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Clinical Trials/NCT00006206
NCT00006206
Completed
Phase 3

COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions

University of North Carolina, Chapel Hill12 sites in 1 country1,375 target enrollmentAugust 1997

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.

Registry
clinicaltrials.gov
Start Date
August 1997
End Date
May 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

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

Study Sites (12)

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