COMBINE (Acamprosate/Naltrexone)

This study has been completed.
Sponsor:
Collaborators:
Lipha Pharmaceuticals
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00006206
First received: September 11, 2000
Last updated: April 30, 2010
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Alcoholism
Drug: naltrexone (Revia)
Drug: acamprosate (Campral)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percent days abstinent
  • Time to relapse to heavy drinking

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

Estimated Enrollment: 1375
Study Start Date: August 1997
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006206

Locations
United States, Connecticut
Substance Abuse Treatment Unit, Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Massachusetts
Harvard University/McLean Hospital
Belmont, Massachusetts, United States, 02478
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New Mexico
Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, Pennsylvania
Treatment and Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Roger Williams Medical Center , Brown University
Providence, Rhode Island, United States, 02908
United States, South Carolina
Center for Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, Washington
Addictions Treatment Center, University of Washington
Seattle, Washington, United States, 98108
United States, Wisconsin
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Lipha Pharmaceuticals
Investigators
Study Chair: Ray Anton, M.D. Medical University of South Carolina
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00006206     History of Changes
Obsolete Identifiers: NCT00000453
Other Study ID Numbers: NIAAAComb, U10AA011721, U10AA011783, U10AA011715, U10AA011799, U10AA011773, U10AA011776, U10AA011777, U10AA011727, U10AA011716, U10AA011787, U10AA011768, U10AA011756
Study First Received: September 11, 2000
Last Updated: April 30, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Acamprosate
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Alcohol Deterrents

ClinicalTrials.gov processed this record on September 29, 2014