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NCT00033085 Clinical Trial

Ondansetron for the Treatment of Cocaine Dependence - 1

Cocaine-Related Disorders Clinical Trial

Official title:
Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00033085
Other study ID # NIDA-CTO-0005-1
Secondary ID
Status Completed
Phase Phase 2
First received April 5, 2002
Last updated January 11, 2017
Start date May 2001
Est. completion date December 2002

Study information
Verified date July 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers
  • NCT00024726

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ondansetron

Locations
Country Name City State
United States University of Texas Hlth Sci Ctr San Ant San Antonio Texas

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) University of Texas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cocaine use
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