Topiramate for the Treatment of Methamphetamine Dependence - 1

This study has been completed.

First Received on June 27, 2006. Last Updated on December 21, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00345371

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	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Topiramate Amphetamine Methamphetamine

U.S. FDA Resources

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

Primary Outcome Measures:

Abstinence [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Withdrawal [ Time Frame: weekly ] [ Designated as safety issue: No ]
Severity of methamphetamine dependence [ Time Frame: weekly ] [ Designated as safety issue: No ]
Methamphetamine Craving [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	April 2006
Study Completion Date:	December 2007
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Topiramate 100 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Department of Veterans Affairs

More Information

No publications provided

Responsible Party:	Liza Gorgon, National Institute on Drug Abuse
ClinicalTrials.gov Identifier:	NCT00345371 History of Changes
Obsolete Identifiers:	NCT00431652
Other Study ID Numbers:	NIDA-CSP-1025-1
Study First Received:	June 27, 2006
Last Updated:	December 21, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Topiramate
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 12, 2012