At a glance
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An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
In Brief
A Phase 2 clinical trial evaluating Placebo, Naltrexone, and 1 other intervention for Alcohol Dependence. Completed, enrolled 65 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
placebo
Naltrexone (25mg or 50 mg per titration schedule)
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)