Ondansetron for the Treatment of Cocaine Dependence - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

July 21, 2008

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cocaine use

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00033085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ondansetron for the Treatment of Cocaine Dependence - 1

Official Title ^ICMJE

Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Cocaine-Related Disorders
Drug Administration Schedule

Intervention ^ICMJE

Drug: Ondansetron

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00033085

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CTO-0005-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Principal Investigator:

John Roache, Ph.D.

University of Texas

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP