New Combination of Treatments is Effective for Alcohol Dependence

McLean Hospital one of nationwide study sites to evaluate COMBINE

May 02, 2006

Public Affairs
Adriana Bobinchock
Laura Neves

Belmont, MA - 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 in the current issue (PubMed) of the Journal of the American Medical Association.

Results from the National Institutes of Health-supported Combining Medications and Behavioral Interventions for Alcoholism (COMBINE) study show 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 of the medication 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 and the results are promising," said Roger Weiss, MD, clinical director of the Alcohol and Drug Abuse Treatment Program for McLean Hospital, a Harvard Medical School affiliate. Weiss was also the principal investigator of COMBINE for the McLean study site.

COMBINE was conducted at academic sites nationwide, where 1383 recently abstinent alcohol dependent patients were recruited and randomly assigned to treatment groups. Patients in eight of the groups received medical management (MM), in which they attended sessions with a health professional (physician, nurse, physicians assistant or pharmacist) and received naltrexone (100 milligrams a day), acamprosate (3 grams a day), both naltrexone and acamprosate, or placebo pills. During the initial MM visit, health professionals reviewed the diagnosis, recommended abstinence and mutual-help participation, dispensed pills and in collaboration with the patients, developed a medication adherence plan.

In subsequent 20-minute sessions, they dispensed pills and reviewed patients' drinking, general function, medication adherence and any side effects. In addition to MM, four of the groups also received specialized alcohol counseling. Called Combined Behavioral Intervention (CBI), the counseling integrated cognitive-behavioral therapy, motivational enhancement and techniques to enhance mutual help group participation-all treatments shown in earlier studies to be beneficial. Patients assigned to CBI could receive up to 20 50-minute sessions in addition to MM; the median number actually received was 10 sessions. To test for any effects of pill taking (placebo), the researchers assigned some patients to a ninth group that received CBI, but no pills, and no more than four visits with a health professional for general medical advice.

After 16 weeks and then one-year of treatment, the researchers assessed the patients for the percentage of days abstinent (PDA) 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.

"We've successfully shown that structured medical management by a trained clinician is an effective treatment for alcohol dependence, when combined with naltrexone or specialized counseling," says Weiss. "If this is incorporated into primary care or mental health settings, it could vastly improve access to treatment for millions of people."

U.S. News & World Report consistently ranks McLean Hospital the nation's top psychiatric hospital. McLean is an affiliate of Harvard Medical School and Massachusetts General Hospital, and a member of Partners HealthCare.

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