Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence|
- 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.
- 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.
|Study Start Date:||May 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687713
|United States, California|
|UCLA Integrated Substance Abuse Program|
|Los Angeles, California, United States, 90025|
|South Bay Treatment Center|
|San Diego, California, United States, 92115|
|Addiction and Pharmacology Research Laboratory|
|San Francisco, California, United States, 94110|
|Friends Research Institute|
|Torrance, California, United States, 90502|
|Woodland Hills, California, United States, 91364|
|United States, Hawaii|
|Pacific Addiction Research Center - U of Hawaii|
|Honolulu, Hawaii, United States, 96817|
|United States, Iowa|
|Iowa Luther Hospital|
|Des Moines, Iowa, United States, 50316|
|United States, Missouri|
|U of Kansas Medical Center|
|Kansas City, Missouri, United States, 64131|
|United States, New York|
|New York University|
|New York, New York, United States, 10010|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|University of Texas Health Science At San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|United States, Utah|
|VA Salt Lake City Health Care System|
|Salt Lake City, Utah, United States, 84148|
|Study Chair:||Jurij Mojsiak||National Institute on Drug Abuse (NIDA)|