RITANSERIN IN THE TREATMENT OF ALCOHOL DEPENDENCE - A MULTI CENTER CLINICAL-TRIAL

Four hundred and twenty-three alcohol dependent subjects were enrolled into a 12-week randomized, double-blind, placebo-controlled study to determine the safety and efficacy of the 5-HT2 receptor antagonist, ri tanserin (2.5 mg/day or 5 mg/day), in reducing alcohol intake and crav ing. All subjects received 1 week of single-blind placebo prior to ran domization into the 11-week double-blind phase. Additionally, all subj ects received weekly individual sessions of manual-guided cognitive-be havioral therapy, Comparing the single-blind period with endpoint, the re was approximately a 33% reduction in drinks/day; 34% fall in the to tal number of drinking days/week; 22% decrease in drinks/drinking day; and a 37% diminution in. alcohol craving for all treatment groups, Al l treatment groups experienced a beneficial clinical outcome as assess ed by the Clinical Global Impression Scale, There was, however. no sig nificant difference between treatment groups on any of these measures of alcohol drinking, craving, or clinical outcome, Subjects were of re latively high social functioning at baseline, and this did not change significantly during treatment, Treatment groups did not differ signif icantly on either medication compliance or reported adverse events, Ri tanserin treatment was associated with a dose-related prolongation of subjects' QTc interval recording on the electrocardiogram, These resul ts suggest that alcohol dependent subjects can show marked clinical im provement within a structured alcohol treatment program, These finding s do not support an important role for ritanserin in the treatment of alcohol dependence.