|Naltrexone or Specialized Alcohol Counseling an Effective
Treatment for Alcohol Dependence When Delivered with Medical Management
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
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
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
"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 from http://www.niaaa.nih.gov/Publications/EducationTrainingMaterials.
“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, in studies to better understand the mechanisms of action in behavioral
treatments, and in 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 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.
The National Institute on Alcohol Abuse and Alcoholism, part of the National
Institutes of Health, is the primary U.S. agency for conducting and supporting
research on the causes, consequences, prevention, and treatment of alcohol
abuse, alcoholism, and alcohol problems and disseminates research findings
to general, professional, and academic audiences. Additional alcohol research
information and publications are available at www.niaaa.nih.gov.
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. It is the primary federal
agency for conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit www.nih.gov.