Ondansetron for the Treatment of Cocaine Dependence - 1

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033085

Purpose

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 II

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

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

Study placed in the following topic categories:

Cocaine-Related Disorders
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Ondansetron
Cocaine
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009