This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Topiramate for the Treatment of Methamphetamine Dependence - 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00345371
First received: June 27, 2006
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Methamphetamine Drug: Topiramate Drug: Placebo Oral Tablet Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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


Enrollment: 140
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345371

Locations
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
UVA CARE
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Bankole Johnson VA Office of Research and Development
  More Information

Additional Information:
Publications:
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
Study First Received: June 27, 2006
Results First Received: January 3, 2017
Last Updated: February 23, 2017

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

Additional relevant MeSH terms:
Topiramate
Methamphetamine
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Central Nervous System Stimulants
Sympathomimetics
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

ClinicalTrials.gov processed this record on September 18, 2017