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

Phase 2

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Other: Placebo; Drug: Bupropion

• Registration Number: NCT00687713
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2016-12-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Results First Posted: 2017-02-15
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Bupropion	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Showing Abstinence	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use	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.

Trial Locations

Locations (12)

Matrix Institute; 🇺🇸 Woodland Hills, California, United States

New York University; 🇺🇸 New York, New York, United States

UCLA Integrated Substance Abuse Program; 🇺🇸 Los Angeles, California, United States

South Bay Treatment Center; 🇺🇸 San Diego, California, United States

Friends Research Institute; 🇺🇸 Torrance, California, United States

Addiction and Pharmacology Research Laboratory; 🇺🇸 San Francisco, California, United States

University of Texas Health Science At San Antonio; 🇺🇸 San Antonio, Texas, United States

VA Salt Lake City Health Care System; 🇺🇸 Salt Lake City, Utah, United States

U of Kansas Medical Center; 🇺🇸 Kansas City, Missouri, United States

Pacific Addiction Research Center - U of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Iowa Luther Hospital; 🇺🇸 Des Moines, Iowa, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States