Ondansetron for the Treatment of Cocaine Dependence - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00033085
• Collaborator: University of Texas (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders; Drug Administration Schedule	Drug: Ondansetron	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence
• Study Start Date: May 1, 2001
• Study Completion Date: Dec 1, 2002

Outcome Measures

Primary Outcome Measures

1. Cocaine use []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Hlth Sci Ctr San Ant	San Antonio	Texas	United States	78284 7828

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)
• University of Texas

Investigators

• Principal Investigator: John Roache, Ph.D., University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00033085
• Other Study ID Numbers: NIDA-CTO-0005-1; NCT00024726
• First Posted: Apr 8, 2002
• Last Update Posted: Jan 12, 2017
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: cocaine dependence
• Additional relevant MeSH terms: Cocaine-Related Disorders; Ondansetron

Study Results

No Results Posted as of Jan 12, 2017