Topiramate for the Treatment of Methamphetamine Dependence - 1

Methamphetamine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345371
• Other study ID #: NIDA-CSP-1025-1
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2006
• Last updated: December 21, 2007
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00431652

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2007
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine

Intervention

Drug:
• Topiramate
100 mg

Locations

Country	Name	City	State
United States	UVA CARE	Charlottesville	Virginia
United States	Matrix Institute on Addictions	Costa Mesa	California
United States	Powell Chemical Dependency Center	Des Moines	Iowa
United States	John A. Burns School of Medicine	Honolulu	Hawaii
United States	University of Missouri - Kansas City	Kansas City	Missouri
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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence		weekly	No
Secondary	Safety		weekly	Yes
Secondary	Withdrawal		weekly	No
Secondary	Severity of methamphetamine dependence		weekly	No
Secondary	Methamphetamine Craving		weekly	No