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Completed

NCT Number: NCT00520286

Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

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Key information

Conditions

Methamphetamine Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

South Bay Treatment Center, San Diego, California, United States

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About this study

To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be between the ages of 18 and 65
  • Methamphetamine dependent as defined by DSM-IV criteria
  • Must be in good general heath with a history of methamphetamine use at screening
  • Must be able to provide written informed consent
  • If female and of child bearing potential, must agree to use birth control.

Exclusion criteria

  • Please contact site for more information

Treatment and study plan

Modafinil

Drug

200 mg or 400 mg /daily

Placebo

Drug

Placebo / daily

Primary outcomes

  1. Abstinence (Week 1 - 12)

    Time frame: Weeks 1 - 12

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

Secondary outcomes

  1. Reduction of Craving

    Time frame: 21 days

    Number of subjects with 21 or more consecutive days of abstinence

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 24, 2007
Registry last updated
Apr 7, 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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