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New hope for the alcoholic.

On January 17, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) announced FDA approval of naltrexone, a drug used since the early '70s to treat heroin addiction, for use as "a safe and effective adjunct to psychosocial treatments for alcoholism."

The NIAAA estimates that more than one third of adult Americans have experience of alcoholism or alcohol abuse in their families. Some 15.3 million adult Americans are alcohol-dependent. Approximately 5 percent of all deaths in the United States can be attributed in some way to alcohol, many of them in automobile accidents. Experts estimate that 50 percent of all automobile fatalities involve the use of alcohol. The estimated cost of alcoholism and alcohol abuse in this country is a staggering $98.6 billion.

Treatment of alcoholism has been a notoriously difficult process. An article in the November 1992 Archives of General Psychiatry states, "Alcoholism is the most prevalent psychiatric syndrome in the U.S. adult population." The authors added, "In a large multicenter controlled study, disulfiram, the only medication specifically approved for treatment of alcoholism, was found to be no better than no medication at all in affecting, rates of abstinence, time to first drink, employment, or social stability."

Alcoholism results from a complex interplay of genetic and environmental influences, and the traditional treatment has been comprehensive rehabilitation services. Overall, reports of alcohol rehabilitation programs show about a 50 percent relapse rate within the first three months. Even in some of the more successful programs, such as Alcoholics Anonymous, there have been many failures.

Researchers have tried many different drugs to treat the disease; only one - disulfiram - seemed to show significant results. Introduced 40 years ago, the drug blocks the metabolism of alcohol, producing, chemical substances that produce nausea and other unpleasant physical symptoms. The anticipation of such symptoms presumably deters patients from drinking. As the article cited above shows, however, it has not been a notably successful adjunct to therapy.

FDA approval of naltrexone - marketed as Trexan by its manufacturer, the DuPont Merck Pharmaceutical Company - results from controlled studies funded by the NIAAA at major U.S. medical centers. When used with comprehensive treatment programs, the drug, reduced the usual relapse rate by half. Less than one quarter of the subjects reverted to drinking; among those who did continue to drink, only half drank heavily.

Says the NIAAA, "While not a `magic bullet,' naltrexone promises to help many patients in their struggle against a chronic relapsing disease. Identification of this pharmacological treatment builds momentum to elucidate the myriad, complex brain mechanisms of alcohol addiction." However, Dr. Richard K. Fuller, director of research at the NIAAA, warns, "For now, at least, only physicians familiar with addiction treatment probably should prescribe naltrexone, and only in the context of an alcoholism treatment program."
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Title Annotation:adapted from the Archives of General Psychiatry, November 1992; FDA approves marketing of naltrexone
Publication:Medical Update
Date:Mar 1, 1995
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