drugset / Trial / NCT00183196
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Phase 3
Completed
150 enrolled
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.
Timeline
- Start
- 2003-01
- Primary completion
- 2008-12
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gabapentin | Small molecule | 1200 mg | — |
| Comparator | Naltrexone | Small molecule | 50 mg | — |