Researchers from the USA investigated the efficacy of naltrexone for the treatment of alcohol dependence.
Although the Food and Drug Administration has approved this opiate-receptor antagonist for the treatment of alcohol dependence, its efficacy is uncertain.
In the multicenter, double-blind, placebo-controlled trial, naltrexone was evaluated as an adjunct to standardized psychosocial treatment.
The researchers randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to one of three treatment regimens. The regimens followed were either 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.
There were 209 patients in each group; all had been sober for at least 5 days before randomization.
|Naltrexone did not improve:|
- Number of days to relapse
- Percentage of drinking days
- Number of drinks per drinking day
| New England Journal of Medicine |
At 13 weeks, the team 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).
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.
Dr John H. Krystal, of the Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, concluded on behalf of his group, "Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence."