Official Title: “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 18 or less days during the 30 days prior to the start of signing consent.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Bupropion
  • 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Abstinence
  • Time Frame: Weeks 11 and 12
    Safety Issue?: No

Secondary Measures

• Overall reduction of use (sustained abstinence)
  • Time Frame: 21 days
    Safety Issue?: No

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
• Must report using methamphetamine for 18 or less days during the 30 day period prior to the start orf screening 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687713

Study ID Number: MDS Bupropion Meth 0001

ClinicalTrials.gov Identifier: NCT00687713

Health Authority: United States: Food and Drug Administration