Clinical Trial: Psilocybin-facilitated Treatment for Cocaine Use

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study

Brief 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 (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.

Detailed Summary:

Individuals who are eligible to participate and provide informed consent will complete baseline questionnaires and be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group. The first MRI assessment will take place shortly thereafter using a 3T head-only Magnetic Resonance Imaging and Spectroscopy scanner (Magnetom Allegra, Siemens medial Solutions, Malvern, PA), optimized for neuroimaging applications.

Preparation sessions (see below) and the drug administration session will take place in a room at the Clinical Research Unit designed to be as comfortable, aesthetically pleasing (i.e., living-room like), and safe (e.g., no furniture with sharp corners or glass objects) as possible, with a directly adjacent, private restroom.

All participants will undergo four weekly preparation sessions of approximately 2 hours each. The purpose of these sessions is to: 1) develop strong therapeutic alliance between the participants and the guide (Dr. Hendricks) and secondary monitor (Dr. Cropsey); 2) establish comfort and rapport between participants and the remainder of the research team; 3) discuss participants' aspirations with regard to their drug administration experience (e.g., What do participants hope to gain from their experience?); 4) discuss the treatment rationale and putative mechanisms of action of psilocybin (e.g., insight and reorientation that boost motivation to quit and abstinence self-efficacy, reduction of withdrawal/craving secondary to mood improvement); 5) obtain a detailed personal history of the participant, with a focus on those factors contributing to their current difficulties; 6) prepare participants for drug administration, including a detailed account of all potential effects of the drug; 7) discuss all aspects of the drug administration protocol (i.e., logistics and procedures
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: January 13, 2014
Date Started: May 2015
Date Completion: May 2018
Last Updated: January 5, 2017
Last Verified: January 2017