Topiramate for the Treatment of Methamphetamine Dependence - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

June 27, 2006

Last Updated Date

December 21, 2007

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Abstinence

Change History

Complete list of historical versions of study NCT00345371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Safety
Withdrawl
Severity of methamphetamine dependence
Methamphetamine Craving

Descriptive Information

Brief Title ^ICMJE

Topiramate for the Treatment of Methamphetamine Dependence - 1

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Methamphetamine

Intervention ^ICMJE

Drug: Topiramate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

140

Completion Date

December 2007

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00345371

Responsible Party

Liza Gorgon, National Institute on Drug Abuse

Study ID Numbers ^ICMJE

NIDA-CSP-1025-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bankole Johnson

Department of Veterans Affairs

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP