drugset / Trial / NCT01141049

Gabapentin for Abstinence Initiation in Alcohol Dependence

NCT01141049

Phase 2/3 Completed 40 enrolled New York State Psychiatric Institute
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Hypotheses: 1\. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method. Secondary Hypotheses: 1\. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.

Timeline

Start
2010-08
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule 1200 mg

Indications