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Psychedelic Therapy

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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average number of no heavy drinking days
Change in Alcohol craving score
Change in PSQI global score
+17 more
Secondary study objectives
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
~530

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
855,877 Total Patients Enrolled
11 Trials studying Alcoholism
1,256 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,448 Total Patients Enrolled
459 Trials studying Alcoholism
823,631 Patients Enrolled for Alcoholism
Michael Bogenschutz, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
100 Total Patients Enrolled
~133 spots leftby Jan 2029
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