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AlcoholismPhase 3NCT00006206

COMBINE (Acamprosate/Naltrexone)

A Phase 3 study testing naltrexone (Revia) and acamprosate (Campral) in people with Alcoholism, run by University of North Carolina, Chapel Hill at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholism
What is being tested?
naltrexone (Revia) and acamprosate (Campral)
How many people
1,375 participants
Where
12 sitesUnited States
Study dates
Aug 1997to May 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following inclusion criteria are to be met:
  • Male and female outpatients > 18 years of age.
  • Participants will have a current DSM-IV diagnosis of alcohol dependence.
  • Participants will have signed a witnessed informed consent.
  • 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.
  • Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA < 8 prior to randomization.
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  • Participants can be abstinent for a maximum of 21 days prior to randomization.
  • Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period.
  • Participants who are able to identify at least one "locator" person to assist in tracking the participant for follow-up assessment.
  • Participants who are able to speak and understand English.

Who cannot join

  • The following exclusion criteria rule out participants:
  • Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder requiring medication.
  • Participants requiring concomitant therapy with any medications that pose safety issues (see Appendix B).
  • 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.
  • 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.
  • 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.
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  • 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.
  • 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.
  • 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.
  • Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico

    Albuquerque, New Mexico, 87106

  • Harvard University/McLean Hospital

    Belmont, Massachusetts, 02478

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Center for Alcohol Programs, Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • University of Wisconsin-Milwaukee

    Milwaukee, Wisconsin, 53233

  • Substance Abuse Treatment Unit, Yale University

    New Haven, Connecticut, 06511

  • Treatment and Research Center, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Roger Williams Medical Center , Brown University

    Providence, Rhode Island, 02908

  • Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center

    San Antonio, Texas, 78229

  • Addictions Treatment Center, University of Washington

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: 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.

Conditions
Alcoholism
Being tested
naltrexone (Revia), acamprosate (Campral)
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • naltrexone (Revia)Drug

  • acamprosate (Campral)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent days abstinent

  2. Time to relapse to heavy drinking

Secondary outcomes (4)

  1. measures of drinking outcomes ((duration of abstinence, measures of frequency and intensity, et al.)

  2. psychological assessments

  3. quality of life

  4. measures of adverse experiences

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2000 (estimated)
  2. Study startAug 1997
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
1,375 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006206
Sponsor's protocol ID
NIAAAComb
Other IDs
U10AA011721, U10AA011783, U10AA011715, U10AA011799, U10AA011773, U10AA011776, U10AA011777, U10AA011727
Status last verified
Nov 2007
First submitted
11 Sep 2000
Last updated
3 May 2010
Results posted
No

Publications

  • Johnson BA, O'Malley SS, Ciraulo DA, Roache JD, Chambers RA, Sarid-Segal O, Couper D. Dose-ranging kinetics and behavioral pharmacology of naltrexone and acamprosate, both alone and combined, in alcohol-dependent subjects. J Clin Psychopharmacol. 2003 Jun;23(3):281-93. doi: 10.1097/01.jcp.0000084029.22282.bb.

    PubMed 12826990

  • COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions for alcohol dependence (the COMBINE study): a pilot feasibility study. Alcohol Clin Exp Res. 2003 Jul;27(7):1123-31. doi: 10.1097/01.ALC.0000078020.92938.0B.

    PubMed 12878918

  • COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. Alcohol Clin Exp Res. 2003 Jul;27(7):1107-22. doi: 10.1097/00000374-200307000-00011.

    PubMed 12878917

  • Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, Longabaugh R, Mason BJ, Mattson ME, Miller WR, Pettinati HM, Randall CL, Swift R, Weiss RD, Williams LD, Zweben A; COMBINE Study Research Group. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006 May 3;295(17):2003-17. doi: 10.1001/jama.295.17.2003.

    PubMed 16670409

  • Acin MT, Rueda JR, Saiz LC, Parent Mathias V, Alzueta N, Sola I, Garjon J, Erviti J. Alcohol intake reduction for controlling hypertension. Cochrane Database Syst Rev. 2020 Sep 21;9(9):CD010022. doi: 10.1002/14651858.CD010022.pub2.

    PubMed 32960976

  • Falk DE, O'Malley SS, Witkiewitz K, Anton RF, Litten RZ, Slater M, Kranzler HR, Mann KF, Hasin DS, Johnson B, Meulien D, Ryan M, Fertig J; Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Psychiatry. 2019 Apr 1;76(4):374-381. doi: 10.1001/jamapsychiatry.2018.3079.

    PubMed 30865232

  • Zarkin GA, Bray JW, Aldridge A, Mitra D, Mills MJ, Couper DJ, Cisler RA; COMBINE Cost-Effectiveness Research Group. Cost and cost-effectiveness of the COMBINE study in alcohol-dependent patients. Arch Gen Psychiatry. 2008 Oct;65(10):1214-21. doi: 10.1001/archpsyc.65.10.1214.

    PubMed 18838638

  • Anton RF, Oroszi G, O'Malley S, Couper D, Swift R, Pettinati H, Goldman D. An evaluation of mu-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study. Arch Gen Psychiatry. 2008 Feb;65(2):135-44. doi: 10.1001/archpsyc.65.2.135.

    PubMed 18250251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing naltrexone (Revia) and acamprosate (Campral) in people with Alcoholism, run by University of North Carolina, Chapel Hill at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent days abstinent. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006206, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2010.

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