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Therapeutics
Naltrexone increased abstinence and reduced heavy drinking during treatment

https://doi.org/10.1136/ebm.12.1.20

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    Anton RF, O’Malley SS, Ciraulo DA, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA 2006;295:2003–17.
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 Q In people with alcohol dependence, is medical management with naltrexone, acamprosate, or both, with or without the addition of a combined behaviour intervention (CBI), effective for increasing abstinence or decreasing heavy drinking?

    Clinical impact ratings GP/FP/Mental health ★★★★★★☆ Psychiatry ★★★★★☆☆

    METHODS

    Embedded ImageDesign:

    randomised placebo controlled trial (Combined Pharmacotherapies and Behavioral Interventions [COMBINE] study).

    Embedded ImageAllocation:

    concealed.*

    Embedded ImageBlinding:

    blinded (patients, healthcare providers, research staff, and outcome assessors were blinded to medication assignment).*

    Embedded ImageFollow up period:

    16 weeks and 1 year.

    Embedded ImageSetting:

    11 academic sites in the US.

    Embedded ImagePatients:

    1383 patients (median age 44 y, 69% men) who met DSM-IV criteria for alcohol dependence, had been abstinent for 4–21 days, and consumed >14 (women) or >21 (men) drinks weekly with ⩾2 heavy drinking days (ie, ⩾4 drinks/d for women, ⩾5 drinks/d for men) during a consecutive 30 day period in the previous 90 days. Exclusion criteria included other substance abuse (except nicotine or cannabis) in the past 90 days, psychiatric disorder requiring medication, unstable medical conditions, and {certain medications that posed a safety risk}†.

    Embedded ImageIntervention:

    patients were allocated …

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    Footnotes

    • ↵* See glossary.

    • ↵†

      Alcohol Clin Exp Res2003;27:1107–22.
      OpenUrlCrossRefPubMedWeb of Science

    • ↵* Calculated from data in article.

    • For correspondence: Dr R F Anton, Medical University of South Carolina, Charleston, SC, USA. antonr{at}musc.edu

    • Source of funding: National Institute on Alcohol Abuse and Alcoholism.

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