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Topiramate for the Treatment of Methamphetamine Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00345371
Recruitment Status : Completed
First Posted : June 28, 2006
Results First Posted : February 23, 2017
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Drug: Topiramate Drug: Placebo Oral Tablet Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence
Study Start Date : April 2006
Primary Completion Date : August 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Topiramate
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Drug: Topiramate
Other Name: 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

Outcome Measures

Primary Outcome Measures :
  1. Abstinence (Weeks 6 - 12) [ Time Frame: weeks 6 through 12 ]
    The number of participants who abstained from methamphetamine from weeks 6 through 12

Secondary Outcome Measures :
  1. Abstinence (Weeks 1 - 12) [ Time Frame: Weeks 1 through 12 ]
    Number of participants who abstained from methamphetamine from weeks 1 through 12

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345371

United States, California
Matrix Institute on Addictions
Costa Mesa, California, United States, 92627
South Bay Treatment Center
San Diego, California, United States, 92105
Torrance Site
Torrance, California, United States, 90502
United States, Hawaii
John A. Burns School of Medicine
Honolulu, Hawaii, United States, 96813
United States, Iowa
Powell Chemical Dependency Center
Des Moines, Iowa, United States, 50316
United States, Missouri
University of Missouri - Kansas City
Kansas City, Missouri, United States, 64108
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
United States, Virginia
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Bankole Johnson VA Office of Research and Development
More Information

Additional Information:
Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00345371     History of Changes
Obsolete Identifiers: NCT00431652
Other Study ID Numbers: NIDA-CSP-1025-1
First Posted: June 28, 2006    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017

Keywords provided by National Institute on Drug Abuse (NIDA):
methamphetamine addiction

Additional relevant MeSH terms:
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors