Evidence for the efficacy of naltrexone in the treatment of alcohol dependence

Each year, more than 1.5 million Americans seek treatment for alcohol-related problems. In 1994, naltrexone became only the second drug approved to date for treating alcoholism by the U.S. FDA. Naltrexone blocks opioid receptors in the brain, stemming the endorphin-mediated reinforcing effects of drinking alcohol. Recognizing that healthcare providers need credible scientific information for decision-making purposes when considering phar-macotherapies for alcoholism, such as naltrexone, this report focuses on the highest level of clinical evidence — randomized con-trolled trials (RCTs). Through year 2001 there were 14 RCTs assessing the effectiveness of naltrexone compared with placebo for treating alcoholism, enrolling 2127 subjects, in five countries. An analysis of these trials, consistent with prior systematic reviews and meta-analyses, concludes: A) RCTs of naltrexone in the treatment of alcoholism are recent, extensive, and of good quality, B) There is strong evidence that naltrexone significantly reduces alcohol relapses to heavy drinking, the frequency and quantity of alcohol consumption in those who do drink, and alcohol craving. In brief, naltrexone is significantly beneficial in helping those patients who cannot remain abstinent to reduce their drinking behaviors, breaking the vicious, self-destructive cycle in alcoholics whereby one drink leads to another, and allowing more quality time for psychosocial therapy to be productive. Naltrexone has demon-strated effectiveness in a variety of alcohol-treatment settings using adjunctive psychosocial therapies that provide motivation to stay in treatment, avoid relapses, and take medications. Individualized, flexible naltrexone dosing can be of benefit. Longer-term naltrexone therapy extending beyond three months may be most effective, and naltrexone might be used on an as-needed, Òtargeted,Ó basis indefinitely. It is expected that the infor-mation in this report will help healthcare providers to better use this effective medication