Ondansetron for the Treatment of Cocaine Dependence - 1

This study has been completed.
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
First received: April 5, 2002
Last updated: July 21, 2008
Last verified: July 2008

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

Condition Intervention Phase
Cocaine-Related Disorders
Drug Administration Schedule
Drug: Ondansetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cocaine use

Estimated Enrollment: 60
Study Start Date: May 2001
Estimated Study Completion Date: December 2002
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00033085

United States, Texas
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
Principal Investigator: John Roache, Ph.D. University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00033085     History of Changes
Obsolete Identifiers: NCT00024726
Other Study ID Numbers: NIDA-CTO-0005-1
Study First Received: April 5, 2002
Last Updated: July 21, 2008
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Anti-Anxiety Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 13, 2015