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Ondansetron for the Treatment of Cocaine Dependence - 1

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ClinicalTrials.gov Identifier: NCT00033085
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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 2001
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Cocaine use


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033085


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

ClinicalTrials.gov Identifier: NCT00033085     History of Changes
Obsolete Identifiers: NCT00024726
Other Study ID Numbers: NIDA-CTO-0005-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2008

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
Ondansetron
Cocaine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
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
Anesthetics
Sensory System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents