Ritanserin in the treatment of alcohol dependence - A multi center clinical trial

被引:72
作者
Johnson, BA
Jasinski, DR
Galloway, GP
Kranzler, H
Weinreib, R
Anton, RF
Mason, BJ
Bohn, MJ
Pettinati, HM
Rawson, R
Clyde, C
机构
[1] FRANCIS SCOTT KEY MED CTR, BALTIMORE, MD 21224 USA
[2] HAIGHT ASHBURY FREE CLIN INC, SAN FRANCISCO, CA 94117 USA
[3] UNIV CONNECTICUT, CTR HLTH, DEPT PSYCHIAT, ALCOHOL RES CTR, FARMINGTON, CT 06003 USA
[4] UNIV PENN, TREATMENT RES CTR, PHILADELPHIA, PA 19104 USA
[5] MED UNIV S CAROLINA, DEPT PSYCHIAT, CHARLESTON, SC 29424 USA
[6] UNIV MIAMI, SCH MED, ALCOHOL DISORDERS RES UNIT, MIAMI, FL 33136 USA
[7] UNIV WISCONSIN, SCH MED, DEPT PSYCHIAT, MADISON, WI 53705 USA
[8] WILLIAM S MIDDLETON MEM VET ADM MED CTR, MADISON, WI 53705 USA
[9] MATRIX CTR, LOS ANGELES, CA 90025 USA
[10] JANSSEN RES FDN, TITUSVILLE, NJ 08560 USA
关键词
serotonin; (5-HT); ritanserin; 5-HT2; antagonist; alcoholism; clinical trial; multi-center; pharmacotherapy; humans;
D O I
10.1007/s002130050126
中图分类号
Q189 [神经科学];
学科分类号
071006 ;
摘要
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, ritanserin (2.5 mg/day or 5 mg/day), in reducing alcohol intake and craving. All subjects received 1 week of single-blind placebo prior to randomization into the 11-week double-blind phase. Additionally, all subjects received weekly individual sessions of manual-guided cognitive-behavioral therapy, Comparing the single-blind period with endpoint, there was approximately a 33% reduction in drinks/day; 34% fall in the total number of drinking days/week; 22% decrease in drinks/drinking day; and a 37% diminution in. alcohol craving for all treatment groups, All treatment groups experienced a beneficial clinical outcome as assessed by the Clinical Global Impression Scale, There was, however. no significant difference between treatment groups on any of these measures of alcohol drinking, craving, or clinical outcome, Subjects were of relatively high social functioning at baseline, and this did not change significantly during treatment, Treatment groups did not differ significantly on either medication compliance or reported adverse events, Ritanserin treatment was associated with a dose-related prolongation of subjects' QTc interval recording on the electrocardiogram, These results suggest that alcohol dependent subjects can show marked clinical improvement within a structured alcohol treatment program, These findings do not support an important role for ritanserin in the treatment of alcohol dependence.
引用
收藏
页码:206 / 215
页数:10
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