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Completed

NCT Number: NCT00345371

Topiramate for the Treatment of Methamphetamine Dependence - 1

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.

Completed

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Matrix Institute on Addictions, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

Other names: Topamax

Placebo oral tablet

Drug

Primary outcomes

  1. Abstinence (Weeks 6 - 12)

    Time frame: weeks 6 through 12

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

Secondary outcomes

  1. Abstinence (Weeks 1 - 12)

    Time frame: Weeks 1 through 12

    Number of participants who abstained from methamphetamine from weeks 1 through 12

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 28, 2006
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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