Ondansetron for the Treatment of Methamphetamine Dependence - 1

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • South Bay Treatment Center
      • Costa Mesa, California, United States, 92627
        • Matrix Institute on Addictions
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • John A. Burns School of Medicine
    • Iowa
      • Des Moines, Iowa, United States, 50316
        • Powell Chemical Dependency Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • University of Missouri - Kansas City
    • Texas
      • Houston, Texas, United States, 77225
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinicial improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

University of Texas

Investigators

  • Principal Investigator: Thomas Newton, M.D., National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

June 18, 2002

First Submitted That Met QC Criteria

June 17, 2002

First Posted (Estimate)

June 18, 2002

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTO-0011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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