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Previous Volume 345:1734-1739 December 13, 2001 Number 24 Next

	Full Text PDF Editorial by Fuller, R. K. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Although naltrexone, an opiate-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, its efficacy is uncertain.

Methods We conducted a multicenter, double-blind, placebo-controlled evaluation of naltrexone as an adjunct to standardized psychosocial treatment. We randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to 12 months of naltrexone (50 mg once daily), 3 months of naltrexone followed by 9 months of placebo, or 12 months of placebo. All patients were offered individual counseling and programs to improve their compliance with study medication and were encouraged to attend Alcoholics Anonymous meetings.

Results There were 209 patients in each group; all had been sober for at least five days before randomization. At 13 weeks, we found no significant difference in the number of days to relapse between patients in the two naltrexone 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 groups in the percentage of days on which drinking occurred and the number of drinks per drinking day.

Conclusions Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence.

Source Information

From the Department of Veterans Affairs Alcohol Research Center, Veterans Affairs Connecticut Healthcare System, West Haven, Conn. (J.H.K., J.A.C., R.A.R.); the Department of Psychiatry, Yale University School of Medicine, New Haven, Conn. (J.H.K., J.A.C., R.A.R.); the Department of Veterans Affairs Cooperative Studies Program Coordinating Center, Perry Point, Md. (W.F.K., G.F.K.); and the Northeast Program Evaluation Center, Department of Veterans Affairs Connecticut Healthcare System, West Haven, Conn. (R.A.R.).

Address reprint requests to Dr. Krystal at the Alcohol Research Center (G7E), the Department of Veterans Affairs Connecticut Healthcare System, 950 Campbell Ave., West Haven, CT 06516-2770, or at john.krystal{at}yale.edu.

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