A study in the current Archives of General Psychiatry (Volume 56, pages 719-724) shows that nalmefene, an opioid antagonist that is not now commercially available in the oral form studied, is effective in preventing relapse to heavy drinking in alcohol dependent individuals. Barbara J. Mason, Ph.D., and colleagues at the University of Miami School of Medicine found from a 12-week double-blind, placebo-controlled clinical trial that patients who received nalmefene were 2.4 times less likely to relapse to heavy drinking than those who received a placebo.
"This study again demonstrates the promise of pharmacologic agents to work with standard behavioral treatments in the treatment of alcoholism. Prospects for improving treatment outcome have never been better," said Enoch Gordis, M.D., Director, National Institute on Alcohol Abuse and Alcoholism, a component of the National Institutes of Health.
Naltrexone, another opioid antagonist that is selective for the mu receptor, was approved by the U.S. Food and Drug Administration in 1994 for use in alcoholism treatment. The newer nalmefene is a "universal" opioid antagonist that works on all opioid receptors.
Men and women aged 18-65 years who met Diagnostic and Statistical Manual, Third Edition, Revised criteria for alcohol dependence participated in the study. Dr. Mason and her colleagues randomly assigned 105 of the 162 individuals screened to oral nalmefene at a dose of either 20 mg or 80 mg per day, or to placebo. All patients received professionally delivered, manual-guided, cognitive-behavioral therapy designed to increase their ability to avoid or cope with high-risk situations that can precipitate drinking.
The researchers found no significant differences between the 20 mg and 80 mg
nalmefene groups and, therefore, presented their results as nalmefene versus
placebo comparisons. Although one-third of the nalmefene patients relapsed to
heavy drinking at least once during the 12-week trial, sign
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Contact: Ann Bradley
abradley@willco.niaaa.nih.gov
301-443-3860
NIH/National Institute on Alcohol Abuse and Alcoholism
30-Aug-1999