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A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

NCT02061293 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-11-08

Study results available
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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.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Psilocybin

DRUG

Diphenhydramine

BEHAVIORAL

Motivational Enhancement and Taking Action (META)

Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.

Sponsors & Collaborators

  • Heffter Research Institute

    collaborator OTHER

  • University of New Mexico

    collaborator OTHER

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Michael P Bogenschutz, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2021-07-30
Completion
2021-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061293 on ClinicalTrials.gov