In the largest and longest placebo-controlled treatment study of its kind, Yale researchers have found that the alcoholism drug naltrexone is not beneficial in treating alcoholism.
Published in today's issue of the New England Journal of Medicine, the three-year study looked at 627 alcohol-dependent veteran patients from 15 Department of Veterans Affairs Medical Centers. Patients were randomly assigned to placebo, short-term naltrexone and long-term naltrexone groups. All groups also received Twelve-Step Facilitation Counseling.
"This combination therapy did not result in a beneficial effect on the veterans," said principal investigator John Krystal, M.D., the Albert E. Kent Professor of Psychiatry at Yale School of Medicine. "It did not delay the relapse to alcohol use; it did not reduce the intensity of alcohol drinking; and it did not reduce the frequency of drinking."
Naltrexone is one of only two FDA-approved drugs to treat alcoholism in the United States. The other medication, antabuse, is frequently ineffective because of poor patient compliance. Naltrexone works by reducing the rewarding effects of alcohol. Past studies by the University of Pennsylvania and by Stephanie O'Malley, professor of psychiatry at Yale, suggested that naltrexone could be used in conjunction with psychotherapy in the treatment of alcoholism. Subsequent studies by other institutions also supported, to varying degrees, the efficacy of naltrexone.
Krystal and a co-author on the study, Robert Rosenheck, M.D., professor of psychiatry and in the Department of Epidemiology and Public Health at Yale School of Medicine, noticed that naltrexone wasn't being used much in the VA even though alcoholism was a prevalent problem among patients treated at VA medical centers.
"We proposed the study to show that naltrexone is an important and underutilized treatment for alcoholism," said Krystal. "This is an FDA-approved drug that many had hoped would revolutionize the treatment of alcoholism, but our data suggest that in the veteran population and in conjunction with the type of counseling provided in our study, naltrexone was not useful."
Krystal said the findings do not rule out the possibility that naltrexone may yet be helpful for some people. He cautioned that if individuals are receiving naltrexone for alcoholism and are finding it helpful, they should not stop their treatment, but naltrexone is clearly limited as a treatment for alcoholism and further research is needed to determine what, if any, role it might play.
Krystal said that a large, multi-center study is underway that will evaluate whether a higher dose of naltrexone (100 mg.) by itself or in combination with another anti-drinking medication in development called acamprosate, is effective in the treatment of alcoholism. The FDA-approved dose of naltrexone is 50 mg. That study is supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Researchers are also studying whether other medication combinations with naltrexone might be effective.
Other study authors include Joyce Cramer at Yale and William Krol and Gail Kirk of the VA Cooperative Studies Program Coordinating Center in Perry Point, Maryland.
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