Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

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.

Topic Addiction Alcohol Use Disorder
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 Ottawa
The 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 sessions
This 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.

Data attribution

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