Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
1 other identifier
interventional
200
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2008
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
February 15, 2017
CompletedMarch 21, 2017
February 1, 2017
3 years
May 29, 2008
December 22, 2016
February 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Showing Abstinence
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.
Weeks 11 and 12
Secondary Outcomes (1)
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
30 days
Study Arms (2)
Bupropion
ACTIVE COMPARATORSubjects 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.
Placebo
PLACEBO COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Please contact study site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCLA Integrated Substance Abuse Program
Los Angeles, California, 90025, United States
South Bay Treatment Center
San Diego, California, 92115, United States
Addiction and Pharmacology Research Laboratory
San Francisco, California, 94110, United States
Friends Research Institute
Torrance, California, 90502, United States
Matrix Institute
Woodland Hills, California, 91364, United States
Pacific Addiction Research Center - U of Hawaii
Honolulu, Hawaii, 96817, United States
Iowa Luther Hospital
Des Moines, Iowa, 50316, United States
U of Kansas Medical Center
Kansas City, Missouri, 64131, United States
New York University
New York, New York, 10010, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas Health Science At San Antonio
San Antonio, Texas, 78229-3900, United States
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148, United States
Related Publications (1)
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.
PMID: 25818061BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ann Anderson, MD
- Organization
- National Institute on Drug Abuse
Study Officials
- STUDY CHAIR
Jurij Mojsiak
National Institute on Drug Abuse (NIDA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 2, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
March 21, 2017
Results First Posted
February 15, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share