Clinical trials: Psilocybin
Major Depressive Disorder
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.
- Trial name
- EXTEND (NCT06605105)
- Testing
- CYB003
- Where
- 49 sites in United States, Australia and 3 more
- Volunteers
- 468 people
- Sponsor
- Cybin IRL Limited
Mood Disturbance, Mood Change
Mood and Cognitive Effects of Psilocybin in Healthy Participants
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…
- Conditions
- Mood Disturbance, Mood Change, Sleep Disturbance, Drug Effect
- Trial name
- MELO (NCT05252598)
- Testing
- Psilocybin, Inonotus Obliquus Whole Extract
- Volunteers
- healthy volunteers welcome
- Sponsor
- Optimi Health Corporation
Treatment Resistant Depression, MDD
Psilocybin rTMS for Treatment Resistant Depression
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…
- Conditions
- Treatment Resistant Depression, MDD, Major Depressive Disorder, Recurrent Depression
- Trial name
- PSILOBSD (NCT06132178)
- Testing
- Psilocybin, Accelerated intermittent theta burst (aiTBS) rTMS treatment, Low-dose psilocybin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Texas at Austin
Treatment-resistant Depression (TRD)
Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions.
- Trial name
- PSI-GROUP (NCT07737990)
- Testing
- Group integration therapy
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- Joshua Rosenblat
Opioid Use Disorder
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
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…
- Trial name
- BIPOD-Out (NCT06067737)
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Johns Hopkins University
Healthy
Psilocybin and Spiritual Practice
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…
- Trial name
- NCT00802282
- Testing
- psilocybin, Intensity of support for spiritual practice, Number of sessions
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Treatment Resistant Depression, Substance Use Disorders
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
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…
- Trial name
- NCT07499583
- Testing
- Psilocybin
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Indiana University
Major Depressive Disorder
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
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
- Trial name
- NCT05733546
- Testing
- Psilocybin
- Where
- 5 sites in United States
- Volunteers
- 102 people
- Sponsor
- COMPASS Pathways
Methamphetamine Use Disorder
Psilocybin for Methamphetamine Addiction
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.
- Trial name
- NCT06899594
- Testing
- Psilocybin 25 mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kevin Murnane
Post Traumatic Stress Disorder, PTSD
Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD
This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
- Conditions
- Post Traumatic Stress Disorder, PTSD, Chronic PTSD
- Trial name
- NCT06386003
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Unity Health Toronto
Depression, Anxiety
Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
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.
- Trial name
- NCT07565909
- Testing
- Psilocybin
- Volunteers
- 72 people
- Sponsor
- University of Washington
Advanced Cancer, Stage IV Solid Tumor Cancer
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Randomized Controlled Trial
Phase II randomized controlled trial, followed by an open-label extension phase. In the main study, participants will receive either a single high or low dose of psilocybin in the context of Psilocybin-assisted Existential…
- Conditions
- Advanced Cancer, Stage IV Solid Tumor Cancer, Stage IV Sarcoma of Bone, Stage IV Lymphoma
- Trial name
- PEARL RCT (NCT07820033)
- Testing
- Psilocybin (high dose), Psilocybin (low dose), PEARL Therapy
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- University Health Network, Toronto
Severe Alcohol Use Disorder
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
- Trial name
- NCT06160232
- Testing
- Psilocybin (high dose)
- Where
- Belgium
- Volunteers
- 62 people
- Sponsor
- Brugmann University Hospital
Anorexia Nervosa
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
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…
- Trial name
- NCT04661514
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of California, San Diego
Distress, Depression
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
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).
- Conditions
- Distress, Depression, Grief
- Trial name
- NCT02950467
- Testing
- Psilocybin, Modified brief Supportive Expressive Group Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Joshua Woolley
Major Depressive Disorder
The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
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.
- Trial name
- NCT04593563
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Maryland Oncology Hematology, PA
Disorders of Consciousness, Psychedelic Experiences
The Effects of Psilocybin on Shared Experience in Film Processing
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).
- Trial name
- NCT06529939
- Testing
- Psilocybin
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Western University, Canada
Major Depressive Disorder
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.
- Trial name
- NCT06247839
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sharmin Ghaznavi
Post-Traumatic Stress Disorder
Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder
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.
- Trial name
- NCT05562973
- Testing
- Psilocybin
- Sponsor
- Johns Hopkins University
PTSD - Post Traumatic Stress Disorder, PTSD
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
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.
- Conditions
- PTSD - Post Traumatic Stress Disorder, PTSD, PTSD Symptoms, PTSD, Post Traumatic Stress Disorder
- Trial name
- Redefine (NCT07570654)
- Testing
- COMP360 psilocybin
- Where
- 10 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- COMPASS Pathways