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

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00687713

First received: May 29, 2008

Last updated: May 23, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 29, 2008
Last Updated Date	May 23, 2011
Start Date ^ICMJE	May 2008
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 29, 2008)	Abstinence [ Time Frame: Weeks 11 and 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00687713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 29, 2008)	Overall reduction of use (sustained abstinence) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Official Title ^ICMJE	Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Methamphetamine Dependence
Intervention ^ICMJE	Drug: Bupropion 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper. Other: Placebo Placebo
Study Arm (s)	Experimental: 1 Intervention: Drug: Bupropion Placebo Comparator: 2 Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00687713
Other Study ID Numbers ^ICMJE	MDS Bupropion Meth 0001
Has Data Monitoring Committee	Yes
Responsible Party	Liza Gorgon, National Institute on Drug Abust (NIDA)
Study Sponsor ^ICMJE	National Institute on Drug Abuse (NIDA)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute on Drug Abuse (NIDA)
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top