COMBINE (Acamprosate/Naltrexone)

April 30, 2010 updated by: University of North Carolina, Chapel Hill

COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Substance Abuse Treatment Unit, Yale University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Harvard University/McLean Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Treatment and Research Center, University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center , Brown University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Center for Alcohol Programs, Medical University of South Carolina
    • Texas
      • San Antonio, Texas, United States, 78229
        • Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center
    • Washington
      • Seattle, Washington, United States, 98108
        • Addictions Treatment Center, University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • University of Wisconsin-Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

The following inclusion criteria are to be met:

  1. Male and female outpatients > 18 years of age.
  2. Participants will have a current DSM-IV diagnosis of alcohol dependence.
  3. Participants will have signed a witnessed informed consent.
  4. Participants must have been drinking a minimum of > 14 drinks (females) or > 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and have two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
  5. Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA < 8 prior to randomization.
  6. Participants can be abstinent for a maximum of 21 days prior to randomization.
  7. Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period.
  8. Participants who are able to identify at least one "locator" person to assist in tracking the participant for follow-up assessment.
  9. Participants who are able to speak and understand English.

Exclusion criteria

The following exclusion criteria rule out participants:

  1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder requiring medication.
  2. Participants requiring concomitant therapy with any medications that pose safety issues (see Appendix B).
  3. Participants with a current diagnosis of dependence on any drug except for nicotine, cannabis, and alcohol, or habitual caffeine use. If there is a positive urine screen the participant can be retested after the (metabolic) interval appropriate to that drug. If the second urine drug screen is positive the person is excluded.
  4. Participants who meet DSM-IV criteria for opiate dependence or abuse within the past 6 months, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids.
  5. Participants who have significant medical disorders that will increase the potential risk of study treatment or interfere with study participation, and participants with sensitivity to study medications or related drugs as evidenced by adverse drug experience, especially with opiate-containing analgesics, opioid antagonists, or acamprosate.
  6. Participants with abnormal AST or ALT (more than 3 times the upper limit of the normal range(ULN)) or elevated bilirubin (more than 10% above the ULN). Tests may be repeated if initial results are out of range.
  7. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
  8. Participants who intend to engage in additional formal treatment for alcohol-related problems, or who intend to continue in current treatment for alcohol-related problems during the active treatment period. Self-help treatments are not considered formal treatment.
  9. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
  10. Participants who have prior use of study medication(s) in the last 30 days.

Any question concerning the interpretation of or application of the inclusion/exclusion criteria will be referred to the medical expert at the Coordinating Center. If he is unavailable, the question will be referred to the Chairperson of the Treatment Subcommittee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent days abstinent
Time to relapse to heavy drinking

Secondary Outcome Measures

Outcome Measure
quality of life
measures of drinking outcomes ((duration of abstinence, measures of frequency and intensity, et al.)
psychological assessments
measures of adverse experiences

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lipha Pharmaceuticals

Investigators

  • Study Chair: Ray Anton, M.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

September 11, 2000

First Posted (Estimate)

September 12, 2000

Study Record Updates

Last Update Posted (Estimate)

May 3, 2010

Last Update Submitted That Met QC Criteria

April 30, 2010

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAComb
  • U10AA011721 (U.S. NIH Grant/Contract)
  • U10AA011783 (U.S. NIH Grant/Contract)
  • U10AA011715 (U.S. NIH Grant/Contract)
  • U10AA011799 (U.S. NIH Grant/Contract)
  • U10AA011773 (U.S. NIH Grant/Contract)
  • U10AA011776 (U.S. NIH Grant/Contract)
  • U10AA011777 (U.S. NIH Grant/Contract)
  • U10AA011727 (U.S. NIH Grant/Contract)
  • U10AA011716 (U.S. NIH Grant/Contract)
  • U10AA011787 (U.S. NIH Grant/Contract)
  • U10AA011768 (U.S. NIH Grant/Contract)
  • U10AA011756 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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