McLEAN IN THE NEWS

New Combination of Treatments is Effective for Alcohol Dependence

June 30th, 2006

McLean Hospital researchers, along with colleagues from 11 other study sites nationwide, report that the medication naltrexone and up to 20 sessions of alcohol counseling delivered by a behavioral specialist are equally effective treatments for alcohol dependence when delivered with structured medical management. The findings are reported in the current issue (abstract) of the Journal of the American Medical Association. Roger Weiss, MD, clinical director of the Alcohol and Drug Abuse Treatment Program and colleagues reported on the study's outcome from the National Institutes of Health-supported Combining Medications and Behavioral Interventions for Alcoholism (COMBINE). The study shows that patients who received naltrexone, specialized alcohol counseling, or both, demonstrated the best drinking outcomes after 16 weeks of outpatient treatment. All patients also received Medical Management, an intervention that consisted of nine brief, structured outpatient sessions provided by a health care professional. Contrary to expectations, the researchers found no effect on drinking when subjects took acamprosate, and no additive benefit from adding acamprosate to naltrexone. This was the largest clinical trial looking at the effectiveness of pharmacologic and behavioral treatments for alcohol dependence ever conducted. COMBINE was conducted at academic sites nationwide, where 1383 recently abstinent alcohol dependent patients were recruited and randomly assigned to treatment groups.

After 16 weeks and then one-year of treatment, the researchers assessed the patients for the percentage of days abstinent from alcohol and time to the first heavy drinking day, defined as four or more drinks per day for women, and five or more drinks per day for men. In addition, they assessed the odds of good composite clinical outcome, defined as abstinence or moderate drinking without alcohol-related problems. As in other large clinical trials, the researchers found that most patients showed substantial improvement during treatment and that both the overall level of improvement and the differences between treatment groups diminished during the follow-up period. In the COMBINE study, however, naltrexone continued to show a small advantage for preventing relapse at one year after the end of active treatment.

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