Results of National NIH Study Released in JAMA

May 2, 2006 @ 4:00 am

Naltrexone or Specialized Counseling an Effective Treatment for Alcoholism

May 2, 2006

New York, NY – The results of a five-year, multi-site study funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is released in the current issue of the Journal of the American Medical Association (JAMA).

COMBINE (“Combining Medications and Behavioral Interventions for Alcoholism”) was launched by the NIAAA 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 1,383 recently abstinent alcohol dependent patients to one of nine treatment groups. Dr. Allen Zweben, Associate Dean of Research and Professor at the Columbia University School of Social Work, was the Principal Investigator for the study at the Center for Addiction and Behavioral Health Research (CABHR) in Milwaukee, Wisconsin. According to the NIAAA, Milwaukee is a preferred site for clinical trials with alcoholics because the area has a large population of heavy drinkers.

“Our data from the COMBINE study underscore the importance of having treatment options for alcohol patients, including naltrexone or specialized alcohol counseling with medical management,” said Dr. Zweben. “The findings are particularly relevant to social workers, psychologists, and other behavioral specialists – many of whom see large numbers of individuals with alcohol problems in various settings. An important next step would be to develop an alcohol education curriculum that would incorporate the findings from the COMBINE study.”

The study tested the efficacy of two “anti-craving drugs” – naltrexone and acamprosate – to determine whether success rates improved when the drugs are combined with each other or with special counseling. During the 16 weeks of treatment and 1 year after the 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 4 or more drinks per day for women and 5 or more drinks per day for men. In addition, they 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.

Results from the COMBINE study showed 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 that consisted of nine brief, structured outpatient sessions provided by a health care professional.

More specifically, COMBINE showed that:

  1. Structured medical management by health care providers, plus either naltrexone or up to 20 sessions of specialized alcohol counseling produced the best outcomes in treating alcohol dependence. The effect was clearest after 16 weeks of treatment, but some benefit was seen one year later.
  2. After 16 weeks of treatment, compared to study entry, percentage days abstinent nearly tripled, from 25% to 73% and weekly drinking dropped 80%. After one year, about one-half of patients had good overall clinical outcomes.
  3. Contrary to expectation, there was no added benefit to combining naltrexone and specialized counseling in combination with medical management.
  4. Acamprosate, found effective in previous studies, was not effective in the COMBINE trial and naltrexone did not work better when combined with acamprosate.
  5. Results were consistent at both 16 weeks and 1 year following the end of treatment for naltrexone’s effect on relapse. Overall, patients who received the behavioral treatment achieved a higher percentage of abstinent days.

“These results demonstrate that either naltrexone or specialized alcohol counseling in the context of medical management is an effective option for treating alcohol dependence,” said Mark L. Willenbring, M.D., Director, Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism (NIAAA). “Currently, about 9 in 10 patients with alcohol dependence do not receive professional treatment. Medical management is a strategy that could be implemented in a variety of health care settings, such as primary care and general mental health care. This would expand access to effective treatment dramatically, while offering patients greater choice.”

To read the study (PDF),Click here.