May 17, 2005 New Haven, Conn.-Long-acting injections of the drug naltrexone, combined with psychotherapy, significantly reduced heavy drinking in patients being treated for alcohol dependence, according to a study in the Journal of the American Medical Association by a Yale School of Medicine researcher.
"The decision to take medication can wane over time," said Stephanie O'Malley, professor of psychiatry and director of the Division of Substance Abuse Research at the Connecticut Mental Health Center at Yale. "This provides coverage for an entire month."
Acohol dependence ranks as the fourth leading cause of disability worldwide, as reported by the World Health Organization's Global Burden of Disease project. Nationwide, it is believed to contribute to more than 100,000 preventable deaths a year.
Naltrexone belongs to a class of drugs called opioid antagonists. Although many clinical trials have shown that oral naltrexone can be effective in treating alcohol dependence, its use in clinical practice has been limited, in part patients have to take the pill daily.
In this trial conducted at 24 sites, 627 alcohol dependent patients were randomly assigned to receive either an injection of long-acting naltrexone or a placebo injection; 624 ultimately received at least one injection. All participants received 12 counseling sessions during the six-month study in addition to the medication. Long-acting naltrexone was associated with a reduction in heavy drinking within the first month of treatment, and this response was maintained over the six month treatment period.
The lead author was James Garbult, M.D., of the University of North Carolina School of Medicine.
The study was funded by Alkermes Inc., a biotechnology company based in Cambridge, Mass., that manufactures the long acting naltrexone formulation.
Journal of the American Medical Association (April 6, 2005)
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