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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) Identifier:
First received: April 5, 2002
Last updated: January 11, 2017
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 to 99 Years   (Adult, Senior)
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
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Please refer to this study by its 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 Identifier: NCT00033085     History of Changes
Obsolete Identifiers: NCT00024726
Other Study ID Numbers: NIDA-CTO-0005-1
Study First Received: April 5, 2002
Last Updated: January 11, 2017

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Anesthetics, Local
Sensory System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents processed this record on April 28, 2017