NCT00006206

COMBINE (Acamprosate/Naltrexone)

COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,375 (planned)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	naltrexone (Revia)
DRUG	acamprosate (Campral)

Timeline

• Start date: 1997-08-01
• Completion: 2006-05-01
• First posted: 2000-09-12
• Last updated: 2010-05-03

Locations

12 sites across 1 country: United States