← Back to Search

Psychedelic Therapy

Oral high-dose of psilocybin for Alcoholism

Phase 2

Waitlist Available

Led By Michael Bogenschutz, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial will study how psilocybin affects the brains of patients with alcohol use disorder. They will use brain scans, alcohol use data, and self-report measures to see if psilocybin

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, common side effects of psilocybin may include changes in perception, mood swings, nausea, dizziness, headache or increased heart rate. Placebo has no active ingredients but can lead to perceived side effects due to the 'placebo effect'.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average number of no heavy drinking days

Change in Alcohol craving score

Change in PSQI global score

+19 more

Secondary outcome measures

Average number of drinks per day

Average number of no drinking days

Percentage of abstinent days

+1 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,309 Total Patients Enrolled

11 Trials studying Alcoholism

1,256 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

805 Previous Clinical Trials

1,365,712 Total Patients Enrolled

425 Trials studying Alcoholism

985,966 Patients Enrolled for Alcoholism

Michael Bogenschutz, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current investigation open for participant enrollment?

"According to details on clinicaltrials.gov, patient recruitment for this trial is currently closed. This study was initially listed on July 1st, 2024 and last revised on April 1st, 2024. Despite the closure of this trial, there are approximately 390 other ongoing studies actively seeking participants."

Answered by AI

To what extent can ingesting a large amount of psilocybin orally be considered safe for individuals?

"Our evaluation at Power rates the safety of high-dose oral psilocybin as a 2 on our scale. This is due to it being in Phase 2, where there is existing safety data but no evidence yet supporting its effectiveness."

Answered by AI