeing,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3709, "title": "PRoMiSS: Psilocybin and the Role of Music in Set and Setting", "normalized_title": "promiss psilocybin and the role of music in set and setting", "authors": "Johns Hopkins University", "abstract": "The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are: Does autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists? How are brain and body responses - including EEG activity, respiration, heart rate, and skin conductance - influenced by autobiographically salient music under psilocybin? Do brain and body responses to specific music features differ when the music is autobiographically salient compared to non-salient playlists? Researchers will compare five music conditions: three conditions where an 80-minute block of autobiographically salient music is placed at different points in the 6-hour psilocybin session (0-80 minutes, 80-160 minutes, or 240-320 minutes), a standardized Johns Hopkins psilocybin playlist, and an ambient playlist with no autobiographical content. Participants will: * Take a single oral dose of psilocybin (25 mg) during one study session * Listen to one of the five music conditions while reclining in a comfortable setting * Complete questionnaires about emotions, acute, subjective effects, insight, etc. * Undergo EEG and physiological monitoring (respiration, heart rate, skin conductance) during the session * Complete MRI brain scans before the session and 1 week after psilocybin * Return for follow-ups at 1 day, 1 week, and 1 month after psilocybin * At 1 month, complete a qualitative interview and a nondrug EEG music listening session, where the participant's hear either music from the participant's own psilocybin session or music from another participant's session Classic psychedelics such as psilocybin reliably alter consciousness, producing changes in perception, emotion, and meaning-making. Music has long been recognized as an important component of psychedelic therapy, serving to guide the experience and shape its trajectory. However, little is known about how different types of music influence outcomes, particularly music that is personally meaningful to participants. This study will investigate the effects of autobiographically salient (AS) music compared to standardized playlists during high-dose psilocybin sessions. The goal is to understand how personally relevant music modulates acute subjective experiences, emotional responses, and longer-term psychological outcomes. In addition, the study will examine brain and body responses to music under psilocybin, including how these responses differ when music is autobiographically salient. The central questions are whether AS music enhances emotional depth, psychological insight, and well-being more than non-autobiographical playlists, and whether the timing of AS music during the session influences these effects. Participants will be followed up after the psilocybin session to assess both short-term and longer-term outcomes, including well-being, mood, and meaning-making. This trial represents one of the first controlled investigations into how personalized music contributes to the therapeutic potential of psychedelics. Findings may help optimize music-based interventions in psychedelic therapy and improve understanding of the role of music in shaping altered states of consciousness.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-17", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07180108", "keywords": "Psilocybin, Music Intervention, Psilocybin (high dose), DMF#037635 (Type II), Purisys LLC, Psilocybin Drug Substance, Playlist 1, Playlist 2, Playlist 3, Playlist 4, Playlist 5, ENROLLING_BY_INVITATION", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07180108\",\"overall_status\":\"ENROLLING_BY_INVITATION\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Consciousness,Wellbeing,Emotional Processing,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3435, "title": "The Impact of Psilocybin on Pain in Fibromyalgia Patients: a Multicentre Trial.", "normalized_title": "the impact of psilocybin on pain in fibromyalgia patients a multicentre trial", "authors": "Maastricht University", "abstract": "Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. It has high direct and indirect costs and it is considered challenging to treat. Most suggested therapies, in fact, are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. Study population: 35 fibromyalgia patients aged 18 to 65 years. Intervention: Placebo, 5 mg or 10 mg of psilocybin in randomized order. Main study parameters/endpoints: Primary outcomes will be subjective and objective measures of pain perception. Secondary measures will assess the effects that placebo and psilocybin will have on mood, cognition and psychedelic experience. Finally, participants will take part to an additional CPT after receiving hypnotic suggestions of analgesia to test whether such intervention may moderate pain ratings of individuals who took small doses of psilocybin. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will visit the research lab 5 times during 5 weeks. Before the first study day, subjects will come for a screening visit during which they will also be familiarized with tests and study procedures. This includes a medical screening by a licensed physician (medical history review, laboratory screening, electrocardiogram recording). The study visits will consist of taking the study treatment (5 mg or 10 mg of psilocybin or placebo), taking part to the experimental tasks, taking blood samples, completing computer tasks and filling out questionnaires. Finally, participants will take part to a final online visit to administer post-study questionnaires.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-14", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06368492", "keywords": "Fibromyalgia, Psilocybin, Hypnosis script, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06368492\",\"overall_status\":\"RECRUITING\",\"phase\":[\"NA\"]}", "topic_tags": "Anxiety,Chronic Pain,Headache / Migraine,Review Article,Case Report,Observational Study,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3699, "title": "Measurement of Serum Cytokine Levels in Samples Collected as Part of a Clinical Trial of Psilocybin for Treatment-resistant Depression.", "normalized_title": "measurement of serum cytokine levels in samples collected as part of a clinical trial of psilocybin for treatment resistant depression", "authors": "King's College London", "abstract": "About one in three people with major depression respond poorly to standard antidepressant treatments. This kind of depression is called treatment-resistant depression, and it can lead to long-term disability, financial challenges, and a higher risk of suicide. Psilocybin-a compound found in certain mushrooms-has shown early promise as a new treatment for this difficult-to-treat depression. Scientists believe it works by affecting a specific brain receptor (called 5-HT2A), which helps the brain become more flexible and adaptable. But there's another possible mechanism of psilocybin that hasn't been studied much: its ability to influence the immune system. Recent research suggests that inflammation in the body might play a role in depression, especially when treatments don't work. High levels of certain inflammatory markers (called cytokines) are linked to poor response to antidepressants, while lower levels are tied to feeling better. Psilocybin may help reduce this inflammation, which could be part of why it helps some people feel better. Still, we don't fully understand how a person's inflammation levels before treatment, and how those levels change afterward, relate to how well psilocybin works. Figuring this out could help doctors better match patients to psychedelic therapy and discover new ways to treat depression. In this study, blood samples from a recent study (called the PsiDeR trial) that tested psilocybin in people with treatment-resistant depression will be analyzed. Cytokine levels in these blood samples, as well as levels of another type of molecule linked to inflammation, called mRNA, will be measured. Chronic and elevated inflammation is associated with depression. Depressed patients tend to have raised inflammatory markers compared to healthy controls, and studies have reported that the greatest elevation is seen in patients with treatment-resistant depression (TRD). Previous studies highlight the bidirectional relationship between inflammation and depression. Elevated pro-inflammatory cytokines are linked to poor antidepressant response, while reductions in these markers are associated with symptom improvement. While neuroinflammation may play a role in the pathophysiology of depression, inflammation is also a causal risk factor for physical illnesses that are often co-morbid with depression, such as cardiovascular disease. As such, targeting inflammation in patients with depression may have significant implications for both their mental and physical health. Psychedelics are emerging as a potential new class of therapeutic agents for psychiatric illness, including depression. It has been suggested that their therapeutic effect may partly be due to reducing inflammation. Psychedelics have been shown reduce markers of inflammation in models of human inflammatory disease, both in vitro and in vivo. While, as might be expected, psilocybin was not found to reduce markers of inflammation in healthy human volunteers, in a clinical sample of people with treatment-resistant depression, use of ayahuasca (containing the psychedelic N,N DMT) resulted in a significant reduction in CRP levels compared to participants given placebo, with the reduction in CRP levels significantly correlated with a reduction in depressive symptoms. Ayahuasca consists of an admixture of multiple different compounds. As such, the relative contribution of the psychedelic to the anti-inflammatory effect that was observed is unknown. The effect of isolated psychedelic compounds such as psilocybin on the systemic inflammatory state of patients, specifically patients with depression, therefore, remains to be investigated. Psilocybin's capacity to reduce inflammation, as evidenced in preclinical models, may be a crucial mechanism underlying its therapeutic effects. Moreover, while it is recognised that baseline inflammation levels can influence the effectiveness of conventional antidepressants, it is unclear whether this is also the case for psilocybin. This study aims to evaluate serum cytokine and inflammatory-related mRNA levels in samples collected from participants with TRD who took part in the (Psi)locybin in (De)pression (R)esistant to Standard Treatments (PsiDeR) Trial, and the relationships between these and psilocybin treatment response. PsiDeR was a randomised, placebo-controlled trial of psilocybin as a treatment for TRD that has now completed.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-09", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT07164755", "keywords": "Depression - Major Depressive Disorder, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT07164755\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[]}", "topic_tags": "Depression,Receptor Pharmacology,Biomarkers,Clinical Trial,Animal Study,In Vitro Study,Treatment-Resistant Depression,Safety,Inflammation,Immune Function", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3562, "title": "Processing Intergenerational Trauma With Psilocybin-Assisted Therapy", "normalized_title": "processing intergenerational trauma with psilocybin assisted therapy", "authors": "Rachel Yehuda", "abstract": "This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience. This study is investigating whether Psilocybin-assisted therapy improves depression, anxiety and stress symptoms in the offspring (biological children) of genocide survivors. Intergenerational trauma is the concept that the effects of experiencing extreme stress can be perpetuated to future generations. A genocide here is defined by the extinction or threat of extinction of a racial, religious or ethnic group, by an oppressive regime. A genocide survivor here is defined by an individual who survived or escaped a genocide in their country of origin. Currently, there are no evidence-based treatments developed specifically for the syndrome associated with Intergenerational trauma. This study aims to assess the safety and tolerability of psilocybin-assisted therapy, and assess the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience. Participants will be asked to attend one or more screening visits to assess eligibility. If eligible, participants will be treated with two separate doses of the study medication, Psilocybin, 3-4 weeks apart. This is an open-label research study, meaning all participants will receive Psilocybin (25mg). Two trained clinical practitioners will work with participants across preparation, dosing, and integration processes. Participants will complete assessments throughout the study until their participation has ended. Safety measures are in place to check the overall health and well-being of participants Participation will consist of: * Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment. * Tapering \\& Enrollment Period (variable): Enrollment, supervised medical tapering where necessary as discussed with the study doctor, biomarker collection and psychometric baseline assessments. * Preparatory \\& Treatment Period (up to 14 weeks): Three preparatory sessions with study clinicians, assessments; two dosing days at least three weeks apart, three weekly integration sessions with study clinicians following each dose, a 72-hour check-in call after each dosing day, assessments. * Follow-Up Period (up to 5 weeks): Follow-up one month after final integration session, assessments, clinical evaluation, biomarker collection", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-07", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06899165", "keywords": "Psychological Stress, Depression, Anxiety, Psilocybin, Psilocybin-Assisted Therapy, Integration sessions, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06899165\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Biomarkers,Wellbeing,Resilience,Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3571, "title": "Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers: a Randomized Controlled Trial", "normalized_title": "effect of psilocybin only and psilocybin assisted cognitive behavioral therapy in the management of major depressive disorder and associated metabolic immune inflammatory neuroplasticity and electrical activity markers a randomized controlled trial", "authors": "Khyber Medical University Peshawar", "abstract": "This randomized controlled clinical trial evaluates the effectiveness of psilocybin and psilocybin-assisted cognitive behavioral therapy (CBT) in the management of Major Depressive Disorder (MDD). The study aims to compare the effects of psilocybin-only therapy, CBT, and psilocybin-assisted CBT on depression symptoms, neurochemical markers, inflammatory markers, and neuroplasticity in individuals with MDD. Participants will continue their routine depression medications and will be assessed for changes in depression scores, biochemical markers, and brain activity patterns using validated tools and tests. This single-masked randomized controlled trial investigates novel therapeutic interventions for Major Depressive Disorder (MDD). MDD is a leading cause of disability worldwide, with a significant proportion of patients being treatment-resistant or showing only partial response to conventional antidepressants. Emerging evidence suggests that psilocybin, a serotonergic psychedelic, has potential as a rapid-acting antidepressant. The study will recruit 60 participants meeting DSM-V criteria for MDD, randomized into four groups: Control group (Conventional therapy only), Psilocybin therapy group, Cognitive Behavioral Therapy (CBT) group, and Psilocybin-assisted CBT group. Participants will receive interventions over 10 weeks, with psilocybin administered in two heroic doses six weeks apart, and CBT delivered in 8-10 structured sessions. Biochemical and neurochemical markers such as CD4/CD8 ratio, TNF-α, IL-6, BDNF, and oxytocin will be measured, along with inflammatory markers (resistin and visfatin). Depression scores will be assessed using scales like HAM-D, MADRS, and BDI. EEG recordings will evaluate changes in brain activity pre- and post-intervention. The primary objective is to assess improvements in depression symptoms, while secondary objectives include evaluating changes in immune, inflammatory, and neurochemical markers and EEG activity. Data will be analyzed using ANOVA with Tukey's post-hoc tests to determine statistical significance.", "journal": "ClinicalTrials.gov", "publication_date": "2025-09-01", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06746441", "keywords": "Major Depressive Disorder, Psilocybin, Psilocin (the active form of psilocybin metabolized in the body), Cognitive Behavioral Therapy (CBT), COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06746441\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Neuroplasticity,Brain Imaging,Biomarkers,Clinical Trial,Randomized Controlled Trial,Inflammation,Immune Function", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3485, "title": "A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)", "normalized_title": "a phase 2 single site double blind placebo controlled randomized clinical trial with an open label extension phase to examine the safety subjective experiences acute effects and suitability of psilocybin combined with psychological support psi ps for military veterans and first responders with co occurring alcohol use disorder aud and posttraumatic stress disorder ptsd", "authors": "Nathan Brashares Sackett", "abstract": "This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD. There is growing evidence suggesting that psychedelic drugs, when paired with therapy, may constitute a safe and effective form of treating a diverse range of psychopathological issues such as alcohol use disorder (AUD) and PTSD (Bogenschutz et al., 2015, 2022; Dakwar et al., 2020; Grabski et al., 2022; Mitchell et al., 2021, 2023). However, to date, no studies have explored any form of psychedelic-assisted therapy in the treatment of patients with co-occurring AUD and PTSD, despite high rates of comorbidity. This study will be the first of its kind to evaluate the safety of psilocybin paired with therapy to target symptoms of comorbid AUD and PTSD. Data derived from this clinical trial will help shed light on whether Psi-PS may be safe for those suffering from both PTSD and AUD. Taken together, we propose the following primary, secondary, and exploratory objectives: 1. Primary Objective: Characterize the safety of psilocybin combined with psychological support (Psi-PS) for participants during the drug administration session (DAS) while the drug's acute effects are ongoing, approximately 24 hours after the DAS when the drug's acute effects have subsided, and approximately one-week post-DAS. 2. Exploratory Objective: (1) Explore the subjective experiences of Psi-PS within approximately 24 hours following the DAS, i.e., when the drug's acute effects have subsided, approximately one-week following the DAS, and at follow-up at approximately three-months. (2) Assess acute effects of Psi-PS on a range of variables at baseline and weeks 1, 2, 4, 12, and 24 post-DAS; (3) Further, assess suitability at baseline and approximately 4-weeks post-DAS. This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: 1. Psi-PS (psilocybin combined with psychological support); and 2. placebo and nondirective psychological support. The study will last approximately 26-32 weeks and is composed of two preparation sessions; one Drug Administration Session (DAS), where 25 mg of oral psilocybin (PEX010) or inert placebo (PCB2) is administered in a clinical setting with two facilitators present; and three integration sessions. Placebo conditions will receive the same psychological support but will receive an inert placebo. 4-weeks after DAS, the study will be unblinded and those who received placebo will be offered Psi-PS for the open-label extension phase, following the same procedures. The intended sample size for the study is approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Study drug shipments will arrive on-site pre randomized by the manufacturer, and double-blinding will be maintained throughout the study by using a placebo that is designed to have similar physical characteristics as the study drug. All participants will then be followed for a total of 6 months (24 weeks) following the DAS to assess durability of potential effects.", "journal": "ClinicalTrials.gov", "publication_date": "2025-08-27", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06853912", "keywords": "Alcohol Use Disorder (AUD), PTSD, Psilocybin 25 mg, PEX010, PYEX, Maltodextrin (Placebo), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06853912\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Addiction,Clinical Trial,Veterans,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3622, "title": "Evaluation of the Effect of a Single Dose of Psilocybin on Neural Correlates of Cognitive Control in Patients With Psychogenic Nonepileptic Seizures", "normalized_title": "evaluation of the effect of a single dose of psilocybin on neural correlates of cognitive control in patients with psychogenic nonepileptic seizures", "authors": "Centre Hospitalier Universitaire de Nīmes", "abstract": "Psychogenic non-epileptic seizures (PNES) are functional paroxysmal motor disorders that may be clinically suggestive of epilepsy but are not associated with the electroencephysiological and electroencephalographic changes of epilepsy. Thus, hyper-connectivity of the regions of the default mode network (DMN) linked to executive control could be involved in the impairment of cognitive control capacities in patients suffering from PNES. Also, the HYCORE study (NCT02329626), showed that dysregulation of frontal regions involved in attentional and emotional regulation is correlated with motor symptoms in patients with functional neurological disorders. The researchers of this study hypothesized that psilocybin would improve cognitive control in patients with PNES.", "journal": "ClinicalTrials.gov", "publication_date": "2025-08-20", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06647056", "keywords": "Psychogenic Nonepileptic Seizures, Psilocybin, MRI, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06647056\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Default Mode Network,Emotional Processing", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3557, "title": "Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression: a Pilot Clinical Neuroimaging Study", "normalized_title": "effect of psilocybin on the positive valence system in treatment resistant depression a pilot clinical neuroimaging study", "authors": "Centre Hospitalier Universitaire de Nīmes", "abstract": "The study hypothesis is that the antidepressant effect of psilocybin is mediated by a normalization of the functioning of the positive valence system. Depressive states, especially moderate to severe depressions that associate a certain level of anhedonia, produce an overvaluation of the cost of efforts and an infra-evaluation of the possible rewards derived from an action. Psilocybin would reduce anhedonia and the cost of efforts, facilitating the anticipation of reward. Thus, the antidepressant effect of psilocybin would be mediated by a greater anticipation of rewards (reduction of anhedonia) and a more optimistic estimation of the results of efforts (increase in motivation). Psilocybin-induced changes in the positive valence system will be observable on brain MRI images, particularly in the effort evaluation circuits: basolateral amygdala, dorsal anterior cingulate cortex, ventral pallidum, ventral striatum (VS), ventral tegmental area (VTA). The mesolimbic circuit (VS, VTA) is the anatomical substrate of anticipation of rewarding stimuli (food, sex, drugs). The amygdala also fulfills an associative function between environmental cues and rewarding stimuli. Structural and functional alterations in this circuit are associated with depressive symptoms such as anhedonia or distortions in the perception and memories of rewards. This hypothesis will be tested on a population of patients with moderate or severe depressive symptoms who meet the criteria for TRD. Depressive disorders are strongly associated with suicide risk and are the leading cause of disability in the world. Psilocybin is a natural alkaloid with psychedelic and hallucinogenic effects, produced by its active metabolite: psilocin. In recent years, there has been a resurgence of research aimed at using psilocybin in the treatment of psychiatric disorders, and in particular depression, combined or not with various psychotherapeutic programs. Psilocybin-assisted therapy is effective in treating cancer-associated depression and resistant depression. The Federal Drug Administration (FDA) has designated it as a \"Breakthrough Therapy\" in the treatment of treatment-resistant depression (TRD). Most researchers consider that the antidepressant effects of psilocybin are associated with the activation of the serotonin 5-HT2a receptor, with acute neuromodulation effects that modify the connectivity of cortico-striatal loops, but the mechanisms supporting this effect are unknown. The purpose of this study is to verify whether the antidepressant action of psilocybin is associated with an activation of the brain areas involved in the positive valence system, by comparing the activity of the neural circuits responsible for the evaluation of effort before and after taking psilocybin. The correlations between the activation of brain areas and the depression severity, behavioral activation and anhedonia scores will help establish a link with the response to treatment. Finally, the study authors wish to test the feasibility of a study with psilocybin in a French clinical population.", "journal": "ClinicalTrials.gov", "publication_date": "2025-08-19", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06650800", "keywords": "Depressive Disorder, Depressive Disorder, Treatment-Resistant, Hallucinogens, Reinforcement, Psychology, Psilocybin, MRI, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06650800\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Aging,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3505, "title": "Effects of Psilocybin in Post-Treatment Lyme Disease", "normalized_title": "effects of psilocybin in post treatment lyme disease", "authors": "Johns Hopkins University", "abstract": "This study will examine the effects of psilocybin on Lyme disease symptom burden and quality of life in people with Post-Treatment Lyme Disease (PTLD). This pilot study will evaluate the therapeutic potential of psilocybin in people with well-documented current Post-Treatment Lyme Disease (PTLD). Study measures will assess the impact of psilocybin-assisted treatment on overall symptom burden and quality of life in 20 people with PTLD. This is an open-label proof-of-concept trial in which participants will complete an 8-week course of study treatment including two psilocybin sessions (15mg in week 4 and 15 or 25mg in week 6) with psychological support, and follow-up assessments 1, 3, and 6 months after the final psilocybin session.", "journal": "ClinicalTrials.gov", "publication_date": "2025-08-19", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05305105", "keywords": "Post-Treatment Lyme Disease, Chronic Lyme Disease, Lyme Disease, Chronic, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05305105\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "General", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3466, "title": "A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder", "normalized_title": "a phase ii multicentre randomised double blind controlled study to investigate the safety tolerability pharmacokinetics and efficacy of comp360 in participants with recurrent major depressive disorder", "authors": "COMPASS Pathways", "abstract": "Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder. This is a phase II, multi-centre, randomised, double-blind, controlled study. The study population will include participants aged ≥18 years with recurrent Major Depressive Disorder (MDD) with up to four prior treatment failures of an antidepressant in their current depressive episode. Overall, 102 participants will be randomised in a 1:1:1 ratio to receive COMP360 25 mg, COMP360 10mg or COMP360 1 mg. In this study the aim is to investigate the safety and tolerability of COMP360, administered with psychological support, in adult participants with MDD with one prior treatment failure. In addition, pharmacokinetics and efficacy of COMP360 will be investigated. The study will last up to 16 weeks including a three- to ten-week Screening Period and a six-week follow-up from investigational product (IP) administration.", "journal": "ClinicalTrials.gov", "publication_date": "2025-08-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05733546", "keywords": "Major Depressive Disorder, Psilocybin, COMP360, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05733546\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Pharmacology,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3691, "title": "Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial", "normalized_title": "outpatient buprenorphine induction with psilocybin for opioid use disorder a randomized double blind trial", "authors": "Johns Hopkins University", "abstract": "This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid use disorder (OUD). The participants will have previously undergone buprenorphine induction before. Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with outpatient buprenorphine maintenance, quality of life, and mood. The proposed study is a double-blind, controlled investigation of the effect of 1 high-dose psilocybin (30 mg) session compared to a very low dose session (1 mg) in the period immediately following standard-of-care outpatient buprenorphine induction on drug abstinence, quality of life, craving, tobacco use, and treatment retention in healthy participants with an active OUD diagnosis and a history of being prescribed buprenorphine previously. Use of buprenorphine is standard of care for OUD, and the investigators are investigating the additive power of adjunctive psilocybin to enhance opioid abstinence, treatment adherence, quality of life, and mood. Of note, this trial is designed with a parallel and complementary structure to IRB00344281 (BIPOD: Buprenorphine Induction with Psilocybin for Opioid use Disorder: A Randomized Controlled Clinical Trial\"). The current proposed trial (\"BIPOD-Out\") differs in that it is tailored specifically to identify participants who have previously been prescribed and tolerated buprenorphine but subsequently relapsed. The study will recruit participants who have very recently (past 3 weeks) undergone standard of care outpatient buprenorphine induction or are interested in undergoing buprenorphine induction by a study team physician and offer experimental psilocybin administration, as utilized in several other studies at this center. As noted above (and unlike in IRB00344281), participants naïve to buprenorphine will be excluded from this study. Outpatient buprenorphine induction will be followed by an 8-week outpatient phase involving standard of care buprenorphine maintenance with participants referred to further buprenorphine treatment in the community and followed in long-term follow-up for 4 to 6 months. The study team will recruit participants who have recently (past 3 weeks) been inducted onto sublingual (SL) buprenorphine (a buprenorphine/naloxone combination product) in the outpatient setting, and also participants interested in participating in a buprenorphine induction conducted by one of the study team physicians. Once buprenorphine induction is complete and participants are deemed eligible, participants will undergo 2-4 preparatory sessions (described below), followed by an experimental drug administration session under supportive conditions, during which the participants will receive either a very low dose (1 mg) or a single high (30mg) oral dose of psilocybin under double-blind conditions. Participants will then complete an 8-week outpatient phase, during which a study team clinician will provide standard of care outpatient buprenorphine maintenance. Participants will undergo outpatient visits at 1, 2, 3, 4, 6, and 8 weeks post-dosing session at the Behavioral Pharmacology Research Unit for monitoring of adverse events, clinical status, treatment adherence, and to receive a weekly supply of buprenorphine. All buprenorphine procedures will be open label and will follow standard-of-care practices.", "journal": "ClinicalTrials.gov", "publication_date": "2025-07-27", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06067737", "keywords": "Opioid Use Disorder, Psilocybin, buprenorphine, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06067737\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Pharmacology,Clinical Trial,Randomized Controlled Trial,Healthy Volunteers,Healthcare Workers,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3424, "title": "Modulation of Serotonin Pathways Using Psilocybin in Adults With and Without Autism Spectrum Disorder (ASD)", "normalized_title": "modulation of serotonin pathways using psilocybin in adults with and without autism spectrum disorder asd", "authors": "King's College London", "abstract": "This study will test the hypothesis that brain systems are differentially regulated by serotonin in individuals with and without Autism Spectrum Disorder. To do this, the brain response to two single acute doses of partial serotonin (5HT)1A/2A receptor agonist psilocybin (COMP360) relative to a single dose of placebo (baseline serotonin activity) will be compared in healthy autistic and non-autistic adults. Brain function will be assessed using a range of MRI (fMRI and MRS), EEG and sensory tasks. Unimodal and multimodal analyses will be conducted. Please note that this study uses psilocybin as a probe of the serotonin system in a Case-Control science study and, following Scope protocol review, the U.K. MHRA confirmed that it is not a 'Clinical Trial of an Investigational Medicinal Product' (IMP) as defined by the EU Directive 2001/20/EC.", "journal": "ClinicalTrials.gov", "publication_date": "2025-07-27", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05651126", "keywords": "Autism Spectrum Disorder, Psilocybin 5 mg, COMP360, Psilocybin 2 mg, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05651126\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Receptor Pharmacology,Clinical Trial,Review Article", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3648, "title": "Mechanistic Studies of Psilocybin in Headache Disorders", "normalized_title": "mechanistic studies of psilocybin in headache disorders", "authors": "Yale University", "abstract": "In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.", "journal": "ClinicalTrials.gov", "publication_date": "2025-07-23", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06464367", "keywords": "Migraine, Psilocybin, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06464367\",\"overall_status\":\"RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Headache / Migraine,Neuroplasticity,Brain Imaging,Biomarkers,Clinical Trial,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3633, "title": "The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)", "normalized_title": "the safety feasibility and acceptability of psilocybin combined with multidisciplinary palliative care in demoralized cancer survivors with chronic pain p pc", "authors": "Emory University", "abstract": "This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together with multidisciplinary palliative and supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life. PRIMARY OBJECTIVE: I. To determine the safety, feasibility, and acceptability of a single administration of 25 mg psilocybin (psilocybin) provided under supportive conditions with multidisciplinary palliative care support (P-PC) in adult cancer survivors living with concurrent demoralization and chronic pain. EXPLORATORY OBJECTIVE: I. To evaluate for changes in demoralization, anxiety, depression, quality of life, pain, other symptoms, mysticism, awe, post-traumatic growth, social isolation, and psychosocial functioning from baseline to end-of-treatment to 3.5-month follow up. OUTLINE: Patients receive psilocybin orally (PO) and undergo observation for up to 8 hours on day 14. After completion of study intervention, patients are followed up on days 15, 21, 42, 56, and 98.", "journal": "ClinicalTrials.gov", "publication_date": "2025-07-22", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05506982", "keywords": "Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Psilocybin, CY-39, Indocybin, Psychotherapy, talk therapy, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05506982\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Chronic Pain,Mystical Experience,Clinical Trial,Cancer Patients,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3581, "title": "Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality", "normalized_title": "acceptability safety of two sequential doses of psilocybin in bipolar disorder ii depression and suicidality", "authors": "The University of Texas Health Science Center, Houston", "abstract": "The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression. This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatment for Bipolar II (BD II) depression, specifically, individuals experiencing suicidal ideation (without having an active plan or intention to act). The design is a non-randomized clinical trial, where patients will receive up to 2 doses of 25mg psilocybin in the context of psychological support informed by mindfulness-based CBT and typical elements of psychedelic treatments (e.g., preparation, intention setting, integration). The investigators will measure suicidality, depression, and acute experiences using validated questionnaires at multiple time points in the study. If this study shows psilocybin to be a feasible, acceptable, and safe treatment option, this would have huge implications for improving outcomes because highly effective treatment for suicidality in patients with Bipolar Disorder is still lacking.", "journal": "ClinicalTrials.gov", "publication_date": "2025-07-17", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06706232", "keywords": "Bipolar II Disorder, Depression, Bipolar, Suicidality, Psilocybin, Therapeutic Support, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06706232\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3682, "title": "Visual Surround Suppression and Perceptual Expectation Under Psilocybin", "normalized_title": "visual surround suppression and perceptual expectation under psilocybin", "authors": "University of Minnesota", "abstract": "The prospective pilot study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. The proposed pilot study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. The data collected in the proposed experiment will make important contributions to knowledge of how psilocybin impacts contextual processing in the brain. Moreover, this will in turn inform the neurobiology of visual surround suppression in general, providing the first investigation of links between surround suppression and serotonergic pathways in humans. Furthermore, the impact of psilocybin on surround suppression will complement recent discoveries of differences in surround suppression present in certain clinical populations. Taken together, these points suggest that this relatively simple and straightforward study could have significant payoff in its contribution to knowledge, not only of the effects of psilocybin but also of key brain processes underpinning human vision and context processing more broadly.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-26", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04424225", "keywords": "Perception Disturbance, Visual Suppression, Psychedelic Experiences, Psilocybin, Niacin, Vitamin B3, TERMINATED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04424225\",\"overall_status\":\"TERMINATED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Mechanism of Action", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3482, "title": "The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder", "normalized_title": "the safety and tolerability of comp360 in participants with post traumatic stress disorder", "authors": "COMPASS Pathways", "abstract": "The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-12", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05312151", "keywords": "Post Traumatic Stress Disorder, Psilocybin, COMP360, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05312151\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "PTSD,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3611, "title": "A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Participants", "normalized_title": "a phase 1 study to evaluate the safety tolerability and pharmacokinetics of multiple doses of mls101 psilocybin in healthy participants", "authors": "MycoMedica Life Sciences PBC", "abstract": "MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy, adult participants. In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited. Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner. As a foundational study of the therapeutic use of psilocybin microdoses, this study will assess the safety, tolerability, pharmacokinetics and sensorial effects using a prospective, controlled, multiple dose regimen in healthy volunteers.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-11", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06643637", "keywords": "Healthy Volunteers, Psilocybin, MLS101, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06643637\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Pharmacology,Microdosing,Clinical Trial,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3617, "title": "Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults", "normalized_title": "comparison of the effects of pex20 oral psilocin pex30 sublingual psilocin and pex10 oral psilocybin in healthy adults", "authors": "University of California, San Francisco", "abstract": "To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults. The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-09", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05317689", "keywords": "Healthy, Psilocin, Psilocybin, Sublingual Psilocin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05317689\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3601, "title": "Psilocybin With Intracranial Neural Sensing", "normalized_title": "psilocybin with intracranial neural sensing", "authors": "Joshua Woolley, MD, PhD", "abstract": "This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions. This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-05", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06919640", "keywords": "Chronic Pain, Psilocybin, ENROLLING_BY_INVITATION", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06919640\",\"overall_status\":\"ENROLLING_BY_INVITATION\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Chronic Pain", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3672, "title": "Low-Income Group Psilocybin Assisted Therapy for Depression: A Feasibility Study", "normalized_title": "low income group psilocybin assisted therapy for depression a feasibility study", "authors": "Matthew Hicks", "abstract": "Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population. Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), Hamilton Depression Inventory, PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview. Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment. The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06372197", "keywords": "Depression, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06372197\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Mechanism of Action,Consciousness,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3480, "title": "Optimizing Microdosing and Meditation", "normalized_title": "optimizing microdosing and meditation", "authors": "National University of Natural Medicine", "abstract": "The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variability, and other biometric outcomes captured by the Oura Ring (3rd generation). 3.2: Explore potential changes in quality of life scores 3.3: Explore potential differences in altered states of consciousness across groups 3.4: Explore qualitative data collected during sessions and at follow-up to assess satisfaction and receive feedback about the intervention. Every participant will receive the psilocybin microdosing intervention, however, half of the participants will be randomly selected to receive the meditation intervention. Research has shown that both meditation and high doses of psilocybin can produce enhanced feelings of well-being that persist. When combined, the synergistic effects might be more than the sum of the parts when treating mental health challenges like depression. The results for microdosing, on the other hand, are mixed, and there have yet to be studies on the synergy between microdosing and meditation. If the synergy between microdoses of psilocybin and meditation is significant, this suggests the possibility of a safe, effective, and low-cost intervention involving group-based meditation training and practice combined with a psilocybin microdosing protocol. The Oregon Psilocybin Services program provides a unique opportunity to test this possibility in the context of services now legally available to clients, allowing researchers to assess the safety and efficacy in a real-life context. Project aims and methods This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability, safety, and preliminary efficacy of the intervention. In addition to an appropriate medical screening and intake we will collect questionnaire data using the Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Five Facet of Mindfulness Questionnaire (FFMQ), Pittsburgh Sleep Quality Index (PSQI), Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview. During a one week wash-in period, the intervention period, and for one month after the intervention, Oura rings will be used to collect over 20 biometric data points including sleep quality, respiration rate, heart rate variability, and more. Participants will consist of adults in Oregon that will be individually screened by a study investigator and then randomized into two arms. One arm will receive microdosing only consisting of one group preparation session and two microdosing sessions per week for two weeks. The other arm will receive the same microdosing protocol with the addition of morning online meditation practice Monday through Friday for both weeks, and will utilize meditation practices during their microdose sessions. The meditation sessions will include opportunities for the group to discuss their meditation experiences and a psychoeducational component to further improve outcomes. This content will provide participants with a better understanding of the ruminations that interrupt their focus while meditating and encourage greater distance from, and less distress concerning, those thoughts. Expected outcomes The authors hypothesize that the model will be feasible if we are able to recruit at least 20 out of 24 expected participants, have an 80% retention rate of participants during the two week intervention period, participants on average rate their satisfaction of the intervention as 3.0 or higher on a 5-point scale, there are no more than ten adverse events or more than one serious adverse event, and data from exploratory measures indicate that further investigation is warranted. Despite the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy status to psilocybin for the treatment of depression,56 it remains on the Drug Enforcement Agency's (DEA) Schedule I list of controlled substances alongside heroin and cocaine. While the DEA and the FDA have become increasingly more willing to grant waivers for research into psychedelic drugs, the proposed study does not require such a waiver to comply with the law. This is due to the unique construction of Oregon's Psilocybin Services Act (Chapter 475A of Oregon Statutes). The state law creates a program wherein licensed growers, inspected by licensed laboratories, can distribute psilocybin mushrooms to licensed service centers. It is only within the approved boundaries of these service centers and while supervised by a licensed facilitator that the mushrooms can be consumed by clients who must stay on site for a designated amount of time that depends on the dose. According to Oregon Health Authority Administrative rule 333-333-5130, facilitators of psilocybin service are prohibited from (1) practicing any other scope of practice they may have (e.g. naturopathic medicine) while facilitating, and (2) handling, selling, or transferring psilocybin at any time. Thus, while it is technically true that growers, services centers, and clients are liable for trafficking and possession of a Schedule I substance, the federal government has adopted a policy of allowing state programs such as this in a manner similar to their policy on cannabis. Complying with Oregon law means that study investigators are not administering or providing psilocybin, but instead are studying the facilitation of the services. At the request of the Institutional Review Board (IRB) of the National University of Natural Medicine (NUNM) for a similar study, this rationale was confirmed via direct communication with the regional DEA office who agreed with this interpretation of both federal and state law. Participants are given clear information on their liability in order to provide consent.", "journal": "ClinicalTrials.gov", "publication_date": "2025-06-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06560658", "keywords": "Meditation, Microdosing, Psilocybin, psilocybin microdosing, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06560658\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Addiction,Consciousness,Microdosing,Wellbeing,Clinical Trial,Review Article,Observational Study,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3603, "title": "Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)", "normalized_title": "exploration of synaptotrophic effects of psilocybin in opioid use disorder oud", "authors": "Yale University", "abstract": "This study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the \\[11C\\]-UCB-J radiotracer while inpatient. Participants will undergo screening as outpatients at the Clinical Neuroscience Research Unit (CNRU). Once deemed eligible, OUD subjects will be studied as inpatients. However, they will have the option of scheduling their second \\[11C\\]-UCB-J PET as an outpatient (pending these participants' agreement to undergo outpatient visits twice per week to provide urine toxicology to monitor abstinence before PET). The only portion of the study that will be available as outpatient for OUD subjects will be the 1-2 weeks before the second \\[11C\\]-UCB-J PET scan. The subject will still be admitted for 1-2 weeks, which will include: inpatient detoxification, baseline \\[11C\\]-UCB-J PET scan, psilocybin administration, and overnight observation after psilocybin administration. However, they may be discharged the day following psilocybin administration and return 2x weekly for urine toxicology testing between discharge and the second \\[11C\\]-UCB-J PET to confirm abstinence. Structural magnetic resonance imaging (MRI) scans will be obtained for anatomical registration/partial volume correction from all subjects. Functional MRI (fMRI) scans will be completed pre- and post-psilocybin administration to evaluate changes in resting state connectivity. All subjects will participate in a battery of behavioral assessments for exploratory correlations with \\[11C\\]-UCB-J. Inpatient subjects who smoke cigarettes will have the option of using nicotine gum and/or nicotine patch while on the unit in order to prevent or minimize nicotine withdrawal. The \\[11C\\]-UCB-J PET scans will be done at the Yale PET Center 1-2 weeks before (baseline) and after psilocybin administration. This is a single-center study at Yale, that will have study activities completed at the following areas: * Clinical Neuroscience Research Unit (CNRU) of the Connecticut Mental Health Center (CMHC) * Yale Positron Emission Tomography (PET) Imaging Center * Yale Magnetic Resonance Research Center (MRRC)", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-28", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06160284", "keywords": "Opioid Use Disorder, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06160284\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Addiction,Brain Imaging,Aging,Toxicity", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3708, "title": "Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness (PDR-Study)", "normalized_title": "role of the serotonin 2a receptor in psilocybin induced altered states of consciousness pdr study", "authors": "University Hospital, Basel, Switzerland", "abstract": "Psilocybin (active compound of \"magic mushrooms\") is a prototypical psychedelic substance that acts via agonism on serotonin (5-HT) 2A receptors. Psilocybin is rapidly metabolized into its active metabolite psilocin. Psilocybin is currently under investigation as potential treatment for various neuropsychiatric disorders. Psilocybin is also widely used for recreational purposes and as research tool in neuroscience. Besides its current clinical development, a clear characterization of the dose-response relationship of psilocybin is lacking. With the present study the investigators aim to close this knowledge gap by administering low (5mg) to high (40mg) single doses of psilocybin to healthy participants. Besides its agonism on 5-HT2A receptors, psilocin also binds to other receptors and inhibits serotonin transporters (SERT). To this data only few studies have investigated these effects and never at a high dose. Psilocybin is widely used for recreational and spiritual purposes. Additionally Psilocybin is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety, depression, addiction personality disorders and other pathological conditions. The present PDR-study will characterize the subjective effects of different doses of psilocybin using modern psychometric instruments, explore the relationship between the plasma-concentration of psilocybin and its subjective effects, and examine the contribution of the 5-HT2A receptor in the psilocybin-induced alterations of consciousness in a mechanistic study in healthy subjects. Participants will recieve doses of 5, 10, 20, and 40 mg psilocybin, 40 mg of psilocybin with pretreatment of 40 mg ketanserin, and placebo (control for psilocybin). Placebo pretreatment (control for ketanserin) will be used for all psilocybin administrations without ketanserin. Administrations will be separated by at least 10 days and are in random and counter-balanced order.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-27", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06796361", "keywords": "Healthy, Ketanserin 40mg plus Psilocybin 40mg, 40mg Psilocybin, 20mg Psilocybin, 10mg Psilocybin, 5mg Psilocybin, Placebo, RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06796361\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Addiction,Receptor Pharmacology,Consciousness,Personality Change,Spirituality,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3655, "title": "Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study", "normalized_title": "psilocybin facilitated smoking cessation treatment a pilot study", "authors": "Johns Hopkins University", "abstract": "One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence. The investigators propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependent individuals in order to provide preliminary data on the efficacy of this combined treatment for smoking cessation. Prior work in the investigators laboratory has shown that under carefully prepared and supportive conditions, psilocybin administration can facilitate highly salient experiences with enduring personal meaning and spiritual significance. It is plausible that embedding such highly meaningful experiences into a drug dependence cessation attempt may provide an enduring motivation for remaining abstinent. Cigarette smoking is a good model system for studying drug dependence because users are less likely to be challenged by the many social and economic impairments that often accompany dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, the investigators propose to conduct a randomized controlled comparative efficacy study in which either psilocybin or transdermal nicotine patch are administered under highly supportive conditions to individuals who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit attempts, and who continue to desire to quit smoking. Other than nicotine dependence, participants will be healthy. Fifteen participants have already completed a preliminary open-label pilot-study with no control condition. Eighty additional participants will be enrolled and randomized to either psilocybin (n=40), or nicotine patch (n=40) treatment. Participants will receive a 13-week course of cognitive behavioral therapy for smoking cessation, with Target Quit Date set for week 5. After several preparation meetings with study monitors, participants will have either a single day-long psilocybin session using a high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment. Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit Date, including biological verification of smoking status through breath and urine samples. Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12 months after the Target Quit Date. Additionally, 50 of these participants (25 per treatment condition) will undergo MRI scanning before and after Target Quit Date to assess the brain-based mechanisms associated with these treatments. Individuals assigned to the nicotine patch study treatment condition will be eligible to undergo an optional high dose psilocybin session after completing the 6-month follow-up meeting.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-24", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT01943994", "keywords": "Nicotine Dependence, Psilocybin-assisted treatment, O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine, Nicotine Replacement Therapy (NRT), Transdermal Nicotine Patch, Nicoderm CQ, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT01943994\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Addiction,Mechanism of Action,Spirituality,Randomized Controlled Trial", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3642, "title": "An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)", "normalized_title": "an investigation of strategies to understand and optimize the antidepressant effects of psilocybin the optimize study", "authors": "Charles Raison", "abstract": "This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes. One hundred forty-one adults ages 18 to 70 experiencing a major depressive episode of at least 60 days duration of moderate or greater severity at screening will be enrolled to obtain evaluable data on approximately 120 subjects. All subjects will receive a single 25 mg dose of psilocybin using a \"set and setting\" therapeutic approach that will include 1) several hours of preparatory sessions prior to dosing and 2) the presence of two facilitators throughout the dosing session; and 3) several post dosing integration sessions with a facilitator. Following the psilocybin dosing session, subjects will be randomized to 1) taVNS (7 days of twice daily taVNS), 2) sham taVNS (7 days of twice daily sham taVNS), or 3) no taVNS. Both taVNS and sham sessions will include guided prompts encouraging participants to reflect on key aspects of their psychedelic experience, accompanied by music previously used during the psilocybin dosing session. Participants will complete assessments at multiple time points to evaluate depression, anxiety, well-being, functional disability, quality of life, social behavior, suicidal ideation, and adverse events before and after psilocybin dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-22", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06512194", "keywords": "Depression, Psilocybin, Psilocybine, Psilocibin, Usona Institute Psilocybin, Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), taVNS, Sham taVNS, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06512194\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Aging,Wellbeing,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3427, "title": "Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase", "normalized_title": "consciousness and psilocybin effects on well being the cope study pilot phase", "authors": "University of Wisconsin, Madison", "abstract": "This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them. The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added. This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two \"IV psilocybin only\" administration protocols in awake subjects. The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit. Adaptive Study Design Change per Protocol Amendment Approved 5/21/24", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-15", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05592379", "keywords": "Healthy, Psychedelic Experiences, Sleep, Psilocybin, Psilocybine, Psilocibin, Clonidine, Saline, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05592379\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Consciousness,Wellbeing", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3694, "title": "Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder", "normalized_title": "investigating the role of serotonin in the mechanism of action of psilocybin in patients with major depressive disorder", "authors": "Icahn School of Medicine at Mount Sinai", "abstract": "This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing. In this study, the researchers want to probe the role of the 5-HT2A receptor in mediating the subjective effects of psilocybin. While previous studies have shown that blockage of the 5-HT2A receptor reduces the psychedelic experience in humans, an animal study revealed that blockage of the 5-HT2A receptor abolished the psychedelic effects without affecting the antidepressant response. This suggests that the pathway responsible for the antidepressant response is dissociated from the psychedelic experience pathway, which is mediated by 5-HT2A signaling.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-13", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06592833", "keywords": "Major Depressive Disorder, Psilocybin, Pimavanserin, Nuplazid, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06592833\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Mechanism of Action,Receptor Pharmacology", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3426, "title": "A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder", "normalized_title": "a phase 2a placebo controlled randomized double blind trial to evaluate the safety tolerability and preliminary efficacy of psilocybin oral solution in adults with generalized anxiety disorder", "authors": "Queen's University", "abstract": "This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Screening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. To qualify, patients must have a clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥14. Additionally, participants must not be on regular anxiolytic treatment or must have discontinued such treatment at least 4 weeks prior to the start of the Open-label Run-in Phase. Open-label Run-in Phase Eligible patients will proceed to the 4-week Open-label Run-in Phase. During this phase, patients will attend four weekly clinic visits, supplemented by weekly remote contacts (via phone or email). At different timepoints during the OL Run-in Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs). Double-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 score from baseline-will be randomized 1:1 to receive either psilocybin oral solution or placebo at the Double-blind Baseline Visit. Patients not meeting the response criteria will undergo End-of-Treatment (ET) procedures at this visit. At different timepoints during the DB Treatment Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs). Completion of the End of Treatment (ET) phase will be 2 weeks to further assess safety and PROs.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-12", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06969170", "keywords": "Generalized Anxiety Disorder (GAD), Psilocybin (drug), Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06969170\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Brain Imaging,Clinical Trial,Healthcare Workers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3539, "title": "The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder", "normalized_title": "the effects of psilocybin on self focus and self related processing in major depressive disorder", "authors": "Sharmin Ghaznavi", "abstract": "This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.", "journal": "ClinicalTrials.gov", "publication_date": "2025-05-05", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06247839", "keywords": "Major Depressive Disorder, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06247839\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Brain Imaging,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3591, "title": "Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial", "normalized_title": "treatment with psilocybin for chronic neuropathic pain and depression transcend an open label clinical trial", "authors": "Centre for Addiction and Mental Health", "abstract": "Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.", "journal": "ClinicalTrials.gov", "publication_date": "2025-04-24", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06518720", "keywords": "Treatment Resistant Depression, Chronic Pain, Psilocybin 25 mg, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06518720\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Chronic Pain,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3465, "title": "A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia", "normalized_title": "a phase 2a open label pilot study to assess the safety and efficacy of psilocybin administration in concert with psychotherapy among adult patients with fibromyalgia", "authors": "Kevin Boehnke", "abstract": "The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to treat chronic pain symptoms in patients with FM. Fibromyalgia is a chronic syndrome of widespread musculoskeletal pain that often manifests with a cluster of co-occurring symptoms, including sleep disturbances, fatigue, cognitive dysfunction, and mood problems including anxiety and depression. Recent studies have provided evidence of altered central pain pathways. Current management of FM typically takes a multidimensional approach including behavioral therapy, exercise, and medication. However, current medications provide only modest benefit and carry significant side effect burden, leading many people with FM to seek other alternatives. Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM. Indeed, psilocybin therapy has shown positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. The United States Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for psilocybin in treatment-resistant depression and major depressive disorder. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. While no clinical studies have explored psychedelic effects among people with FM, a recent review outlined potential mechanisms through which psychedelics could alleviate chronic pain symptoms.", "journal": "ClinicalTrials.gov", "publication_date": "2025-04-15", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05128162", "keywords": "Fibromyalgia, Psilocybin, Psychotherapy, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05128162\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Chronic Pain,Mechanism of Action,Clinical Trial,Review Article,Cancer Patients,Treatment-Resistant Depression,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3612, "title": "The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training", "normalized_title": "the role of personal experience for the therapeutic attitude in the context of substance assisted therapy training", "authors": "Felix Mueller", "abstract": "The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).", "journal": "ClinicalTrials.gov", "publication_date": "2025-04-13", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05570708", "keywords": "Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD, MDMA, LSD, psilocybin, ENROLLING_BY_INVITATION", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05570708\",\"overall_status\":\"ENROLLING_BY_INVITATION\",\"phase\":[\"NA\"]}", "topic_tags": "Consciousness,Safety,Drug Interactions", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3646, "title": "Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).", "normalized_title": "acute dose dependent effects of dmt bolus applications in healthy subjects a placebo controlled cross over study dmt bdr study", "authors": "University Hospital, Basel, Switzerland", "abstract": "N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects. N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\\", "journal": "ClinicalTrials.gov", "publication_date": "2025-04-10", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05695495", "keywords": "Healthy, N,N-Dimethyltryptamine (5mg), N,N-Dimethyltryptamine (10mg), N,N-Dimethyltryptamine (15mg), N,N-Dimethyltryptamine (20mg), N,N-Dimethyltryptamine (25mg), Placebo (saline), COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05695495\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Consciousness,Spirituality", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3446, "title": "Psilocybin-assisted Interpersonal Therapy for Depression", "normalized_title": "psilocybin assisted interpersonal therapy for depression", "authors": "University of Otago", "abstract": "This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin. Study Design Interventional, Single arm, open label 1\\. Hypotheses: 1. It is feasible to deliver Psilocybin treatment integrated into interpersonal therapy for people with treatment resistant major depression (TRD). 2. It is feasible to recruit patients with TRD for this treatment in New Zealand. 2\\. Participants The study will recruit 20 participants who have a current diagnosis of Treatment resistant Major Depressive Disorder. The participants will need to agree to cease psychotropic medications including antidepressants as part of the preparation for psilocybin dosing. 3\\. Recruitment Participants will be recruited by referral from mental health services, primary care and community advertisements. 4\\. Screening Screening involves a two-step process: 1. Participants will register their interest via a secure online Redcap website that will ask questions regarding initial eligibility. Those who pass the initial online screening and consent to further assessment of eligibility will be screened via telephone and review of online health records to determine whether they meet major inclusion/exclusion criteria, and thus whether they are eligible for an in-person screening session. 2. In-person screening will include a history and physical examination, ECG, a 30 cc blood draw for study measures and medical screening, a personal and family medical history questionnaire, psychiatric /psychological assessments and urine drug and pregnancy tests. These will be performed by clinical staff in the Clinical Research Unit (CRU, University of Otago, Christchurch Whatu Ora Waitaha). 5\\. Clinical assessment Psychiatric screening will be conducted by structured assessments Structured Clinical Interview for DSM Disorders (SCID), (mood and substance use sections) by the study team. After this screening potential participants will be clinically assessed by a consultant psychiatrist on the team, who will oversee participants care throughout the study and will liaise with the participants current health provider regarding the study, antidepressant discontinuation, clinical progress and any support required at the conclusion of the study. Psychoactive drug-use history, history of antidepressant treatments, and information about employment status and current functioning (including mood and psychological and psychosomatic symptoms) will be obtained. Participants will be required to refrain from illicit drug use during the course of the study, and a urine test will be conducted before each psilocybin dosing session (e.g., testing for various opioids, stimulants and sedatives). Pregnant or nursing women are ineligible; female participants will receive a urine pregnancy test at intake and before each drug session and must agree to use effective methods of contraception during the study. 6\\. Informed consent process Written informed consent will be obtained at the Clinical Research Unit at the start of the in-person screening. 7\\. Intervention The study intervention is described in detail in the Interpersonal Therapy (IPT)+ Psilocybin Manual and is modified from Yale Manual for Psilocybin-assisted Therapy of Depression and Protocol for 'Effects of Psilocybin therapy for major depressive disorder: randomized clinical trial'. The intervention involves 8 sessions of psychotherapy and two doses of psilocybin over 10 weeks and one follow-up session at 18 weeks in the Clinical Research Unit, Dept of Psychological Medicine, University of Otago, Christchurch. During the study period (week 0-9) the participants will be under the care of the consultant psychiatrists and clinical team at the Clinical Research Unit, this includes the planned weekly contact as well as provision of urgent care during hours (via a duty clinician and psychiatrist), and the Crisis Resolution Team (CDHB) after hours. Following screening and baseline measurements antidepressants will be gradually discontinued and Interpersonal Therapy (IPT) will be commenced in preparation for psilocybin dosing. Antidepressant discontinuation will follow clinical guidelines and will be supervised by consultant psychiatrist on the team, who will oversee participants care throughout the study. The discontinuation schedule is initial dropping of dose by half followed by tapering over 2-6 weeks. The 3 IPT preparation sessions are designed around the beginning phase of IPT (timeline of stressors and mood episodes, interpersonal inventory and identification of psychotherapy focus). The next sessions will involve psilocybin dosing and debriefing (2 psilocybin dosing sessions and 1 debriefing). This will be followed by 5 integration sessions of IPT. The IPT integration sessions will formulate the psilocybin experience within an IPT framework. IPT utilises emotional processing to facilitate change and it is anticipated this will be intensified in the psilocybin sessions. Consultant psychiatrists will review each participant after completing psychotherapy to assess participants' ongoing treatment needs, including recommencing antidepressant medication if needed and referral to specialist mental health service if required.", "journal": "ClinicalTrials.gov", "publication_date": "2025-04-08", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05581797", "keywords": "Depressive Disorder, Treatment-Resistant, Psilocybin-assisted psychotherapy, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05581797\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Addiction,Emotional Processing,Clinical Trial,Review Article,Treatment-Resistant Depression,Healthcare Workers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3635, "title": "Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN", "normalized_title": "psilocybin for enhanced analgesia in chronic neuropathic pain", "authors": "Unity Health Toronto", "abstract": "This is a feasibility study to examine the use of use of Psilocybin (magic mushrooms) to alleviate pain in chronic neuropathic pain. While theoretical mechanisms demonstrate promise, there is no clinical evidence. This vacuum of clinical evidence has been occupied by a \"psychedelic hype bubble\" with media communications touting psychedelics as a 'miracle cures'. The mismatch between evidence and perception creates an urgent need for RCT to fill this significant gap. This trial aims to address this gap by conducting a pilot trial assessing the feasibility, tolerability, and preliminary efficacy of psilocybin for chronic neuropathic pain to inform a future larger, multi-centre study. The purpose is to conduct a randomized control double-blinded trial of psilocybin and active placebo (dextromethorphan). At this time, the aim of the trial is to recruit 30 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study in the future. Brief title PEACE-PAIN Trial Indication Adult patients suffering from chronic neuropathic pain Condition(s) of focus of study Moderate-to-severe chronic neuropathic pain Number of participants 30 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome Change in pain intensity and pain interference Study design Study type: An intervention trial Allocation: Randomized Intervention model: 2-Arm Parallel Group Primary purpose: Feasibility Phase: Phase II Masking Participants, all study team including outcome assessors Test Products, Dose, and Mode of Administration Treatment arm: Psilocybin 25mg + placebo PO single dose plus psychological support Placebo arm: Dextromethorphan 400mg PO single dose plus psychological support Follow-Up Days: 1, 7, 14, 30, and 90", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-29", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06731335", "keywords": "Chronic Neuropathic Pain, Pain Management, Psilocybin, Psychotherapy, Active Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06731335\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Chronic Pain,Mechanism of Action,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3586, "title": "Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in a Randomized, Placebo-controlled, Cross-over Trial in Healthy Participants (LPD-Study)", "normalized_title": "direct comparison of altered states of consciousness induced by lsd psilocybin and dmt in a randomized placebo controlled cross over trial in healthy participants lpd study", "authors": "University Hospital, Basel, Switzerland", "abstract": "The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. A DMT infusion mimicking oral LSD and psilocybin administrations will be tested, as well as intravenously administered ketanserin. Lysergic acid diethylamide (LSD), psilocybin, and N,N-dimethyltryptamine (DMT) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. They are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-HT)2A receptor. However, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. Moreover, they exhibit different pharmacokinetic qualities. In comparative studies of LSD and psilocybin blinding was impaired by the different duration of subjective effects. This study aims to ensure blinding by ending all experiences at the same time with the 5HT2A antagonist ketanserin. Moreover, no study has yet directly compared DMT to LSD and psilocybin. The DMT infusion will be modeled in accordance with the course of an oral LSD and psilocybin administration. Therefore, the LPD-study compares the acute and subacute effects of LSD, psilocybin, and DMT while standardizing the time course and the duration of action for all substances.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-26", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06899334", "keywords": "Healthy, LSD, Psilocybin, DMT, Placebo, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06899334\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Pharmacology,Receptor Pharmacology,Consciousness,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3544, "title": "An 8-week Phase 2 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-assisted-psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study", "normalized_title": "an 8 week phase 2 clinical trial to evaluate the safety tolerability and efficacy of psilocybin assisted psychotherapy in adults with cannabis use disorder a proof of concept study", "authors": "McMaster University", "abstract": "Cannabis is the most commonly used psychoactive substance in Canada (Lowry \\& Corsi, 2020). A sub-group of cannabis users develop a condition known as Cannabis Use Disorder (CUD), which is defined as a regular pattern of cannabis use that causes performance difficulty at work, school and relationships (Hasin et al., 2013). A review of current treatments available for CUD indicate the lack of a pharmacological and psychological treatment with high success rates, which highlights the importance of exploring potential psychosocial interventions for the treatment of CUD. Given the evidence of psilocybin's therapeutic potential in the treatment of substance use disorders (de Veen et al., 2017), we aim to conduct a study using psilocybin-assisted-psychotherapy in the treatment of CUD. The study aims to evaluate the feasibility, safety, tolerability and potential therapeutic effect of 2 doses \\[25 mg\\] of psilocybin administered as part of an 8-week Motivational Enhancement Therapy (MET) and supportive therapy. This trial will be the first to evaluate the potential treatment effects of psilocybin on symptoms of CUD.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06225232", "keywords": "Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe, Psilocybin combined with Psychotherapy, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06225232\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Clinical Trial,Review Article,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3476, "title": "Molecular Imaging Study of Harmine/DMT: a Basic Research Approach", "normalized_title": "molecular imaging study of harmine dmt a basic research approach", "authors": "Insel Gruppe AG, University Hospital Bern", "abstract": "The few reports on effects of psychedelic substances on cerebral metabolic rate (CMRglc) indicate increases (psilocybin; human FDG-PET) or decreases (LSD, rat autoradiography; 5-MeO-DMT rat autoradiography). There are no reports of effects of DMT and/or harmine on cerebral energy metabolism. The primary objective of this study is thus to assess acute cerebrometabolic effects of harmine/DMT in healthy volunteers using quantitative FDG-PET, that is, to measure CMRglc before and after simultaneous treatment with an oral harmine and DMT formulation developed (and already applied) by the investigators' project partners at the University of Zurich. As a secondary objective, the researchers aim to correlate the time-dependent effects on CMRglc as assessed in the PET images with the time-dependent self-reported intensity of participants' psychedelic experience.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06252506", "keywords": "Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine, N,N-dimethyltryptamine (DMT) + harmine, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06252506\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Pharmacology,Aging,Animal Study,Healthy Volunteers", "study_type": "Animal Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3457, "title": "Psilocybin in Alcohol Use Disorder With Comorbid Depression", "normalized_title": "psilocybin in alcohol use disorder with comorbid depression", "authors": "Centre Hospitalier Universitaire de Nīmes", "abstract": "Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approximately 6 hours, psilocybin action appears to be beneficial for preventing alcohol relapse in recently weaned people suffering from comorbid depression. Whilst the public perception of psilocybin therapy is poorly documented in France, the rapid changes in the legal status of psilocybin elsewhere, the positive media coverage of recent trials in depression, and the recent designation as an \"innovative therapy\" by the FDA could lead to the refusal of randomization of eligible participants. It is therefore essential to evaluate the feasibility and acceptability of psilocybin treatment and blinded randomized design in our clinical population of hospitalized patients with AUD and depressive symptoms. Recent data suggest that the effect size of psilocybin is much higher than other currently available treatments. However, this paradigm shift must be confirmed in our cohort of people with AUD and depressive symptoms, and in the context of treatment in addition to usual care, by an estimation of the expected effect size based on real data. This will allow the sample size to be accurately calculated for a large-scale randomized clinical trial. Finally, the potential mechanisms of action of psilocybin to prevent relapse in AUD with comorbid depression after withdrawal need to be documented. The objective of this pilot study is to evaluate the feasibility, acceptability, neural mechanisms and preliminary results of the effectiveness of psilocybin in the treatment of AUD and depressive symptoms after withdrawal, in addition to usual treatment. The study authors hypothesize that two oral administrations of 25 mg psilocybin at three-week intervals versus a control condition (1 mg psilocybin), in addition to the usual treatment, will be acceptable and feasible in recently withdrawn individuals suffering from AUD and depressive symptoms, between 14 and 60 days after their last alcohol consumption", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-18", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06235411", "keywords": "Alcohol-Related Disorders, Depressive Disorder, Addiction, Psilocybin therapy, Inactive Psilocybin therapy, Electroencephalogram, Blood samples for the analysis of immune and inflammatory profiles, stool samples, MRI functional and cerebral, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06235411\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Addiction,Mechanism of Action,Clinical Trial,Observational Study,Safety,Inflammation,Immune Function", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3530, "title": "A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout", "normalized_title": "a randomized placebo controlled trial of psychedelic assisted psychotherapy with single dose psilocybin for frontline clinicians experiencing covid related symptoms of depression and burnout", "authors": "University of Washington", "abstract": "This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic. Aim 1: To assess short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of depression experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 1.1: Compared to active placebo, PAP will result in short term improvement in symptoms of depression 1 day and 1 week after the psilocybin dose session. Hypothesis 1.2: Compared to active placebo, PAP will result in longer term improvement of symptoms of depression 4 weeks after the medication dosing session. The primary outcome will be a comparison between the psilocybin 25 mg vs control groups of a combination of depression symptoms measured at 4 weeks post medication dose session. 1.1.2. Aim 2: To explore short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of burnout experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 2.1: Compared to active placebo, PAP will result in short term improvement in symptoms of burnout 1 day and 1 week after the psilocybin dose session.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-17", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05163496", "keywords": "Burnout, Caregiver, Burnout, Professional, COVID-19, Depression, Post Traumatic Stress Disorder, Moral Injury, Psilocybin (Usona Institute), Psychedelic-assisted psychotherapy (PAP), Active placebo, PAP with placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05163496\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE3\"]}", "topic_tags": "Depression,Healthcare Workers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3649, "title": "Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety", "normalized_title": "effects of psilocybin in advanced stage cancer patients with anxiety", "authors": "Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center", "abstract": "Psychiatric Research Study For Cancer Patients The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain. The significance of this study is that it is addressing the important issues of psychological and spiritual well being of people who have advanced cancer. In 2001, the National Cancer Policy Board of the Institute of Medicine and National Research Council issued a report (Improving Palliative Care for Cancer: Summary and Recommendations) that specifically recommended research be conducted using novel agents and methods. Psilocybin is a novel agent which produces a profound alteration in your state of consciousness. It is the main active ingredient found in \"magic mushrooms\". Our specific aim is to learn whether this psychoactive drug, psilocybin, might be effective in reducing anxiety, depression and physical pain, and therefore improving your quality of life. This pilot study will start with 12 people ages 18-70. For each participant there will be two overnight admissions to the hospital. In one session you will be given a placebo and in the other you will get the active medication, but no one will know which drug is administered when. This is called a double blind study. You will be asked to fill out questionnaires about how you feel, your pain levels and your moods. There will also be at least two psychotherapy meetings before the study sessions, so that you are fully aware of what to expect and to have all your questions answered. We cannot take you in the study if you have central nervous system (CNS) cancers, kidney disease, diabetes, abnormal liver function tests, epilepsy, cardiovascular disease including untreated high blood pressure (BP greater than 140/90), and pregnancy. The psychiatric exclusions are: you or an immediate family member with a history of a major psychiatric disorder, a current substance abuse problem, or an anxiety or a mood disorder within 1 year prior to the onset of symptoms of your current illness. We also cannot take you in the study if you are taking certain medications, such as: anti-seizure, insulin and oral hypoglycemics, and cardiovascular drugs (except anti-hypertensive medications). Some antidepressant (SSRIs) medications cannot be taken within the two weeks prior to the session (except for Prozac, which cannot be taken in the last 5 weeks prior to the session). You will get a MRI of the brain prior to admission (if you haven't had one in the prior two months), at the study's expense, to be sure there is no CNS involvement. You can provide us, or the study will pay for, lab work from the prior 2 weeks (CBC, liver function and renal function). The history and physical, neurological exam, EKG, and a urine pregnancy test (if you are a woman with child-bearing potential), will be done on admission by the house staff doctors. You will be allowed to take your own medications while in the hospital, and will be encouraged to bring to the hospital personal photos, small memorabilia, and some of your favorite music that can be played during the sessions.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-12", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT00302744", "keywords": "Anxiety, Psilocybin (drug), 4-phosphoryloxy-N,N-dimethyltryptamine, Niacin, nicotinamide, vitamin B3, MRI, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT00302744\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Chronic Pain,Consciousness,Spirituality,Cancer Patients", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3666, "title": "Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects", "normalized_title": "acute effects of 2c b compared with mdma and psilocybin in healthy subjects", "authors": "University Hospital, Basel, Switzerland", "abstract": "4-bromo-2,5-dimethoxyphenethylamine (2C-B) is a psychoactive substance with reportedly similar acute effects to both the prototypical empathogen 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) and the classic psychedelic substance psilocybin (contained in \"magic, hallucinogenic mushrooms\"). Pharmacologically, MDMA mainly releases serotonin (5-HT) via the serotonin transporter (SERT) and psilocybin mainly acts as direct agonist at 5-HT2A receptors. 2C-B interacts with both the 5-HT2A receptor and SERT which is in line with its reported mixed effects profile. However, scientific studies are lacking. There is an increased interest in psychiatric research on the therapeutic properties of MDMA and psilocybin and also on mixed empathogenic-psychedelic substances. 2C-B is a phenethylamine and belongs to the so-called 2C drugs, a group of novel psychoactive substances (NPS) with some structural similarity to the classic psychedelic mescaline. 2C-B is relatively widely used as recreational substance often replacing or mimicking classic substances such as LSD or MDMA. 2C-B also ranks high among the substances found as substitutes or adulterants of tablets sold as MDMA or Ecstasy. Users report that 2C-B has similar acute effects to MDMA when used at low (5-10 mg) and medium doses (10-25 mg) and more psychedelic effects when used at a high doses (25-40 mg). Additionally, in two open labeled studies the effects have been defined by the researchers as entactogenic (MDMA-like) with psychedelic/hallucinogenic properties when administering 20 mg and on the other hand as psychedelic-psychostimulant like when administering a mean dose of 16 mg (4 used 10 mg, 5 used 15 mg and 7 used 20 mg). Subjective effects peaked at 1-2h and lasted 5h. The 2C drugs act mainly as agonists on the 5-HT2A receptor very similar to classic psychedelics like LSD or psilocybin. Furthermore, 2C-B may interact with monoaminergic systems more similar to MDMA and may share some empathogenic or even stimulant-type actions. 2C-B also inhibits the SERT similar to MDMA, however, only at low potency in vitro. Thus, taken together, the pharmacology of 2C-B in vitro is somewhat inconclusive but would be consistent with both MDMA- and psychedelic-type actions in vivo in humans. Increases in blood pressure and heart rate are moderate and regarded as lower than those of MDMA. No severe cases were observed. The safety profile of 2C-B is considered to be similar to MDMA. Psilocybin is a classic serotonergic psychedelic. Psilocybin is a prodrug which is activated to psilocin within the body. The psychoactive action of psilocin primarily involves an interaction with the serotonin 5-HT2A receptor. Currently, psilocybin is the most investigated psychedelic substance among the classic psychedelics. In particular, there are high hopes of using psilocybin in patients with treatment resistant major depression and pharmaceutical companies are currently conducting phase III studies. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the SERT and it less potently also releases dopamine and norepinephrine through the dopamine transporter (DAT) and norepinephrine transporter (NET), respectively. Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy and is therefore referred to as an \"entactogen\" or \"empathogen\". Being granted as a \"breakthrough therapy\" by the FDA, MDMA is currently investigated in substance-assisted psychotherapy for treatment of PTSD. By using a placebo-controlled double-blind cross-over design the study will provide insight into the effects profiles of recreationally used psychoactive substances relevant for psychiatric research. Therefore the study will compare the acute subjective, physiological and endocrine effects of low (10 mg), medium (20 mg) and high (30 mg) doses of 2C-B with standard doses of MDMA (125 mg) and psilocybin (25 mg) in healthy subjects. Finally, the study will also allow to newly directly compare MDMA and psilocybin effects at representative doses and within the same subjects which will provide for a better characterization of these substances increasingly used in psychiatric research.", "journal": "ClinicalTrials.gov", "publication_date": "2025-03-04", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05523401", "keywords": "Healthy, 4-bromo-2,5-dimethoxyphenethylamine (10 mg), 2C-B, 4-bromo-2,5-dimethoxyphenethylamine (20 mg), 4-bromo-2,5-dimethoxyphenethylamine (30 mg), 3,4-methylenedioxymethamphetamine, MDMA, Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05523401\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,PTSD,Pharmacology,Receptor Pharmacology,Clinical Trial,In Vitro Study,Safety,Drug Interactions", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3679, "title": "A Phase II Randomized, Double-blind, Active Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Psilocybin in Treatment-resistant Major Depression", "normalized_title": "a phase ii randomized double blind active placebo controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment resistant major depression", "authors": "Central Institute of Mental Health, Mannheim", "abstract": "The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD). The study is a bi-centric, prospective, randomized, active placebo-controlled study investigating the effects of 25 mg and 5 mg (p.o.) psilocybin versus placebo (100 mg nicotinamide) in a psychotherapeutic context in 144 patients with TRD from moderate to severe degree (ICD-10 F32/F33). After giving written informed consent and down-titration of their monoaminergic medication under supervision of the treating psychiatrist and the study team, patients will be randomly assigned to one of four trial arms using an online randomization tool: 1) receiving placebo (100 mg nicotinamide) at the first session and the full dose (25 mg) at the second; 2) receiving the presumably sub-effective dose (5 mg) at the first session and the full dose (25 mg) at the second; 3a) receiving the full dose (25 mg) at the first session and 5 mg at the second; 3b) receiving the full dose at both sessions. The two dosing sessions are accompanied by three preparatory and four integration sessions. Drug administration must occur under psychotherapeutic conditions. Two trained therapists (one male, one female) will be assigned to each patient and be present during each dosing, preparatory and integration sessions. We will follow the safety guidelines provided by Johnson et al. (2), including a thorough preparation, establishment of trust/rapport, a safe and pleasing physical environment and sufficient interpersonal support. For safety reasons and close monitoring, patients will stay hospitalized for one night after each dosing session (i.e. in-patient setting).", "journal": "ClinicalTrials.gov", "publication_date": "2025-01-19", "publication_year": 2025, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04670081", "keywords": "Treatment-resistant Depression, Psilocybin, Nicotinamide, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04670081\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3687, "title": "Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study", "normalized_title": "psilocybin therapy for depression and anxiety in parkinson s disease a pilot study", "authors": "Joshua Woolley, MD, PhD", "abstract": "The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease. This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an \"off\" period), who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions designed to provide information about the psilocybin experience and to build rapport/trust with the study team. Next, participants will complete a first psilocybin administration session, receiving a low-moderate dose of 10 mg oral psilocybin in a supervised setting with safety monitoring by a physician. Participants who do not experience significant adverse events during or following the session will complete a second psilocybin administration session approximately two weeks later. During the second psilocybin administration session, participants will receive a moderate-high dose of 25 mg oral. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions designed to assess PD and psychiatric symptoms as well as to provide support as they process their psilocybin experiences. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability, and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function.", "journal": "ClinicalTrials.gov", "publication_date": "2024-12-31", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04932434", "keywords": "Parkinson Disease, Depression, Anxiety, Psilocybin therapy, 4-phosphoryloxy-N,N-dimethyltryptamine, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04932434\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Safety,Adverse Events", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3627, "title": "The Neurobiological Effect of 5-HT2AR Modulation", "normalized_title": "the neurobiological effect of 5 ht2ar modulation", "authors": "Gitte Moos Knudsen", "abstract": "The investigators wish to investigate neurobiological effects of serotonin 2A receptor modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an antagonist (ketanserin). Magnetic resonance imaging (MRI) and positron emission tomography (PET) will be used as neuroimaging tools. This project applies an experimental medicine strategy coupled with human functional and molecular neuroimaging to elucidate the effects of 5-HT2A receptor (5-HT2AR) modulation on brain function and mood in healthy individuals. We compare psilocybin (5-HT2AR agonist) and ketanserin (5-HT2AR antagonist) effects on brain function to identify neural mechanisms mediating the clinical effects of psilocybin and, more broadly, to establish this comparative strategy as a pathway for delineating pharmacological effects on the brain in humans.", "journal": "ClinicalTrials.gov", "publication_date": "2024-12-15", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03289949", "keywords": "Basic Science, Psilocybine, Psilocybin, Ketanserin, Ketensin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03289949\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Receptor Pharmacology,Aging,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3689, "title": "Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study", "normalized_title": "efficacy and safety of comp360 psilocybin therapy in anorexia nervosa a proof of concept study", "authors": "COMPASS Pathways", "abstract": "Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support in participants with Anorexia Nervosa", "journal": "ClinicalTrials.gov", "publication_date": "2024-12-03", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05481736", "keywords": "Anorexia Nervosa, Psilocybin, COMP360, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05481736\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Eating Disorders,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3488, "title": "Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates.", "normalized_title": "psilocybin treatment in obsessive compulsive disorder a preliminary efficacy study and exploratory investigation of neural correlates", "authors": "Yale University", "abstract": "This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeutic effects on OCD. Aim 1: To investigate the effects of psilocybin on OCD symptomatology. OCD symptom severity will be assessed before treatment and 24 and 48 hours after treatment, one week after treatment, two weeks, one month, and three months after treatment. Hypothesis: We hypothesize that 0.25mg/kg of psilocybin will lead to greater symptom improvement than niacin (as the active-placebo-control agent) at the primary endpoint of 48 hours post-dosing and at all other assessment points. Aim 2: To explore the relationship between the psilocybin-induced brain connectivity changes and symptom change in OCD. Resting-state brain connectivity will be assessed before and 48 hours after treatment. Hypothesis: We hypothesize that (i) psilocybin will normalize abnormal fronto-striatal functional connectivity in patients with OCD; and (ii) normalization of these abnormalities will correlate with improvement in symptomatology after psilocybin treatment. This study will pilot a single-center, randomized, active-placebo-controlled, double-blind design to examine the clinical and neural effects on OCD, of either 0.25mg/kg of psilocybin or active placebo-control agent (niacin 250mg), given along with non-drug preparatory and follow-up support appointments to 30 study participants. The duration of the randomized study phase is from consent until two weeks after drug administration. Participants will be followed for 12 weeks (3 months) post-study drug administration. Eligible participants will be admitted as an inpatient for at least 3 nights / 4 days surrounding the initial drug administration (or more, at the option of the subject and the investigator). Participants will be randomized into active medication and active-placebo-control groups, and will be blinded as to their study condition. This admission 2 nights prior to the drug administration will allow the participant to adjust to sleeping on the unit and allow them to settle in to the research unit routine. A return for an fMRI scan (48 hours after the administration session) will be scheduled. The participants who received active-placebo-control will be offered the option to receive open-label psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2024-11-19", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03356483", "keywords": "Obsessive-Compulsive Disorder, Psilocybin (0.25mg/kg), \"Magic Mushrooms\", Niacin (250mg), Nicotinic acid, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03356483\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "OCD,Brain Imaging,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3512, "title": "A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder", "normalized_title": "a phase 2a safety and feasibility study evaluating psilocybin trp 8802 administration in concert with psychotherapy in the treatment of binge eating disorder", "authors": "TRYP Therapeutics", "abstract": "To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP8802 among individuals with Binge Eating Disorder. This is a single-center phase 2a open-label study to assess the safety and feasibility of a single dose of TRP8802 in subjects with BED. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 12 weeks following the dose of TRP8802. The total participation in the study will be up to approximately 5 months. Binge eating disorder is the most common eating disorder and is associated with obesity and psychiatric comorbidities, including depression, and impulsive and compulsive disorders. Binge eating disorder is marked by severe disturbance to a person's control over their eating behaviors and high anxiety around food. Various programs using psilocybin paired with psychotherapy have shown positive effects in treating a variety of psychiatric and behavioral conditions, including cancer-related psychiatric distress, anxiety, treatment-resistant depression, and nicotine and alcohol addiction. Based on clinical precedents, relevant neuropharmacology, and mechanistic similarities, psilocybin is theorized to have the potential to be part of the treatment of overeating disorders. TRP-8802 could accomplish this by moderating overall anxiety, anxiety around food, perseveration, and repetitive and intrusive thoughts about food in people with BED. The primary objective of this study is to: 1\\. Assess the safety of a single dose of TRP8802 in participants with binge eating disorder (BED) during the TRP8802 dosing session, and through 12 weeks following dosing (i.e., Week 14).", "journal": "ClinicalTrials.gov", "publication_date": "2024-11-18", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05035927", "keywords": "Binge Eating Disorder, TRYP-0082, Psilocybin, Psychotherapy, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05035927\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Eating Disorders,Pharmacology,Clinical Trial,Cancer Patients,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3430, "title": "PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (MBSR) for Front-line Healthcare Provider COVID-19 Related Burnout", "normalized_title": "papr psilocybin assisted psychotherapy mindfulness based stress reduction mbsr for front line healthcare provider covid 19 related burnout", "authors": "University of Utah", "abstract": "This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic. Following consenting and enrollment a total of 24 participants will be randomized to receive either an 8-week MBSR curriculum or the same 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention. The group psilocybin-assisted psychotherapy intervention will involve 3 group preparatory sessions (2 hours each), a single 8 hour group psilocybin administration session with a 1:1 therapist to participant ratio (25mg psilocybin dose), and 3 group integration sessions (2 hours each).", "journal": "ClinicalTrials.gov", "publication_date": "2024-11-11", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05557643", "keywords": "Depression, Burnout, Professional, Psilocybin, Mindfulness-Based Stress Reduction (MBSR), COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05557643\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3669, "title": "PsilOCD: Evaluating the Effects of the 5-HT2A Agonist Psilocybin on the Neurocognitive and Clinical Correlates of Compulsivity (A Pharmacological-Challenge Feasibility Study)", "normalized_title": "psilocd evaluating the effects of the 5 ht2a agonist psilocybin on the neurocognitive and clinical correlates of compulsivity a pharmacological challenge feasibility study", "authors": "Imperial College London", "abstract": "The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD). This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four weeks apart. To ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session. Additionally, acute post-dosing EEG recordings will be conducted, and blood samples will be taken after each dosing session. OCD symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. Collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and EEG measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.", "journal": "ClinicalTrials.gov", "publication_date": "2024-11-05", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06258031", "keywords": "Obsessive-Compulsive Disorder, Psilocybin (COMP360), O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06258031\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "OCD,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Observational Study,Safety,Inflammation", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3584, "title": "A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study", "normalized_title": "a registered clinical trial of pex010 assisted therapy for stimulant use disorder a safety feasibility and efficacy study", "authors": "Filament Health Corp.", "abstract": "The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX010? Researchers will compare an active PEX010 dose containing 25 mg psilocybin to an active placebo arm, to see if PEX010 works to reduce stimulant use. Participants will: Take PEX010 or the active placebo once during the study, engage in cognitive behavioural therapy, and visit the clinic twice weekly for study intervention and follow-up assessments. In this randomized, controlled trial study participants will receive one capsule of PEX010 containing 25 mg or 1 mg of psilocybin, in conjunction with therapy. Following screening and baseline visits, participants will receive 2 preparation sessions, 1 PEX010 dosing session, 1 integration session, and 7 follow-up visits.", "journal": "ClinicalTrials.gov", "publication_date": "2024-10-29", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06666010", "keywords": "Stimulant Use Disorder, PEX010-Assisted Therapy, PEX010(01), NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06666010\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3644, "title": "Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms", "normalized_title": "psilocybin vs escitalopram for major depressive disorder comparative mechanisms", "authors": "Imperial College London", "abstract": "This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).", "journal": "ClinicalTrials.gov", "publication_date": "2024-10-23", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03429075", "keywords": "Depressive Disorder, Major, Psilocybin + Placebo, Psilocybin + Escitalopram, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03429075\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Mechanism of Action,Receptor Pharmacology,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3453, "title": "Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression: An Emotional-Processing fMRI Pilot Study", "normalized_title": "neurobiological effects of psilocybin in treatment resistant bipolar depression an emotional processing fmri pilot study", "authors": "University Health Network, Toronto", "abstract": "This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the findings of this study will provide data on the neurobiological mechanism of psilocybin in TRBD. The primary objective is to understand the dynamic role of amygdala activity by evaluating the neurobiological effects of a single psychedelic dose (25 mg) of oral psilocybin in individuals with a moderate to severe major depressive episode and a primary diagnosis of Bipolar II Disorder, with 2 or more failed treatment trials (i.e., treatment resistant bipolar depression \\[TRBD\\]). Neurobiological effects will be determined by evaluating the association between post-treatment right amygdala activity during the facial affect task (determined by fMRI one day after the psilocybin dose) and antidepressant effects (determined by changes in the Montgomery-Åsberg Depression Rating Scale \\[MADRS\\] scores over time, during the one-week period post-psilocybin dose). This is a single-arm, open-label clinical trial wherein all participants will receive the same study intervention. Hypothesis: Increased right amygdala activity on fMRI with emotional stimuli one day after psilocybin treatment will be associated with greater antidepressant effects in the one-week period post-treatment in individuals with TRBD. Individuals with bipolar disorder (BD) spend a third of their lives in the midst of a depressive episode. BD is a severe and persistent mental illness with a lifetime prevalence of 2-3%. Bipolar depression remains a significant treatment challenge, with a paucity of evidence-based treatments. Only four pharmacological treatments for acute bipolar depression (cariprazine, olanzapine-fluoxetine combination, quetiapine, and lurasidone) are approved by the US Food and Drug Administration (FDA). Other medications often used for the treatment of BD are those primarily used to treat mania or psychosis (i.e., lithium; antipsychotics) or major depressive disorder (MDD) (i.e., antidepressants). Lamotrigine, which is recommended by international guidelines as a maintenance treatment for BD to prevent depressive recurrence, has limited efficacy for acute BD. Current medication options are also limited by adverse effects, including renal and thyroid impairment with long-term lithium therapy and weight gain and metabolic abnormalities with atypical antipsychotics. Furthermore, treatment outcomes remain poor, particularly for depressive episodes, with over one-third of patients failing to respond to two or more first-line treatments. Hence, there is a clear need for novel and efficacious treatments for BD. However, there is a limited understanding of the neurobiology of BD, which poses as a major barrier to identifying truly innovative treatments. Psilocybin is a chemical compound that naturally occurs in certain species of mushrooms, (for example, in the psilocybe genus, among others). It belongs to a class of drugs referred to as \"psychedelics\". Psilocybin is a tryptamine which is chemically similar to the neurotransmitter, serotonin, and the essential amino acid, tryptophan. It is considered a 5-hydroxytrptamineric (serotonergic) psychedelic along with other similar drugs such as dimethyltryptamine (DMT) and lysergic acid dieythamide (LSD). Psilocybin is a product for the pharmacologically active ingredient psilocin, which readily crosses the blood-brain barrier and acts as a potential partial agonist at serotonin 5HT2A and 5HT2c receptors in the brain. Typical effects of psilocybin include significantly altered states of consciousness, experienced through visual and auditory effects, changes in perception, distortions of time; and a range of effects including a sense of awe, novel perspectives, existential and personal insight, dramatically heightened empathy and feelings of compassion, strong emotions, and unitive experience. With proper screening and preparation, psilocybin has a safe physiological and psychological profile. Psilocybin is currently the preferred compound for use in clinical research involving 5-hydroxytrptaminergic psychedelics because it has a shorter duration of action and suffers from less notoriety and stigma than other similar drugs. Two recently completed clinical trials have assessed the effects of psilocybin on TRD in participants with BDII. The first study was a non-randomized controlled trial that demonstrated a single 25 mg dose of psilocybin with accompanying PAP led to a decrease in MADRS scores in all study participants (n=15) at the 3-week primary endpoint. The second study was a randomized controlled trial that included participants with both unipolar (n=27) and bipolar treatment-resistant depression (n=4), wherein all participants received at least one 25 mg dose of psilocybin with accompanying PAP (with the exception of one participant who dropped out of the study before receiving the study intervention). Participants had the opportunity to receive up to two additional 25 mg doses of psilocybin with accompanying PAP, if they were eligible to receive a repeat dose as per the study protocol. Both trials demonstrated that 25 mg of psilocybin resulted in a decrease of depressive symptoms in participants with treatment-resistant bipolar depression, without increased incidence of manic or hypomanic symptoms. Beyond the clinical benefits observed, psilocybin has provided several new insights into the neurobiology of depression, with dozens of additional, ongoing mechanistic studies underway. Neuroimaging studies evaluating the effects of psilocybin in treatment-resistant (unipolar) depression (TRD) have provided surprising neurobiological insights that have called into question several assumptions of mood disorders. In an open-label TRD trial evaluating the antidepressant and neurobiological effects of psilocybin, increased activity of the right amygdala was observed in response to fearful and happy faces post-treatment. Psilocybin's antidepressant effects were associated with increased right amygdala responses to negative emotional stimuli, an opposite effect to previous findings with selective serotonin reuptake inhibitors (SSRIs). Wherein SSRIs mitigate negative emotions, psilocybin might allow patients to feel, confront and work through them. These findings also suggest that neurobiological targets and mechanisms required to alleviate TRD, may be different from non-resistant depression, where SSRIs are often effective by reducing amygdala response to negative stimuli. Notably, the impact of psilocybin on amygdala function varies inter-individually depending on baseline mood state. More specifically, in healthy volunteers, psilocybin has been shown to decrease amygdala response to emotional stimuli, whereas in TRD, psilocybin was associated with increased amygdala response. Evaluating the effects of psilocybin in TRBD may improve the investigator's understanding of the neurobiology of bipolar depression by dynamically evaluating altered amygdala function and associated changes in depressive symptoms over time.", "journal": "ClinicalTrials.gov", "publication_date": "2024-10-17", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06506019", "keywords": "Bipolar Depression, Psilocybin, Functional MRI, RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06506019\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Consciousness,Aging,Emotional Processing,Clinical Trial,Randomized Controlled Trial,Healthy Volunteers,Treatment-Resistant Depression", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3469, "title": "A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (psilocybin) in Healthy Participants", "normalized_title": "a phase 1 dose escalation study to evaluate the safety tolerability and pharmacokinetics of mls101 psilocybin in healthy participants", "authors": "MycoMedica Life Sciences PBC", "abstract": "MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants. In recent years, high-dose psilocybin has gained attention for its potential therapeutic benefits in many psychiatric indications, however existing clinical data for low psilocybin doses are limited. Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner. As a foundational study of the therapeutic use of low doses of psilocybin, this study will evaluate the safety, tolerability, pharmacokinetics, and sensorial effects using a prospective, controlled, single ascending dose/multiple ascending doses in healthy volunteers.", "journal": "ClinicalTrials.gov", "publication_date": "2024-10-08", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06326606", "keywords": "Healthy Volunteers, Psilocybin, MLS101, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06326606\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Pharmacology,Microdosing,Clinical Trial,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3546, "title": "The Effects of Psilocybin on Shared Experience in Film Processing", "normalized_title": "the effects of psilocybin on shared experience in film processing", "authors": "Western University, Canada", "abstract": "The goal of this clinical trial is to learn whether certain methods of detecting awareness in vegetative or minimally conscious patients (using neuroimaging) are sensitive to the effects of psilocybin (a psychedelic drug). One of these methods includes scanning peoples\\' brains while they watch a film. When different individuals watch a film, their brains become synchronized with each other as they watch the plot unfold. Most importantly, if a seemingly unconscious patient also shows the same brain-synchronization, it means they might actually be conscious and aware. To approach this goal, the investigators will be carrying out this trial in healthy volunteers. This will help better understand whether psilocybin may be a potential treatment for restoring awareness in these patients. The main questions it aims to answer are: * Does psilocybin enhance or diminish brain synchrony during a film? * Do changes in brain synchrony reflect differences in each individual\\'s conscious experience? Participants will be asked to: * Attend two brain scanning sessions and watch a series of film clips, perform a brief mental imagery task, and listen to music - once under a placebo, and once under psilocybin. * Play a series of games that assess their cognition (memory, reasoning, planning, etc.). * Perform a series of visual illusions tasks.", "journal": "ClinicalTrials.gov", "publication_date": "2024-09-26", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06529939", "keywords": "Disorders of Consciousness, Psychedelic Experiences, Psilocybin, Placebo, NOT_YET_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06529939\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"NA\"]}", "topic_tags": "Brain Imaging,Consciousness,Aging,Clinical Trial,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3592, "title": "An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder", "normalized_title": "an open label pilot study examining the feasibility safety and effectiveness of psilocybin therapy for depression in bipolar ii disorder", "authors": "University of California, San Francisco", "abstract": "The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder. The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD II with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. Participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. Primary outcome measures will assess safety, tolerability, and feasibility of study procedures. Efficacy will be measured by change in depression as measured by the MADRS three weeks after the final psilocybin administration. Exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.", "journal": "ClinicalTrials.gov", "publication_date": "2024-09-24", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05065294", "keywords": "Bipolar II Disorder, Psilocybin therapy, 4-phosphoryloxy-N,N-dimethyltryptamine, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05065294\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Healthcare Workers,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3528, "title": "Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus", "normalized_title": "psilocybin assisted psychotherapy in the treatment of patients hospitalized for treatment resistant depression an open label feasibility study with an experiential and systemic focus", "authors": "University Hospital, Ghent", "abstract": "The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. The proposed study will assess the safety, feasibility, preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients with treatment-resistant depression. Screening, after signing the ICF, is done in patients newly admitted to the psychiatric service of Ghent University Hospital or patients referred for hospitalization through the outpatient clinic of the psychiatric service of Ghent University Hospital. Involved patients are hospitalized at the Anxiety, Compulsion and Mood Unit for 8 weeks. They will receive add-on treatment with psilocybin-supported psychotherapy in addition to standard treatment (daily group therapies, mainly non-verbal and activating). This consists of a preparatory phase (4 sessions of 1.5 hours before the first psilocybin session and 1 session of 1.5 hours before the second psilocybin session), the psilocybin sessions themselves (2 sessions, week 3 and week 6) and an integration phase (3 sessions of 1.5 hours after each psilocybin session). All sessions occur with the same 2 therapists throughout the entire course. Therapists are trained to provide experiential and systemic psychotherapeutic interventions. After hospitalization, weekly outpatient follow-up consultations continue until 12 weeks after the last psilocybin session. Subsequently, patients may still agree to a prospective, observational and naturalistic follow-up until 1 year after the last psilocybin session, during which they will be called monthly by a psychiatrist from the research team to inquire about current mental status and any therapies undertaken in the interim. During the study, patients are required to fill out questionnaires at regular intervals. Video-recordings will be made of certain parts of the preparation and integration sessions, for analysis with the client experience scale (EXP). The morning of each psilocybin session, female patients must provide a blood sample for a pregnancy test. The morning of each psilocybin session, all patients must provide a urine sample for toxicology screening. EEGs are also taken from patients the day before each psilocybin session, the morning of the first integration session after each psilocybin session and 12 weeks after the last psilocybin session (at the last outpatient consultation). At the start and at the end of the hospitalization phase, a semi-structured interview will be conducted with the patient to gauge expectations on the one hand and experiences on the other. Throughout the study, the patient's partner will be involved. The partner must complete a number of questionnaires at baseline and throughout the study and will have to be present at 3 EEGs. In addition, the partner will also participate in 1 preparatory session and 2 integration sessions. The partner will also be given the opportunity to spend the night of a psilocybin session with the patient in the hospital (rooming-in). At the start and at the end of the hospitalization phase, a semi-structured interview will be conducted with the partner to gauge expectations on the one hand and experiences on the other.", "journal": "ClinicalTrials.gov", "publication_date": "2024-09-18", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06378229", "keywords": "Treatment Resistant Depression, Psilocybin, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06378229\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Brain Imaging,Observational Study,Treatment-Resistant Depression,Safety,Toxicity", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3593, "title": "Psilocybin for Treatment of Obsessive Compulsive Disorder", "normalized_title": "psilocybin for treatment of obsessive compulsive disorder", "authors": "University of Arizona", "abstract": "This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works. The study seeks to improve our ability to treat and improve the lives of people who have obsessive-compulsive disorder (OCD) by exploring the benefits of psilocybin, a mind-altering drug that changes activity in brain areas believed to be involved in OCD. Anecdotal reports and results from previous research support this idea. This two-phase study will enroll patients with symptomatic OCD who are not taking mind-altering medications or street drugs. During Phase One, neither participants nor the investigators will know which drugs or doses are administered. This information will be available if it is medically necessary to reveal which drugs and doses were administered. Five subjects in each group will receive study drug a total of four times, separated by one week. During Phase Two, participants will not know which drugs or doses they receive, but the investigators will know. All participants will receive psilocybin at some point during study participation. Participants will be randomly assigned to one of the following groups: 1. Low dose (100 µg/kg) psilocybin, 2. High dose (300 µg/kg) psilocybin, or 3. Lorazepam (1 mg), a calming medication. Lorazepam is used often for anxiety and will be used to mask which drug participants receive. Participants will spend approximately 12 hours at the research site under observation during each visit, until they are free of the mind-altering effects of the drug and are determined by the psychiatrist to be safe to go home accompanied by a responsible adult. The effects of low versus high doses, and the additive effects of repeated doses will be analyzed and will be compared to the effects of lorazepam.", "journal": "ClinicalTrials.gov", "publication_date": "2024-08-29", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03300947", "keywords": "Obsessive-compulsive Disorder (OCD), Psilocybin 100 mcg/kg, Psilocybine, \"magic mushrooms\", Psilocybin 300 mcg/kg, Lorazepam 1 mg, Ativan, Intensol, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03300947\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Anxiety,OCD,Mechanism of Action", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3428, "title": "A24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)", "normalized_title": "a24 week multicentre randomised double blind placebo controlled parallel group phase 2 clinical trial to evaluate efficacy and safety of psilocybin assisted psychotherapy in adults with alcohol use disorder aud", "authors": "Clairvoyant Therapeutics", "abstract": "The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\\[s\\] it aims to answer are: * Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? * Is treatment with psilocybin and therapy safe for participants? Participants will * Attend 13 study visits * Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo * Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.", "journal": "ClinicalTrials.gov", "publication_date": "2024-08-14", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05646303", "keywords": "Alcohol Use Disorder, Psilocybin, Placebo, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05646303\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3609, "title": "An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)", "normalized_title": "an open label study of the safety and efficacy of psilocybin in participants with treatment resistant depression p trd", "authors": "Sheppard Pratt Health System", "abstract": "The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.", "journal": "ClinicalTrials.gov", "publication_date": "2024-08-08", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04433858", "keywords": "Treatment Resistant Depression, Psilocybin, COMP360, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04433858\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3467, "title": "PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical Trial", "normalized_title": "psilocybin for psychological and existential distress in palliative care psyched pal a multi site open label single arm phase i ii proof of concept dose finding and feasibility clinical trial", "authors": "Ottawa Hospital Research Institute", "abstract": "The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured. Patients with advanced illness report feeling a sense of hopelessness, loss of autonomy and relationships, and a lack of purpose in life. These feelings of psychological suffering have been described as \"existential distress\" and are associated with poor outcomes, including decreased medication adherence and quality of life, increased desire for hastened death and rates of suicide, and has been identified as a primary reason why individuals pursue medical assistance in dying (MAiD). Current treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. Pharmacological approaches for treating psychological suffering may reduce symptoms of depression and anxiety, but evidence to support their efficacy in palliative care (PC) is underwhelming. Antidepressant and anxiolytic medications also take time to work and can cause serious side effects such as falls and confusion, which can be substantial deterrents for patients. Similarly, results from randomized controlled trials (RCTs) and meta-analyses have demonstrated psychotherapeutic interventions show limited benefit in a PC population. Further, psychotherapy can be time consuming and slow to work, which is not ideal for patients with limited life expectancy. Given the burden of psychological and existential distress among patients followed by PC providers, there is a need to develop scalable, brief, and rapidly effective therapeutic approaches to reduce this distress. Psychedelic medications offer an innovative, safe, complementary approach to address psychological and existential suffering in patients receiving PC. Studies from the 1950's showed serotonergic hallucinogens (\"psychedelics\") improved depression and anxiety symptoms in cancer patients. However, legislative changes restricted the use of these medications in clinical care and research. Interest in psychedelic medications has been rekindled by two recently published RCTs that studied the use of psilocybin (a mushroom-derived 5HT2A agonist) during a single psychotherapeutic session in cancer patients with anxiety and/or depression. These trials demonstrated rapid, clinically meaningful, and long-lasting reductions in depressed mood and/or anxiety symptoms and improvements in quality of life and death acceptance. There is also evidence suggesting psilocybin microdosing - taking sub-hallucinogenic doses continuously over longer time periods, rather than a one-time hallucinogenic dose - can improve mood and anxiety. The effects of microdosing, however, have not been rigorously evaluated, particularly in patients with life limiting illness. Results from recent trials are encouraging but knowledge gaps remain. First, studies to date primarily enrolled patients with localized disease who experience different distress than that of patients with advanced disease who are near the end of life. Second, it is unclear if Canadians would find psilocybin an attractive option in the context of MAiD legalization, which provides an alternative option for patients with severe psychological suffering. Third, there is no empirical research on the therapeutic effects of psilocybin microdosing, as most studies have followed macrodosing protocols. While preliminary efficacy of macrodosing has been demonstrated, there are important barriers to administering this therapy in a PC context. Previous trials had slow recruitment rates, suggesting there may be barriers related to the acceptability of psilocybin macrodosing from the perspectives of patients and families. Macrodosing requires the patient to dedicate an entire day to participating in a guided hallucinogenic experience and remain in an acute care setting where they can be closely monitored. It also requires patients to engage in preparatory sessions with monitors and a post-therapy session. In a PC context, this time commitment may not be acceptable or feasible for patients who are nearing the end of life. Additionally, macrodosing requires at least two trained moderators to guide the patient through their psychedelic experience and facilitate the pre- and post-dosing sessions. In most PC settings, it is not feasible to have clinicians dedicate two days to a single patient, thus limiting the scalability of this intervention. Psilocybin microdosing has the potential to overcome barriers to the feasibility and acceptability of macrodosing. By removing the requirement for trained moderators, minimizing the time commitment required of patients, eliminating the hallucinogenic effects of the therapy, and allowing patients to receive treatment either as an inpatient or in the community, microdosing may be a more acceptable option to patients and families and allow psychedelic therapy to be scalable across various PC settings. Psilocybin microdosing is a novel, complementary therapy that, while still unproven for patients near the end of life, has the potential to fundamentally change the way psychological and existential distress is responded to in PC, improving the lives of the 30% of patients who experience this suffering at the end of life. Objective To determine if psilocybin microdosing is a safe and feasible treatment for psychological distress among patients nearing the end of life followed by palliative care providers. All participants will receive a 4-week psilocybin microdosing intervention. The secondary objective is to examine the preliminary efficacy of psilocybin microdosing. Sample Size As this is a feasibility study, no formal sample size calculation was performed to determine the number of patients required to reach a level of precision on any study endpoint. Rather, the goal of this study is to provide estimates, along with their margins of error, of the recruitment rate and efficacy outcomes which will inform a subsequent two-arm randomized controlled trial. Participating sites see approximately 5,300 patients per year. It is anticipated that 30% will have psychological distress. Assuming a minimum of 1 in 6 patients are eligible and 15% of eligible patients will enroll, the goal is to enroll a sample of 20 participants in up to 1-year period. Statistical Analysis Analyses will adopt an intent-to-treat approach. Because the goal of this trial is to demonstrate feasibility and preliminary measures of efficacy, the main analyses will include calculation of feasibility outcomes using descriptive statistics and 95% confidence intervals (CIs), as well as effect sizes with 95% CIs for primary and secondary efficacy measures, comparing patients' 4-week follow-up assessments to baseline assessments. Participants will also be stratified based on demographic and clinical characteristics to assess trends in outcomes. Notably, there is some evidence that selective serotonin reuptake inhibitors (SSRIs) in particular may attenuate the effects of psilocybin. As such, sub-analyses will evaluate outcomes in participants taking an SSRI medication versus those who are not. A sub-group analysis by setting of care (inpatient vs outpatient/community) will also be conducted. Analyses of safety data will include the mean and standard deviation of the peak effect observed (i.e. highest observed blood pressure, heart rate) and proportion of participants experiencing adverse mood and behaviour events. The incidence of delirium and serotonin syndrome will also be recorded. Details of Eligibility, Intervention Protocol, and Outcome Measures are provided elsewhere.", "journal": "ClinicalTrials.gov", "publication_date": "2024-08-08", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04754061", "keywords": "Depression, Anxiety, Distress, Emotional, Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04754061\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Receptor Pharmacology,Aging,Microdosing,Wellbeing,Emotional Processing,Clinical Trial,Randomized Controlled Trial,Cancer Patients,Healthcare Workers,Safety,Adverse Events", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3438, "title": "Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms", "normalized_title": "psilocybin assisted therapy for severe alcohol use disorder feasibility clinical efficacy neuro cognitive mechanisms", "authors": "Brugmann University Hospital", "abstract": "Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial A substantial proportion of patients with alcohol use disorder does not respond to available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results. Building on extant findings, the proposed study aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder, and to characterize associated changes in the two key neurocognitive systems identified by dual-process models of addiction. In this double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial, 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy within the context of a 4-week inpatient rehabilitation for severe alcohol use disorder. The experimental group will receive a high dose of psilocybin (30 mg), whereas the control group will receive an active placebo dose of psilocybin, both within the context of a brief standardized psychotherapeutic intervention. The primary clinical outcome is the between-group difference in terms of the change in percentage of heavy drinking days from baseline to four weeks post-hospital discharge, whilst safety and feasibility metrics will also be reported as primary outcomes. Key secondary assessments include between-group differences in terms of changes in 1) drinking behavior parameters up to six months post-hospital discharge, 2) phosphatidyl-ethanol blood concentration, an objective biomarker of alcohol consumption, 3) symptoms of depression, anxiety, trauma, and global functioning, 4) neuroplasticity and key neurocognitive mechanisms associated with addiction, 5) psychological processes and alcohol-related parameters.", "journal": "ClinicalTrials.gov", "publication_date": "2024-08-06", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06160232", "keywords": "Severe Alcohol Use Disorder, Psilocybin (high dose), Active placebo (low dose of psilocybin), RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06160232\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Neuroplasticity,Mechanism of Action,Biomarkers,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3450, "title": "Psilocybin for the Treatment of Major Depressive Disorder", "normalized_title": "psilocybin for the treatment of major depressive disorder", "authors": "Washington University School of Medicine", "abstract": "The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.", "journal": "ClinicalTrials.gov", "publication_date": "2024-07-24", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05675800", "keywords": "Major Depressive Disorder, Psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05675800\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Mechanism of Action", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3638, "title": "Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study", "normalized_title": "psilocybin for treatment of alcohol use disorder a feasibility study", "authors": "Anders Fink-Jensen, MD, DMSci", "abstract": "The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD. The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per in- and exclusion criteria and baseline values will be recorded as per outcome measures. All patients will receive a single administration of 25 mg of psilocybin. As per safety guidelines patients will be monitored the entire dosing session by study staff familiar with the psychedelic effects of psilocybin. In addition, the patients will meet before and after the dosing session with a psychologist connected to the study for preparation and post-session debriefing, respectively. During dosing session, the investigators will collect blood plasma psilocin levels in order to establish pharmacokinetics and an estimated brain 5-HT2AR occupancy. When the effects of psilocybin subside, the investigators will ask the patients to fill out questionnaires encapsulating the psychedelic experience. One week after drug administration the patients are required to meet for an end-of-study assessment of outcome measures including adverse events.", "journal": "ClinicalTrials.gov", "publication_date": "2024-07-11", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04718792", "keywords": "Alcohol Use Disorder (AUD), Psilocybin, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04718792\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Pharmacology,Receptor Pharmacology,Safety,Adverse Events", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3535, "title": "Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders", "normalized_title": "assessing the feasibility of a custom psychedelic assisted group program on mental and physical health in first responders", "authors": "Empower Research Inc", "abstract": "This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. Group 1 (control): 12-week group-based program, with a breathwork day at week 10 Group 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10 Assessment timepoints: * Baseline * Mid-program (Week 6) * End of program (Week 12) * 6-month follow up All participants will undergo a 12-week, group-based program (one session per week, for 12 weeks). The first group session, as well as the Week 10 session will occur in-person. The remainder of the sessions will occur remotely. Each week, trained facilitators will help create a trauma-informed safe space for the group to thrive and promote cognitive resilience. The topics covered throughout the 12-week program include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. During Week 10, participants will be provided with either psilocybin (active group) or complete a breathwork day (control group). For participants randomized to the active group, they will receive 10mg of psilocybin on Week 10. A clinician certified and trained in the therapeutic use of psilocybin will be on site for participants in the psilocybin group. During the dosing session, the clinicians will respond to whatever needs arise. This may include escorting them to the bathroom, giving them a drink of water. At least two staff (one facilitator and one clinician) will be on site during dosing days. The dose will be administered in clear capsules with approximately 500ml of water. Aside from the dose provided, the weekly session will continue as usual, with a focus on breath-work, embodiment, and gentle movement on dosing days. Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules.", "journal": "ClinicalTrials.gov", "publication_date": "2024-06-23", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06471959", "keywords": "Psilocybin, Psychotherapy, Group, PEX010, UNKNOWN", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06471959\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Resilience,Healthcare Workers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3545, "title": "Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion", "normalized_title": "effects of psilocybin facilitated experience on the psychology and effectiveness of professional leaders in religion", "authors": "Johns Hopkins University", "abstract": "The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.", "journal": "ClinicalTrials.gov", "publication_date": "2024-06-17", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02243813", "keywords": "Healthy, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02243813\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "General", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3462, "title": "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study", "normalized_title": "psilocybin as a treatment for anorexia nervosa a pilot study", "authors": "Imperial College London", "abstract": "The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group. Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of effective pharmacological and psychological treatments, and fewer than half of those diagnosed making a full recovery, there is a great need for new treatment avenues to be explored. For this study, we will recruit patients who have a primary diagnosis of anorexia nervosa as defined by DSM-V criteria, which has been established by their specialist ED team to have been present for at least 3 years, and who have found other forms of treatment ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of psychological measures (questionnaires and interviews). There will be a follow-up period of 12 months following the final study visit.", "journal": "ClinicalTrials.gov", "publication_date": "2024-06-16", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04505189", "keywords": "Anorexia Nervosa, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04505189\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Eating Disorders,Brain Imaging,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3445, "title": "A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder", "normalized_title": "a multi centre double blinded placebo controlled randomised phase ii clinical trial for psilocybin assisted therapy for alcohol use disorder", "authors": "University of Sydney", "abstract": "To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial. New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being. This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days (HDD) per week among individuals with AUD. Primary Objective To conduct a double-blind, randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder (AUD). The primary aim is to compare the efficacy of psilocybin-assisted therapy (two sessions of psilocybin, 25 mg per dosing session) versus control (niacin 250mg) and therapy in reducing alcohol consumption, specifically measuring the number of heavy drinking days (HDD) per week. Secondary Objectives To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD, including depression and anxiety. Study Design The trial will employ a double-blind, randomised, controlled design. A sample of 90 individuals with AUD will undergo 14 weeks of treatment, which includes 12 therapy sessions and 2 dosing sessions with either psilocybin (25 mg) or control (niacin 250mg). Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety.", "journal": "ClinicalTrials.gov", "publication_date": "2024-06-09", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06444243", "keywords": "Alcohol Use Disorder, Alcohol Dependence, Depression, Anxiety, Psilocybin, Niacin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06444243\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Wellbeing,Clinical Trial,Randomized Controlled Trial,Safety", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3534, "title": "An Open-Label Investigation of the Effects of Sub-Perceptual Repeat Dosing of Psilocybin on the Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients", "normalized_title": "an open label investigation of the effects of sub perceptual repeat dosing of psilocybin on the behavioural and cognitive symptoms of fragile x syndrome in adult patients", "authors": "Nova Mentis Life Science Corp", "abstract": "Diverse symptomatology makes Fragile X Syndrome (FXS) difficult to treat, and currently there are no approved prevention or treatment methods for FXS. Current therapies, including pharmaceutical and behavioural interventions, offer a patchwork of solutions that have limited efficacy and high toxicity. The current study aims to examine psilocybin as a safe treatment alternative with the ability to improve markers of cognition, communication, mood, behavior as well as markers of neuroinflammation, serotonin levels in exosomes, and neuroplasticity at sub-hallucinogenic doses (microdosing). The overall objective of this study is to assess the feasibility of low-dose psilocybin as a therapeutic option for individuals living with FXS and to improve diagnostic parameters of FXS, as well as therapeutic responses with the use of biomarkers. A total of 10 subjects who meet all the inclusion criteria and does not meet any of the exclusion criteria will be enrolled into the study. Any subjects prematurely terminated from the study will be replaced to ensure 10 subjects complete the study. A study coordinator will contact referring clinicians, caregivers, and subjects to pre-screen for initial eligibility. Those deemed eligible will be invited for an in-person screening along with the participating caregiver. The screening visit will be approximately two hours long and will consist of informed consent, diagnostic interview, physical examination, drugs of abuse test (DOA), ECG, medical/treatment history review, and demographic forms. A pregnancy test will be performed on females of child-bearing during screening, baseline, and end-of-study visits. All eligible subjects will enter the treatment arm of the study. Subjects and caregivers will return to the clinic for a baseline visit within three weeks of their screening completion. Baseline visit will include saliva/buccal swab collection, and clinician and self-report assessments for subjects and caregivers. These assessments will include the Vineland Adaptive Behavior Scales-Third Edition (VABS-3), Clinical Global Impressions-Improvement scale (CGI-I), Visual Analog Scale-Treatment Satisfaction (VAS-TS), the Anxiety, Depression and Mood Scale (ADAMS), and the Systematic Assessment For Treatment Emergent Events (SAFTEE). Digital assessments may also be performed at the baseline visit or at home at the discretion of the qualified investigator. Digital assessments will include the NIH Toolbox Cognitive Battery Modified for Intellectual Disabilities (NIH-TCB), the Trail Making Test (TMT), and the Multifaceted Empathy Test (MET). The study drug will be dispensed in blister packs to monitor adherence and improve subject compliance. Blister packs will be prepared and distributed at each subsequent visit. Subjects will return to the clinic for study visits on day 8, 15, 22, and 28 (study end date). Subjects and caregivers will complete the assessments described above. Subjects will provide additional saliva/buccal swab samples at day 15 and day 28.", "journal": "ClinicalTrials.gov", "publication_date": "2024-05-07", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05832255", "keywords": "Fragile X Syndrome, Behavior, Cognitive Dysfunction, Psilocybin, 1.5 mg, SUSPENDED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05832255\",\"overall_status\":\"SUSPENDED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Neuroplasticity,Receptor Pharmacology,Biomarkers,Microdosing,Review Article,Healthcare Workers,Toxicity,Inflammation", "study_type": "Review Article", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3632, "title": "Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial", "normalized_title": "mechanisms supporting psilocybin assisted psychotherapy for alcohol use disorder a randomized controlled clinical trial", "authors": "University of Calgary", "abstract": "The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD). The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing. A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing", "journal": "ClinicalTrials.gov", "publication_date": "2024-05-06", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05995769", "keywords": "Alcohol Use Disorder, Alcoholism, Psilocybin, magic mushrooms, PEX010, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05995769\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Brain Imaging,Mechanism of Action,Aging,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3564, "title": "Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study", "normalized_title": "acute dose dependent effects of dmt in healthy subjects a placebo controlled cross over study", "authors": "University Hospital, Basel, Switzerland", "abstract": "N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects. N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\\", "journal": "ClinicalTrials.gov", "publication_date": "2024-04-24", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05384678", "keywords": "Healthy, N,N-Dimethyltryptamine (54 mg), N,N-Dimethyltryptamine (108 mg), N,N-Dimethyltryptamine (162 mg), N,N-Dimethyltryptamine (216 mg), Placebo, N,N-Dimethyltryptamine (108 mg) + dose titration, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05384678\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Consciousness,Spirituality", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3434, "title": "The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density - A Single Dose Randomized, Double Blind, Placebo- Controlled Phase 2 Positron Emission Tomography Study", "normalized_title": "the effect of psilocybin on mdd symptom severity and synaptic density a single dose randomized double blind placebo controlled phase 2 positron emission tomography study", "authors": "Section for Affective Disorders; Northern Stockholm Psychiatry", "abstract": "PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms Psykiatri Vårdvägen 3 112 19 Stockholm Sweden Medical Monitor Inspira Medical AB Phase of Study Phase 2b Sample Size 30 randomized Name of Investigational Product (IP) Psilocybin, 3-\\[2-(dimethylamino)ethyl\\]-1H-indol-4-yl\\] dihydrogen phosphate Name of Active Placebo Niacin EudraCT 2020-002790-94 Description of IP and Active Placebo PSIPET Protocol 5 200821 Page 14 Study Intervention Name: Psilocybin (active drug product) Niacin (active placebo product) Dosage formulation: One active capsule contains 25 mg of psilocybin One active placebo capsule contains 100 mg of niacin Capsule: Size 2 hydroxypropyl methylcellulose (HPMC), opaque Size 2 HPMC, opaque Unit dose strength: 25 mg 100 mg Route of Administration: Oral (solid dose) Oral (solid dose) Dosing instructions: One capsule administered with water One capsule administered with water Packaging and Labeling: Study Intervention will be provided in a high-density polyethylene (HDPE) bottle. Each bottle will contain one capsule (psilocybin or niacin) and will be labeled as required per Swedish requirement for blinded study. Study Description and Overview Thirty participants (males and females) ages 20 to 65 inclusive, who, at Screening, meet ICD-10 criteria for major depressive disorder (MDD), have a current depressive episode of at least 30-day duration, have a Screening Montgomery-Asberg Depression Rating Scale (MADRS) total score \\>= 22 and meet all other inclusion/exclusion criteria will be randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo control that provides an acute physiological response (flushing) that is intended to aid in blinding of intervention allocation. All randomized participants will be included in the Full Analysis Set (FAS) population used in analyzing primary and secondary study endpoints. Only participants who meet depressive symptom severity criteria at web screening (MADRS self-rating (MADRS-S) score \\> =19) and who do not show an unacceptably large degree of symptom improvement between the web screening and in-person screening (indexed by change in MADRS-S (improvement) 30% (MADRS representing web screening will be approximated to MADRS-S + 3) will be eligible for randomization. This is to minimize the risk for spontaneous remission before dosing. Participants deemed eligible following successful completion of all screening assessments including a structural Magnetic Resonance Imaging (MRI) examination will be determined as eligible. Eligible participants at Baseline will submit cerebrospinal fluid (CSF), submit blood samples, be examined with positron emission tomography (PET) and the radioligand \\[11C\\]UCB-J and receive one preparation session (see further below) to be eligible for randomization on Dosing (Day 0) to receive either psilocybin or niacin active-placebo. They will complete follow-up visits, including outcome measures assessments, on study Day 1, 8, 15, 42 and 365 (within corresponding visit windows). At day 15 the sampling of CSF, blood and \\[11C\\]UCB-J PET will be repeated. PSIPET Protocol 5 200821 Page 15 After day 42, all participants will be given follow-up visits at Norra Stockholms Psykiatri for up to one year after dosing, to study dedicated physicians or nurses at a frequency determined by the health care professional. If needed to reach/stay in remission, the participants will be provided antidepressant treatment in accordance with the regional guidelines for antidepressant treatment (https://psykiatristod.se/regionala-vardprogram/ depression). At least monthly the participants will be asked to provide on-line symptom rating data (via 1177.se). At the 365-day visit, symptoms will be evaluated using MADRS, Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales. After completing the study (one year or withdrawal), participants will be subject to standard care, including referral in accordance with regional guidelines. The study outcome measures will be used to assess depressive symptoms, clinical global functioning, functional disability, anxiety symptoms and health-related quality of life. Safety outcome measures will be collected at all assessment time points from the time of consent through the end of study. To enhance participant safety, the current study proposes to test psilocybin within a \"set and setting\" (SaS) protocol similar to the protocol that has been used in all modern studies of psilocybin in both diseased and normal healthy populations. The SaS protocol for this study includes: 1) a preparation with session Facilitators (licensed psychologists) prior to dosing; 2) administration of study medications in an aesthetically neutral room under the supervision of two Facilitators who are present throughout the session (with the exception of short, temporary allowances for facilitator breaks; e.g. bathroom breaks); and 3) three post-dose integration sessions during which participants are encouraged to discuss their intervention experience with the Facilitators. To evaluate the Facilitators' adherence to the study manual, and the role of Facilitators' and participants' in-session behaviors for treatment outcome, all five sessions in the trial with Facilitators present will be recorded. The SaS will be identical for those randomized to psilocybin or niacin active placebo. Study Duration The planned maximum study duration for each participant will be approximately one year, with variation primarily dependent on the length of the screening period, the number of days between baseline and dosing, and the visit windows provided for each post-dose assessment. For each participant, the study will be divided into two phases: Phase A or treatment phase (day 0 to and including day 42), and phase B or follow-up phase (day 43 -365). The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (niacin) in otherwise medically-healthy participants between the ages of 20 and 65, assessed as the difference between groups in changes in depressive symptoms. Primary Outcome Measure Change in blinded rater MADRS total score from Baseline to Day 8.", "journal": "ClinicalTrials.gov", "publication_date": "2024-04-18", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04630964", "keywords": "Major Depressive Disorder, Depression, Psilocybin, Niacin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04630964\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Neuroplasticity,Brain Imaging,Aging,Clinical Trial,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3610, "title": "Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)", "normalized_title": "psilocybin assisted psychotherapy for treatment resistant depression a randomized phase ii clinical trial comparing one versus two psychedelic doses of psilocybin psi 1v2", "authors": "University Health Network, Toronto", "abstract": "The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. During the past decade, there has been increased interest in the use of psilocybin as a novel treatment for mental health disorders, including treatment-resistant depression (TRD). Recent studies have suggested that psilocybin has the potential to relieve depressive symptoms when combined with psychotherapy (i.e., psilocybin-assisted psychotherapy \\[PAP\\]). Each psilocybin dosing session requires the use of extensive resources, including two specialized therapists supporting the patient for 6-8 hours per dosing session. If two doses of psilocybin prove to be more effective than a single dose of psilocybin in relieving depressive symptoms, then two doses should be the standard intervention for future trials and clinical application. However, if a second dose of psilocybin does not offer increased anti-depressant benefit from the first dose, then a second dose of psilocybin would only increase the risk of adverse side effects and cost of treatment. Therefore, the purpose of this study is to determine whether a second dose of psilocybin provides better efficacy, safety and tolerability than a single dose. The investigators hypothesize that two doses of psilocybin will be more beneficial compared to a single dose, and that there will be no significant difference between the groups (one dose versus two doses) in safety or tolerability. The primary objective of assessing antidepressant efficacy will be evaluated by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) between baseline and Week 8. Safety and tolerability will be assessed using standardized adverse effects monitoring, in addition to close participant monitoring during the dosing day (e.g., blood pressure changes, dissociative and psychotomimetic effects, treatment-emergent manic symptoms, and suicidality). Secondary objectives include evaluating the effects of one versus two psilocybin doses on suicidality, quality of life, functioning, cognition, and duration of clinical benefits during the six month observational follow-up period. Exploratory objectives include evaluating predictors of response, such as static and dynamic clinical factors and expectancy effects, and cost-effectiveness of one versus two psilocybin doses.", "journal": "ClinicalTrials.gov", "publication_date": "2024-04-01", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06341426", "keywords": "Major Depressive Disorder, Depression, Treatment-Resistant Depression, Mood Disorders, Single Psychedelic Dose Psilocybin, Two Psychedelic Doses Psilocybin, RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06341426\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Observational Study,Treatment-Resistant Depression,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3697, "title": "A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer", "normalized_title": "a pilot study of psilocybin enhanced group psychotherapy in patients with cancer", "authors": "University of Utah", "abstract": "This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of therapist hours per subject compared to standard individual therapy protocols. Two groups of six will be treated on this trial. After the enrollment and treatment of the first group of six patients, accrual will be placed on hold to ensure subject safety. If stopping rules are not met (Section 11), the next group of six patients will be enrolled and treated on study. The study intervention will include a total of seven group therapy sessions including three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The group therapy sessions will occur on a weekly basis, followed one week later by the psilocybin session. The first integration group session will occur 1-2 days following the psilocybin session.", "journal": "ClinicalTrials.gov", "publication_date": "2024-03-19", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04522804", "keywords": "Cancer, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04522804\",\"overall_status\":\"COMPLETED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3498, "title": "Repeat Dosing of Psilocybin in Headache Disorders", "normalized_title": "repeat dosing of psilocybin in headache disorders", "authors": "Yale University", "abstract": "In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.", "journal": "ClinicalTrials.gov", "publication_date": "2024-02-08", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04218539", "keywords": "Migraine Headache, Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04218539\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Headache / Migraine,Biomarkers,Inflammation", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3518, "title": "A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use", "normalized_title": "a randomized double blind study of psilocybin for opioid use disorder in patients on methadone maintenance with ongoing opioid use", "authors": "Johns Hopkins University", "abstract": "This study will investigate whether psilocybin administered under supportive conditions can reduce illicit opioid use and improve quality of life in individuals with Opioid Use Disorder (OUD) in Methadone Maintenance Treatment (MMT) who are concurrently using other opioids illicitly. This randomized double-blind placebo-controlled trial will investigate whether 2 doses of psilocybin administered under supportive conditions can reduce illicit opioid use (assessed by self-report and urine toxicology) and improve quality of life as measured by World Health Organization Quality of Life (WHOQOL-BREF) in individuals with OUD in MMT who are concurrently using other opioids illicitly. In addition, the investigators will investigate secondary outcomes including whether psilocybin under supportive conditions improves mood, reduces use of tobacco and other non-opioid drugs, improves chronic pain and sleep. Ninety-two participants aged 21-70 who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for OUD, are enrolled in a MMT program for at least 3 months, and have urine toxicology positive for methadone and another opioid will be recruited from the community and complete all study procedures. Participants will be randomized to an active group or control group (46 per group). Participants will undergo a total of 2 dosing sessions (whether psilocybin or placebo). The active group will receive 40mg psilocybin first. All participants will receive a second dosing session at three months. The active group will be further randomized, with half receiving 40mg psilocybin, and half receiving placebo at three months to test a secondary hypothesis that two doses of psilocybin are more effective in treating OUD than a single dose.", "journal": "ClinicalTrials.gov", "publication_date": "2024-02-01", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05242029", "keywords": "Opioid Use Disorder, Placebo, Psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05242029\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Chronic Pain,Toxicity", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3706, "title": "Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects", "normalized_title": "comparative acute effects of lsd psilocybin and mescaline in a random order placebo controlled cross over study in healthy subjects", "authors": "University Hospital, Basel, Switzerland", "abstract": "LSD, psilocybin and mescaline are widely used for recreational and ethnomedical purposes. All three substances are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in the substances' molecular structures and receptor activation profiles which may induce differential subjective effects. To date, there are no modern studies comparing LSD, psilocybin and mescaline directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo. LSD (lysergic acid diethylamide), psilocybin (the active substance in \"magic mushrooms\") and mescaline (the active substance in Peyote and San Pedro cacti) are serotonergic hallucinogens widely used for recreational and/or ethnomedical purposes. LSD, psilocybin and mescaline are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in their molecular structures (LSD: ergoline, psilocybin: tryptamine; mescaline: phenethylamine)and receptor activation profiles which may induce different subjective effects. To date, there are no modern studies comparing these three substances directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo. The main objective of this study is to determine whether LSD, psilocybin and mescaline produce qualitatively similar subjective alterations of mind and associated brain activity patterns despite their unique receptor activation profiles. The study investigates psychological (psychometry), physiological and neuronal (magnetic resonance imaging) variables. The LPM-Study provides insight into the acute effects profiles of three serotonergic hallucinogens. It will enhance the understanding of psychedelic-induced altered states of consciousness in humans and will be relevant for the fields of psychiatry, psychology, and forensic toxicology.", "journal": "ClinicalTrials.gov", "publication_date": "2024-01-23", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04227756", "keywords": "Healthy, LSD, Psilocybin, Mescaline, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04227756\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Receptor Pharmacology,Consciousness,Aging,Toxicity", "study_type": "Qualitative Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3492, "title": "The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD", "normalized_title": "the effects of psilocybin on self focus and self related processing in treatment resistant mdd", "authors": "Massachusetts General Hospital", "abstract": "This open-label fMRI study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with treatment-resistant major depressive disorder.", "journal": "ClinicalTrials.gov", "publication_date": "2024-01-23", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05381974", "keywords": "Treatment-Resistant Major Depressive Disorder, Psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05381974\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Brain Imaging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3499, "title": "Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action", "normalized_title": "psilocybin in patients with fibromyalgia eeg measured brain biomarkers of action", "authors": "Imperial College London", "abstract": "The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia. This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, separated by four weeks with in-dosing EEG recordings. The primary end-point will take place 8 weeks from the first dosing session after which patients will be remotely monitored monthly for 6 months.", "journal": "ClinicalTrials.gov", "publication_date": "2024-01-18", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05548075", "keywords": "Fibromyalgia, Psilocybin, O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine, Therapeutic support, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05548075\",\"overall_status\":\"UNKNOWN\",\"phase\":[]}", "topic_tags": "Neuroplasticity,Brain Imaging,Biomarkers,Observational Study", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3623, "title": "Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder", "normalized_title": "safety and tolerability of psilocybin in post traumatic stress disorder", "authors": "Johns Hopkins University", "abstract": "The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD. The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce PTSD severity in a sample of individuals with PTSD. A sample of up to 30 individuals with PTSD will be recruited. All participants will receive the intervention, which will consist of three psilocybin sessions with an interval of approximately 2 weeks between each session. A3+3 Phase I trial design will be used to evaluate a range of possible dose sequences with doses ranging from 15 mg up to 45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups.", "journal": "ClinicalTrials.gov", "publication_date": "2024-01-04", "publication_year": 2024, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05562973", "keywords": "Post-Traumatic Stress Disorder, Psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05562973\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE1\"]}", "topic_tags": "PTSD,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3572, "title": "Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.", "normalized_title": "psilocybin assisted psychotherapy in the management of anxiety associated with stage iv melanoma", "authors": "Multidisciplinary Association for Psychedelic Studies", "abstract": "This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people will keep daily diaries reporting on how anxious they feel for each day in the study. Melanoma is a cancer arising from pigment-producing cells, or melanocytes. These cells are chiefly located in the skin, but they can also be found in other parts of the body, including eyes, ears and GI tract. A diagnosis of stage IV melanoma can create great stress and anxiety for an individual and his or her caregivers. Psilocybin (4-phosphoryloxy- N,N-dimethyl-tryptamine) is a psychedelic (hallucinogenic) compound found in certain species of mushrooms that can produce spiritual or mystical experiences and that has been used in psychotherapy prior to being made illegal. This study will be a randomized, active-placebo controlled pilot study of the safety and efficacy of psilocybin-assisted psychotherapy as a means of managing anxiety in association with stage IV melanoma. This study will examine whether two sessions of psilocybin-assisted psychotherapy scheduled seen to 14 days apart will reduce anxiety, improve quality of life and be safe in people with stage IV melanoma. Subjects in this study will have a 66% chance of receiving the full dose of 25 mg psilocybin and a 33% of receiving 4 mg psilocybin. The first dose is expected to change how people feel, think and see the world, while the lower dose is expected to have only slight effects. Each subject will receive these conditions at random, as if by coin-toss. The researchers, including the therapists, and the subject will not know whether they are assigned to get 25 or 4 mg psilocybin. The entire study can last up to three and a half months (14 weeks) but the main part of the study lasts six weeks. After the researchers determine that a person with stage IV melanoma and anxiety can be in the study, there will be two introductory psychotherapy sessions with the therapist-investigators. They will prepare the participant for psilocybin-assisted psychotherapy. The subject will have a day-long psilocybin-assisted psychotherapy session after introductory sessions, and he or she will remain overnight at the clinic. There will be a psychotherapy follow-up scheduled the day after each psilocybin-assisted session to help people work with the psilocybin-assisted psychotherapy, and there will be a psychotherapy session in between the first and second psilocybin-assisted psychotherapy sessions. Two weeks after the second psilocybin-assisted psychotherapy session, subjects will return for another follow-up visit. The subjects will answer questions or fill out questionnaires about anxiety, depression, quality of life, spirituality and sense of self at the start of the study, two weeks after the second psilocybin-assisted session and at least once during the study. Subjects will have blood draws to assess liver function before each psilocybin-assisted session and they will have a blood draw to assess natural killer (NK) cells the day after each psilocybin-assisted session. On the day after each psilocybin-assisted session, subjects will also complete a questionnaire about their experiences during the psilocybin-assisted session. Two weeks after the second experimental psilocybin-assisted session, subjects will learn if they got the full or active placebo dose of psilocybin. Any of the three subjects who receive the active placebo dose can take part in an \"open-label\" study phase that will last another six weeks. The open-label phase will be nearly identical to those used in the first study phase except that there will be one, and not two, introductory psychotherapy sessions, and the subject and therapists will know that the subject will be receiving 25 mg psilocybin. People who got the full dose of 25 mg psilocybin will not take part in the open-label study phase. If they are well enough to do so, subjects who received the full dose of psilocybin will have anxiety, depression, quality of life and spirituality measured again two months after the second experimental session. Subjects who received active placebo psilocybin will have anxiety, depression, quality of life and spirituality measured two months after the second open-label psilocybin-assisted session.", "journal": "ClinicalTrials.gov", "publication_date": "2023-12-25", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT00979693", "keywords": "Anxiety, Stage IV Melanoma, psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT00979693\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Aging,Spirituality,Mystical Experience,Safety,Immune Function", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3549, "title": "Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders", "normalized_title": "safety and efficacy of psilocybin for the treatment of headache disorders", "authors": "Yale University", "abstract": "The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2023-12-14", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02981173", "keywords": "Cluster Headache, 0.143 mg/kg Psilocybin or 10 mg Psilocybin, 0.0143 mg/kg Psilocybin or 1 mg Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02981173\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Headache / Migraine,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3629, "title": "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).", "normalized_title": "a randomized double blind placebo controlled study to evaluate the safety tolerability and efficacy of psilocybin assisted psychotherapy in treating severe depression among adults with post traumatic stress disorder ptsd", "authors": "Apex Labs Ltd.", "abstract": "Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is often accompanied by other psychiatric and physical comorbidities, both of which are associated with elevated healthcare costs. Depression, psychosis and suicide rates are consistently reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and comorbid depression, there is a shortfall of effective treatments with few side effects that target the broad range of symptoms, including depression. Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating safety and efficacy for a variety of indications, with no significant adverse events occurring during the course of treatment and follow-up. Notably, in a participant group distinguished by long-standing, moderate to severe major depressive disorder, two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression. Based on previous research, psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence. Furthermore, the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions.", "journal": "ClinicalTrials.gov", "publication_date": "2023-11-28", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06141876", "keywords": "Post-traumatic Stress Disorder, Depression, APEX-002-A02, psilocybin, Placebo, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT06141876\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,PTSD,Addiction,OCD,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3680, "title": "The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression", "normalized_title": "the safety and efficacy of psilocybin as an adjunctive therapy in participants with treatment resistant depression", "authors": "COMPASS Pathways", "abstract": "The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.", "journal": "ClinicalTrials.gov", "publication_date": "2023-11-08", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04739865", "keywords": "Treatment Resistant Depression, Psilocybin, COMP360, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04739865\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3619, "title": "Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II", "normalized_title": "safety and efficacy of psilocybin for the treatment of headache disorders sub study ii", "authors": "Yale University", "abstract": "The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.", "journal": "ClinicalTrials.gov", "publication_date": "2023-10-11", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03806985", "keywords": "Post-Traumatic Headache, Placebo oral capsule, Low Dose Psilocybin, High Dose Psilocybin, TERMINATED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03806985\",\"overall_status\":\"TERMINATED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Headache / Migraine,Safety,Inflammation", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3569, "title": "Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I", "normalized_title": "safety and efficacy of psilocybin for the treatment of headache disorders sub study i", "authors": "Yale University", "abstract": "The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies. The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.", "journal": "ClinicalTrials.gov", "publication_date": "2023-10-11", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03341689", "keywords": "Migraine Headache, High Dose Psilocybin, Low Dose Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03341689\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Headache / Migraine,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3667, "title": "Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence", "normalized_title": "effects and therapeutic potential of psilocybin in alcohol dependence", "authors": "University of New Mexico", "abstract": "This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in recent studies. Psilocybin administration will occur in the context of a behavioral intervention including a total of 12 sessions over 12 weeks, incorporating Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before and debriefing after the psilocybin administration sessions. The MET will incorporate attention to spirituality as well as drinking behavior as a primary subject of change. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured during treatment and for 24 weeks after the end of treatment. The investigators hypothesize that drinking will decrease following the psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks vs. baseline) will be observed among study participants.", "journal": "ClinicalTrials.gov", "publication_date": "2023-09-25", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT01534494", "keywords": "Alcohol Dependence, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT01534494\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Spirituality,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3605, "title": "Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators", "normalized_title": "mindfulness and psychedelics a combined neurophenomenological and pharmacological approach to the characterization of mindfulness states in experienced meditators", "authors": "Milan Scheidegger", "abstract": "The investigators are doing this project to investigate potential neurophysiological synergy effects between mindfulness meditation and psychedelics. Previous studies have found that both mindfulness and psychedelics like psilocybin modulate neural activity and connectivity of the same brain network. However, little is known about the potential interactions between mindfulness meditation and psychedelics. The indigenous plant preparation \"Ayahuasca\" is particularly interesting for the combination with mindfulness meditation. It contains two components, N,N-dimethyltryptamine (DMT) and harmine, which are very similar to the body's own messenger substance serotonin and increase its effect in the body. The investigators would now like to find out how these corresponding networks change in experienced meditators after DMT/Harmine-enhanced mindfulness meditation and how this affects their subjective experience. For this functional MRI imaging will be performed, as well as psychometric assessments and detailed experiential interviews before and after a three-day meditation retreat. Participants will be randomly assigned to one of two groups. One group receives DMT and harmine during the sitting meditation on the second day, the other group receives a corresponding placebo. Neither the participants nor the investigator know who will receive a placebo or the combination of DMT/harmine on the day of the experiment. The pre- and post-measurements of the MRI imaging and psychometric questionnaires of the DMT/Harmine group are compared with those of the placebo control group. By examining the synergistic effects of mindfulness meditation and DMT/harmine, the aim of this study is to contribute to a comprehensive understanding of the neurophenomenology of rare and inaccessible phenomena of consciousness.", "journal": "ClinicalTrials.gov", "publication_date": "2023-09-20", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05780216", "keywords": "Healthy Participants, DMT + harmine, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05780216\",\"overall_status\":\"COMPLETED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Receptor Pharmacology,Consciousness,Aging,Healthy Volunteers,Drug Interactions", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3573, "title": "Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder", "normalized_title": "phase ii randomized double blind placebo controlled parallel group single center study of psilocybin efficacy and mechanism in alcohol use disorder", "authors": "University of Zurich", "abstract": "Effects of serotonin 2A/1A receptor stimulation by psilocybin on alcohol addicted patients: a randomized double-blind placebo-controlled study Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs). Of all the diseases, conditions, and injuries attributable to alcohol use, alcohol use disorders (AUDs) create the largest health burden globally. However, approved pharmacological treatments for alcoholism are limited in their effectiveness. A recent proof of- concept study testing psilocybin in ten alcohol dependent patients provides encouraging efficacy results and safety data. The investigators, therefore, propose to test the efficacy of psilocybin for treating alcohol use disorder and study its underlying neurobiological mechanisms in a randomized, placebo controlled, double blind study. To evaluate effects of psilocybin on alcohol use behaviour, clinical symptoms, neurocognitive and emotional measures in patients with alcohol use disorder. The present clinical trial aims at investigation the clinical and mechanistic effects of Psilocybin in Alcohol Addicted Patients. Patients with alcohol use disorder who have undergone withdrawal treatment within the last 6 weeks will be investigated in a single-centre, double-blind, placebo-controlled, parallel-group design clinical trial contrasting the acute and persisting effects of psilocybin to those of placebo. Patients will be randomly assigned to psilocybin or placebo group with a 1:1 allocation ratio. The study comprises a total of 6 visits during 6 weeks and two follow-up online surveys (3 and 6 months after treatment). In addition, two follow-up surveys that can be completed from home will guarantee monitoring of long-lasting changes in symptomology and ensure all potential side-effects can be captured. On the treatment visit, a single dose of psilocybin (25mg) or placebo will be administered. Patients will be monitored until all effects have worn off.", "journal": "ClinicalTrials.gov", "publication_date": "2023-09-20", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04141501", "keywords": "Alcohol Use Disorder, Psilocybin, Placebo oral capsule, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04141501\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Addiction,Mechanism of Action,Receptor Pharmacology,Aging,Emotional Processing,Clinical Trial,Observational Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3543, "title": "Phase 1, Open-Label, One-Treatment, Single-Dose, One-Period, Pharmacokinetic Study of Psilocin 4 mg as Its Mucic Acid Salt (L-130) Form, in Healthy Subjects Under Fasted Conditions", "normalized_title": "phase 1 open label one treatment single dose one period pharmacokinetic study of psilocin 4 mg as its mucic acid salt l 130 form in healthy subjects under fasted conditions", "authors": "Lobe Sciences Ltd.", "abstract": "Psilocin is the active metabolite of psilocybin a natural material found in several types of fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been reported. This Phase I \"First in Man\" study of psilocin mucate is designed to determine its safety, pharmacokinetics, and bioavailability. The study is conducted under the supervision of physicians and psychiatrists who also will administer a mini-mental state evaluation and report observable anti-anxiolytic effect of the dosage. Safety and possible indications of efficacy will be tracked during the study period, a week following the dose administration and one month after. This study is designed to assess the bioavailability and pharmacokinetic parameters and to monitor the safety and tolerability of Psilocin 2 mg as its Mucic Acid Salt (L-130) form, a proprietary drug candidate of Lobe Sciences Ltd., in healthy subjects under fasted conditions. The study will be conducted in compliance with the protocol and applicable regulatory requirements, GCP and GLP principles and guidelines: Declaration of Helsinki as amended by the 64th WMA General Assembly, Fortaleza, Brazil, November 2013, FDA Guidelines for Bioavailability \\& Bioequivalence Studies and OECD Principles of Good Laboratory Practice will be observed. The study population will consist of 10 Healthy Subjects aged between 21 and 50 years (inclusive), body mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight for males and 45 kg for females), nonsmokers or quit smoking 24 hours prior to dosing. The investigational test product L-130 Capsules containing 2 mg of psilocin as its Mucic Acid Salt of Lobe Sciences Ltd. consisted of single oral dose containing 2 mg of Psilocin (equivalent to 4 mg as Psilocin Mucate salt). Each dose will be administered orally, with 240 mL of water in sitting position under sodium light to healthy subjects after an overnight fast of at least 10 hours in the morning of study dosing day. The study will be conducted as an open label study. Therefore, blinding will not be done. However, the bioanalysis will be performed blinded with regard to the sequence of product administration. Each subject will have a pre-dose sample of 8 ml collected and 13 additional 8 ml samples collected over a 24 hour period. The principal and/ or clinical investigator and study staff will monitor subjects throughout the hospitalization periods. Blood pressure and heart rate will be measured before dosing and at scheduled intervals after dosing. The principal and/ or clinical Investigator will be available throughout each hospitalization period. During outpatient phases, study staff will be available during regular working hours. Subjects' safety will be observed at scheduled intervals of before dosing (-1.00) and 0.50, 0.75, 1.00, 2.00, 3.00, 5.00, 8.00, 12.00, 16.00 and 24.00 hours after drug administration. Subjects will be queried on adverse events. In addition, voluntary reporting of adverse events by subjects will be reported. Mini Mental State Examination (MMSE) score will be assessed to dosed subjects by CI/PI approximately two hours after drug administration, and the results will be tabulated in the final report. Subjects will be asked to report changes in their mood, or other observations during and following the study period. Subjects will also be followed up by phone call after one week and four weeks of dosing to assess if they are experiencing changes in feeling or having improved mood, and the outcomes of the phone calls will be tabulated in the final report. Following the collection of blood samples and appropriate processing, each sample will be analyzed with a validated analytical method to determine the pharmacokinetic profile of psilocin mucate in plasma. All clinical laboratories test results of screening lab tests will be summarized by descriptive statistics. Follow up lab tests will also be summarized by descriptive statistics. The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to monitor the safety and tolerability of the formulation in healthy subjects under fasting conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its Mucic Acid Salt. The final report will provide safety, tolerability and pharmacokinetics of the test product. The study will also report patient reported pharmacology.", "journal": "ClinicalTrials.gov", "publication_date": "2023-09-12", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT06035900", "keywords": "Side Effect of Drug, Psilocin, Psilocin Mucate, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT06035900\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Addiction,Pharmacology,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3618, "title": "A Phase 1, Two-Part Study in Healthy Volunteers to Evaluate The Effect of Psilocybin on Cardiac Repolarization and The Effect of Food on Psilocybin Pharmacokinetics", "normalized_title": "a phase 1 two part study in healthy volunteers to evaluate the effect of psilocybin on cardiac repolarization and the effect of food on psilocybin pharmacokinetics", "authors": "Usona Institute", "abstract": "This study is comprised of two parts. The purpose of the first part of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization. The purpose of the second part of the study is to evaluate the effects of food on the pharmacokinetics of psilocybin. Part one of this study will be a double-blind, single-dose, randomized, placebo-controlled, 4-treatment, 4-period, 12-sequence crossover design in 36 healthy volunteers (adult male and/or female subjects). Subjects will be randomly assigned to 1 of 12 different treatment administration sequences, whereby each sequence will include 3 double-blind treatments (therapeutic dose of psilocybin, supratherapeutic dose of psilocybin, and placebo) and 1 open-label positive control treatment (moxifloxacin). Part two of this study will be an open-label, randomized, 2-period, 2-sequence crossover design in 24 healthy volunteers (adult male and/or female subjects). Each assigned treatment will be administered under fasting or fed conditions as a single dose on Day 1 of the respective study period.", "journal": "ClinicalTrials.gov", "publication_date": "2023-08-14", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05478278", "keywords": "QTc Interval, Pharmacokinetics, Psilocybin, Psilocybine, Psilocibin, Indocybin, Moxifloxacin, Avelox, Moxeza, Micro-Crystalline Cellulose, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05478278\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Pharmacology,Clinical Trial,Healthy Volunteers", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3519, "title": "The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study", "normalized_title": "the efficacy and tolerability of psilocybin in participants with treatment resistant depression a phase 2 randomized feasibility study", "authors": "Brain and Cognition Discovery Foundation", "abstract": "The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve. This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants' depressive symptoms and side effects will also be measured during the study. This randomized clinical trial will assess the feasibility, safety, and efficacy of single and repeat doses of psilocybin at point-of-care in persons with treatment-resistant depression as part of major depressive disorder or bipolar II disorder. The primary objective is to evaluate the feasibility of psilocybin in adults with treatment-resistant depression. The secondary objectives are to assess the efficacy and tolerability of psilocybin at point-of-care.", "journal": "ClinicalTrials.gov", "publication_date": "2023-07-26", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05029466", "keywords": "Treatment Resistant Depression, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05029466\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Treatment-Resistant Depression,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3470, "title": "An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.", "normalized_title": "an open label pragmatic feasibility study on a resilience focused community of practice program with psilocybin assisted therapy pat for end of life patients", "authors": "The Roots to Thrive Society for Psychedelic Therapy", "abstract": "The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session. Target population: The treatment team will treat a total of 64 patients who have: * a terminal diagnosis (experiencing end of life distress), * AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society. Treatment will take place at the Snuneymuxw Traditional Medicines Clinic, 1984 Woobank Rd, Nanaimo, B.C.Research data will be coordinated and held through RedCap, hosted by Island Health. Data collection centres on 1) understanding the feasibility; 2) collecting safety data; 3) exploring the mental health impacts of a community of practice as the vessel for psilocybin-assisted therapy for those with end-of-life distress. There is a mixed method approach for data collection, including: * Collect attendance * Biomedical measures taken during psilocybin sessions (blood pressure, pulse, medications to manage side effects). * Quantitative Health and Wellness Questionnaires of participants before, within, immediately after, and six months after completion. * Qualitative Surveys and Exit Interviews.", "journal": "ClinicalTrials.gov", "publication_date": "2023-07-24", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05958758", "keywords": "End of Life, Psilocybin-assisted therapy within a community of practice model (group administered), UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05958758\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "End-of-Life Distress,Wellbeing,Resilience,Observational Study,Safety,Adverse Events", "study_type": "Observational Study", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3449, "title": "Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD)", "normalized_title": "evaluating the effect of length of time on selective serotonin reuptake inhibitors ssris on the response to psilocybin assisted therapy in individuals with mild moderate major depressive disorder mdd", "authors": "Cybin Therapeutics Inc.", "abstract": "This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups: * Group 1: ≤ 1 year * Group 2: 1 to ≤ 5 years * Group 3: 5 to ≤ 10 years * Group 4: \\> 10 years The majority of clinical investigations with psilocybin to date either exclude participants on SSRIs or taper them off SSRIs prior to psilocybin administration. While evidence derived from the use of larger doses of psilocybin suggests that its predominately serotonergic effects are safe when administered in controlled settings, research investigating the effects of psilocybin with individuals taking SSRIs is lacking, despite the prevalent and chronic use of SSRIs in individuals with depression. The aim of this study is to investigate the effect of length of time on SSRIs on psilocybin-assisted therapy response in individuals with MDD. Specifically, this feasibility study investigates participants who undergo a single-dose of psilocybin (25mg) in combination with pre- and post-dose therapy sessions. The follow-up period in the present study is 12 weeks (3 months).", "journal": "ClinicalTrials.gov", "publication_date": "2023-07-05", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05594667", "keywords": "Depression, Major Depressive Disorder, Mild Depression, Moderate Depression, Depressive Disorder, Psilocybin, PEX010, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05594667\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Receptor Pharmacology", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3538, "title": "Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder", "normalized_title": "investigating the therapeutic effects of psilocybin in treatment resistant post traumatic stress disorder", "authors": "Halucenex Life Sciences Inc.", "abstract": "Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD. Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. These selective serotonin reuptake inhibitors (SSRIs) have limited efficacy. Furthermore, there is a lack of efficacious pharmacotherapy for treatment-resistant PTSD; PTSD remains a chronic and sometimes debilitating condition. New research into other treatment options for PTSD are warranted. Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Psilocybin has received breakthrough designation for treatment of depression. Research on psilocybin has shown that it facilitates fear extinction in mice and promotes neuroplasticity, increasing neurogenesis, spinogenesis and synaptogenesis. These properties may contribute to antidepressive and anxiolytic effects. Psilocybin also reduces activity in the amygdala during threat responses; decreased amygdala reactivity is correlated with positive mood. This is particularly relevant since individuals with PTSD showed increased reactivity in the amygdala, which may increase the ability to process traumatic memories. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.", "journal": "ClinicalTrials.gov", "publication_date": "2023-06-28", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05243329", "keywords": "Treatment Resistant Disorders, Post Traumatic Stress Disorder, Psilocybin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05243329\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,PTSD,Neuroplasticity,Neurogenesis,Receptor Pharmacology,Clinical Trial,Animal Study,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3475, "title": "Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans", "normalized_title": "evaluation of the acceptability safety feasibility and efficacy of psilocybin assisted psychotherapy pap for the treatment of post traumatic stress disorder ptsd in military veterans", "authors": "Combat Stress", "abstract": "Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to PaP being designated as a \"breakthrough treatment\" by the FDA in the US. Despite indications that PaP may hold benefits in treating individuals with posttraumatic stress disorder (PTSD), this remains to be investigated. As such, the present study aims to examine the acceptability, feasibility, safety, and efficacy of PaP (psilocybin administered with psychotherapy) in treating PTSD in military veterans. Recent studies have shown that Psilocybin-Assisted Psychotherapy (PaP) for individuals with treatment-resistant depression can result in outcomes that exceed routine psychotherapy. Psilocybin may have a catalytic effect on the psychotherapeutic process, enhancing introspection and interoception. PaP may similarly benefit the treatment of posttraumatic stress disorder (PTSD). Research indicates high treatment drop-out rates (approximately 30%) among PTSD patients, and moderate remission rates (approximately 44%) 40 months after completing treatment. Furthermore, some veterans with PTSD have poorer treatment responses than members of the general public. This suggests that alternative treatment approaches may be required to support veterans who do not benefit from standard evidence-based approaches. This study aims to explore the acceptability, feasibility, safety and efficacy of PaP for veterans with PTSD. A total of eight military veterans will be recruited. The study involves two non-directive preparatory sessions, two dosing sessions of psilocybin, followed by 12 sessions of Cognitive Processing Therapy. It is hypothesised that PaP will result in a significant reduction in PTSD symptoms, as indicated by PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5; PCL-5) scores from baseline to one-month follow-up.", "journal": "ClinicalTrials.gov", "publication_date": "2023-05-24", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05876481", "keywords": "PTSD, Psilocybin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05876481\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,PTSD,Treatment-Resistant Depression,Veterans,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3683, "title": "Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers", "normalized_title": "recall of experience and conscious awareness in psilocybin treatment of depression the recap study pilot phase in healthy adult volunteers", "authors": "University of Wisconsin, Madison", "abstract": "The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study. The PILOT RECAP Study will investigate the effect of co- administering the amnestic agent midazolam with a single 25 mg dose of psilocybin on the induction of a psychedelic experience and subsequent memory for the experience with the goal of identifying an optimal dosing regimen of midazolam that will allow a psychedelic experience to occur while also inducing amnesia for the experience. Identifying this midazolam dosing regimen will allow us in a subsequent stage of the RECAP program to test whether memory for the psychedelic experience is required/important for psilocybin to produce longer-term antidepressant effects. This is a phase 1 study in psychiatrically and medically healthy volunteers. Given this, there is no disease background for PILOT RECAP per se. However, the purpose of PILOT RECAP is to identify an optimal midazolam dosing schedule to be used in a subsequent study (RECAP) in patients with major depressive disorder (MDD). The investigational treatment for PILOT RECAP is a single 25 mg dose of psilocybin combined with repeated intravenous (IV) boluses of midazolam dosed at levels known to maintain conscious experience while inducing subsequent amnesia for the experience upon its conclusion. Because PILOT RECAP is the first study to examine this drug combination, no data are currently available on this approach. Psilocybin + midazolam will be administered within a \"Set and Setting\" (SaS) protocol that provides psychoeducation and therapeutic support prior to, during, and following psychedelic dosing, and that has been standard procedure for recent studies of psilocybin in humans. It is believed that this SaS approach enhances clinical efficacy and safety. SaS is an integral component of the PILOT RECAP intervention. The PILOT RECAP study will not enroll vulnerable populations. During this study, participants are asked to: * Refrain from use of psychotropic medications. Use of such medications prior to psilocybin/midazolam dosing will result in a participant being discontinued from the study. * Refrain from use of any illegal psychoactive substances from screening until study termination. * Refrain from using legal psychoactive substance for the following defined time periods (the exception is caffeine): * Tobacco and Nicotine: from screening until study termination * Alcohol: 72 hours prior to the Dosing Visit", "journal": "ClinicalTrials.gov", "publication_date": "2023-05-18", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04842045", "keywords": "Psychedelic Experiences, Amnesia, Psilocybin and Midazolam, Psilocybine, Psilocibin, benzodiazepine, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04842045\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Addiction,Clinical Trial,Healthy Volunteers,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3634, "title": "A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin", "normalized_title": "a phase 1 study comparing the pharmacokinetics and safety of intravenous and oral psilocybin", "authors": "University of Wisconsin, Madison", "abstract": "The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks. Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2023-05-14", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05467761", "keywords": "Healthy, Oral Psilocybin, IV Psilocybin, WITHDRAWN", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05467761\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Addiction,Pharmacology,Clinical Trial,Cancer Patients,Treatment-Resistant Depression,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3463, "title": "Effects of Psilocybin in Anorexia Nervosa", "normalized_title": "effects of psilocybin in anorexia nervosa", "authors": "Johns Hopkins University", "abstract": "This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.", "journal": "ClinicalTrials.gov", "publication_date": "2023-05-05", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04052568", "keywords": "Anorexia Nervosa, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04052568\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Eating Disorders,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3563, "title": "The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression", "normalized_title": "the safety and efficacy of psilocybin in participants with treatment resistant depression", "authors": "COMPASS Pathways", "abstract": "The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study", "journal": "ClinicalTrials.gov", "publication_date": "2023-04-23", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03775200", "keywords": "Treatment Resistant Depression, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03775200\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3468, "title": "Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness", "normalized_title": "role of the serotonin 5 ht2a receptor in mescaline induced altered states of consciousness", "authors": "University Hospital, Basel, Switzerland", "abstract": "Mescaline (the active substance in Peyote and San Pedro cacti) is a classic and long known serotonergic psychedelic substance (hallucinogen) that is widely used for recreational, spiritual, and/or ethno medical purposes. Despite its long history, modern data on the acute effects of mescaline on human is lacking. Mescaline produces prototypical psychedelic effects, similar as lysergic acid diethylamide (LSD) and psilocybin. The serotonin 2A (5-HT2A) receptor is thought to primarily mediate acute alterations of consciousness induced by LSD and psilocybin. However, the contributory role of the 5-HT2A receptor in mescaline-induced alterations of consciousness is unclear. Using 5-HT2A receptor antagonist ketanserin, the psychedelic experience induced by LSD and psilocybin can be attenuated and shortened. The present study therefore explores the role the 5-HT2A receptor in mescaline-induced altered states of consciousness using escalating doses of mescaline and the 5-HT2A receptor blocker ketanserin administered before a high dose of mescaline. Objective: The present MDR-study will characterize the subjective effects of different doses of mescaline using modern psychometric instruments and examine the contribution of the 5-HT2A receptor in the mescaline-induced alterations of consciousness. Design: Double-blind, placebo-controlled, 6-period cross-over design with six treatment conditions. 1) Placebo (Pla + Pla), 2) 100 mg mescaline (Pla + 100mg mescaline), 3) 200 mg mescaline (Pla + 200mg mescaline), 4) 400 mg mescaline (Pla + 400mg mescaline), 5) 800 mg mescaline (Pla + 800mg mescaline), and 6) 40mg ketanserin and 800mg mescaline (Ket + 800mg mescaline). Participants: 16 healthy participants aged ≥ 25 and ≤ 65 years (8 female, 8 male)", "journal": "ClinicalTrials.gov", "publication_date": "2023-03-28", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04849013", "keywords": "Healthy, Placebo, Mescaline 100mg, Mescaline 200mg, Mescaline 400mg, Mescaline 800mg, Mescaline 800mg + Ketanserin 40mg, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04849013\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Receptor Pharmacology,Consciousness,Spirituality,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3433, "title": "Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects (\"MELO\"): A Blinded, Placebo-Controlled, Dose-Finding Study", "normalized_title": "mood and cognitive effects of low doses of psilocybin observed in healthy subjects melo a blinded placebo controlled dose finding study", "authors": "Optimi Health Corporation", "abstract": "This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic effects. Psilocybin is a natural psychoactive alkaloid component of more than 200 species of naturally growing mushrooms that can be found throughout the world. Psilocybin use as a ceremonious ritual has been well documented in ancient Aztec and Mesoamerican history. Psilocybin was chemically isolated and synthesized in the 1950s by American scientists, who found that mushroom varieties offered varying ranges of natural psilocybin (from 0.2-1% of dry weight). The psychological benefits of psilocybin are well-documented, as are the safety profile, low toxicity, and significant lack of abuse or overdose potential in comparison to other scheduled and non-scheduled drug, including alcohol. Many clinical studies demonstrate the benefit of psilocybin on feelings of depression, mood, and overall feelings of well-being, particularly at higher doses greater than 25mg. At these doses, hallucinations and psychedelic effects also occur. A growing body of evidence suggests that extremely low doses, or microdoses, may offer similar psychological benefits to individuals without any hallucinogenic effect that may impair daily function. The purpose of this study is to examine an optimal small/microdose of psilocybin, taken orally, that may provide such benefits. Optimi,is committed to providing MELOCIN, an oral, pharmaceutical grade, but naturally derived, mushroom powder (Psilocybe cubensis), containing a specific dose of psilocybin and a controlled range of other natural compounds and excipients within the formulation. Clinical studies will inform the desired low to very low psilocybin dosing range for specific indications which do not elicit any psychedelic effects but are correlated to specific mood and cognition-related enhancements or improvements in otherwise healthy individuals. Primary objective: To assess the safety and tolerability of varying low doses and microdoses of Optimi psilocybin-containing mushroom powder in healthy humans. Secondary objective: To assess the magnitude of effects of varying low doses and microdoses of Optimi psilocybin-containing mushroom powder on general mood, physiological responses, cognitive performance, focus, and feelings of anxiety. Methodology: Double-blind, randomized, placebo-controlled trial examining effects of six oral doses of MELOCIN, a psilocybin-containing Psilocybe cubensis mushroom powder, with 0 (placebo), 1, 2, 5, 8 and 10mg of psilocybin, administered on six separate test days in a randomized fashion. Participants will be randomized to the order that doses are administered. Study days will be scheduled 6-9 days apart to avoid any carry-over effects of a previous dose. Each study day will require ingestion of 10 capsules, which will be a combination of placebo and Psilocybe cubensis powder containing the prescribed daily dose. On the placebo study day, participants will digest 9 placebo capsules and one Chaga mushroom (non-active, non-hallucinogenic) capsule such that the mushroom after-taste commonly present with hallucinogenic magic mushrooms is mimicked and still present to preserve the blinding of the study dosing regimen. Participants will be scheduled for 7 total weekly visits (6 dosing days, 1 follow up/close out visit) at the study clinic, each estimated to be 8-9 hours in duration. At each weekly study visit, participants will be continuously monitored and asked to complete cognitive, mood, and other psychological questionnaires and provide minimal blood work at 80-105 mins, 2.5 hrs, 5 hrs, and 7.5hrs post-drug administration in order to monitor the physiological and psychological effects of the dose provided that day. At the follow-up visit, final questionnaires will be completed and qualitative feedback on the experience will be collected", "journal": "ClinicalTrials.gov", "publication_date": "2023-03-19", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05252598", "keywords": "Mood Disturbance, Mood Change, Sleep Disturbance, Drug Effect, Psychedelic Experiences, Health, Subjective, Psilocin Toxicity, Psilocybin Toxicity, Psilocybin Causing Adverse Effects in Therapeutic Use, Anxiety, Psilocybin, Melocin, Inonotus Obliquus Whole Extract, Chaga, WITHDRAWN", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT05252598\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Anxiety,Microdosing,Wellbeing,Safety,Toxicity", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3524, "title": "Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder", "normalized_title": "safety and efficacy of psilocybin for body dysmorphic disorder", "authors": "New York State Psychiatric Institute", "abstract": "In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period. In this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.", "journal": "ClinicalTrials.gov", "publication_date": "2023-03-12", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04656301", "keywords": "Body Dysmorphic Disorders, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04656301\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Brain Imaging,Receptor Pharmacology,Aging,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3695, "title": "SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression", "normalized_title": "sv2a marker of synaptogenesis in a clinical trial of psilocybin for depression", "authors": "Washington University School of Medicine", "abstract": "Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin. The investigators are studying the neurotrophic effects of psilocybin using 11C-UCB-J, a PET marker for synaptogenesis. Psilocybin is a naturally occurring psychedelic and exerts perceptual effects via 5-HT2A receptor agonism. Psilocybin has gained a great deal of attention as a tool for psychiatric treatment, with clinical trials demonstrating symptom relief after a single dose that is immediate and persists for months. Recognizing the therapeutic potential of psilocybin, the US Food and Drug Administration granted breakthrough therapy status to the Usona Institute for Phase 2 testing of psilocybin in depression. Animal models suggest that psychedelics exert antidepressant effects by producing a rapid and powerful neurotrophic response in the brain. The investigators will enroll patients with major depressive disorder and anhedonia. Participants will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo PET imaging before and one week after drug using 11C-UCB-J, a radiotracer that binds to SV2A - a marker of synaptic density and synaptogenesis. This design allows the investigators to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.", "journal": "ClinicalTrials.gov", "publication_date": "2023-01-29", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05601648", "keywords": "Major Depressive Disorder, Anhedonia, Psilocybin, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05601648\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Aging,Clinical Trial,Animal Study", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3568, "title": "Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder", "normalized_title": "pilot trial of visual healing a nature themed virtual immersive experience to optimize set and setting in psilocybin assisted therapy for alcohol use disorder", "authors": "Keith Heinzerling", "abstract": "Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing, a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants with alcohol use disorder. The objective of the study is to test a strategy for optimizing Set and Setting for psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials for alcohol use disorder, but initial results suggest that patients with alcohol use disorder may be less likely to achieve a mystical experience with standard doses of psilocybin. Optimizing Set and Setting for the psilocybin experience may improve outcomes without requiring higher drug doses. The current study will complete a pilot randomized clinical trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition, participants will view nature-themed video programs during the Prep session and during the Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing Visual Healing creates a tranquil and calming environment that fosters a stronger connection between the viewer and nature. Psilocybin increases the users feeling of connection to nature and having an intention to connect with nature during the psychedelic session is associated with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing anxiety/apprehension and enhancing connections to nature with Visual Healing may improve outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.", "journal": "ClinicalTrials.gov", "publication_date": "2023-01-16", "publication_year": 2023, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04410913", "keywords": "Alcohol Use Disorder, Psilocybin plus Visual Healing Set and Setting, Psilocybin plus Standard Set and Setting, ACTIVE_NOT_RECRUITING", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04410913\",\"overall_status\":\"ACTIVE_NOT_RECRUITING\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Anxiety,Addiction,Mystical Experience,Clinical Trial,Review Article,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3639, "title": "NW Trauma Therapies, Chronic Illness of Chronic Depression, PTSD, MS, HIV, and SARS-CoV-2, Long Haulers Syndrome. Treatment of Unregulaaible Trauma by the Treatment of Enhanced Micro Dosing the Levels of 0.15, Thru 0.33, With a Maintenance Dose of 1 Gram Per Month for Neural Pathway Increase of Non Synthesized Psilocybin, Using the Actual Plant to Regulate the Highjacked Nervous System.", "normalized_title": "nw trauma therapies chronic illness of chronic depression ptsd ms hiv and sars cov 2 long haulers syndrome treatment of unregulaaible trauma by the treatment of enhanced micro dosing the levels of 0 15 thru 0 33 with a maintenance dose of 1 gram per month for neural pathway increase of non synthesized psilocybin using the actual plant to regulate the highjacked nervous system", "authors": "NWTraumatherapies", "abstract": "The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many lead to death and are often the cause or perpetuate unregulated trauma and create an unstable population. Psychiatrists have testified before congress that the SSSRI medications are not fully functional cures and are not working for patients. Enchanced Psilocybin micro-dosing at the levels of 0.15g. ranging to 0.33g. every other day an 0.50g. for monthly maintenance of neural pathway production is proving to shave back the highjacked nervous system, thus stopping or rerouting the ruminating neurotransmitters, by rerouting thru new neural pathways. The body has a additional natural pathway in place then to decrease/stop these thoughts by have open pathways to process the thought differently. Serotonin is a neurotransmitter and which is the most famous of all the neurotransmitters. Serotonin is very similar in its compound structure to the plant medicine family of psilocybin, serotonin and psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of psilocybin at the levels of 0.15 to 0.33 and of 1 gram to 1.5 grams monthly for maintenance of the newly opened neural pathways is postulated to be a mental health game changer. Psilocybin helps shave back the highjacked nervous system which is a condition known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to process the subconscious held in the subconscious and shave back the somatic feelings resulting from the trauma of the individuals who have on-boarded chronic disease(s) of Trauma,PTSD, Unregulated Chronic Depression, MS, Cancer, HIV, and SARS-CoV-2- Long Haulers Syndrome. Patients will work with a team: The Administrator Of Study, participants will be onboarded into the study by a Psychiatrist, Therapist LCPC, Micro Dosing Advisor/On-Boarding Provider, going forward referred to as a PMOP ( PLANT MEDICINE ON-BOARDING PROVIDER. The PMOP will administrate, chart dosing and file reports with the Psychiatrist, General Provider, Psychologist, or the LCPC Therapist. Adding a PMOP to Western Medicine could be the key to making treatment available at a functional cost. The dosage will be ( enhanced micro-dosing which is 1 gram to 1.5 grams of psilocybin every other day for 5 days then moving into a M/W/F dose ranging in the enhanced micro-dose levels of 0.15G. thru 0..33 for 8 weeks. Patients will be accepted in the study they must present with one of the following diagnosed conditions, chronic illness' of Trauma, PTSD, Unregulated Chronic Depression, MS, HIV, Cancer, or SARS-CoV-2- Long Haulers Syndrome. As participants with unregulated trauma can tend to have a severely compromised un-functional compromised immune system. This compromised low functioning compromised immune system creates additional health crisis and can cost a great deal of money for the patients and the healthcare system. As testified to congress, the SSRI's are not fully able to manage the on boarding of severe trauma resulting often in PTST/Trauma, these pharmaceuticals tend to become in effective for treatment within 6 months to a year. The SSRI's and pharmaceuticals available for treatment currently have a success rate of 35 %. These diagnosis' of mental compromise are currently being managed at great human cost and financial cost for a decade or more for many patients. Working in conjunction with the General Provider, Psychiatrist, Psychologist, and LCPC Therapist, with a PMOP ( Enhanced Micro Dosing Provider),The PMOP On-Boarding Provider will tailor the dose of plant medicine which this study postulates will result in a positive treatment and will result in improved (Quality of Life) and in the cases of terminal illness, result in (Dying Well)\" A mind without rumination. As Stated, this study is looking for evidence this Plant Medicine Psilocybin would become a path to shave back the SSRI's and treat with dosing of of M/W/F of enhance Microdosing at the levels of 0.15g. thru 0.33G. The Monthly dose of 1 to 1.5 grams of Plant Medicine for maintenance of the increase in newly opened neural pathways. This Study will introduce Non Synthetic Psilocybin every other day for 8 weeks, and the 1G to 1.1.5 G once time per month. The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has reached an epidemic classification. The population with chronic illness as stated: Trauma, PTSD, Chronic Depression, MS, Caner, HIV, and SARS-CoV-2- Long Haulers Syndrome, these conditions are severe and the treatments are often not effective. These chronic illnesses which can result in unregulated trauma and create an unstable portion of the population. Psychiatrists have testified before congress that the SSRI's medications are not functional cures and are often not working for patients. Psilocybin micro-dosing by many studies is proving to shave back the highjacked nervous system, stopping or rerouting the neural pathways lessening or stopping the ruminating neurotransmitters. This is the 1st study to support the treatment in the Enhanced Microdosing levels in the range of 0.15g. to 0.33g, and adding a dose of 1g. to 1.5 g. monthly for maintence. The body has a natural path to stop these thoughts by a neurotransmitter called serotonin This famous neurotransmitter Serotonin, is very similar to the plant medicine family of psilocybin, Serotonin and Psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of 0.15 to 0.33 with month dose of 1 gram to 1.5 grams of psilocybin is postulated to shave back and reroute the highjacked nervous system known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to reverse back the somatic feelings resulting from the trauma of the individuals who are on boarding chronic diseases of PTSD, Chronic Depression, MS, HIV, Cancer, and SARS-CoV-2- Long Haulers Syndrome. Ross Allison Administrator NPI#1437519899", "journal": "ClinicalTrials.gov", "publication_date": "2022-11-15", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05042466", "keywords": "Trauma, Nervous System, Trauma, psilocybin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05042466\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,PTSD,End-of-Life Distress,Mechanism of Action,Receptor Pharmacology,Microdosing,Immune Function", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3442, "title": "A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence", "normalized_title": "a double blind trial of psilocybin assisted treatment of alcohol dependence", "authors": "NYU Langone Health", "abstract": "Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment. Two to four sites will participate in this study. Aims of the study are 1) to characterize the acute effects of PO psilocybin 25 mg/70 kg, 30 mg/70 kg, and 40 mg/70 kg in alcohol dependent patients; 2) to evaluate the effect of psilocybin treatment on drinking outcomes for 32 weeks after the first administration, relative to diphenhydramine control; 3) to test whether or not characteristics of the drug administration session experiences mediate effects of psilocybin on short-term (1 week) persisting effects and post-session drinking behavior, 4) to evaluate the explanatory value of changes in alcohol craving, self-efficacy, motivation, and other psychological domains in accounting for the observed experimental effect of psilocybin relative to diphenhydramine control, and 5) to evaluate pre-post changes in drinking in participants after they receive psilocybin in the third session. The total duration of psychosocial treatment in the double-blind period will be 12 weeks, and double-blind drug administration sessions will occur after 4 and 8 weeks. In the first psilocybin session, a dose of 25 mg/70 kg will be administered. Depending on the response in the first session, the dose for the second session may be increased to 30 mg/70 kg or 40 mg/70 kg, or held at 25mg/70kg. The dose of diphenhydramine will start at 50 mg, and may be increased to 100 mg or held at 50 mg in the second session, depending on response in the first session. Following completion of the double-blind period (34 weeks after randomization) all participants who meet interim safety criteria will be offered an additional session in which psilocybin will be administered. The drug will be administered during 8-hour sessions in an outpatient setting under close medical and psychiatric monitoring. The drug administration sessions will occur in the context of an extended version of Motivational Enhancement Therapy (Motivational Enhancement and Taking Action, META) with the addition of standardized preparation before and debriefing and follow-up after the psilocybin administration sessions. Extensive screening and baseline assessment will be completed, including thorough safety screening and assessment of participant characteristics that could potentially moderate treatment response. Within-session and short-term persisting effects will be assessed. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured until 50 weeks after the first drug administration session, for a total of 54 weeks from the initiation of treatment.", "journal": "ClinicalTrials.gov", "publication_date": "2022-11-07", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02061293", "keywords": "Alcohol Dependence, Psilocybin, Diphenhydramine, Motivational Enhancement and Taking Action (META), COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02061293\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Spirituality,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3461, "title": "The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.", "normalized_title": "the safety and efficacy of psilocybin in participants with type 2 bipolar disorder bp ii depression", "authors": "Sheppard Pratt Health System", "abstract": "The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.", "journal": "ClinicalTrials.gov", "publication_date": "2022-10-24", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04433845", "keywords": "Treatment Resistant Depression, Psilocybin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04433845\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3685, "title": "An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)", "normalized_title": "an exploratory open label phase 1b ascending dose study to evaluate the effects of oral 3 2 dimethylamino ethyl 1h indol 4 yl dihydrogen phosphate psilocybin bpl psilo on cognition in patients with chronic short lasting unilateral neuralgiform headache attacks sunha", "authors": "Beckley Psytech Limited", "abstract": "This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) The study aims to: Determine the safety and tolerability of psilocybin when administered to patients with chronic SUNHA Determine the effects of psilocybin on cognition when administered to patients with chronic SUNHA Explore the change in frequency, duration, and intensity of headache attacks with escalating doses of psilocybin in patients with chronic SUNHA", "journal": "ClinicalTrials.gov", "publication_date": "2022-10-11", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04905121", "keywords": "Short Lasting Unilateral Neuralgiform Headache Attacks, Psilocybin, TERMINATED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04905121\",\"overall_status\":\"TERMINATED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Headache / Migraine,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3477, "title": "Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of COMP001 And COMP003 Trials (P-TRD LTFU)", "normalized_title": "multicentre study to assess safety and efficacy of psilocybin in patients with treatment resistant depression following completion of comp001 and comp003 trials p trd ltfu", "authors": "COMPASS Pathways", "abstract": "The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP001). In this present study (COMP004), the aim is to follow up participants from COMP001 and COMP003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP003. Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.", "journal": "ClinicalTrials.gov", "publication_date": "2022-09-21", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04519957", "keywords": "Treatment Resistant Depression, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04519957\",\"overall_status\":\"COMPLETED\",\"phase\":[]}", "topic_tags": "Depression,Treatment-Resistant Depression,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3554, "title": "Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study", "normalized_title": "prophylactic effects of psilocybin on chronic cluster headache an open label clinical trial and neuroimaging study", "authors": "Gitte Moos Knudsen", "abstract": "The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week. Subjects will maintain a headache diary prior to, during, and after the administrations in order to document headache frequency, intensity and duration. Subjects will undergo a fMRI scanning before the first and after the last psilocybin session. Cluster headache (CH) is one of the most painful conditions known. CH affects 1 out 1000 and exists in two well-defined forms: episodic (ECH) and chronic (CCH). Ten to fifteen percent of patients have CCH and have less than three months of pain-free time during a year. Medical treatment for CH is divided into acute abortive treatment for the single attack and a prophylactic treatment. The most commonly used prophylactic, verapamil, decreases attack frequency but does not induce remission and very high doses are needed. Although most therapeutic options ameliorate CH, they may be problematic due to major side effects, unsatisfactory treatment response or availability. Thus, novel treatment options are needed. According to several studies, patients that self-medicate with low doses of the serotonin 2A receptor (5-HT2AR) agonist and psychedelic psilocybin report that this is effective as CH prophylaxis or even to induce remission. So far, no clinical trials to confirm this have been conducted, nor is there any objective measures of brain function in association with psilocybin intake in CH. There is, however, already some evidence from functional magnetic resonance (fMRI) imaging studies suggesting that CH patients have abnormal functional connectivity patterns involving the hypothalamus and distributed brain networks, but the implication of these abnormalities is unknown. The investigators are conducting a prospective pilot study, evaluating prophylactic effects of psilocybin in CCH using an open-label study design. They're also going to investigate psilocybin's active metabolite psilocin and brain function (fMRI) to identify possible brain mechanisms underlying CCH and treatment response, including the correlation of treatment response with psilocin levels and estimated 5-HT2AR occupancy and the extent to which brain network changes are affected by psilocybin and correlated with treatment response. Effects of psilocybin on headache frequency, duration and intensity will be assessed in a sample of 20 patients with CCH. Participants will fill out headache logs during the entire study period, in total 10 weeks. Before study inclusion, participants taking prophylactic medication will first go through a 2-week wash-out period to allow for elimination of the medicine. Inclusion is followed by a baseline observation period lasting four weeks, after which patients will first undergo a baseline rs fMRI scanning followed by the first dose of 0.14 mg/kg psilocybin p.o. Blood samples will be collected during the first psilocybin intervention to establish psilocin plasma concentrations, which will be used for estimating receptor occupancy. Participants will then undergo two additional psilocybin administrations spaced by one-week. The last psilocybin dose will be followed by 4 weeks of observation. One week after the last administration of psilocybin, participants will undergo a follow-up MRI scan. Participants will be contacted 3, 6 and 12 months after the last psilocybin dose to gain information about the duration of potential remission periods. All regular acute treatments are permitted during the study period and a systematic record hereof has to be noted in the headache diary. No other prophylactic medication is allowed during the trial and at least a two-week washout period before inclusion is required. Prophylactics are allowed again after the 4 weeks follow-up, with dose and type carefully recorded. Participants will fill out questionnaires during the observation period, in conjunction with psilocybin interventions and at follow-up.", "journal": "ClinicalTrials.gov", "publication_date": "2022-08-09", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04280055", "keywords": "Cluster Headache, Psilocybin, TERMINATED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04280055\",\"overall_status\":\"TERMINATED\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Chronic Pain,Headache / Migraine,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Aging,Clinical Trial,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3594, "title": "Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy", "normalized_title": "evaluation of psilocybin in anorexia nervosa safety and efficacy", "authors": "University of California, San Diego", "abstract": "The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight. Because there are no proven treatments that normalize core symptoms in adult anorexia nervosa, a disorder with high chronicity, many individuals seek out alternative approaches to care. Recent evidence has suggested that anxiety, obsessive compulsive disorder, and diminished reward or motivation play key roles in the development and maintenance of dysfunctional eating, and poor outcome. In recent years, a growing number of studies have demonstrated the safety and preliminary efficacy of psilocybin in clinical trials for a range of psychiatric illnesses including treatment resistant depression, obsessive compulsive disorder, addiction, and anxiety. Psilocybin may represent a promising new treatment for anorexia nervosa. However, no studies have tested psilocybin in this eating disorder population. Accordingly, this study aims to establish the safety, tolerability and dosing of psilocybin in adult patients with anorexia nervosa, as well as gather pilot data on possible efficacy. For this study, the investigators will recruit adults who currently have a DSM-V diagnosis of anorexia nervosa. Participants will undergo medical and psychological screening and those who are deemed eligible will partake in a maximum of 7 study visits, lasting from 4-8 weeks. On dosing day, participants will receive a single 25 mg dose of psilocybin along with psychotherapeutic support, which includes preparation and integration sessions surrounding the experience. There will be a follow-up period of one month following the psilocybin session during which a range of psychological measures (questionnaires and interviews) will be collected.", "journal": "ClinicalTrials.gov", "publication_date": "2022-07-24", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04661514", "keywords": "Anorexia Nervosa, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04661514\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Addiction,Eating Disorders,Clinical Trial,Safety,Adverse Events", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3653, "title": "Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults", "normalized_title": "randomized double blind placebo controlled assessing the efficacy of micro dosed psilocybin in reducing anxiety and or depression levels in adults", "authors": "Wake Network, Inc.", "abstract": "To investigate the efficacy of a 16 week treatment with PSIL428 patient reported anxiety levels in otherwise healthy individuals suffering from depression and or anxiety symptoms. Randomized, double-blind, placebo-controlled study assessing the efficacy of micro-dosed psilocybin on reducing anxiety and/or depression levels in adults Study summary: The Institute for Health Metrics and Evaluation reported that Anxiety disorders currently affect an estimated 275 million people worldwide, about one in 13 people (7.3 percent). COVID-19 has accelerated the rate of new anxiety diagnoses and exacerbated pre-existing diagnoses of anxiety in individuals worldwide. The effectiveness of full dose psilocybin for treatment of anxiety and depression has been shown in a number of clinical trials. While there is a significant evidence of clinical efficacy of full dose psilocybin, acute effects of the dose result in a significant impairment - perceptual and sensory distortions incapacitating the patient for the duration of drug activity. Recent work suggests while not producing perceptual changes, micro-dosing may indeed be associated with improved mood and enhanced well-being. The practice of micro-dosing is gaining popularity in the general population, while clinical data on its safety and efficacy is lacking. This will be a novel randomized, double-blind, placebo-controlled study aimed at establishment of safety and anxiolytic efficacy of psilocybin PSIL428 administered in a micro-dosing regimen (2-5% of a full therapeutic dose) to adults suffering from depression or anxiety. The primary outcome of this study is the change in anxiety and/or depression levels from screening to week 16. Participant anxiety levels will be monitored through Beck Anxiety inventory, depression levels - through Beck Depression Inventory forms on a bi-weekly basis across the course of the study. Study Drug PSIL428 is an experimental intervention and the active ingredient psilocybin is botanically derived. Similar interventions are currently undergoing Phase IIb/III clinical trials in international jurisdictions. It is being assessed for treatment of depressive disorders. Typically psilocybin used in full therapeutic doses associated with significant acute adverse effects. The proposed trial would utilize psilocybin in different dosing regimen - as micro-dosing - ingesting of sub-perceptual doses of the drug equal to 2-10% of the full dose. The micro-dosing practice is gaining significant popularity world-wide, however evidence-based data around it is minimal. Risks and benefits associated with the trial are not definitively established, however existing pre-clinical and clinical data around full-dose use of the drug carries a favorable risk-benefit potential. The trial will be conducted in accordance with the most recently acceptable version of the Declaration of Helsinki, Good Clinical Practice (GCP) according to International Conference on Harmonization (ICH) guidelines, and applicable Standard Operating Procedures (SOPs). The trial will be conducted under a protocol reviewed and approved by an IRB; the trial will be conducted by scientifically and medically qualified persons; the benefits of the study are in proportion to the risks; the rights and welfare of the subjects will be respected; each subject will give his or her written informed consent before any protocol-driven tests or evaluations are performed. The investigators are responsible for obtaining informed consent in adherence to GCP and according to applicable regulations prior to entering the subject into the trial. A positive change in Beck Anxiety and/or Beck Depression numeric levels between PSIL428 and placebo groups will mark our primary outcome achievement of confirming beneficial effects of micro-dose-administered psilocybin on study participants' overall anxiety and/or depression levels", "journal": "ClinicalTrials.gov", "publication_date": "2022-06-29", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04989972", "keywords": "Anxiety and Depression, PSIL428, Oyster mushroom, WITHDRAWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT04989972\",\"overall_status\":\"WITHDRAWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Wellbeing,Clinical Trial,Review Article,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3676, "title": "Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression", "normalized_title": "psilocybin versus ketamine fast acting antidepressant strategies in treatment resistant depression", "authors": "National Institute of Mental Health, Czech Republic", "abstract": "The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients with TRD versus the antidepressant inactive substance midazolam. The primary endpoint will be the antidepressant effect on the Montgomery- Asberg Depression Rating Scale (MADRS) 24 hours after treatment, the key secondary endpoints being the duration of antidepressant effect, the number of responses and remissions, and the time to standard antidepressant treatment during 3 months of observation. The exploratory part of the study aims to monitor changes in the functional brain states using simultaneous EEG / fMRI, before treatment versus 1 day and 1 week after. Based on literature data and recent data from healthy volunteers who participated in a previous study with psilocybin, the investigator will correlate antidepressant effects of drugs (using psychometric scales and reactions to emotionally salient stimuli (eye tracker)) with entropy and functional connectivity measures. Finally the investigator will explore the role of plasmatic neurobiological biomarkers in depression (BDNF, prolactin, ACTH and oxytocin). The main aim of the study is to verify the efficacy and safety of a single dose of psilocybin 20 mg in the treatment of TRD in adults in a randomized clinical trial with active comparator ketamine 200 mg (rapid onset acting antidepressant) and negative control midazolam 5 mg (drug with no antidepressant properties). Primary objective: 1) verification of the rapid antidepressant effect of psilocybin compared to ketamine using the MADRS scale at 24 hours. Secondary objectives: 1) on days 3, 7 and 14 and 3, 4, 5, 6, 8 and 12 weeks after application of the substances, evaluate / compare: a) the duration of effects of both substances using the MADRS scale b) antidepressant effects according to the subjective evaluation of patients - QIDS scale. c) response rate (50% reduction on the MADRS scale) and remission (MADRS? 10). 2) time to return of depressive symptoms defined according to the criteria for the use of antidepressants within 12 weeks 3) safety profile of study medication Exploratory objectives: 1) Evaluate the antidepressant effect depending on: a) the intensity of acute psychological effects assessed using the subjective scale of 5D-ASCs and the objective scale of BPRS, b) depending on the retrospective assessment of persistent effects using the Persisting effects scale, c) the degree of eye contact with negative and neutral emotion faces measured by eye-tracking before and after treatment (on days 1 and 7). 2) To evaluate the neurobiology of the antidepressant effect in relation to: a) plasma levels of the major metabolite of psilocin, markers of neuroplasticity, antidepressant effect and stress (BDNF, prolactin, oxytocin, ACTH) at 90 min, 3, and 6 h after administration of study medication compared to pre-administration levels, b) changes in resting-state brain activity (connectivity, entropy) measured by simultaneous EEG / fMRI functional imaging methods before and after 1 and 7 days after treatment.", "journal": "ClinicalTrials.gov", "publication_date": "2022-05-19", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05383313", "keywords": "Treatment Resistant Depression, Psilocybin, Ketamine Hydrochloride, Midazolam Ph. Eur 9.0, UNKNOWN", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05383313\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Neuroplasticity,Brain Imaging,Biomarkers,Aging,Emotional Processing,Clinical Trial,Healthy Volunteers,Treatment-Resistant Depression,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3659, "title": "Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression", "normalized_title": "phase ii randomized double blind placebo controlled parallel group single center study of psilocybin efficacy in major depression", "authors": "University of Zurich", "abstract": "Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study Major depressive disorder (MDD) is one of the world's greatest contributor to the global burden of disease and MDD affects around 17% of the Swiss population (Tomonaga et al. 2013). It is a chronic condition and can cause the affected person to suffer greatly and function poorly at work, at school and in the family. More than 1'000 suicides were recorded in Switzerland in 2014, about 90% of these fatalities were related to depression or other psychiatric problems. Suicide is the second leading cause of death in individuals 15-24 years of age (Insel \\& Charney 2003). Current pharmacotherapies, including monoaminergic-acting antidepressants, require prolonged administration (weeks if not months) for clinical improvement. This lag time, as well as a high non-response rate, emphasizes the need for better and faster-acting antidepressant medications. However, psychopharmacological research has largely failed to produce novel and more efficacious treatment options for MDD since decades. Advanced pharmaceutical antidepressants should ideally facilitate the psychotherapeutic process for patients, reduce the time onset of antidepressant efficacy, and prime neuroplastic adaptations relevant to symptom improvement. Such novel therapeutics are much needed and would address this detrimental public health problem, particularly in treatment-resistant patients. Early clinical studies using the psychotropic compound psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine) as an adjunct in psychotherapy reported a significant improvement of clinical symptoms in depression and anxiety disorder (Leuner 1961, 1981). Psilocybin is the main psychoactive principle of the group of hallucinogenic fungi (Hofmann 1968), commonly known as magic mushrooms, and acts as partial agonist at cortical and sub-cortical serotonin 5-HT2A and 5-HT1A receptors. At moderate doses, psilocybin produces a dream-like state of consciousness (Kraehenmann et al. 2016) characterized by perceptual alterations, enhanced mood, facilitated autobiographic memory recollection, and a change of perspective on the self (Leuner 1981; Studerus et al. 2011). Recent clinical studies applying placebo-controlled designs support and extend these early findings by showing that a single dose of psilocybin leads to a fast and sustained reduction in anxiety and depression as well as an improvement of quality of life in advanced cancer patients (Griffiths 2015, Grob et al. 2011). Furthermore, a recent open-label feasibility study showed rapid-onset, sustained symptom improvements over 3 weeks in a small sample of treatment-resistant depressed patients following two psilocybin treatment sessions (Carhart-Harris et al. 2016). Accumulating evidence from pharmacological and neuroimaging studies suggests that psilocybin may produce its antidepressant effects via activation of 5-HT2A receptors located in prefrontal-limbic structures that are also implicated in the pathophysiology of depression (Kraehenmann \\& Vollenweider et al. 2015; Vollenweider und Kometer 2010; Disner et al. 2011). In addition, molecular studies suggest that the enduring symptom improvement after a single dose of psilocybin may be mediated through downstream effects on the glutamate system and a subsequent activation of neuroplastic factors such as brain-derived neurotrophic factor (BDNF) (Catlow et al. 2013, Barre et al. 2016). The present clinical trial aims at investigating the putative antidepressant effects of a single moderate dose of psilocybin (0.215 mg/kg) in patients suffering from MDD by applying a randomized, double-blind, placebo-controlled design. The specific aims of this project are: 1. To investigate whether psilocybin in combination with short-term focused psychotherapy will reduce core symptoms in patients with MDD. 2. Using functional magnetic resonance imaging (fMRI) to longitudinally assess whether a single dose of psilocybin will post-acutely change the negative emotion processing bias in patients with MDD and whether the change in emotion processing bias will predict subsequent symptom improvement. In addition, the investigators will analyze whether psilocybin will lead to sustained changes in functional neuronal network connectivity (FC), e.g. in amygdala-prefrontal FC. 3. To investigate whether psilocybin will increase BDNF plasma concentration and whether the change in BDNF is related to changes in fMRI markers and the subsequent mood improvement. Recent reviews indicate that impaired neuroplasticity is at the core of the pathophysiology moods and stress-related disorders. Current available antidepressants have been developed with the aim of providing symptom relief rather than targeting neuroplastic impairments. In contrast to this, the present proposal builds on promising new findings that single dose of psilocybin, presumably via a 5-HT2A receptor driven glutamatergic mechanism, leads to a rapid enhancement in neuronal resilience and a to a change in the function of neuronal networks underlying depressive symptoms and behavior. Targeting neuroplasticity with such novel approaches appears to be important for reversing cognitive schemata and emotion processing biases, fostering enduring improvements in mood and cognitive flexibility (Krystal et al. 2009). Expected value: this is the first randomized, double-blind, placebo-controlled clinical trial (RCT) of psilocybin treatment in MDD. Using state-of-the art behavioral, neuroimaging, and neuroplasticity methodology, the results of this study will help elucidate urgently needed new treatment mechanisms in MDD. Should it turn out that a single moderate dose of psilocybin vs. placebo in conjunction with psychotherapy may rapidly and sustainedly reduce depressive symptoms, this will be a major breakthrough in finding a novel and fast acting treatment strategy in depressed patients. Therefore, the results of this study will have high impact on the field of pharmacological research into novel antidepressant medication.", "journal": "ClinicalTrials.gov", "publication_date": "2022-04-28", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03715127", "keywords": "Depressive Disorder, Major, Psilocybine oral capsule, Placebo oral capsule, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03715127\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Neuroplasticity,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Consciousness,Biomarkers,Aging,Resilience,Emotional Processing,Clinical Trial,Randomized Controlled Trial,Review Article,Cancer Patients", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3508, "title": "A Randomized Controlled Trial of the Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion", "normalized_title": "a randomized controlled trial of the effects of psilocybin facilitated experience on the psychology and effectiveness of professional leaders in religion", "authors": "NYU Langone Health", "abstract": "The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders. We hypothesize that religious professionals, given their interests, training, and life experience, will be able to make nuanced discriminations of their psilocybin experiences, thus contributing to the scientific understanding of mystical-type experience. As we better characterize the phenomenology of psilocybin-induced mystical experiences, we may apply this knowledge to improve potential treatment studies in the future. A primary objective is to investigate changes in psychological functioning, spirituality, health, well-being, prosocial attitudes and behavior in professional religious leaders that may occur after receiving psilocybin under supportive conditions. A secondary objective is to determine whether participants who report having had the strongest mystical-type effects during psilocybin sessions will show the largest positive changes in the Interim Questionnaire. This randomized-controlled pilot study uses a wait-list control design. A wait-list design includes a control group that is assigned to a waiting list to receive an intervention after the active treatment group does. In this study, the active group will receive the psilocybin at weeks 5 and 9 and the wait-list control group will receive psilocybin at weeks 30 and 34. The wait-list control group serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the wait-list participants an opportunity to obtain the intervention at a later date. This study's procedures include screening, preparatory meetings, psilocybin sessions, and follow-up assessments. A large battery of behavioral and psychological measures will be assessed throughout. The study team will consent and enroll up to 86 subjects to obtain a total of 12 completer participants as well as 2-3 family members or friends per study participant who can assess said completers on the Observer Rating Form (COM-R). This number will account for screen-failures and dropouts as well. The 12 participants will be randomly assigned to either an immediate participation group (N=6) or a 6-month delayed participation group (N=6). Although statistical power calculations show that 12 participants will be sufficient to detect the major effects anticipated in this study, the sponsor of this study (The Council on Spiritual Practices) is concurrently funding Johns Hopkins University School of Medicine to conduct a methodologically identical study with 12 additional participants (IND #59009). This will permit the two sites to collaborate post study completion and combine the data from the two studies to provide statistical power to detect even more subtle effects of the psilocybin intervention. Twelve volunteers (6 from each group) will participate at Johns Hopkins and 12 at New York University. Randomization and data analysis will be conducted at New York University.", "journal": "ClinicalTrials.gov", "publication_date": "2022-02-13", "publication_year": 2022, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02421263", "keywords": "Religious or Spiritual Problem, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02421263\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Wellbeing,Spirituality,Mystical Experience,Randomized Controlled Trial", "study_type": "Randomized Controlled Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3526, "title": "LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study", "normalized_title": "lsd treatment in persons suffering from anxiety symptoms in severe somatic diseases or in psychiatric anxiety disorders a randomized double blind placebo controlled phase ii study", "authors": "University Hospital, Basel, Switzerland", "abstract": "Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in experimental studies in healthy subjects and in the treatment for anxiety in patients with life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies are warranted. Similar studies have recently been completed with the hallucinogen psilocybin. Objective: To test the efficacy of LSD in patients with anxiety with or without life-threatening diseases. Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg) and two placebo sessions with subjects acting as their own control. Participants: 40 patients aged \\> 25 years with anxiety disorder (according to DSM-IV or a state-trait anxiety inventory score \\>40 in the STAI trait or state scale) with or without life-threatening illness. Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with placebo-assisted psychotherapy. Significance: Anxiety disorder (alone or in the context of life-threatening illness) is frequent and often insufficiently managed with available medications. This study will evaluate the potential benefits of single treatments with LSD in anxiety disorder.", "journal": "ClinicalTrials.gov", "publication_date": "2021-12-21", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03153579", "keywords": "Patients, Anxiety Disorders, LSD, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03153579\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,End-of-Life Distress,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3671, "title": "Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health", "normalized_title": "double blind placebo controlled naturalistic study of microdosing with psilocybin effects on brain activity behavior cognition creativity and mental health", "authors": "National Council of Scientific and Technical Research, Argentina", "abstract": "This study seeks to understand the neural, cognitive and behavioral effects of low doses of psilocybin administered in the form of dried mushroom material (0.5 g of Psilocybe cubensis) consumed in natural settings following a placebo-controlled double-blind experimental design. Sub-threshold doses of serotonergic psychedelics are frequently consumed as cognitive enhancers, and due to their purported positive effects on mood, energy and creativity (\"microdosing\"). The acute and short-term effects of psilocybin (the psychoactive compound of Psilocybe cubensis mushrooms) on several variables will be investigated, comprising spontaneous and evoked electrophysiological brain activity, perception and cognitive function (cognitive flexibility, attention, inhibitory control, conscious access, visual perception), creativity (problem solving, divergent and convergent thinking), behavior (actigraphy and sleep patterns, natural language production) and several domains related to well-being and mental health of the participants. This study is simultaneously naturalistic (i.e. recruited subjects are intrinsically motivated to microdose, as they have decided to embark in a microdosing protocol) and controlled by expectations, following a double-blind placebo-controlled design. Participants will microdose according to the following schedule: Two sessions (0.5 g dried Psilocybin mushrooms vs. dried edible mushroom material without psychoactive effects as a placebo condition) will be conducted. A third party will be in charge of generating their active dose and placebo capsules, and they will also implement a blinding procedure. Each session will span one week of measurements. Subjects will be given a smartwatch to monitor activity and sleeping patterns at the beginning of the week. At days 3 and 5, subjects will take capsules with active mushroom material or placebo, and then several variables will be recorded. Experiments will be conducted in a setting that is natural and comfortable for the participants, e.g. their homes. The main outcome measures consist of resting state activity recorded with EEG, evoked response potentials and performance during cognitive tasks, behavioral variables obtained with actigraphy and automated sleep scoring, natural language analysis, and several measurs self-reported via standarized questionnaires. After completion, this study will provide direct evidence concerning the efficacy of microdosing for cognitive enhancement under natural conditions, i.e. those most frequently used by individuals who microdose, as well as provide information concerning the potential underlying neurobiological mechanisms.", "journal": "ClinicalTrials.gov", "publication_date": "2021-12-15", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT05160220", "keywords": "Cognitive Change, Creativity, Mood Change, Sleep, Psilocybin, Placebo, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT05160220\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Microdosing,Wellbeing,Creativity", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3500, "title": "Effects of Psilocybin in Major Depressive Disorder", "normalized_title": "effects of psilocybin in major depressive disorder", "authors": "Johns Hopkins University", "abstract": "The proposed pilot study will assess whether people with major depressive disorder experience psychological and behavioral benefits and/or harms from psilocybin. This study will investigate acute and persisting effects of psilocybin on depressive symptoms and other moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid and sustained antidepressant response, as measured with standard depression rating scales.", "journal": "ClinicalTrials.gov", "publication_date": "2021-12-14", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03181529", "keywords": "Major Depressive Disorder, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03181529\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3459, "title": "The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder", "normalized_title": "the safety and efficacy of psilocybin in cancer patients with major depressive disorder", "authors": "Maryland Oncology Hematology, PA", "abstract": "This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm. MDD is defined as those who meet DSM5 diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the ICD-10. Recent randomized, placebo-controlled clinical trials of psilocybin therapy for anxiety and depression associated with cancer diagnosis showed significant improvement in study endpoints reflecting psychological distress, as compared to placebo. The effects of a single psilocybin therapy session endured for up to six months with no specific follow-up care. In this study, we aim to explore the safety and efficacy of psilocybin therapy in cancer patients, diagnosed with Major Depressive Disorder (MDD).", "journal": "ClinicalTrials.gov", "publication_date": "2021-10-14", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04593563", "keywords": "Major Depressive Disorder, Psilocybin, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04593563\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Clinical Trial,Cancer Patients,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3481, "title": "A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study", "normalized_title": "a randomised placebo controlled trial of psilocybin in treatment resistant depression a feasibility study", "authors": "King's College London", "abstract": "A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).", "journal": "ClinicalTrials.gov", "publication_date": "2021-07-21", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT04959253", "keywords": "Treatment Resistant Depression, Psilocybin assisted therapy, Placebo assisted therapy, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT04959253\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Clinical Trial,Safety", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3487, "title": "Characterization of Altered Waking States of Consciousness in Healthy Humans", "normalized_title": "characterization of altered waking states of consciousness in healthy humans", "authors": "University of Zurich", "abstract": "Altered waking states of consciousness and its underlying functional organization have gained increasing interest in recent years, i.e. in identifying the neural basis of consciousness. To overcome fundamental shortcomings of current methods to objectively assess the level of consciousness, the investigators propose here to apply a novel and empirically validated measure called 'perturbational complexity index' (PCI) based on the integrated information theory (IIT). This involves a combination of transcranial magnetic stimulation (TMS) and highdensity electroencephalography (hd-EEG) to measure electrocortical responses as distributed cerebral interactions ('integration') and spatiotemporal pattern ('information'). Given the finding of subjectively expanded consciousness as induced here by psilocybin, the investigators hypothesize that the PCI may be higher in such states. This will be the first TMS/hd-EEG study to investigate quantitatively the level of consciousness in a pharmacologically altered waking state of consciousness. In this study the investigators will apply navigated TMS/high-density(hd)-EEG to directly stimulate defined cortical areas and investigate quantitatively the level of consciousness in psilocybin-induced altered brain states. For this purpose, PCI is the primary outcome in psilocybin versus placebo condition. Given the findings and the subjective feeling of an 'expanded' consciousness in such states, the investigators primarily hypothesize that psilocybin will induce a higher PCI as compared to placebo in TMS/hd-EEG measurements over all targeted cortical areas in the acute phase of treatment (80 minutes after substance intake). Measurements will be done over the premotor cortex (Brodmann-Areal BA06), the midline sensorimotor cortex (BA04) and the superior occipital gyrus/cuneus (BA19) and may be related to the experience of an altered sense of self, e.g. measures of selflessness and egodissolution. This study further seeks to characterize the effects of psilocybin compared to placebo on resting state EEG. To this aim, the current source density and the lagged phase synchronization of neuronal oscillations across distributed brain regions will be computed and correlated to reproduce interesting results in a recent work of Kometer and colleagues. More specifically, psilocybin decreased the current source density of neuronal oscillations within a neural network comprising the anterior and posterior cingulate cortices and parahippocampal regions. Even more, psilocybin-induced insightfulness and spiritual experience correlated with the lagged phase synchronization of delta oscillations between the retrosplenial cortex, the parahippocampus and the lateral orbitofrontal area, showing evidence for a direct association of spatiotemporal neuronal mechanism with enhanced insight into life and existence. The investigators therefore hypothesize that current source density of neuronal oscillations within the cingulate cortices and the parahippocampal regions (1.5-20 Hz) will be decreased and the lagged-phase synchronization of delta oscillations (1.5-4 Hz) between the retrosplenial cortex, the parahippocampus and the lateral orbitofrontal area will be correlated to insightfulness. Additionally, psychometric assessment of the sense of self, of perceptual alterations and of mood will be conducted before and after each TMS session (Hood's Mysticism-Scale; 5-Dimensional Altered States of Consciousness Rating Scale; Positive and Negative Affect Schedule). the investigators expect to find a relationship between substance induced changes in perception and mood as indexed by these questionnaires. Furthermore, the investigators will be conducting a probabilistic learning task (emotLearn) to examine the computational processes behind the interaction between reward learning and subconscious versus conscious emotional processing to estimate how emotional stimuli affect the learning rate in psilocybin compared to placebo condition. The investigators hypothesize that psilocybin decreases the conscious and subconscious learning rate by attenuating the processing of emotional cues. The study design will be randomized, double-blind, placebo-controlled with one-time application of a single dose for each substance (moderate psilocybin dose of 20mg versus mannitol), within-subject and single center at the Psychiatrische Universitätsklinik Zurich. The number of participants is 25 healthy subjects as determined by power analysis. Inclusion criteria are healthy male or female volunteers aged 18-40 years. Exclusion criteria are personal and family history of major psychiatric disease (e.g. major depression, bipolar disorder, psychotic disorder) as defined in the DSM-V, any major medical condition (e.g. neurologic, cardiovascular, metabolic disease), family history of seizure disorder, current psychopharmacological treatment or pregnant respectively breastfeeding women. The study comprises a total of 3 visits in 3 weeks - 1 screening visit and 2 investigational visits and a written follow-up 12 weeks after the last investigational visit per participant. On the investigational visits participants will receive placebo or psilocybin in a randomized and counterbalanced order. The screening visit consists of a psychiatric assessment, physical examination, routine lab/toxicology, electrocardiogram (ECG), EEG and cranial T1 weighted magnetic resonance tomography (MRT). Study duration will be 2-3 years. The research project was approved by the local ethics committee (KEK Zurich) in December 2018 as \"Other clinical trial\" as specified in the \"Ordinance on Clinical Trials in Human Research\" (KlinV, Chapter 2) without health-related intervention or investigational Medical Product (IMP) \\[25\\], Category B.", "journal": "ClinicalTrials.gov", "publication_date": "2021-04-28", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03853577", "keywords": "Altered Waking States of Consciousness in Healthy Humans, TMS/EEG, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03853577\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Depression,Brain Imaging,Consciousness,Emotional Processing,Spirituality,Mystical Experience,Clinical Trial,Toxicity,Drug Interactions", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3441, "title": "Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects", "normalized_title": "direct comparison of altered states of consciousness induced by lsd and psilocybin in a random order placebo controlled cross over study in healthy subjects", "authors": "University Hospital, Basel, Switzerland", "abstract": "LSD (lysergic acid diethylamide) and psilocybin (the active substance in \"magic mushrooms\") are widely used for recreational purposes. Both substances are also increasingly used in psychiatric and psychological research to induce and investigate alterations in waking consciousness and associated brain functions (functional brain imaging, \"model psychosis\"). However, it has never been studied whether there are differences in the alterations in mind produced by these two substances. Both LSD and psilocybin are thought to induce hallucinations primarily via stimulation of the 5-HT2A receptor. However, there are differences in the receptor activation profiles between the two substances that may also induce different subjective effects. LSD potently stimulates the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and D1-3 receptors. Psilocin (the active metabolite of the prodrug psilocybin) also stimulates the 5-HT2A receptor but additionally inhibits the 5-HT transporter. In contrast to LSD, psilocybin has no affinity for D2 receptors. Both substances are used in neuroscience as pharmacological tools. However, there are no modern studies comparing these two substances directly within the same clinical study and research subjects and using validated psychometric tools. Therefore, the investigators will compare the acute effects of LSD, psilocybin and placebo.", "journal": "ClinicalTrials.gov", "publication_date": "2021-04-26", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03604744", "keywords": "Healthy, LSD, Psilocybin, COMPLETED", "substance_tags": "psilocybin,psilocin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03604744\",\"overall_status\":\"COMPLETED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Receptor Pharmacology,Consciousness,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3556, "title": "Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors", "normalized_title": "psilocybin assisted group therapy for demoralization in long term aids survivors", "authors": "Joshua Woolley", "abstract": "The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS). This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.", "journal": "ClinicalTrials.gov", "publication_date": "2021-01-06", "publication_year": 2021, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02950467", "keywords": "Distress, Depression, Grief, Psilocybin, 4-phosphoryloxy-N,N-dimethyltryptamine, Indocybin, Modified brief Supportive Expressive Group Therapy, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02950467\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,End-of-Life Distress", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3491, "title": "Effects of Serotonin Transporter Inhibition on the Subjective Response to Psilocybin in Healthy Subjects", "normalized_title": "effects of serotonin transporter inhibition on the subjective response to psilocybin in healthy subjects", "authors": "University Hospital, Basel, Switzerland", "abstract": "Psilocybin is a classic serotonergic hallucinogen acting on the 5-HT2A receptor. It is used recreationally and in psychiatric research. Selective serotonin reuptake inhibitors (SSRIs) like escitalopram are first-line treatments for depression. They inhibit the serotonin transporter (SERT). This might cause a possible downregulation of postsynaptic 5-HT receptors, e.g. the 5-HT2A receptor. The aim of the study is to investigate the effects of psilocybin after escitalopram and Placebo pretreatment. Subjective and physiological effects as well as effects on gene expression will be assessed. Psilocybin (the active substance in \"magic mushrooms\") is a classic serotonergic hallucinogen acting on the serotonin 5-HT2A receptor. Psilocybin is used recreationally and in psychiatric research. First studies suggest efficacy in psychiatric disorders, such as depression. SSRIs like escitalopram are currently among the first-line treatments of this disorder. Escitalopram acts as a serotonin transporter (SERT) inhibitor. However, the link between this mechanism and its positive effects on mood remains to be established. Several studies suggest a possible downregulation of postsynaptic serotonin (5-HT) receptors such as the 5-HT2A receptor. The aim of the study is to assess whether SERT inhibition reduces expression of the gene coding for the 5-HT2A receptor and the response to psilocybin. Participants will be treated with escitalopram (10 mg in the 1st and 20 mg in the 2nd week) or placebo for 14 days. Pretreatment is followed the first study day. A single dose of psilocybin (25 mg) will be administered. Primary study endpoint are the subjective effects on consciousness (measured by the 5D-ASC total score). Secondary study endpoints include additional psychological measurements, plasma concentrations of psilocybin and escitalopram, hydroxytryptamine receptor (HTR) gene expression, as well as some safety measures (autonomic effects, ECG). The washout between the first study day and the second pretreatment will be at least 2 days. In the second pretreatment period, participants will be treated with placebo or escitalopram (cross-over) for another 14 days. This is followed by the second study day and administration of psilocybin (25 mg). Based on a power analysis the sample size is 24 participants (12 female and 12 male).", "journal": "ClinicalTrials.gov", "publication_date": "2020-11-30", "publication_year": 2020, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03912974", "keywords": "Healthy, Escitalopram, Placebo oral capsule, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03912974\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Neuroplasticity,Receptor Pharmacology,Consciousness,Safety", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3448, "title": "Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self", "normalized_title": "beyond the self and back neuropharmacological mechanisms underlying the dissolution of the self", "authors": "University of Zurich", "abstract": "The aim of the study is to identify neural signatures, behavioral and phenomenological expressions of self-related processes including: sense of agency, semantic distinction between self and other, selflessness (altruism), social agency, embodied self (interoception), perceptual functioning of dissolved self including hallucinations and crossmodal processing, and finally the mystical type dissolution of the self. Four placebo-controlled, double blind sets of procedures using psilocybin with four independent study groups will be conducted. The number of subjects, testing procedures and dose of psilocybin for each group are as follows: group 1 (20 subjects, EEG, questionnaires, 0.200 mg/Kg body weight), group 2 (30 subjects, functional magnetic resonance imaging (fMRI), questionnaires, 0.200 mg/Kg body weight), group 3 (10 subjects, fMRI, questionnaires, 0.215 mg/Kg body weight), study group 4 (80 subjects, blood serum and saliva parameters, questionnaires, fMRI (only in 20 subjects from this group), 0.315 mg/Kg body weight). The groups 1, 2 and 3 involve healthy volunteers. The group 4 involves healthy volunteer long-term and short-term meditators during a 5-day group meditation retreat. Together, 140 subjects will participate in the study.", "journal": "ClinicalTrials.gov", "publication_date": "2020-11-03", "publication_year": 2020, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03736980", "keywords": "Healthy, Placebo, Psilocybine, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03736980\",\"overall_status\":\"COMPLETED\",\"phase\":[\"NA\"]}", "topic_tags": "Brain Imaging,Mechanism of Action,Aging,Mystical Experience,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3429, "title": "Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients", "normalized_title": "effects of psilocybin on anxiety and psychosocial distress in cancer patients", "authors": "NYU Langone Health", "abstract": "The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license. It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.", "journal": "ClinicalTrials.gov", "publication_date": "2020-10-19", "publication_year": 2020, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT00957359", "keywords": "Cancer, Psilocybin, 4-phosphoryloxy-N,N-dimethyltryptamine, Niacin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT00957359\",\"overall_status\":\"COMPLETED\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Depression,Anxiety,Chronic Pain,Mechanism of Action,Consciousness,Emotional Processing,Spirituality,Mystical Experience,Review Article,Cancer Patients,Safety", "study_type": "Review Article", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3451, "title": "Pharmacokinetics of Psilocybin in Normal Adult Volunteers", "normalized_title": "pharmacokinetics of psilocybin in normal adult volunteers", "authors": "University of Wisconsin, Madison", "abstract": "Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The study is performed in support of Phase II and Phase III studies of psilocybin for the treatment of refractory anxiety associated with incurable cancer, as well as other possible indications. Psilocybin is at present not an FDA-approved drug. The primary objective of this clinical trial is to determine the pharmacokinetics of an extemporaneous oral formulation of psilocybin in normal, healthy adults. This study is intended to add to the existing body of modern clinical research on psilocybin to support future multi-institutional Phase III clinical trials seeking to decrease anxiety and depression in patients with incurable cancer. The long-term goal of this research is to submit a successful new drug application for psilocybin to the FDA. Subjects will initially take one 0.3 mg/kg (approximately 20mg/70kg) oral dose of psilocybin to initiate an eight hour chaperoned outpatient experience. After eight hours of outpatient sampling, the subject will be transported across the street to the UW Institute for Clinical and Translational Research Clinical Research Unit (ICTR CRU) for an overnight stay and additional blood and urine sampling. Pre- and post-treatment psychologic preparation and debriefing interviews will be required. A minimum of four weeks after the first dose, the subject will receive a second oral dose of psilocybin at the higher dose of 0.45 mg/kg (approximately 30 mg/70 kg). This dosing will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours). A minimum of four weeks after the second dose, the subject will receive a third oral dose of psilocybin at the highest dose of 0.6 mg/kg (approximately 40 mg/70 kg). This dose will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours). 12-lead ECGs will be obtained at specified time points before and during each treatment period. Throughout the duration of drug action for each dose participants will be attended by two trained monitors, and a physician will available during the entire 24 hour treatment and sampling period. Subjects who have been administered the first dose but decline to receive any subsequent doses will remain evaluable. At that time their active study participation will end.", "journal": "ClinicalTrials.gov", "publication_date": "2020-04-14", "publication_year": 2020, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02163707", "keywords": "Healthy, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02163707\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Depression,Anxiety,Pharmacology,Clinical Trial", "study_type": "Clinical Trial", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3579, "title": "Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators", "normalized_title": "effects of psilocybin on behavior psychology and brain function in long term meditators", "authors": "Johns Hopkins University", "abstract": "This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning. This study will use questionnaires and functional magnetic resonance imaging (fMRI) to examine the acute and persisting effects of psilocybin on brain function, meditation, spirituality, and psychology. The majority of the study procedures -- including screening, preparatory meetings, placebo and psilocybin sessions, and a large battery of behavioral and psychological measures -- will be conducted at the investigator's laboratory at the Behavioral Pharmacology Research Unit (BPRU) on the Johns Hopkins Bayview campus. The brain imaging procedures will be conducted at F.M. Kirby Research Center at the Kennedy Krieger Institute (KKI).", "journal": "ClinicalTrials.gov", "publication_date": "2019-12-29", "publication_year": 2019, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02145091", "keywords": "Healthy, Moderately-high dose of psilocybin, O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine, Moderately-low dose of psilocybin, Very-low dose of psilocybin, Placebo, Lactose, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02145091\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Pharmacology,Aging,Wellbeing,Spirituality", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3504, "title": "Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin", "normalized_title": "measurement of persisting changes in emotional brain functioning produced by psilocybin", "authors": "Johns Hopkins University", "abstract": "The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin) leads to changes in emotion processing and neural circuitry that may predict repeated self-administration of this drug and underlie an atypical mechanism of abuse liability, which may vitally contribute to the understanding of the potential for abuse and the underlying mechanisms supporting abuse of classic hallucinogens.", "journal": "ClinicalTrials.gov", "publication_date": "2019-09-09", "publication_year": 2019, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT02971605", "keywords": "Healthy, Psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT02971605\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\",\"PHASE2\"]}", "topic_tags": "Mechanism of Action,Emotional Processing,Abuse Liability", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3583, "title": "A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.", "normalized_title": "a randomised balanced double blind two way crossover design study to evaluate the effects of src kinase inhibitor saracatinib on brain activity associated with visual processing in patients with parkinson s disease psychosis", "authors": "King's College London", "abstract": "Parkinson's disease is often characterised by movement symptoms such as rigidity and bradykinesia, however, there are a number of non-motor symptoms that can have a significant impact on quality of life. One of the most common non-motor symptoms of Parkinson's disease is visual hallucinations (where someone sees things that don't exist outside their mind).. Recent findings led to the approval of a drug called Pimavanserin as a treatment for PD psychosis in the USA. Based on other recent studies, we believe that Saracatinib, a drug that interacts within the same system as Pimavanserin, is a potential treatment for PD psychosis. Saracatinib has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms) and attenuate social cognition and brain changes in healthy volunteers. The aim of this study is to test the effects of 14 days dosing of saracatinib or placebo on 30 volunteers with PD psychosis. We aim to to use neuroimaging combined with psychopharmacology to provide evidence that a putative new treatment approach can modulate abnormal visual cortex activation in patients with PD psychosis. If positive, this proof of mechanism study would provide a strong platform to pursue symptom modification studies with Saracatinib. Parkinson's disease (PD) is a neurodegenerative condition which has a 1% prevalence in the over 60s and also affects young adults. As well as motor symptoms such as akinesia or rigidity, many patients also experience non-motor symptoms of which psychosis is the most common (Chang and Fox, 2016). Current treatments for Parkinson's disease psychosis include atypical antipsychotics such as quetiapine, clozapine and pimavanserin (a 5-HT2a inverse agonist). Pimavanserin has recently been approved in the USA as a PD psychosis treatment; it has been shown to have an overall effect on reducing hallucinations as a whole, but not on visual hallucinations specifically. Functional neuroimaging evidence confirms dysfunctional ventral visual pathway activity in PD psychosis with altered metabolism, blood flow and brain activation following visual stimulation (Chang and Fox, 2016). Outside of the ventral visual pathways, two imaging studies in PD patients with visual hallucinations have shown altered connectivity within the default mode network, a brain system implicated in many neuropsychiatric conditions, pointing to more widespread abnormalities (Chang and Fox, 2016). Structural imaging studies show some atrophy within the ventral visual pathways, but also implicates brain regions outside of visual processing areas, including parietal, frontal, and cerebellar and hippocampal regions (Ffytche et al., 2017). Moreover, even though the serotoninergic dysfunction underpinning Parkinson's disease psychosis is not fully understood, animal studies with psychedelics have pointed to the dimerisation of the 5-HT2A and mGlu2 receptors and the over recruitment of specific downstream signalling pathways. Src kinase inhibition is a potential mechanism for blocking the hallucinogenic effects of 5-HT2A receptor agonism. Src kinase inhibitor, Saracatinib, has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms (Byock, 2018)) and attenuate social cognition and brain changes in healthy volunteers. We will test the effects of Saracatinib on brain activity associated with visual processing using a visual processing task, known to be sensitive to 5-HT2a receptor stimulation in previous studies with psilocybin (Carter et al., 2004), and a visual recognition task (Meppelink et al., 2009) with known sensitivity to PD psychosis, both scanned using the latest implementation of multi-echo blood oxygen level dependent (BOLD) functional Magnetic Resonance Imaging (fMRI). We aim to conduct a double-blind crossover design study, looking at the effects of Saracatinib and placebo treatment on 26 patients who have PD with psychosis. Existing data shows that 10 days of dosing with Saracatinib will achieve a steady state level that is known to be well tolerated in people with Alzheimer's disease (Nygaard et al., 2015). Therefore, participants will be given an oral dose of 100mg of Saracatinib or placebo as two 50mg tablets to be taken once daily for 14 days. Participants will return to the clinic on day 14 for their final dose of Saracatinib or placebo, fMRI and EEG scans, cognitive assessments, physical examination and blood screen. The participants will then move onto the second treatment arm where they will receive a further 14 days of dosing with saracatinib or placebo depending on the group they were in for the first treatment arm. There will be a minimum 2-week washout between treatment arms to avoid potential carry over effects.", "journal": "ClinicalTrials.gov", "publication_date": "2019-08-12", "publication_year": 2019, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03661125", "keywords": "Parkinson Disease Psychosis, Saracatinib, Placebo Oral Tablet, UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT03661125\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"EARLY_PHASE1\"]}", "topic_tags": "Brain Imaging,Pharmacology,Mechanism of Action,Receptor Pharmacology,Default Mode Network,Aging,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3553, "title": "Psychopharmacology of Psilocybin in Cancer Patients", "normalized_title": "psychopharmacology of psilocybin in cancer patients", "authors": "Johns Hopkins University", "abstract": "This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes. An earlier study that was done in our lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. This study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 80 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.", "journal": "ClinicalTrials.gov", "publication_date": "2018-07-18", "publication_year": 2018, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT00465595", "keywords": "Depressive Symptoms, Anxiety, Cancer, psilocybin, O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT00465595\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Anxiety,Pharmacology,Consciousness,Spirituality,Healthy Volunteers,Cancer Patients", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3631, "title": "Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression", "normalized_title": "psilocybin and depression assessing the long term effects of a single administration of psilocybin on the psychiatric symptoms and brain activity of patients with severe depression", "authors": "University of Helsinki", "abstract": "The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.", "journal": "ClinicalTrials.gov", "publication_date": "2017-12-20", "publication_year": 2017, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT03380442", "keywords": "Severe Depression, Psilocybin, Ketamine (Ketalar), UNKNOWN", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT03380442\",\"overall_status\":\"UNKNOWN\",\"phase\":[\"PHASE2\"]}", "topic_tags": "Depression,Brain Imaging,Mechanism of Action,Biomarkers,Aging,Emotional Processing", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3628, "title": "Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior", "normalized_title": "effects of psilocybin and spiritual practice on persisting changes in attitudes and behavior", "authors": "Johns Hopkins University", "abstract": "This study will investigate the effects of psilocybin dose and the frequency and intensity of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program of spiritual practices with the intention applying spiritual insights and knowledge to everyday life. After screening and study enrollment, each volunteer will be assigned to one of five groups that vary in dose, frequency and intensity of support for spiritual practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They will be told that each participant will receive 2 or more dose levels of psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in which he or she receives a moderately high or high dose of psilocybin. The duration of each volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive several hours of preparation with the study guides in the month prior to the first psilocybin session; the first two sessions will be separated by one month. Various measures will be assessed before, during and immediately after sessions. A battery of longitudinal measures will be evaluated immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months after the second psilocybin session (6 months after study enrollment). For purposes of controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will not know which volunteers or how many volunteers will be scheduled for a third session.", "journal": "ClinicalTrials.gov", "publication_date": "2016-02-23", "publication_year": 2016, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT00802282", "keywords": "Healthy, psilocybin, Intensity of support for spiritual practice, Number of sessions, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:28", "last_checked": "2026-07-01 11:22:34", "raw_json": "{\"nct_id\":\"NCT00802282\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Spirituality,Healthy Volunteers", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" }, { "id": 3484, "title": "Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators", "normalized_title": "pilot study effects of psilocybin on behavior psychology and brain function in long term meditators", "authors": "Johns Hopkins University", "abstract": "This is a pilot study to finalize methods for a larger study being planned for the future. This research is being done to characterize performance of tasks, brain functioning, and the effects of psilocybin in individuals with a long-term meditation practice. There are three different parts of the pilot study: 1. Effects of psilocybin on psychological function: This version of the pilot study will involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus). 2. Performance on behavioral and cognitive tasks: This version of the pilot study will involve completing various behavioral and cognitive tasks at our research unit. You will make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus). 3. Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI) measurements. You will make a total of about 2 to 5 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the Johns Hopkins Hospital). People who are between the ages of 25 and 80 years old, who have a current, regular meditation practice, and who meet the medical requirements may join.", "journal": "ClinicalTrials.gov", "publication_date": "2014-05-19", "publication_year": 2014, "doi": null, "pubmed_id": null, "source_url": "https://clinicaltrials.gov/study/NCT01988311", "keywords": "Psilocybin, Hallucinogens, Pharmacologic Actions, Central Nervous System Agents, Therapeutic Uses, Psychotropic Drugs, psilocybin, COMPLETED", "substance_tags": "psilocybin", "source_name": "ClinicalTrials.gov", "date_added": "2026-07-01 11:04:27", "last_checked": "2026-07-01 11:22:33", "raw_json": "{\"nct_id\":\"NCT01988311\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}", "topic_tags": "Brain Imaging,Aging", "study_type": "Other", "hidden": 0, "false_positive": 0, "curation_notes": null, "merged_into_id": null, "curation_locked": 0, "publication_status": "clinical trial" } ] }