Conditions: Alcohol Dependence
Keywords: Alcohol Dependence Alcoholism Naltrexone Aripiprazole Substance Abuse
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 65
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: Naltrexone arm 3: Naltrexone + Aripiprazole

Interventions: intervention 1: Placebo intervention 2: Naltrexone intervention 3: Naltrexone + Aripiprazole
Intervention descriptions: intervention 1: placebo intervention 2: Naltrexone (25mg or 50 mg per titration schedule) intervention 3: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Protocol document: