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Five-year study is largest clinical trial ever conducted of this kind
A new study reveals that patients who received either naltrexone, an anti-craving drug, and medical management or specialized alcohol counseling with medical management demonstrated a reduction of alcohol dependency after 16 weeks of outpatient treatment. Medical management (MM) is an intervention that consists of nine brief, structured outpatient sessions provided by a healthcare professional. Funded by the National Institute of Alcohol Abuse and Alcoholism (NIAAA), the study, titled "COMBINE" (Combining Medications and Behavioral Interventions for Alcoholism), is the largest clinical trial ever conducted of pharmacologic and behavioral treatments for alcohol dependence.
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| Zweben received his doctorate in social welfare from Columbia in 1977. |
Allen Zweben, associate dean for research and special projects, and professor of social work at the Columbia University School of Social Work, co-authored the study and was the principal investigator at the Center for Addiction and Behavioral Health Research (CABHR) in Milwaukee.
"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 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 five-year, multisite study appears in the May 3 issue of the Journal of the American Medical Association (JAMA).
COMBINE was launched by the NIAAA in 2001 to identify the most effective treatments for alcoholism. The study 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.
The study tested the efficacy of anticraving drugs naltrexone and acamprosate to determine whether success rates improved when the drugs are combined with each other or with special counseling. Acamprosate, typically used in similar studies and found effective in previous ones, was not effective in the COMBINE trial, and naltrexone did not work better in combination with acamprosate. However, the combination of naltrexone and medical management (MM) proved to be an effective treatment.
During the 16 weeks of treatment and one year after the treatment, researchers assessed 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 for men. They also assessed the odds of good clinical outcome, defined as abstinence or moderate drinking without alcohol-related problems. Results were consistent at both 16 weeks and one year following the end of treatment for naltrexone's effect on relapse. Overall, patients who received the specialized alcohol counseling along with medical management achieved a higher percentage of abstinent days.
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