Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: Results of a placebo-controlled trial

Objective: The opiate antagonist drug naltrexone has been shown in a few st udies with limited sample sizes to be effective when combined with psychoso cial therapies for the treatment of alcohol dependence. The goal of this st udy was to obtain additional information regarding its efficacy in pertinen t alcoholic populations and with a well-defined therapy. Method: In this st udy, 131 recently abstinent alcohol-dependent outpatients were treated with 12 weekly sessions of manual-guided cognitive behavioral therapy and eithe r 50 mg/day of naltrexone (N=68) or placebo (N=63) (with riboflavin added a s a marker of compliance) in a double-blind, randomized clinical trial. Alc ohol consumption, craving, adverse events, and urinary riboflavin levels we re assessed weekly. Levels of blood markers of alcohol abuse were also asce rtained during the trial, Results: The study completion, therapy participat ion, and medication compliance rates in the trial were high, with no differ ences between treatment groups. Naltrexone-treated subjects drank less, too k longer to relapse, and had more time between relapses. They also exhibite d more resistance to and control over alcohol-related thoughts and urges, a s measured by a subscale of the Obsessive Compulsive Drinking Scale. Over t he study period, 62% of the naltrexone group did not relapse into heavy dri nking, in comparison with 40% of the placebo group. Conclusions: Motivated individuals with moderate alcohol dependence can be treated with greater ef fectiveness when naltrexone is used in conjunction with weekly outpatient c ognitive behavioral therapy. Naltrexone increases control over alcohol urge s and improves cognitive resistance to thoughts about drinking. Thus, the t herapeutic effects of cognitive behavioral therapy and naltrexone may be sy nergistic.