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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00687713
First received: May 29, 2008
Last updated: February 14, 2017
Last verified: February 2017
May 29, 2008
February 14, 2017
May 2008
May 2011   (Final data collection date for primary outcome measure)
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.
Abstinence [ Time Frame: Weeks 11 and 12 ]
Complete list of historical versions of study NCT00687713 on ClinicalTrials.gov Archive Site
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.
Overall Reduction of Use (Sustained Abstinence) [ Time Frame: 21 days ]
Not Provided
Not Provided
 
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Methamphetamine Dependence
  • Drug: Bupropion
    150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
  • Other: Placebo
    Placebo
  • Active Comparator: 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: Drug: Bupropion
  • Placebo Comparator: 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: Other: Placebo
Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00687713
MDS Bupropion Meth 0001
Yes
Not Provided
Plan to Share IPD: No
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Study Chair: Jurij Mojsiak National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP