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Poor Results For Naltrexone In Alcoholism Study

Serious doubts have been raised about the use of naltrexone for men with chronic severe alcohol dependence.

A multicentre United States study has found no evidence that naltrexone in combination with psychosocial therapy is an effective treatment for this devastating condition.

This was a double-blind, placebo controlled evaluation of the drug as an adjunct to standardized psychosocial treatment.

John H. Krystal and colleagues from the Department of Veterans Affairs Alcohol Research Center, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, and other US centres did this work for the Veterans Affairs Naltrexone Cooperative Study 425 Group.

The Food and Drug Administration (FDA) approved naltrexone, an opioid-receptor antagonist, for treatment of ethanol dependence in 1995, in part on the basis of two well-designed single-site studies. Initial studies suggested the drug substantially increased sobriety and reduced ethanol consumption when combined with psychosocial treatment.

Until now, however, the efficacy of naltrexone for alcoholism has remained uncertain.

Participants in this study were 627 veterans (almost all of them men) with chronic, severe alcohol dependence. Researchers randomly assigned them to 12 months of naltrexone (50 mg once daily), three months of naltrexone followed by nine months of placebo or 12 months of placebo.

All patients were offered individual counselling and programs to improve their compliance with study medication and were encouraged to attend meetings of Alcoholics Anonymous.

There were 209 patients in each group; all had been sober for at least five days before randomisation.

At 13 weeks, there was no significant difference in the number of days to relapse between patients in the two naltrexone groups (mean, 72.3 days) and those in the placebo group (mean, 62.4 days).

At 52 weeks, there were no significant differences among the three groups in the percentage of days on which drinking occurred or in the number of drinkers per drinking day.

These findings thus do not support the use of naltrexone for the treatment of men with chronic severe alcohol dependence, the researchers conclude.

At the same time, the study authors suggest their findings do not rule out the possibility of using naltrexone in combination with other medications, other types of psychosocial interventions, or in other patients groups. If additional studies find naltrexone effective, it will be important to identify which patients are likely to benefit and which are not.

However, if no benefit is found, such results, coupled with those of this study, would weigh against use of naltrexone as an adjunctive treatment for alcoholism.

Meanwhile, doctors should continue to prescribe naltrexone for patients they consider might benefit from it; these patients appear to be those who have been drinking heavily for 20 years or fewer and have stable social support and living situations.
N Engl J Med 2001;345: 1734-9. "Naltrexone in the Treatment of Alcohol Dependence"

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