Ondansetron for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00033085

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2002-12-31

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.

Conditions

Cocaine-Related Disorders; Drug Administration Schedule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ondansetron

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Principal Investigators

John Roache, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Hlth Sci Ctr San Ant

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NIDA-CTO-0005-1

Identifier Type: -

Identifier Source: org_study_id

NCT00024726

Identifier Type: -

Identifier Source: nct_alias