Ondansetron for the Treatment of Cocaine Dependence - 1

Phase 2

Completed

• Conditions: Drug Administration Schedule; Cocaine-Related Disorders

• Registration Number: NCT00033085
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2002-04-05
• Study First Submitted QC: 2002-04-05
• Study First Posted: 2002-04-08
• Study Completion: 2002-12
• Status Verified: 2008-07
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cocaine use

Trial Locations

Locations (1)

University of Texas Hlth Sci Ctr San Ant; 🇺🇸 San Antonio, Texas, United States