Ritanserin in the treatment of alcohol dependence – a multi-center clinical trial (original) (raw)

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.

Access this article

Log in via an institution

Subscribe and save

• Starting from 10 chapters or articles per month
• Access and download chapters and articles from more than 300k books and 2,500 journals
• Cancel anytime View plans

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

Author information

Authors and Affiliations

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
   B. A. Johnson
2. Francis Scott Key Medical Center, Clinical Pharmacology, D. Building, 1 Center 4940 Eastern Avenue, Baltimore, MD 21224, USA, , , , , , TP
   Donald R. Jasinski
3. Haight-Ashbury Free Clinics Inc., 529 Clayton Street, San Francisco, CA 94117, USA, , , , , , US
   Gantt P. Galloway
4. Alcohol Research Center, Department of Psychiatry, University of Connecticut Health Center, Farmington, CT 06003, USA, , , , , , US
   Henry Kranzler
5. Treatment Research Center, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA, , , , , , US
   Robert Weinreib
6. Department of Psychiatry, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29424, USA, , , , , , US
   Raymond F. Anton
7. Alcohol Disorders Research Unit, University of Miami School of Medicine, 1400 NW 10th Avenue, Miami, FL 33136, USA, , , , , , US
   Barbara J. Mason
8. Department of Psychiatry, University of Wisconsin Medical School and W.S. Middleton Memorial Veterans Hospital, Madison, WI 53705, USA, , , , , , US
   Michael J. Bohn
9. University of Pennsylvania, Treatment Research Center, 3900 Chestnut Street, Philadelphia, PA 19104, USA, , , , , , US
   Helen M. Pettinati
10. Matrix Center, 12304 Santa Monica Boulevard, Suite 200, West Los Angeles, CA 90025, USA, , , , , , US
    Richard Rawson
11. Janssen Research Foundation, 1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, New Jersey, NJ 08560–0200, USA, , , , , , US
    Christopher Clyde

Authors

1. B. A. Johnson
2. Donald R. Jasinski
3. Gantt P. Galloway
4. Henry Kranzler
5. Robert Weinreib
6. Raymond F. Anton
7. Barbara J. Mason
8. Michael J. Bohn
9. Helen M. Pettinati
10. Richard Rawson
11. Christopher Clyde

Consortia

Ritanserin Study Group

Additional information

Received: 30 April 1996/Final version: 3 July 1996

Rights and permissions

About this article

Cite this article

Johnson, B., Jasinski, D., Galloway, G. et al. Ritanserin in the treatment of alcohol dependence – a multi-center clinical trial.Psychopharmacology 128, 206–215 (1996). https://doi.org/10.1007/s002130050126

Download citation

• Issue date: November 1996
• DOI: https://doi.org/10.1007/s002130050126