drugset / Trial / NCT01980706
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
Phase 2
Completed
120 enrolled
University of North Carolina, Chapel Hill
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.
Timeline
- Start
- 2013-12-12
- Primary completion
- 2017-10-26
- Completion
- 2017-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Baclofen | Small molecule | 30 mg | — |
| Comparator | Baclofen | Small molecule | 90 mg | — |