Ondansetron for the Treatment of Cocaine Dependence - 1
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders; Drug Administration Schedule
Intervention: Ondansetron (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
John Roache, Ph.D., Principal Investigator, Affiliation: University of Texas
The purpose of this study is to assess the efficacy and safety of ondansetron to reduce
cocaine use in subjects with cocaine dependence.
Official title: Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Cocaine use
Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety
of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine
dependence and to determine the optimal dose of ondansetron.
Minimum age: 18 Years.
Maximum age: N/A.
Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking
Treatment for cocaine dependence; have ability to understand, having understood and provide
written consent; females of child bearing potential that use accepted method of birth
Additional criteria available during screening at the site.
Locations and Contacts
University of Texas Hlth Sci Ctr San Ant, San Antonio, Texas 78284 7828, United States
Starting date: May 2001
Ending date: December 2002
Last updated: February 8, 2007