Topiramate for the Treatment of Methamphetamine Dependence - 1

NCT ID: NCT00345371

Last Updated: 2017-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Methamphetamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Topiramate

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

Group Type ACTIVE_COMPARATOR

Topiramate

Intervention Type DRUG

Placebo Oral Tablet

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Interventions

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Topiramate

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Topamax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bankole Johnson

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center

Locations

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Matrix Institute on Addictions

Costa Mesa, California, United States

Site Status

South Bay Treatment Center

San Diego, California, United States

Site Status

Torrance Site

Torrance, California, United States

Site Status

John A. Burns School of Medicine

Honolulu, Hawaii, United States

Site Status

Powell Chemical Dependency Center

Des Moines, Iowa, United States

Site Status

University of Missouri - Kansas City

Kansas City, Missouri, United States

Site Status

Salt Lake City VA Medical Center

Salt Lake City, Utah, United States

Site Status

UVA CARE

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22221594 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25495887 (View on PubMed)

Related Links

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Other Identifiers

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NIDA-CSP-1025-1

Identifier Type: -

Identifier Source: org_study_id

NCT00431652

Identifier Type: -

Identifier Source: nct_alias

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