News Release

Low-intensity therapy plus medication may provide
more accessible treatment for alcoholism: study

CHAPEL HILL - Low-intensity therapy offered by medical doctors, combined with either medication or specialized behavior therapy, can effectively treat alcoholism, making treatment more readily available to people who need it, according to a study conducted by researchers at the University of North Carolina at Chapel Hill and numerous other sites nationwide.

The study, conducted over the past five years and sponsored by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), appears in the current issue of the Journal of the American Medical Association. The NIAAA is a component of the National Institutes of Health.

The results show that medical doctors and other health-care professionals who prescribed the medication naltrexone and held nine brief sessions with the patient (called medical management) were as successful in treating alcohol dependence as when the patient also receives intensive behavioral counseling, for example, in an alcohol treatment facility. Medical doctors who held the nine sessions with patients but did not prescribe naltrexone were not as successful as those who did or as those whose patients also received more intensive behavioral counseling.

"Only about one-fourth of alcoholics get any treatment," said Dr. J.C. Garbutt, medical director of UNC Health Care's Alcohol and Substance Abuse Program, research scientist at the Bowles Center for Alcohol Studies and professor of psychiatry in UNC's School of Medicine.

"This study indicates that less intense treatment counseling combined with naltrexone really can make a difference for the alcoholic. Hopefully, this research will give primary-care physicians more confidence that they can make a difference for these patients; if so, then more patients will have access to treatment options."

The NIAAA launched the Combining Medications and Behavioral Interventions for Alcoholism (COMBINE) study 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.

After 16 weeks of treatment, all groups substantially reduced drinking during treatment. The overall percentage of days the patient was abstinent tripled, from 25 percent to 73 percent, and alcohol consumption per week decreased from 66 to 13 drinks, a decrease of 80 percent. Patients who received medical management from their health-care provider (such as an internist) and either took naltrexone or received specialized alcohol counseling had nearly double the chance to do well in controlling their alcohol use.

One year later, those taking naltrexone continued to show a small advantage of less relapse to heavy drinking, most markedly in patients who received medical management, but not in those who received specialized alcohol counseling.

"We are quite proud to have been a part of this study which will help individuals and their family members more easily find help for alcohol dependence," said Dr. James D. Hosking, a principal investigator of the study and associate director of the Collaborative Studies Coordinating Center (CSCC), part of the UNC School of Public Health's department of biostatistics.

"Many people, even in very rural areas, have access to a physician, but a specialized alcohol treatment facility may be quite far off. This study shows that a general internist and his or her staff can prescribe the medicines and provide the help many patients need to control alcohol dependence."

The CCSC was responsible for standardization, quality control, statistical analysis and data management for the study, as well as for providing monitoring of the clinical centers.

Contrary to investigators' expectations, neither combining naltrexone with the medication acamprosate nor combining medication and specialized behavioral therapy produced added benefit. Acamprosate, effective in many previous studies, did not show effectiveness in the COMBINE study.

"These results demonstrate that either naltrexone or specialized alcohol counseling - with structured medical management - is an effective option for treating alcohol dependence," said Dr. Mark L. Willenbring, director of the NIAAA's Division of Treatment and Recovery Research. "Although medical management 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.

"Medical management'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 the application of medical management, the NIAAA will develop an abbreviated version to be available in early summer. More information is available at www.niaaa.nih.gov.

Other institutions participating in the study were: the Medical University of South Carolina, Yale University School of Medicine, Boston University School of Medicine, the University of Wisconsin at Milwaukee, the University of Washington, the University of Virginia Health System, the University of Texas Health Science Center, Boston University School of Medicine, Brown University, the University of Miami School of Medicine, the University of New Mexico, the University of Pennsylvania, Harvard University and Columbia University.

Also participating in the study from UNC were Dr. Ed Davis, a biostatistics professor in the School of Public Health; Dr. Lisa LaVange, biostatistics professor and director of the Collaborative Studies Coordinating Center; Dr. David Couper, biostatistics research associate professor; and Marston Youngblood, project manager and staff biostatistician.

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Note: Contact Hosking at (919) 962-3085 or jim_hosking@unc.edu.

School of Public Health contact: Ramona DuBose, (919) 966-7467 or ramona_dubose@unc.edu