Clinical trial NCT00687713: Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2008-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Showing Abstinence
timeFrame: Weeks 11 and 12
Secondary outcomes:
measure: Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
city: San Diego
country: United States
facility: South Bay Treatment Center
state: California
city: San Francisco
country: United States
facility: Addiction and Pharmacology Research Laboratory
state: California
city: Torrance
country: United States
facility: Friends Research Institute
state: California
city: Woodland Hills
country: United States
facility: Matrix Institute
state: California
city: Honolulu
country: United States
facility: Pacific Addiction Research Center - U of Hawaii
state: Hawaii
city: Des Moines
country: United States
facility: Iowa Luther Hospital
state: Iowa
city: Kansas City
country: United States
facility: U of Kansas Medical Center
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science At San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Jurij Mojsiak
role: STUDY_CHAIR
References:
citation: 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.