CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Psilocybin +1 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/NCT02037126
NCT02037126Phase 2Completed

Psilocybin-facilitated Treatment for Cocaine Use

University of Alabama at Birmingham·interventional·Posted Jan 15, 2014·Updated May 18, 2026

In Brief

A Phase 2 clinical trial evaluating Psilocybin and Diphenhydramine for Cocaine-Related Disorders. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 15, 2014
Enrollment StartMay 1, 2015
Primary CompletionMay 1, 2024
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 12.5 years ago

Interventions

Psilocybindrug

this has been used in treating obsessive-compulsive disorders, cluster headaches, anxiety, and drug dependence.

Diphenhydraminedrug

This drug will be used as the control. Diphenhydramine is a histamine blocker.