{"rows":[{"id":1922,"title":"Phase 1 trial suggests benefit of psilocybin in OCD treatment","normalized_title":"phase 1 trial suggests benefit of psilocybin in ocd treatment","authors":"","abstract":"A Phase 1 trial comprising 15 patients has found that repeated high-dose administration of psilocybin was more effective than low-dose psilocybin or placebo in reducing symptoms of obsessive-compulsive disorder (OCD). Psilocybin was generally well-tolerated, with no reports of serious adverse events.","journal":"The Brown University Psychopharmacology Update","publication_date":"2026-07-31","publication_year":2026,"doi":"10.1002/pu.31474","pubmed_id":null,"source_url":"https://doi.org/10.1002/pu.31474","keywords":"","substance_tags":"psilocybin","source_name":"Crossref","date_added":"2026-07-01 06:49:23","last_checked":"2026-07-05 01:20:21","raw_json":"{\"doi\":\"10.1002/pu.31474\",\"reference_dois\":[],\"reference_count\":0,\"openalex_enrichment\":{\"openalex_id\":\"https://openalex.org/W7166436628\",\"openalex_url\":\"https://openalex.org/W7166436628\",\"openalex_relevance_score\":9,\"openalex_relevance_reasons\":[\"title:psilocybin\",\"abstract:psilocybin\",\"metadata:psilocybin\"],\"openalex_type\":\"article\",\"openalex_work_type\":null,\"cited_by_count\":0,\"referenced_works\":[],\"authorships\":[],\"primary_location\":{\"source_id\":\"https://openalex.org/S1022177896\",\"source_display_name\":\"The Brown University Psychopharmacology Update\",\"landing_page_url\":\"https://doi.org/10.1002/pu.31474\",\"is_oa\":false}}}","topic_tags":"OCD,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":"published","openalex_id":"https://openalex.org/W7166436628"},{"id":5676,"title":"Psilocybin therapy for adult females with anorexia nervosa: pilot study.","normalized_title":"psilocybin therapy for adult females with anorexia nervosa pilot study","authors":"Douglass HM, Spriggs MJ, Godfrey K, Danby JL, de Magalhaes FJC, Macdonald L, Alderton KL, Archer S, Ahmad K, Martell J, Frias JT, Sawicka G, Read T, Blemings A, Lafrance A, Nicholls D, Erritzoe D, Park RJ, Nutt DJ, Carhart-Harris RL.","abstract":"BackgroundAnorexia nervosa is a debilitating eating disorder with high mortality and chronicity rates owing to the paucity of effective existing treatments. Several clinical trials using psilocybin therapy have demonstrated therapeutic efficacy and safety in psychiatric conditions, including anorexia nervosa.AimsThis study aimed to further assess the safety, feasibility and potential efficacy of psilocybin therapy in anorexia nervosa.MethodThis single-blind, within-individual pilot study recruited 21 females with anorexia nervosa, who underwent three dosing sessions with oral psilocybin (COMP360) over 6 weeks in a fixed order (1 mg, 25 mg, 25 mg), alongside talk therapy and adjunctive to treatment as usual. Adverse events were monitored throughout the study. Primary clinical outcome measures were global Eating Disorder Examination Interview (EDE) and Readiness and Motivation Questionnaire (RMQ) precontemplation scores. Primary time points for the EDE were the 6-week final visit, 3-month follow-up and 6-month follow-up; and for the RMQ, they were the 6-week final visit and comparison between dosing days. Global EDE Questionnaire scores were a key secondary outcome. Key time points were the 6-week final visit and comparison between dosing days. There was a 12-month remote follow-up.ResultsPsilocybin was well tolerated by all participants. The most common adverse events were headache, nausea and dizziness. Two serious adverse events (suicide attempts) were reported for one participant within the 6-12-month period. Relative to baseline, participants displayed significant improvements in their eating disorder symptoms (EDE scores: p < 0.0001, d = 0.98, 6 months) and motivation to change (RMQ scores: p = 0.0017, d = 0.65, 12 months). However, there was a large variation in improvement and maintenance during the follow-up.ConclusionsThis study further provides preliminary support for the feasibility, safety and potential efficacy of this intervention to treat adult females with anorexia nervosa, and warrants further investigation in larger and more rigorously designed studies.","journal":"The British Journal of Psychiatry","publication_date":"2026-07-07","publication_year":2026,"doi":"10.1192/bjp.2026.10687","pubmed_id":"42414058","source_url":"https://doi.org/10.1192/bjp.2026.10687","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-08 01:20:22","last_checked":"2026-07-09 01:20:15","raw_json":"{\"europe_pmc_id\":\"42414058\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe PMC\",\"openalex_enrichment\":{\"openalex_id\":\"https://openalex.org/W7167587921\",\"openalex_url\":\"https://openalex.org/W7167587921\",\"openalex_relevance_score\":11,\"openalex_relevance_reasons\":[\"title:psilocybin\",\"abstract:psilocybin\",\"metadata:psilocybin\",\"compound:comp360\"],\"openalex_type\":\"article\",\"openalex_work_type\":null,\"cited_by_count\":0,\"referenced_works\":[\"https://openalex.org/W1539080424\",\"https://openalex.org/W1554763052\",\"https://openalex.org/W1994387760\",\"https://openalex.org/W2001008250\",\"https://openalex.org/W2001060580\",\"https://openalex.org/W2055312975\",\"https://openalex.org/W2070836248\",\"https://openalex.org/W2093980670\",\"https://openalex.org/W2108143240\",\"https://openalex.org/W2564469912\",\"https://openalex.org/W2619816586\",\"https://openalex.org/W2753989225\",\"https://openalex.org/W2777124046\",\"https://openalex.org/W2883430979\",\"https://openalex.org/W2901877120\",\"https://openalex.org/W2998935314\",\"https://openalex.org/W3046100757\",\"https://openalex.org/W3080226154\",\"https://openalex.org/W3083797211\",\"https://openalex.org/W3087074748\",\"https://openalex.org/W3153606049\",\"https://openalex.org/W3164618783\",\"https://openalex.org/W3205506305\",\"https://openalex.org/W4221114092\",\"https://openalex.org/W4361279088\",\"https://openalex.org/W4379967727\",\"https://openalex.org/W4385197359\",\"https://openalex.org/W4387026668\",\"https://openalex.org/W4387674199\",\"https://openalex.org/W4394693583\",\"https://openalex.org/W4395110324\"],\"authorships\":[{\"id\":\"https://openalex.org/A5031966441\",\"display_name\":\"Hannah Douglass\",\"orcid\":\"https://orcid.org/0000-0002-4033-385X\"},{\"id\":\"https://openalex.org/A5140199765\",\"display_name\":\"Meg J. Spriggs\",\"orcid\":null},{\"id\":\"https://openalex.org/A5121806282\",\"display_name\":\"K. Godfrey\",\"orcid\":null},{\"id\":\"https://openalex.org/A5046578118\",\"display_name\":\"Jennifer L. Danby\",\"orcid\":null},{\"id\":\"https://openalex.org/A5140220796\",\"display_name\":\"Frederico J. C. de Magalhaes\",\"orcid\":null},{\"id\":\"https://openalex.org/A5109728412\",\"display_name\":\"Lauren Macdonald\",\"orcid\":null},{\"id\":\"https://openalex.org/A5008058826\",\"display_name\":\"Kirsty L. Alderton\",\"orcid\":null},{\"id\":\"https://openalex.org/A5140174385\",\"display_name\":\"Stephanie Archer\",\"orcid\":null},{\"id\":\"https://openalex.org/A5100595075\",\"display_name\":\"Kirran Ahmad\",\"orcid\":null},{\"id\":\"https://openalex.org/A5036560266\",\"display_name\":\"Jonny Martell\",\"orcid\":\"https://orcid.org/0000-0002-4194-7669\"},{\"id\":\"https://openalex.org/A5140192900\",\"display_name\":\"Jennifer T. Frias\",\"orcid\":null},{\"id\":\"https://openalex.org/A5115003013\",\"display_name\":\"Gabriela Sawicka\",\"orcid\":null},{\"id\":\"https://openalex.org/A5104065435\",\"display_name\":\"Tim Read\",\"orcid\":null},{\"id\":\"https://openalex.org/A5048534479\",\"display_name\":\"Allan Blemings\",\"orcid\":null},{\"id\":\"https://openalex.org/A5035542356\",\"display_name\":\"Adèle Lafrance\",\"orcid\":\"https://orcid.org/0000-0002-4935-7786\"},{\"id\":\"https://openalex.org/A5030053635\",\"display_name\":\"Dasha Nicholls\",\"orcid\":\"https://orcid.org/0000-0001-7257-6605\"},{\"id\":\"https://openalex.org/A5044907549\",\"display_name\":\"David Erritzøe\",\"orcid\":\"https://orcid.org/0000-0002-7022-6211\"},{\"id\":\"https://openalex.org/A5005010143\",\"display_name\":\"Rebecca J. Park\",\"orcid\":\"https://orcid.org/0000-0002-8611-4409\"},{\"id\":\"https://openalex.org/A5016082897\",\"display_name\":\"David Nutt\",\"orcid\":\"https://orcid.org/0000-0002-1286-1401\"},{\"id\":\"https://openalex.org/A5140218191\",\"display_name\":\"Robin L. Carhart-Harris\",\"orcid\":null}],\"primary_location\":{\"source_id\":\"https://openalex.org/S127936299\",\"source_display_name\":\"The British Journal of Psychiatry\",\"landing_page_url\":\"https://doi.org/10.1192/bjp.2026.10687\",\"is_oa\":false}}}","topic_tags":"Eating Disorders,Headache / Migraine,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":"published","openalex_id":"https://openalex.org/W7167587921"},{"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":"2026-07-06","publication_year":2026,"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":"2026-07-09 01:22:31","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","openalex_id":null},{"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":"2026-07-06","publication_year":2026,"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":"2026-07-09 01:22:31","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","openalex_id":null},{"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":"2026-07-05","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":"2026-07-09 01:22:31","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","openalex_id":null},{"id":3976,"title":"Psilocybin as a Transdiagnostic Treatment for Eating Disorders and Comorbid Psychopathology: Implications for Clinical Nosology and Research Directions.","normalized_title":"psilocybin as a transdiagnostic treatment for eating disorders and comorbid psychopathology implications for clinical nosology and research directions","authors":"Koning E, Richard J, Keshen A.","abstract":"ObjectiveEating disorders (EDs) are characterized by high rates of psychiatric comorbidity and suboptimal treatment outcomes. There remain critical gaps in research, including the exploration of effective transdiagnostic interventions. This forum article examines the potential of psilocybin treatment (PT) as a transdiagnostic intervention for EDs and common comorbidities, including the implications for alternative nosological frameworks, trial design, and clinical care.MethodA narrative review was conducted synthesizing clinical, mechanistic, and conceptual literature on PT for EDs and common psychiatric comorbidities. Searches of academic databases were supplemented by hand-searching and clinical trial registries. Thematic synthesis focused on transdiagnostic clinical evidence, mechanistic theories, and implications for the Hierarchical Taxonomy of Psychopathology (HiTOP), Research Domain Criteria (RDoC), treatment development, and clinical trial design.ResultsPreliminary clinical evidence supports the feasibility, safety, and therapeutic effects of PT for EDs, with robust transdiagnostic effects observed across comorbid conditions. Proposed mechanisms (i.e., serotonergic receptor agonism, psychoplastogenic effects, neural network desynchronization) target shared vulnerabilities that map onto dimensional constructs in HiTOP (Emotional Dysfunction superspectrum, Internalizing spectrum) and RDoC (negative/positive valence, cognitive, and social process domains) nosologies. Future research should explore pragmatic trial designs and dimensional outcome measures to capture the real-world complexities of PT for EDs.DiscussionPT demonstrates transdiagnostic therapeutic potential for EDs, and the advancement of dimensional nosologies, complex intervention frameworks, and personalized treatment protocols may address existing gaps in research and clinical care.","journal":"International Journal of Eating Disorders","publication_date":"2026-07-01","publication_year":2026,"doi":"10.1002/eat.70164","pubmed_id":"42393007","source_url":"https://doi.org/10.1002/eat.70164","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-04 01:20:05","last_checked":"2026-07-09 01:20:16","raw_json":"{\"europe_pmc_id\":\"42393007\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe 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\":\"Elena Koning\",\"orcid\":\"https://orcid.org/0000-0001-5241-0288\"},{\"id\":\"https://openalex.org/A5006203775\",\"display_name\":\"Jérémie Richard\",\"orcid\":\"https://orcid.org/0000-0001-9893-1353\"},{\"id\":\"https://openalex.org/A5023552725\",\"display_name\":\"Aaron Keshen\",\"orcid\":\"https://orcid.org/0000-0003-0462-9749\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S74080386\",\"source_display_name\":\"International Journal of Eating Disorders\",\"landing_page_url\":\"https://doi.org/10.1002/eat.70164\",\"is_oa\":false}}}","topic_tags":"Eating Disorders,Mechanism of Action,Receptor Pharmacology,Emotional Processing,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":"published","openalex_id":"https://openalex.org/W7167014213"},{"id":3811,"title":"Investigating the impact of serotonergic psychedelic drugs, MDMA and ketamine on social cognition in psychiatric disorders: A scoping review.","normalized_title":"investigating the impact of serotonergic psychedelic drugs mdma and ketamine on social cognition in psychiatric disorders a scoping review","authors":"Smith SA, Mohammad H, Lee LHN, Dennett L, Smith S, Burback L, Winkler O, Greenshaw A, Jetly R, Kennedy SH, Bhat V, Swainson J, Vermetten E, Cao B, Li XM, Zhang Y.","abstract":"RationaleInterest in psychedelic drugs has increased rapidly because of their potential therapeutic role in psychiatric disorders. Impairments in the sociocognitive skills needed to build and maintain social relationships are prominent features of many psychiatric and neurodevelopmental disorders. Emerging evidence suggests that compounds such as 3,4-methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and psilocybin may influence these impairments.ObjectivesThis review aimed to determine whether psychedelic drugs may modulate social cognition in individuals with psychiatric or neurodevelopmental disorders associated with cognitive impairment.MethodsA search of the MEDLINE, PsycINFO, EMBASE, and Scopus databases was conducted. Twenty studies were identified that evaluated the effects of ketamine, MDMA, psilocybin, LSD, and ayahuasca in depressive disorders, anxiety disorders, autism spectrum disorder (ASD), and post-traumatic stress disorder (PTSD).ResultsFindings included neural activation patterns suggesting that ketamine and psilocybin may modulate processes relevant to social perception, particularly facial emotion processing, in depressive disorders. Positive findings were also reported for MDMA in participants with PTSD, including improvements in self-reported psychosocial functioning, self-awareness, and self-compassion.ConclusionsCurrent evidence suggests that psychedelic drugs may modulate processes relevant to social cognition in psychiatric disorders, although direct evidence of improved social-cognitive functioning remains limited.Clinical trial numberNot applicable.","journal":null,"publication_date":"2026-06-30","publication_year":2026,"doi":"10.1007/s00213-026-07110-y","pubmed_id":"42380668","source_url":"https://doi.org/10.1007/s00213-026-07110-y","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-01 13:00:05","last_checked":"2026-07-08 01:20:23","raw_json":"{\"europe_pmc_id\":\"42380668\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe PMC\"}","topic_tags":"Depression,Anxiety,PTSD,Emotional Processing,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":"published","openalex_id":null},{"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":"2026-07-07 01:23:04","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","openalex_id":null},{"id":107,"title":"Implementing psilocybin-assisted therapy in palliative care settings: A survey of stakeholders.","normalized_title":"implementing psilocybin assisted therapy in palliative care settings a survey of stakeholders","authors":"Plourde L, Chang SL, Nguyen O, Garel N, Farzin H, Stephan JF, Fallu JS, Dorval M, P3A Research Group","abstract":"While the adoption of psilocybin-assisted therapy for existential distress offers promising support for patients with life-threatening illnesses, implementing this intervention into palliative care settings presents significant real-world challenges. To examine palliative care stakeholders' knowledge and attitudes regarding psilocybin-assisted therapy, and identify barriers and facilitators to its implementation. We conducted a cross-sectional online survey between April 15 and December 18, 2024. The survey assessed perceived knowledge, attitudes, and perceived barriers and facilitators to the effective integration of psilocybin-assisted therapy into palliative care settings. One hundred and twenty-one adults involved in palliative care (physicians, other healthcare professionals, caregivers, and managers) were recruited from Canada's four most populous provinces: Québec, Ontario, Alberta, and British Columbia. Forty-three percent of stakeholders reported having good knowledge of psilocybin's potential benefits and risks. Attitudes towards psilocybin-assisted therapy were predominantly non-favourable (61%), yet varied across occupational groups ( Translating the potential of psilocybin-assisted therapy for existential distress from clinical trials into palliative care settings requires careful consideration and collaboration with stakeholders. Given the significant divergence in perspectives between clinical and non-clinical groups, tailored interprofessional education could help build shared understanding and support effective implementation. Being conducted in Canada, transferability to different regulatory frameworks may be limited.","journal":"Palliative medicine","publication_date":"2026-06-30","publication_year":2026,"doi":"10.1177/02692163261446141","pubmed_id":"42154482","source_url":"https://pubmed.ncbi.nlm.nih.gov/42154482/","keywords":"attitude of health personnel, hallucinogens, palliative care, psilocybin, surveys and questionnaires","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-08 01:20:05","raw_json":"{\"pubmed_id\":\"42154482\"}","topic_tags":"End-of-Life Distress,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":"published","openalex_id":null},{"id":17,"title":"Psychedelics, entactogens and psychoplastogens for depression and related disorders.","normalized_title":"psychedelics entactogens and psychoplastogens for depression and related disorders","authors":"Hoyer D","abstract":"Currently, the most actively investigated rapidly acting antidepressants, anxiolytics and/or anti PTSD agents, include psychedelics e.g. psilocybin, LSD, N,N-dimethyltryptamine, ayahuasca; non-hallucinogenic entactogens, e.g. MDMA; psychoplastogens which rapidly promote neuroplasticity, e.g. ibogaine, ketamine and esketamine; and other atypicals e.g. dextromorphan/bupropion, esmethadone. Late-stage clinical trials support psychedelics and/or MDMA-assisted psychotherapy as rapidly acting treatments for major depressive disorder (MDD), treatment-resistant depression (TRD), PTSD or generalised anxiety disorders (GAD). Psilocybin, MDMA and LSD were granted FDA breakthrough status for TRD/MDD, PTSD and GAD, respectively, although FDA recently rejected the new drug application of MDMA in PTSD. Most of these drugs target the 5-HT and monoamine systems. Classical psychedelics act as 5-HT receptor agonists, although LSD, DMT and psilocybin target other 5-HT and/or dopamine receptors. Psychedelic-dependent 5-HT receptor agonism also has profound anti-(neuro)inflammatory effects. Advanced imaging studies suggest that brain 5-HT levels are reduced in depression. Functional magnetic resonance studies show that neural networks (cortico thalamic, salience, default mode) are profoundly impaired in depression. Such network defects are corrected upon psychedelic/entactogen treatment, offering a unique opportunity to serve as biomarkers for depression, anxiety and PTSD precision medicine trials. Psychedelics and entactogens target common end pathways, namely neuroplasticity/synaptogenesis, either directly via monoamine or glutamate receptors and/or indirectly, via BDNF and mTORC1 pathways. Together, these findings strongly support a biological basis for MDD, GAD, PTSD and related conditions, which can be considered as mixed biochemical, neurological and neuroimmune disorders, and are profoundly modified by psychedelics, entactogens and the newly developed psychoplastogens. LINKED ARTICLES: This article is part of a themed issue Emerging Therapeutic Opportunities for Psychedelic and Related Drugs. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v183.14/issuetoc.","journal":"British journal of pharmacology","publication_date":"2026-06-30","publication_year":2026,"doi":"10.1111/bph.70088","pubmed_id":"40518133","source_url":"https://pubmed.ncbi.nlm.nih.gov/40518133/","keywords":"5-HT (serotonin), Brain-derived neurotrophic factor (BDNF), Empathogens, Entactogens, LSD (lysergic acid diethylamide), MDMA (3,4-methylenedioxy methamphetamine), Post-traumatic stress disorders (PTSD), Psychedelics, Psychoplastogens, Treatment resistant depression (TRD)","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-08 01:20:06","raw_json":"{\"pubmed_id\":\"40518133\"}","topic_tags":"Depression,Anxiety,PTSD,Neuroplasticity,Brain Imaging,Mechanism of Action,Receptor Pharmacology,Biomarkers,Aging,Clinical Trial,Treatment-Resistant Depression,Inflammation,Immune Function","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null},{"id":14,"title":"Psychedelics as pharmacotherapeutics for substance use disorders: A scoping review on clinical trials and perspectives on underlying neurobiology.","normalized_title":"psychedelics as pharmacotherapeutics for substance use disorders a scoping review on clinical trials and perspectives on underlying neurobiology","authors":"Wittenkeller L, Gudelsky G, Winhusen TJ, Amato D","abstract":"Psychedelics have garnered great attention in recent years as treatments for major depressive disorder (MDD) and treatment-resistant depression because of their ability to alter consciousness and afflicted cognitive processes with lasting effects. We aimed to characterise how psychedelics are currently being investigated to treat substance use disorders (SUDs). Additionally, we aimed to summarise the available literature on the dopaminergic consequences of classic psychedelics in the nucleus accumbens (NAc), a foundational component of SUDs, to understand how psychedelics may be therapeutically relevant for SUDs from a neurobiological perspective. Two scoping review approaches adhering to PRISMA-SCR guidelines were conducted. The first screened for ongoing clinical trials utilising psychedelics for SUD treatment registered at ClinicalTrials.gov. The second screened for in vivo microdialysis studies measuring psychedelic-induced changes in extracellular NAc dopamine in rats, found using PubMed, SCOPUS or Google Scholar. Thirty-four unique clinical trials were identified targeting alcohol, cannabis, cocaine, methamphetamine, nicotine, and opioid use disorders and mostly consisting of open-label trials lacking placebo-treated controls. The most common SUD investigated was alcohol use disorder (AUD). Following stringent exclusion criteria, four publications were identified that measured extracellular dopamine in the NAc following systemic administration of psilocybin or 3,4-methylenedioxymethamphetamine (MDMA). A sustained mild increase of dopamine was observed that was unique to high-dose psilocybin. In addition to known therapeutic mechanisms of psychedelics, findings herein suggest that psilocybin may support dopamine homeostasis through restoration of tonic dopamine levels. LINKED ARTICLES: This article is part of a themed issue Emerging Therapeutic Opportunities for Psychedelic and Related Drugs. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v183.14/issuetoc.","journal":"British journal of pharmacology","publication_date":"2026-06-30","publication_year":2026,"doi":"10.1111/bph.70181","pubmed_id":"40891276","source_url":"https://pubmed.ncbi.nlm.nih.gov/40891276/","keywords":"MDMA, addiction, psilocybin, psychedelics, psychedelic-assisted therapy, substance use disorders","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-08 01:20:06","raw_json":"{\"pubmed_id\":\"40891276\"}","topic_tags":"Depression,Addiction,Mechanism of Action,Consciousness,Clinical Trial,Review Article,Treatment-Resistant Depression","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null},{"id":303,"title":"Study Protocol for \"Exploring the safety and therapeutic potential of psilocybin in the treatment of anorexia nervosa in adolescents and young adults\".","normalized_title":"study protocol for exploring the safety and therapeutic potential of psilocybin in the treatment of anorexia nervosa in adolescents and young adults","authors":"Sjöström D, Schau Rybäck O, Claesdotter Knutsson E, Kajonius P, Jensen Sondén O, Carlbring P, Björkstrand J, Movahed Rad P.","abstract":"BackgroundAnorexia nervosa (AN) is a severe psychiatric disorder with high morbidity, mortality, and relapse rates, most commonly emerging during adolescence. Despite specialized psychological and nutritional treatments, outcomes remain suboptimal, with high rates of relapse and chronicity. Psilocybin has been investigated with preliminary efficacy in other psychiatric conditions characterized by rigidity and treatment resistance, but clinical evidence in AN-particularly in adolescents-is limited.ObjectiveThe psiAN study aims to evaluate the safety, tolerability, and feasibility of psilocybin therapy combined with psychological support in adolescents and young adults with relapsing AN, while exploring clinical, experiential, and neurobiological correlates of change.MethodsA phase IIa, open-label, randomized controlled trial enrolling individuals aged 16-35 years with DSM-5 AN and a history of relapse. Participants are randomized to receive either two administrations of psilocybin (25 mg) with manualized psychological support plus treatment as usual (TAU), or TAU alone. Primary outcomes focus on safety and tolerability, assessed through adverse events, psychiatric monitoring, and medical parameters measured from first dosing to primary endpoint. Secondary outcomes include change in eating disorder symptom severity, relapse composite measures, mood, well-being, personality traits from baseline to primary endpoint with follow-up to 12 months. Functional magnetic resonance imaging (fMRI) and peripheral brain-derived neurotrophic factor are included as exploratory mechanistic measures. fMRI will evaluate pre- to post-intervention changes in structural and functional connectivity and task-related responses during a simplified Monetary Incentive Delay task (MIDT) and a Calorie-Cue Task (CCT). ClinicalTrials.gov Identifier: NCT07169747.Ethics and disseminationThe study follows Good Clinical Practice (GCP), the Declaration of Helsinki, and EU Clinical Trials Regulation requirements, with staged inclusion of adolescents (16-17-year-olds) after a safety board review of adult data (18-35-year-olds). This protocol was prepared with reference to the SPIRIT 2025 guidelines (Chan et al., 2025) to enhance transparency and inform future trials.","journal":"PLoS ONE","publication_date":"2026-06-29","publication_year":2026,"doi":"10.1371/journal.pone.0352246","pubmed_id":"42378255","source_url":"https://doi.org/10.1371/journal.pone.0352246","keywords":"Humans, Hallucinogens, Treatment Outcome, Anorexia Nervosa, Adolescent, Adult, Female, Randomized Controlled Trials as Topic, Clinical Trials, Phase II as Topic, Young Adult, Psilocybin","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-01 06:48:03","last_checked":"2026-07-07 01:20:41","raw_json":"{\"europe_pmc_id\":\"42378255\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe 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K. Sjöström\",\"orcid\":\"https://orcid.org/0000-0003-0004-1892\"},{\"id\":\"https://openalex.org/A5073798116\",\"display_name\":\"Olea Schau Rybäck\",\"orcid\":null},{\"id\":\"https://openalex.org/A5111008178\",\"display_name\":\"Emma Claesdotter Knutsson\",\"orcid\":null},{\"id\":\"https://openalex.org/A5135752675\",\"display_name\":\"Petri Kajonius\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139709727\",\"display_name\":\"Oskar Jensen Sondén\",\"orcid\":null},{\"id\":\"https://openalex.org/A5082635131\",\"display_name\":\"Per Carlbring\",\"orcid\":\"https://orcid.org/0000-0002-2172-8813\"},{\"id\":\"https://openalex.org/A5017431485\",\"display_name\":\"Johannes Björkstrand\",\"orcid\":\"https://orcid.org/0000-0002-1786-1064\"},{\"id\":\"https://openalex.org/A5018302853\",\"display_name\":\"Pouya Movahed\",\"orcid\":\"https://orcid.org/0000-0003-2041-3550\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S202381698\",\"source_display_name\":\"PLoS ONE\",\"landing_page_url\":\"https://doi.org/10.1371/journal.pone.0352246\",\"is_oa\":true}}}","topic_tags":"Eating Disorders,Brain Imaging,Aging,Wellbeing,Personality Change,Clinical Trial,Randomized Controlled Trial,Review Article,Adolescents,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":"published","openalex_id":"https://openalex.org/W7166779507"},{"id":3979,"title":"Naturally Derived Psilocybin for Therapeutic Use: A Six-Criterion Framework for Evidence, Safety, and Benefit-Risk Considerations in Policy and Clinical Development","normalized_title":"naturally derived psilocybin for therapeutic use a six criterion framework for evidence safety and benefit risk considerations in policy and clinical development","authors":"Stefanie Enriquez Geppert, Lisa Bevers, Arvid Rosander, Peter Fodran, Vince Polito","abstract":"","journal":"University of Groningen research database (University of Groningen / Centre for Information Technology)","publication_date":"2026-06-28","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://research.rug.nl/en/publications/370a82bd-d8db-4a02-b644-bf0c9131680b","keywords":"Psilocybin, Drug development, Psychology, Medicine, Psychotherapist, MEDLINE, Psychiatry, Clinical trial, Intensive care medicine, Perspective (graphical), Psychedelics and Drug Studies, Forensic Toxicology and Drug Analysis, Cannabis and Cannabinoid Research","substance_tags":"psilocybin","source_name":"OpenAlex","date_added":"2026-07-04 01:20:27","last_checked":"2026-07-06 01:20:37","raw_json":"{\"openalex_id\":\"https://openalex.org/W7167168218\",\"openalex_url\":\"https://openalex.org/W7167168218\",\"openalex_relevance_score\":6,\"openalex_relevance_reasons\":[\"title:psilocybin\",\"metadata:psilocybin\"],\"openalex_type\":\"article\",\"openalex_work_type\":null,\"cited_by_count\":0,\"referenced_works\":[],\"authorships\":[{\"id\":\"https://openalex.org/A5139873851\",\"display_name\":\"Stefanie Enriquez Geppert\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139893961\",\"display_name\":\"Lisa Bevers\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139856970\",\"display_name\":\"Arvid Rosander\",\"orcid\":null},{\"id\":\"https://openalex.org/A5079289829\",\"display_name\":\"Peter Fodran\",\"orcid\":\"https://orcid.org/0000-0003-0348-8331\"},{\"id\":\"https://openalex.org/A5045686739\",\"display_name\":\"Vince Polito\",\"orcid\":\"https://orcid.org/0000-0003-3242-9074\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S4306400420\",\"source_display_name\":\"University of Groningen research database (University of Groningen / Centre for Information Technology)\",\"landing_page_url\":\"https://research.rug.nl/en/publications/370a82bd-d8db-4a02-b644-bf0c9131680b\",\"is_oa\":false}}","topic_tags":"Clinical Trial,Safety,Toxicity","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7167168218"},{"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":"2026-07-05 01:22:40","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","openalex_id":null},{"id":29,"title":"Novel approaches in depression treatment: from rapid-acting antidepressants to personalized interventions.","normalized_title":"novel approaches in depression treatment from rapid acting antidepressants to personalized interventions","authors":"Guidetti C, Fava M, Papakostas GI.","abstract":"Major depressive disorder (MDD) and treatment-resistant depression (TRD) are prevalent and debilitating conditions. Over 50% of patients have inadequate response to first-line serotonergic antidepressants and are left with suboptimal treatment options. Rapid-acting and individually tailored treatments for MDD remain major unmet needs. This review discusses promising rapid-acting treatments, including psychedelic and neuroplastogen compounds, currently under investigation for the treatment of MDD and TRD. Among these, psilocybin has advanced to late-stage trials. In addition, we examine the emerging role of repetitive transcranial magnetic stimulation (rTMS), including novel personalized interventions, such as the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, which has demonstrated rapid antidepressant effects and is now FDA-cleared for TRD, positioning it closest to clinical translation. We also highlight the ongoing ALTO-300 trial, which is evaluating an adjunctive treatment for MDD in patients identified by an EEG biomarker-representing another promising step toward personalized treatment. Finally, we review the results of a Phase 2 study reporting outcomes that vary by a specific genotype sequence, underscoring the potential for genetically guided personalized interventions. Despite these advances, key limitations, including unblinding in psychedelic trials, scalability challenges of intensive neuromodulation protocols, and the need for validated biomarkers, pose ongoing challenges for real-world implementation.","journal":null,"publication_date":"2026-06-24","publication_year":2026,"doi":"10.1038/s41380-026-03722-0","pubmed_id":"42350785","source_url":"https://doi.org/10.1038/s41380-026-03722-0","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-02 23:03:30","raw_json":"{\"europe_pmc_id\":\"42350785\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe PMC\"}","topic_tags":"Depression,Brain Imaging,Biomarkers,Clinical Trial,Review Article,Treatment-Resistant Depression","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null},{"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","openalex_id":null},{"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","openalex_id":null},{"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","openalex_id":null},{"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","openalex_id":null},{"id":3024,"title":"Sex-Specific Effects of Psilocybin Versus Escitalopram on Anxiety and Anhedonia: A Bayesian Reanalysis of Antidepressant Treatment Outcomes","normalized_title":"sex specific effects of psilocybin versus escitalopram on anxiety and anhedonia a bayesian reanalysis of antidepressant treatment outcomes","authors":"Frick A, Blest-Hopley G, Grin M, Erritzoe D, Nutt D, Carhart-Harris R.","abstract":"Abstract Rationale: Major depressive disorder (MDD) shows marked sex differences in prevalence, symptomatology, and treatment response. However, women remain underrepresented in many clinical trials, and sex-specific treatment outcomes are rarely examined. Objectives This study reanalyzed data from a randomized controlled trial comparing psilocybin and escitalopram for MDD to evaluate sex differences across multiple psychological domains. Methods We reanalyzed data from a six-week, double-blind randomized controlled trial comparing psilocybin with escitalopram in adults with moderate-to-severe MDD. Post-treatment depressive symptoms (MADRS, QIDS-SR-16, BDI), anhedonia (SHAPS), anxiety (STAI), thought suppression (WBSI), and well-being (WEMWBS) were modeled as a function of sex, treatment condition, their interaction, and baseline symptom severity. Sexual dysfunction severity (PRSexDQ-SALSEX), assessed only at the six-week follow-up, was analyzed separately as an ordinal outcome. Results Sex-related patterns emerged for anxiety and anhedonia. Women receiving psilocybin showed greater reductions in anxiety than men (STAI: 95% CrI − 17.5 to − 3.29), whereas women receiving escitalopram showed greater reductions in anhedonia than men (SHAPS: 95% CrI − 4.63 to 0.00). For the remaining continuous outcomes, sex differences were generally small and uncertain. Sexual dysfunction severity was lower overall in the psilocybin group than in the escitalopram group and lower in women than in men, although the treatment-by-sex interaction was not significant. Conclusions This reanalysis identified domain-specific sex-related patterns in anxiety and anhedonia, suggesting that responses to psilocybin and escitalopram may differ between women and men. These preliminary findings support adequately powered, sex-balanced, and hormone-informed trials of serotonergic treatments for MDD.","journal":"Research Square","publication_date":"2026-06-18","publication_year":2026,"doi":"10.21203/rs.3.rs-9880403/v1","pubmed_id":null,"source_url":"https://doi.org/10.21203/rs.3.rs-9880403/v1","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-01 11:03:45","last_checked":"2026-07-01 11:22:00","raw_json":"{\"europe_pmc_id\":\"PPR1255612\",\"source\":\"PPR\",\"pub_type\":null,\"publisher\":\"Research Square\",\"importer\":\"Europe PMC\"}","topic_tags":"Depression,Anxiety,Wellbeing,Clinical Trial,Randomized Controlled Trial,Drug Interactions","study_type":"Randomized Controlled Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"preprint","openalex_id":null}],"total":802,"page":1,"per_page":20,"pages":41,"resource":"papers","filters":{"q":null,"author":null,"substances":["psilocybin","psilocin"],"topic":"Clinical Trial","study_type":null,"cited_doi":null,"sources":[],"publication_statuses":[],"year":null,"journal":null,"from":null,"to":null,"added_from":null,"added_to":null,"sort":"newest","page":1,"per_page":"20"}}