PLACEBO-CONTROLLED TRIAL OF FLUOXETINE AS AN ADJUNCT TO RELAPSE PREVENTION IN ALCOHOLICS

Objective: The authors tested the hypothesis that fluoxetine, when use d in combination with relapse prevention psychotherapy, directly reduc es relapse frequency and severity for alcoholics. Method: The authors conducted a randomized, placebo-controlled trial of fluoxetine (up to a maximum of 60 mg/day) for 12 weeks in combination with weekly psycho therapy for 101 alcohol-dependent subjects who were not selected on th e basis of comorbid major depression. Outcomes were measured at the en d of treatment and 6 months after treatment. Results: Placebo-treated subjects were more compliant with the medication regimen and remained in the study longer than fluoxetine-treated subjects. There was signif icantly less alcohol consumption in both groups during treatment than before treatment. These effects persisted during the posttreatment per iod. Although fluoxetine treatment had no significant effects on alcoh ol consumption, it reduced Hamilton Depression Rating Scale scores mor e than placebo treatment among subjects with current major depression. Conclusions: Fluoxetine at a dose of 60 mg/day is probably not of use for relapse prevention in alcoholics with mild to moderate alcohol de pendence and no comorbid depression. In alcoholics with major depressi on, the drug may reduce depressive symptoms. Subsequent studies with f luoxetine should probably focus on more severely alcohol-dependent sub jects or those with comorbid depression.