Alcohol dependence is a major public health problem, which worldwide is the fourth leading cause of disability, according to background information in the article. Alcohol dependence is present in approximately 4 percent of the U.S. adult population, is common among primary care patients, and may contribute to more than 100,000 preventable deaths per year. The drug naltrexone has shown efficacy for treatment of alcohol dependence. However, adherence to daily oral doses can be problematic, and clinical acceptance and utility of oral naltrexone have been limited.
James C. Garbutt, M.D., of the University of North Carolina at Chapel Hill, N.C., and colleagues conducted a study to determine the efficacy and safety of a new formulation, which releases naltrexone for 1 month following a single injection, for treatment of alcohol dependence.
The 6-month, randomized, double-blind, placebo-controlled trial was conducted between February 2002 and September 2003 at 24 U.S. public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals screened, 627 who were diagnosed as being actively drinking alcohol-dependent adults were randomized to receive treatment and 624 received at least 1 injection. Participants received either an intramuscular injection of 380 mg. of long-acting naltrexone (n = 205), 190 mg. of long-acting naltrexone (n = 210), or a matching volume of placebo (n = 209), each administered monthly and combined with 12 sessions of low-intensity psychosocial intervention.
The researchers found that compared with placebo, 380 mg. of long-acting naltrexone resulted in a 25 percent decrease in the event rate of heavy drinki
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