drugset / Trial / NCT04322305
Pregabalin Trial for the Treatment of Alcohol Use Disorder
Phase 2
Suspended
50 enrolled
New York State Psychiatric Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
In a 10-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of pregabalin in the treatment of alcohol dependence will be studied in 50 treatment-seeking outpatients. Participants will report drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days.
Timeline
- Start
- 2021-01-11
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Outcome
Outcome not reported
Stopped (Enrollment): “U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 600 mg | — |