NCT00667875

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Placebo	placebo
DRUG	Naltrexone	Naltrexone (25mg or 50 mg per titration schedule)
DRUG	Naltrexone + Aripiprazole	Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-04-28
• Last updated: 2017-09-29
• Results posted: 2016-04-18

Locations

1 site across 1 country: United States