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Psychedelic

Psilocybin for Alcoholism

Phase 2
Waitlist Available
Led By Michael P 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 from week 33 up to week 36
Awards & highlights

Study Summary

Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 33 up to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 33 up to week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drinks Per Day
Percent of Drinking Days
Percent of Heavy Drinking Days
Secondary outcome measures
Percent of Participants Achieving No Heavy Drinking Days
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PsilocybinExperimental Treatment2 Interventions
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Group II: DiphenhydramineActive Control2 Interventions
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Enhancement and Taking Action (META)
2014
Completed Phase 2
~100
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,503 Total Patients Enrolled
11 Trials studying Alcoholism
1,361 Patients Enrolled for Alcoholism
Heffter Research InstituteOTHER
13 Previous Clinical Trials
403 Total Patients Enrolled
1 Trials studying Alcoholism
10 Patients Enrolled for Alcoholism
University of New MexicoOTHER
372 Previous Clinical Trials
3,528,694 Total Patients Enrolled
15 Trials studying Alcoholism
2,661 Patients Enrolled for Alcoholism

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Clinical and Translational Science Institute, NYU Langone Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
2014. "A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02061293.
~9 spots leftby Apr 2025
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