Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

Brief Summary

This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in recent studies. Psilocybin administration will occur in the context of a behavioral intervention including a total of 12 sessions over 12 weeks, incorporating Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before and debriefing after the psilocybin administration sessions. The MET will incorporate attention to spirituality as well as drinking behavior as a primary subject of change. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured during treatment and for 24 weeks after the end of treatment. The investigators hypothesize that drinking will decrease following the psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks vs. baseline) will be observed among study participants.

Intervention / Treatment

  • Drug: Psilocybin

Condition or Disease

  • Alcohol Dependence

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 25 Years to 65 Years   (Adult, Older Adult)
Enrollment: 10 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 01, 2012
Primary Completion: Sep 01, 2013
Completion Date: Mar 01, 2014
Study First Posted: Feb 16, 2012
Results First Posted: Aug 30, 2020
Last Updated: Feb 10, 2014

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 25
Maximum Age: 65

More Details

NCT Number: NCT01534494
Other IDs: Heffter-UNM-HSC-15671
Study URL: https://ClinicalTrials.gov/show/NCT01534494
Last updated: Jun 16, 2022