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Completed

NCT Number: NCT00687713

Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Integrated Substance Abuse Program, Los Angeles, California, United States

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About this study

The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.

It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI
  • Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained
  • Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method
  • Must be willing and able to comply with study procedures
  • Must be able to verbalize and understand consent forms and provide written informed consent
  • Must be seeking treatment for methamphetamine dependence

Exclusion criteria

  • Please contact study site for more information

Treatment and study plan

bupropion

Drug

150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

Placebo

Other

Placebo

Primary outcomes

  1. Number of Subjects Showing Abstinence

    Time frame: Weeks 11 and 12

    The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.

Secondary outcomes

  1. Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use

    Time frame: 30 days

    The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 2, 2008
Registry last updated
Mar 21, 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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