Psilocybin-facilitated Treatment for Cocaine Use
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.
|Cocaine-Related Disorders||Drug: Psilocybin Drug: Diphenhydramine||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study|
- 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.
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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|