drugset / Trial / NCT00667875

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

NCT00667875

RandomizedFactorialQuadruple-blindTreatment

Summary

The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.

Timeline

Start
2008-04
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 15 mg
Comparator Naltrexone Small molecule 50 mg

Indications