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Executed search Journal: ClinicalTrials.gov 287 matching records are displayed.

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287 matching results

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

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.

ClinicalTrials.gov 2025-05-05 Sharmin Ghaznavi

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionBrain ImagingAging Other Major Depressive DisorderPsilocybin

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial

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-...

ClinicalTrials.gov 2025-04-24 Centre for Addiction and Mental Health

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionChronic PainClinical TrialRandomized Controlled TrialSafety Clinical Trial Treatment Resistant DepressionChronic Pain

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

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 ...

ClinicalTrials.gov 2025-04-15 Kevin Boehnke

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionChronic PainMechanism of ActionClinical TrialReview ArticleCancer PatientsTreatment-Resistant DepressionSafetyAdverse Events Clinical Trial FibromyalgiaPsilocybin

The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training

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. Sp...

ClinicalTrials.gov 2025-04-13 Felix Mueller

ClinicalTrials.gov CLINICAL TRIAL psilocybin ConsciousnessSafetyDrug Interactions Other Personal Experience of Substance-assisted Therapy Using PsilocybinMDMA

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).

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 sub...

ClinicalTrials.gov 2025-04-10 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin ConsciousnessSpirituality Clinical Trial HealthyN

Psilocybin-assisted Interpersonal Therapy for Depression

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 feas...

ClinicalTrials.gov 2025-04-08 University of Otago

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAddictionEmotional ProcessingClinical TrialReview ArticleTreatment-Resistant DepressionHealthcare Workers Clinical Trial Depressive DisorderTreatment-Resistant

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

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 cur...

ClinicalTrials.gov 2025-03-29 Unity Health Toronto

ClinicalTrials.gov CLINICAL TRIAL psilocybin Chronic PainMechanism of ActionClinical TrialRandomized Controlled TrialSafety Randomized Controlled Trial Chronic Neuropathic PainPain Management

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)

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. Lysergi...

ClinicalTrials.gov 2025-03-26 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin PharmacologyReceptor PharmacologyConsciousnessHealthy Volunteers Clinical Trial HealthyLSD

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

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 avai...

ClinicalTrials.gov 2025-03-18 McMaster University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionClinical TrialReview ArticleSafety Clinical Trial Cannabis Use DisorderModerate

Molecular Imaging Study of Harmine/DMT: a Basic Research Approach

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 cerebro...

ClinicalTrials.gov 2025-03-18 Insel Gruppe AG, University Hospital Bern

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingPharmacologyAgingAnimal StudyHealthy Volunteers Animal Study Neuropharmacological Investigation of Ayahuasca Constituents DMT and HarmineN

Psilocybin in Alcohol Use Disorder With Comorbid Depression

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 approx...

ClinicalTrials.gov 2025-03-18 Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAddictionMechanism of ActionClinical TrialObservational StudySafetyInflammationImmune Function Clinical Trial Alcohol-Related DisordersDepressive Disorder

A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout

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 sympt...

ClinicalTrials.gov 2025-03-17 University of Washington

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionHealthcare Workers Clinical Trial BurnoutCaregiver

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

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...

ClinicalTrials.gov 2025-03-12 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyEnd-of-Life DistressChronic PainConsciousnessSpiritualityCancer Patients Other AnxietyPsilocybin (drug)

Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects

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 s...

ClinicalTrials.gov 2025-03-04 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionPTSDPharmacologyReceptor PharmacologyClinical TrialIn Vitro StudySafetyDrug Interactions Clinical Trial Healthy4-bromo-2

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

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 psychothera...

ClinicalTrials.gov 2025-01-19 Central Institute of Mental Health, Mannheim

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionClinical TrialTreatment-Resistant DepressionSafety Clinical Trial Treatment-resistant DepressionPsilocybin

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

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...

ClinicalTrials.gov 2024-12-31 Joshua Woolley, MD, PhD

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietySafetyAdverse Events Other Parkinson DiseaseDepression

The Neurobiological Effect of 5-HT2AR Modulation

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 strate...

ClinicalTrials.gov 2024-12-15 Gitte Moos Knudsen

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingMechanism of ActionReceptor PharmacologyAgingHealthy Volunteers Other Basic SciencePsilocybine

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study

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

ClinicalTrials.gov 2024-12-03 COMPASS Pathways

ClinicalTrials.gov CLINICAL TRIAL psilocybin Eating DisordersSafety Other Anorexia NervosaPsilocybin

Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates.

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 t...

ClinicalTrials.gov 2024-11-19 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin OCDBrain ImagingClinical Trial Clinical Trial Obsessive-Compulsive DisorderPsilocybin (0.25mg/kg)

A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder

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. Subject...

ClinicalTrials.gov 2024-11-18 TRYP Therapeutics

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionEating DisordersPharmacologyClinical TrialCancer PatientsTreatment-Resistant DepressionSafety Clinical Trial Binge Eating DisorderTRYP-0082

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