The medication naltrexone and up to 20 sessions of alcohol counseling by a behavioral specialist are equally effective treatments for alcohol dependence when delivered with structured medical management, according to results from "Combining Medications and Behavioral Interventions for Alcoholism" (The COMBINE Study). Results from the National Institutes of Health-supported 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 (MM), an intervention consisting 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. Effect of Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence appears in the current issue of the Journal of the American Medical Association,Volume 295, Number 17, pages 2003-2017.
NIH's National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched COMBINE in 2001 to identify the most effective current treatments and treatment combinations for alcohol dependence. The largest clinical trial ever conducted of pharmacologic and behavioral treatments for alcohol dependence, COMBINE was carried out at 11 academic sites that recruited and randomly assigned 1383 recently abstinent alcohol dependent patients to one of nine treatment groups "Combine Study Design" (see figure ro right). The following Image "Combine Study Design" displays Medical Management and Combined Behavioral Intervention Chart
Eight treatment groups received MM; four of these received naltrexone (100 milligrams a day), acamprosate (3 grams a day), both naltrexone and acamprosate, or placebo pills. The other four groups received in addition specialized alcohol counseling. Termed 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 the specialized alcohol counseling could receive up to twenty 50-minute sessions in addition to medical management; the median number received was 10 sessions. To test for any effects of pill taking (placebo), the researchers assigned some patients to a ninth group that received specialized alcohol counseling, but no pills, and no more than four visits with a health professional for general medical advice.
During the 16 weeks of treatment and 1 year after the treatment, the researchers assessed the patients for the percentage of days abstinent from alcohol and time to the first heavy drinking day, defined as 4 or more drinks per day for women and 5 or more drinks per day for men. They also assessed the odds of good 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 1 year after the end of active treatment. Specific findings from the COMBINE study are summarized at ( COMBINE Findings: Highlights).
"These results demonstrate that either naltrexone or specialized alcohol counseling--with structured medical management--is an effective option for treating alcohol dependence," said Mark L. Willenbring, M.D., Director, Division of Treatment and Recovery Research, NIAAA. "Although MM is somewhat more intensive than the alcohol dependence interventions offered in most of today's health care settings, it is not unlike other patient care models such as initiating insulin therapy in patients with diabetes mellitus. MM's application in primary care and general mental health care settings would expand access to effective treatment dramatically, while offering patients greater choice." To expand its application, NIAAA will develop an abbreviated version of MM to be available in early summer. Print copies of the treatment manuals used in COMBINE are available by order http://www.niaaa.nih.gov/publications/clinical-guides-and-manuals.
"The COMBINE results provide guidance for applying today's treatment tools. NIAAA continues to explore new treatment tools in more than 50 current medication trials, studies to better understand the mechanisms of action in behavioral treatments, and our search for new molecular targets and novel compounds for clinical testing," according to Raye Z. Litten, Ph.D., COMBINE's government director and co-leader of NIAAA medications development team.
COMBINE chairpersons Raymond F. Anton, M.D., Department of Psychiatry, Medical University of South Carolina, and Stephanie O'Malley, Ph.D., Yale University School of Medicine, and Drs. Willenbring and Litten discussed the COMBINE results in a news teleconference, held on May 1, 2006, from 1:00 to 2:00 PM.
For interviews with Drs. Anton and O'Malley, telephone 301/443-3860 through May 2. Otherwise, you may reach Drs. Anton and O'Malley and the other COMBINE Study Authors at their respective institutions. For interviews with Drs. Willenbring and Litten, please telephone the NIAAA Press Office, 301/443-3860.