COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Alcoholism
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 1375
- Locations
- 12
- Primary Endpoint
- Percent days abstinent
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percent days abstinent
Time to relapse to heavy drinking
Secondary Outcomes
- measures of drinking outcomes ((duration of abstinence, measures of frequency and intensity, et al.)
- psychological assessments
- quality of life
- measures of adverse experiences