CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Psilocybin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02061293
NCT02061293Phase 2Completed
CompareCT.gov

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

NYU Langone Health·interventional·Posted Feb 12, 2014·Updated Nov 8, 2022

In Brief

A Phase 2 clinical trial evaluating Psilocybin, Diphenhydramine, and 1 other intervention for Alcohol Dependence. Completed, enrolled 95 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesUnited States
CollaboratorsHeffter Research Institute, University of New Mexico

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2014
Enrollment StartJun 1, 2014
Primary CompletionJul 30, 2021
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 12.4 years ago

Interventions

Psilocybindrug

Diphenhydraminedrug

Motivational Enhancement and Taking Action (META)behavioral

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