Clinical trials: Psilocybin
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants
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…
- Trial name
- NCT06643637
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Alcohol Use Disorder (AUD)
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
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).
- Trial name
- NCT04718792
- Testing
- Psilocybin
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Anders Fink-Jensen, MD, DMSci
Amyotrophic Lateral Sclerosis
Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood.
- Trial name
- NCT06656702
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Johns Hopkins University
Parkinson Disease, Depression
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease
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.
- Conditions
- Parkinson Disease, Depression, Anxiety
- Trial name
- PDP1 (NCT04932434)
- Testing
- Psilocybin therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Joshua Woolley, MD, PhD
Psychedelic Experiences, Amnesia
Pilot RECAP Study in Healthy Volunteers
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.
- Trial name
- RECAP (NCT04842045)
- Testing
- Psilocybin and Midazolam
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Pain Management, Postoperative Pain
Psilocybin After Trauma Surgery for Pain
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.
- Trial name
- NCT07406828
- Testing
- Psilocybin (Usona Institute), Postoperative analgesia
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Trent Emerick
Chronic Pelvic Pain
Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
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…
- Trial name
- NCT06988319
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Oregon Health and Science University
Psilocybin, Music Intervention
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
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.
- Trial name
- PRoMiSS (NCT07180108)
- Testing
- Psilocybin (high dose), Playlist 1, Playlist 2
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Cluster Headache
Prophylactic Effects of Psilocybin on Chronic Cluster Headache
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.
- Trial name
- EPOCH (NCT04280055)
- Testing
- Psilocybin
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Gitte Moos Knudsen
Alcohol Use Disorder, Alcohol Dependence
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD).
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
- Trial name
- Psi or Ket (NCT06405607)
- Testing
- Psilocybin, Ketamine
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Iowa
Self Harm
PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm
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.
- Trial name
- PsiloIMAGINE (NCT06798636)
- Testing
- Psilocybin 5 mg with cognitive behavioural therapy intervention
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Imperial College London
Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are…
- Trial name
- PRISM (NCT07756736)
- Testing
- Psilocybin 5 mg, Psilocybin 25 mg, Motivational Support
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nicky Mehtani, MD, MPH
Opioid Use Disorder
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)
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…
- Trial name
- NCT06160284
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Yale University
Major Depressive Disorder
Psilocybin for Major Depressive Disorder
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms.
- Trial name
- NCT05675800
- Testing
- Psilocybin
- Sponsor
- Washington University School of Medicine
Alcohol Use Disorder, Alcohol Dependence
Psilocybin-assisted Therapy for Alcohol Use Disorder
To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Depression, Anxiety
- Trial name
- NCT06444243
- Testing
- Psilocybin, Niacin
- Volunteers
- 90 people
- Sponsor
- University of Sydney
Persisting Symptoms After Concussion
Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
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…
- Trial name
- PatACT (NCT06615908)
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Calgary
Bipolar II Depression
Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial.
- Trial name
- PAT-BD-01 (NCT06943573)
- Testing
- psilocybin (25 mg), psilocybin 1mg micro-dose
- Where
- 3 sites in Canada
- Volunteers
- 90 people
- Sponsor
- Lakshmi N Yatham
Perception Disorders
Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain
The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment.
- Trial name
- NCT05265546
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Healthy Volunteer
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
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…
- Trial name
- NCT07050368
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Major Depressive Disorder
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
- Trial name
- NCT05385783
- Testing
- CYB003, Psychotherapy, Psychological Support
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Cybin IRL Limited