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

Tracking Information

First Received Date ^ICMJE

June 18, 2002

Last Updated Date

July 21, 2008

Start Date ^ICMJE

June 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinicial improvement

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00040053 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 Methamphetamine Dependence - 1

Official Title ^ICMJE

Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.

Brief Summary

The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

Detailed Description

This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison

Condition ^ICMJE

Amphetamine-Related Disorders

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

154

Completion Date

February 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

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

NCT00040053

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CTO-0011-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Principal Investigator:

Thomas Newton, M.D.

National Institute on Drug Abuse (NIDA)

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