drugset / Trial / NCT02037126

Psilocybin-facilitated Treatment for Cocaine Use

NCT02037126 ↗

Phase 2 Completed 40 enrolled University of Alabama at Birmingham
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-05
Primary completion
2024-05
Completion
2024-05

Outcome

Met primary endpoint

paper Psilocybin recipients had a higher percentage of cocaine abstinent days (β = 28.95; 95% CI, 18.22-39.67; P < .001) PMID 42096204 ↗

paper greater likelihood of complete cocaine abstinence (odds ratio, 18.37; 95% CI, 1.92-2468.17; P = .007) PMID 42096204 ↗

paper and a reduced risk of cocaine lapse over time (hazard ratio, 0.28; 95% CI, 0.13-0.60; P = .001) PMID 42096204 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg Oral