Topiramate for the Treatment of Methamphetamine Dependence - 1

Phase 2

Completed

• Conditions: Methamphetamine
• Interventions: Drug: Placebo Oral Tablet; Drug: Topiramate

• Registration Number: NCT00345371
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Results First Submitted: 2017-01-03
• Results First Submitted QC: 2017-01-03
• Status Verified: 2017-02
• Results First Posted: 2017-02-23
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet	Placebo Oral Tablet	After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Topiramate	Topiramate	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.

Primary Outcome Measures

Name	Time	Method
Abstinence (Weeks 6 - 12)	weeks 6 through 12	The number of participants who abstained from methamphetamine from weeks 6 through 12

Secondary Outcome Measures

Name	Time	Method
Abstinence (Weeks 1 - 12)	Weeks 1 through 12	Number of participants who abstained from methamphetamine from weeks 1 through 12

Trial Locations

Locations (8)

Matrix Institute on Addictions; 🇺🇸 Costa Mesa, California, United States

John A. Burns School of Medicine; 🇺🇸 Honolulu, Hawaii, United States

University of Missouri - Kansas City; 🇺🇸 Kansas City, Missouri, United States

UVA CARE; 🇺🇸 Charlottesville, Virginia, United States

Salt Lake City VA Medical Center; 🇺🇸 Salt Lake City, Utah, United States

South Bay Treatment Center; 🇺🇸 San Diego, California, United States

Torrance Site; 🇺🇸 Torrance, California, United States

Powell Chemical Dependency Center; 🇺🇸 Des Moines, Iowa, United States