Psilocybin for Alcoholism

Recruiting in Palo Alto (17 mi)

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.

Inclusion Criteria

Have at least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to admission to SHH

Have a negative pregnancy test at screening, Baseline, Day 0 (pre-IP administration); and Day 2.

I agree to use birth control during the trial if I can become pregnant or father a child.

+11 more

Exclusion Criteria

I do not have any health conditions that would make it unsafe for me to join the study.

Pregnancy or lactation

Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History at the Screening Visit: Lifetime history of schizophrenia spectrum or other psychotic disorder, current alcohol withdrawal, history of mania, active suicidal ideation with intent, made a medically significant suicide attempt within the past 12 months, family history of certain psychiatric disorders, history of hallucinogen use disorder, history of hallucinogen persisting perceptual disorder, any use of classic psychedelics in the past 1 year, > 25 lifetime uses of classic psychedelics, incarcerated or have pending legal action that could prevent participation in study activities, court-mandated to complete residential treatment at SHH, unable or unwilling to discontinue taking any protocol-prohibited medications and supplements, known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study, allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary during or immediately after the IP Administration Session, have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of psilocybin or fMRI scanning, inability to safely complete fMRI sessions, any history of severe traumatic brain injury.

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: