naltrexone

Naltrexone for alcohol dependence

approved in 1995 by the Food and Drug Administration (FDA) for treatment of alcoholism,
with disulfiram (Antabuse) is one of only two medications approved for alcoholism treatment
reduced the pleasurable effects of alcohol, contributing to lower consumption and craving.
A recent study of 165 alcoholics conducted by Brown University researchers found that naltrexone in combination with coping-skills training helped to reduce the severity of or even prevent a relapse (see ADAW, Dec. 3).
alcoholics who have a family and are employed have a better prognosis than do those who live alone or are unemployed.

"But a new study conducted by researchers at the Department of Veterans Affairs (VA) Alcohol Research Center, Veterans Affairs Connecticut Healthcare System raises questions about the usefulness of naltrexone for treating chronic, severe alcoholic dependence in men.

"The study was published in the Dec. 13 issue of the New England Journal of Medicine.

"Previous studies found that naltrexone, marketed in this country ReVia, According to the researchers, subsequent studies found the drug less effective for treating alcohol dependence.

"This most recent study, however, involved a much larger sample than the Brown study had. The researchers randomly assigned 627 veterans with chronic, severe alcohol dependence to three different groups:

one group received naltrexone for 12 months;
the second group received naltrexone for three months followed by nine months with a placebo;
and the third group received a placebo for 12 months.

All patients received individual counseling and were encouraged to attend Alcoholics Anonymous (AA) meetings. Counseling was aimed at promoting abstinence.

Seventy-three percent of the patients completed the trial. In the first 13 weeks, researchers obtained data from 378 patients who received naltrexone and 187 patients who received placebo. They found no significant differences between the two groups in the period of time to relapse. There were also no differences between the groups in relapse rate, percentage of drinking days or number of drinks per drinking day.

At 52 weeks, there was no difference among the study's three groups in the percentage of drinking days or the number of drinks per drinking day.

According to the researchers, patients who were more compliant with their medication and attended more counseling or AA sessions had better outcomes, regardless of whether they took naltrexone or a placebo.

Analysis of the research data found that attending counseling sessions and attending AA meetings had the greatest effect on the number of drinking days, and compliance with medication had the greatest effect on the number of drinks per drinking day.

The researchers concluded that they did not detect an effect of naltrexone. Compared to placebo, naltrexone did not prevent or delay relapse to heavy drinking, reduce the number of drinking days, or decrease the amount of alcohol consumed during episodes of drinking.

The researchers concluded that their data do not support the treatment of alcohol dependence with naltrexone combined with a psychosocial treatment program in men with chronic, severe alcohol dependence.

Limitations of Study

The researchers do not rule out the possibility that a different dose of naltrexone or the use of other medications along with naltrexone might have been effective with their patients. The researchers also say that their results might not be generalizable to patients with less chronic or severe alcohol dependence, patients in non-VA settings, or women.

In an editorial accompanying the study article in the New England Journal of Medicine, Enoch Gordis, M.D., director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and Richard K. Fuller, director of NIAAA's Division of Clinical and Prevention Research, also point out that the study may not be generalizable to other people.

They point out that in general, alcoholics who have a family and are employed have a better prognosis than do those who live alone or are unemployed. Only one-third of the veterans in the study were married or living with a partner. One-third of the veterans were receiving a disability pension, indicating that they may not have been working.

Gordis and Fuller also theorize that in order to benefit from naltrexone, patients with more severe alcohol dependence may require more intensive counseling. They also cite the many successful clinical trials of the drug conducted in Europe.

The two NIAAA officials conclude that until more information is available, physicians should continue to prescribe naltrexone for patients who they think might benefit from it. Such patients appear to be those who have been drinking heavily for 20 years or less and have stable social support and living situations, Gordis and Fuller wrote.

The table below summarizes the major budget categories of interest to the addiction field.

- from "Study Raises Questions About Naltrexone's Effectiveness"