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ohol dependence in previous studies, no large-scale randomized controlled study had evaluated whether combined drug treatment with or without behavioral therapy could improve outcome. In 2001, the National Institute on Alcohol Abuse and Alcoholism, part of the National Institutes of Health, launched "Combining Medications and Behavioral Interventions for Alcoholism" (COMBINE) to identify the most effective current treatments and treatment combinations.

The trial, conducted at 11 sites around the country from January 2001 to January 2004, recruited and randomly assigned 1,383 recently abstinent alcohol dependent patients.

Individuals were assigned to one of nine treatment groups. In eight of the nine groups, patients received what the paper called "medical management," attending sessions with a physician, nurse, physicians assistant, or pharmacist where these health care professionals reviewed the diagnosis, recommended abstinence and mutual-help participation, and reviewed patients' progress. Some groups also received pills: naltrexone (100 milligrams a day), acamprosate (3 grams a day), both naltrexone and acamprosate, or placebos. Four groups also received "Combined Behavioral Intervention (CBI)"-an alcohol counseling program with a behavioral specialist that was offered in up to 20 50-minute sessions. A ninth group received the specialized counseling, but no pills.

Patients were assessed during the 16 weeks of active treatment and one year after treatment.

Contrary to expectation, neither combining naltrexone with the medication acamprosate nor combining naltrexone with the program's specialized behavioral treatment provided an additive benefit to taking naltrexone alone.

Also contrary to expectation, the medication acamprosate was shown similar to placebo in this trial. Mason comments, "Previous studies have shown that acamprosate alone and in combination with naltrexone can work in settings that reflect clinical practic
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Contact: Keith McKeown
kmckeown@scripps.edu
858-784-8134
Scripps Research Institute
2-May-2006

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