COMBINE (Acamprosate/Naltrexone)

Phase 3

Completed

• 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

Study Timeline

• Study Start: 1997-08
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2000-09-11
• Study First Posted: 2000-09-12
• Study Completion: 2006-05
• Status Verified: 2007-11
• Last Update Submitted: 2010-04-30
• Last Update Posted: 2010-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1375

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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)

Harvard University/McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States

University of Wisconsin-Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Center for Alcohol Programs, Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Substance Abuse Treatment Unit, Yale University; 🇺🇸 New Haven, Connecticut, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Roger Williams Medical Center , Brown University; 🇺🇸 Providence, Rhode Island, United States

Addictions Treatment Center, University of Washington; 🇺🇸 Seattle, Washington, United States

Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States

Treatment and Research Center, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States