drugset / Trial / NCT05781009
Pregnenolone for the Treatment of Alcohol Use Disorder
Phase 2
Recruiting
150 enrolled
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).
Timeline
- Start
- 2024-01-08
- Primary completion
- 2028-07-31
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pregnenolone | Other / unclassified | 300 mg | — |