NCT00345371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

March 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

June 27, 2006

Results QC Date

January 3, 2017

Last Update Submit

February 23, 2017

Conditions

Methamphetamine

Keywords

methamphetamine addiction

Outcome Measures

Primary Outcomes (1)

  • Abstinence (Weeks 6 - 12)

    The number of participants who abstained from methamphetamine from weeks 6 through 12

    weeks 6 through 12

Secondary Outcomes (1)

  • Abstinence (Weeks 1 - 12)

    Weeks 1 through 12

Study Arms (2)

Topiramate

ACTIVE COMPARATOR

Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.

Drug: Topiramate

Placebo Oral Tablet

PLACEBO COMPARATOR

After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.

Drug: Placebo Oral Tablet

Interventions

TopiramateDRUG
Also known as: Topamax
Topiramate
Placebo Oral TabletDRUG
Placebo Oral Tablet

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Please contact the site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Matrix Institute on Addictions

Costa Mesa, California, 92627, United States

Location

South Bay Treatment Center

San Diego, California, 92105, United States

Location

Torrance Site

Torrance, California, 90502, United States

Location

John A. Burns School of Medicine

Honolulu, Hawaii, 96813, United States

Location

Powell Chemical Dependency Center

Des Moines, Iowa, 50316, United States

Location

University of Missouri - Kansas City

Kansas City, Missouri, 64108, United States

Location

Salt Lake City VA Medical Center

Salt Lake City, Utah, 84148, United States

Location

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

Related Publications (2)

  • Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.

    PMID: 22221594BACKGROUND

  • Li MD, Wang J, Niu T, Ma JZ, Seneviratne C, Ait-Daoud N, Saadvandi J, Morris R, Weiss D, Campbell J, Haning W, Mawhinney DJ, Weis D, McCann M, Stock C, Kahn R, Iturriaga E, Yu E, Elkashef A, Johnson BA. Transcriptome profiling and pathway analysis of genes expressed differentially in participants with or without a positive response to topiramate treatment for methamphetamine addiction. BMC Med Genomics. 2014 Dec 12;7:65. doi: 10.1186/s12920-014-0065-x.

    PMID: 25495887DERIVED

Related Links

MeSH Terms

Interventions

Topiramate

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Results Point of Contact

Title
Liza Zeinert
Organization
National Institute on Drug Abuse
liza.zeinert@nih.gov
301-443-1138

Study Officials

  • Bankole Johnson

    VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

March 27, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-02

Locations

US(8)