Psilocybin-facilitated Treatment for Cocaine Use
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|ClinicalTrials.gov Identifier: NCT02037126|
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : November 23, 2020
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 (e.g., criminal 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.
|Condition or disease||Intervention/treatment||Phase|
|Cocaine-Related Disorders||Drug: Psilocybin Drug: Diphenhydramine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Psilocybin administration
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
this has been used in treating obsessive-compulsive disorders, cluster headaches, anxiety, and drug dependence.
Other Name: psychedelic compound
Active Comparator: Diphenhydramine administration
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
This drug will be used as the control. Diphenhydramine is a histamine blocker.
Other Name: Benadryl
- The difference between the treatment and placebo groups in the number of participants with biochemically verified cocaine abstinence. [ Time Frame: 16 and 28 weeks after psilocybin or placebo administration. ]Number of subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) with biochemically verified cocaine presence as assessed via a urine drug screen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037126
|Contact: Peter S. Hendricks, Ph.D.||email@example.com|
|Contact: Sarah Simpson, B.S.||firstname.lastname@example.org|
|United States, Alabama|
|UAB Outpatient Clinical Research Unit||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Peter S Hendricks, Ph.D. 415-509-7376 email@example.com|
|Principal Investigator:||Peter S. Hendricks, Ph.D.||UAB School of Public Health Department of Health Behavior|