Topiramate for the Treatment of Methamphetamine Dependence - 1

February 23, 2017 updated by: National Institute on Drug Abuse (NIDA)

Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence

The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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
      • Costa Mesa, California, United States, 92627
        • Matrix Institute on Addictions
      • San Diego, California, United States, 92105
        • South Bay Treatment Center
      • Torrance, California, United States, 90502
        • Torrance Site
    • 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
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City VA Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • UVA CARE

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment seeking individuals as the time of the study
  • Must be able to proved written informed consent
  • Must have a body mass index greater than 18 kg/m(2)
  • Must meet DSM-IV criteria for methamphetamine dependence
  • Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
  • If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

  • Please contact the site for more information

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
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topiramate
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Drug: Topiramate
Other Names:
  • Topamax
Placebo Comparator: Placebo Oral Tablet
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence (Weeks 6 - 12)
Time Frame: weeks 6 through 12
The number of participants who abstained from methamphetamine from weeks 6 through 12
weeks 6 through 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence (Weeks 1 - 12)
Time Frame: Weeks 1 through 12
Number of participants who abstained from methamphetamine from weeks 1 through 12
Weeks 1 through 12

Collaborators and Investigators

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

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Bankole Johnson, VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CSP-1025-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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