COMBINE (Acamprosate/Naltrexone)
- Conditions
- Alcoholism
- Registration Number
- NCT00006206
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1375
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Percent days abstinent Time to relapse to heavy drinking
- Secondary Outcome Measures
Name Time Method measures of drinking outcomes ((duration of abstinence, measures of frequency and intensity, et al.) psychological assessments quality of life measures of adverse experiences
Trial Locations
- Locations (12)
Substance Abuse Treatment Unit, Yale University
🇺🇸New Haven, Connecticut, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Harvard University/McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Treatment and Research Center, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Roger Williams Medical Center , Brown University
🇺🇸Providence, Rhode Island, United States
Center for Alcohol Programs, Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Scroll for more (2 remaining)Substance Abuse Treatment Unit, Yale University🇺🇸New Haven, Connecticut, United States