Clinical trials: Psilocybin, active
Posttraumatic Stress Disorder
Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD).
- Trial name
- PAM-VET (NCT06989957)
- Testing
- Psilocybin, MDMA
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins University
PTSD
Psilocybin-Assisted Therapy
This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms.
- Trial name
- NCT07332143
- Testing
- psilocybin, Supportive Therapy, Prolonged Exposure Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Emory University
Major Depression
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S.
- Trial name
- PIVOT (NCT07226232)
- Testing
- Psilocybin
- Where
- 5 sites in United States
- Volunteers
- 240 people
- Sponsor
- VA Office of Research and Development
Alcohol Use Disorder
Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use.
- Trial name
- NCT05421065
- Testing
- Psilocybin, Ketamine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Peggy C Nopoulos
Depressive Disorder, Major Depressive Disorder
A Randomized Neuroimaging Trial of Psilocybin in Depression
The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in…
- Trial name
- EMBRACE (NCT06072898)
- Testing
- Psilocybin, Microcrystalline cellulose, Supportive psychotherapy
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
Healthy Volunteers
Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1.
- Trial name
- NCT07079930
- Testing
- Psilocybin and D-Serine, Physical Examination, Vital signs
- Where
- Israel
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
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
Stuttering
Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter
This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with…
- Trial name
- NCT07296328
- Testing
- Psilocybin, Speech therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NYU Langone Health
Post Traumatic Stress Disorder, PTSD
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
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).
- Trial name
- SUN004 (NCT06902974)
- Testing
- Psilocybin 25 mg
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Sunstone Medical
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
Psychological Distress
Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress.
- Trial name
- NCT07063862
- Testing
- Psilocybin
- Where
- 7 sites in Canada
- Volunteers
- 120 people
- Sponsor
- Bruyère Health Research Institute.
PTSD
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study.
- Trial name
- PASSAGE (NCT07275970)
- Testing
- Psychedelic
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Scottsdale Research Institute
Anhedonia, Emotional Blunting
Psilocybin as a Novel Therapy for Residual Anhedonia
This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting.
- Trial name
- NCT07607938
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- NYU Langone Health
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
Cancer, Major Depressive Disorder
Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer
This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer.
- Trial name
- 2Dose (NCT05947383)
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Sunstone Medical
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
Alzheimer's Disease
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking.
- Trial name
- NCT07721467
- Testing
- Psilocybin, Cognitive Training
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Gambling Disorder
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder.
- Trial name
- PASSENGER (NCT07391332)
- Testing
- Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Nantes University Hospital
Mental Health
Mindfulness-Assisted Psychedelic Therapy
The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy…
- Trial name
- MAPT (NCT06233344)
- Testing
- Psilocybin plus mindfulness training, Psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Southern California