Overseen ByMichael Bogenschutz, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: NYU Langone Health
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals with alcohol use disorder (AUD). Participants should be willing to undergo MRI scans and provide self-reports on their alcohol consumption. Details about specific inclusion and exclusion criteria are not provided, but typically these would cover health status, age range, severity of AUD, and other factors relevant to the study.Participant Groups
The trial is testing whether psilocybin can help treat AUD compared to an inactive placebo. All participants will receive supportive therapy sessions. The effects will be measured using brain imaging (fMRI), blood tests for alcohol biomarkers, and questionnaires assessing emotional response and drinking behavior.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral high-dose of psilocybinExperimental Treatment2 Interventions
Participants will receive a single IP administration session of psilocybin (30 mg total) and three supportive therapy sessions.
Group II: Placebo controlPlacebo Group2 Interventions
Participants will receive a single IP administration session of matching placebo capsules and three supportive therapy sessions.
Psilocybin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Psilocybin for:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺 Approved in European Union as Psilocybin for:
- Treatment-resistant depression (TRD) under PRIME designation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator