Naltrexone in the treatment of alcohol dependence.

Background: Although naltrexone, an opiate-receptor antagonist, has been ap proved by the Food and Drug Administration for the treatment of alcohol dep endence, its efficacy is uncertain. Methods: We conducted a multicenter, double-blind, placebo-controlled evalu ation of naltrexone as an adjunct to standardized psychosocial treatment. W e randomly assigned 627 veterans (almost all men) with chronic, severe alco hol dependence to 12 months of naltrexone (50 mg once daily), 3 months of n altrexone followed by 9 months of placebo, or 12 months of placebo. All pat ients were offered individual counseling and programs to improve their comp liance with study medication and were encouraged to attend Alcoholics Anony mous meetings. Results: There were 209 patients in each group; all had been sober for at l east five days before randomization. At 13 weeks, we found no significant d ifference in the number of days to relapse between patients in the two nalt rexone groups (mean, 72.3 days) and the placebo group (mean, 62.4 days; 95 percent confidence interval for the difference between groups, -3.0 to 22.8 ). At 52 weeks, there were no significant differences among the three group s in the percentage of days on which drinking occurred and the number of dr inks per drinking day. Conclusions: Our findings do not support the use of naltrexone for the trea tment of men with chronic, severe alcohol dependence. (N Engl J Med 2001;34 5:1734-9.) Copyright (C) 2001 Massachusetts Medical Society.