The Pharmaceutical Journal Vol 267 No 7178 p839-846
15 December 2001

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Naltrexone use for alcohol dependence not supported

New data do not support the use of naltrexone, as an adjunct to psychosocial treatment, for the treatment of men with chronic, severe alcohol dependence, American researchers say. Naltrexone, an opioid-receptor antagonist, has been approved for the treatment of alcohol dependence in the United States by the Food and Drug Administration.

Dr John Krystal, Department of Veterans Affairs Alcohol Research Centre, West Haven, Connecticut, and colleagues randomly assigned 627 veterans (mainly men) with chronic, severe alcohol dependence to one of three treatment groups: naltrexone once daily for 12 months; naltrexone once daily for three months followed by placebo for nine months; or placebo for 12 months. Patients receiving naltrexone started with a dose of 25mg once daily for two days and then 50mg once daily for the remainder of the assigned treatment period.

Compared with placebo, naltrexone did not prevent or delay relapse to heavy drinking. It also did not reduce the number of drinking days or decrease the amount of alcohol consumed during episodes of drinking. The researchers conclude that their data raise doubts about the current use of naltrexone for patients with chronic, severe alcohol dependence. However, they add: "Our findings do not rule out the possibility that naltrexone in combination with other medications or with other types of psychosocial interventions, or in other patient groups, may have a role in the treatment of alcoholism" (The New England Journal of Medicine 2001;345:1734).

A spokeswoman for Bristol-Myers Squibb Pharmaceuticals told The Journal that naltrexone is licensed in 14 European countries for the treatment of alcohol dependency, under the trade name ReVia. However, there are no plans for the company to submit an application for such a licence in the United Kingdom.

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