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NCT07296094 · ClinicalTrials.gov registry record · Phase 2
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT07296094: Clinical Trial Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT07296094 is a Phase 2 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07296094, a Phase 2 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).
Primary Outcome
Percent Heavy Drinking Days (PHDD) is defined as the percentage of days in which participants engage in heavy drinking, calculated using the Timeline Follow-Back (TLFB) method. Heavy drinking is defined using NIAAA criteria (≥4 drinks/day for women; ≥5 drinks/day for men). PHDD will be analyzed as a continuous outcome to compare change over time between the full-dose and low-dose psilocybin groups.
Interventions
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2030-02 |
| Phase | Phase 2 |
What is known before NCT07296094 opens enrollment
NCT07296094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin is the first listed.
NCT07296094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07296094 about?
NCT07296094 is a clinical study titled "Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder". This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured ps...
What is the current status of trial NCT07296094?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-06-15. Estimated completion is 2030-02.
What interventions are being tested in trial NCT07296094?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT07296094?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07296094's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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