Ritanserin in the treatment of alcohol dependence – a multi-center clinical trial |
| |
| Authors: | B A Johnson Donald R Jasinski Gantt P Galloway Henry Kranzler Robert Weinreib Raymond F Anton Barbara J Mason Michael J Bohn Helen M Pettinati Richard Rawson Christopher Clyde |
| |
| Institution: | (1) Clinical Laboratory, and Experimental Alcohol Research (C.L.E.A.R), University of Texas, Health Science Center at Houston, 1300 Moursund, Houston, TX 77030, USA, US;(2) Francis Scott Key Medical Center, Clinical Pharmacology, D. Building, 1 Center 4940 Eastern Avenue, Baltimore, MD 21224, USA, TP;(3) Haight-Ashbury Free Clinics Inc., 529 Clayton Street, San Francisco, CA 94117, USA, US;(4) Alcohol Research Center, Department of Psychiatry, University of Connecticut Health Center, Farmington, CT 06003, USA, US;(5) Treatment Research Center, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA, US;(6) Department of Psychiatry, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29424, USA, US;(7) Alcohol Disorders Research Unit, University of Miami School of Medicine, 1400 NW 10th Avenue, Miami, FL 33136, USA, US;(8) Department of Psychiatry, University of Wisconsin Medical School and W.S. Middleton Memorial Veterans Hospital, Madison, WI 53705, USA, US;(9) University of Pennsylvania, Treatment Research Center, 3900 Chestnut Street, Philadelphia, PA 19104, USA, US;(10) Matrix Center, 12304 Santa Monica Boulevard, Suite 200, West Los Angeles, CA 90025, USA, US;(11) Janssen Research Foundation, 1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, New Jersey, NJ 08560–0200, USA, US |
| |
| Abstract: | 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 23% 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.
Received: 30 April 1996/Final version: 3 July 1996 |
| |
| Keywords: | Serotonin (5-HT) Ritanserin 5-HT2 antagonist Alcoholism Clinical trial Multi-center Pharmacotherapy Humans |
| 本文献已被 SpringerLink 等数据库收录！ |
|
