Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Overview
- Phase
- Phase 2
- Intervention
- Bupropion
- Conditions
- Methamphetamine Dependence
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Enrollment
- 200
- Locations
- 12
- Primary Endpoint
- Number of Subjects Showing Abstinence
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Bupropion
Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Intervention: Bupropion
Placebo
Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Intervention: Placebo
Outcomes
Primary Outcomes
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
- Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use(30 days)