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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

Summary

The purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.

Clinical Details

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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 control

Exclusion Criteria:

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
Additional Information

Starting date: May 2001
Ending date: December 2002
Last updated: February 8, 2007

Page last updated: June 20, 2008

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