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.
Compound Psilocybin
Country Canada
Visit trial
Status
Completed
Results Published
Yes
Start date
01 January 2012
End date
01 March 2014
Chance of happening
100%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
10
Sex
All
Age
25- 65
Therapy
Yes
Trial Details
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.NCT Number NCT01534494
Sponsors & Collaborators
University of OttawaThe University of Ottawa launched The Psychedelics & Spirituality Studies Initiative (PSSI) in 2021. PSSI is an interdisciplinary group of faculty and graduate students who share a common interest in the study of psychedelics, spirituality and integrative healing.
Canadian Institutes of Health Research
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
The psychedelic debriefing in alcohol dependence treatment: illustrating key change phenomena through qualitative content analysis of clinical sessionsThis open-label pilot study (n=10) of psilocybin-assisted treatment of alcohol dependence (21mg/70kg) presents a qualitative content analysis of the 17 debriefing sessions conducted in the pilot study, which occurred the day after corresponding psilocybin medication sessions. Participants articulated a series of key phenomena related to change in drinking outcomes and acute subjective effects of psilocybin.
Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study
This open-label study (n=10) combined therapy with two psilocybin (21-28mg) sessions and showed a significant reduction in (heavy) drinking days up to 36 weeks later.