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NCT01534494 · ClinicalTrials.gov registry record · Phase 2
Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
A Phase 2 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01534494: Completed Phase 2 study, sponsored by University of New Mexico.
NCT01534494 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534494, a Phase 2 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01534494 record still lists
NCT01534494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin is the first listed.
NCT01534494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01534494 about?
NCT01534494 is a clinical study titled "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. Participants will receive psilocybin ...
What is the current status of trial NCT01534494?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01534494?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT01534494?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01534494's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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