Topiramate for the Treatment of Methamphetamine Dependence - 1

This study has been completed.

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

Sponsored by:	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

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Topiramate Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence

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

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Central Nervous System Stimulants
Neuroprotective Agents
Anti-Obesity Agents
Methamphetamine

Dopamine
Topiramate
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Anticonvulsants

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents

Pharmacologic Actions
Anti-Obesity Agents
Methamphetamine
Autonomic Agents
Therapeutic Uses
Topiramate
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009