title: A prospective, open-label trial of ondansetron in adolescents with alcohol dependence.
abstract: Ondansetron has been shown to be effective in the treatment of early-onset adult alcohol dependence. To date, no studies have been conducted in adolescents with alcohol dependence to assess the feasibility, safety, tolerability, and potential utility of ondansetron treatment. We conducted an 8-week, prospective, open-label study of ondansetron (4 microg/kg b.i.d.) in 12 adolescents who had alcohol dependence. Oral ondansetron was safe and well tolerated in our sample. Adverse events were mild and resolved quickly without intervention. No subjects discontinued due to adverse events. Intent-to-treat analyses showed a significant within-group decrease (improvement) for drinks/drinking day (t=-3.10, df=11, p=0.01), as well as decreases in drinks/day (t=-2.01, df=11, p=0.06) and percentage of days abstinent (t=1.45, df=11, p=0.18). These preliminary data suggest that ondansetron is safe and well tolerated in adolescents with alcohol dependence. Findings of decreased drinking underscore the need for future double-blind, placebo-controlled studies in this adolescent population.
authors.affiliation: START Center, Division of Alcohol and Drug Addiction, Department of Psychiatry, The University of Texas Health Science Center at San Antonio (UTHSCSA), 3939 Medical Drive, Suite 100, San Antonio, TX 78229-3900, USA. dawes@uthscsa.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Dawes
authors.forename: Bankole A
authors.initials: BA
authors.lastname: Johnson
authors.forename: Nassima
authors.initials: N
authors.lastname: Ait-Daoud
authors.forename: Jennie Z
authors.initials: JZ
authors.lastname: Ma
authors.forename: Jack R
authors.initials: JR
authors.lastname: Cornelius
mesh_terms: D000293:Adolescent; D000328:Adult; D000437:Alcoholism / Q000534:rehabilitation*; D015928:Cognitive Behavioral Therapy / Q000379:methods; D006801:Humans; D008297:Male; D017294:Ondansetron / Q000627:therapeutic use*; D010349:Patient Compliance; D011446:Prospective Studies; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D012702:Serotonin Antagonists; D017294:Ondansetron