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

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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Dependence
• Intervention / Treatment: Other: Placebo; Drug: Bupropion

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • UCLA Integrated Substance Abuse Program
    • San Diego, California, United States, 92115
      • South Bay Treatment Center
    • San Francisco, California, United States, 94110
      • Addiction and Pharmacology Research Laboratory
    • Torrance, California, United States, 90502
      • Friends Research Institute
    • Woodland Hills, California, United States, 91364
      • Matrix Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Pacific Addiction Research Center - U of Hawaii
  • Iowa
    • Des Moines, Iowa, United States, 50316
      • Iowa Luther Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • U of Kansas Medical Center
  • New York
    • New York, New York, United States, 10010
      • New York University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science At San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • VA Salt Lake City Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Bupropion; 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.	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use	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.	30 days

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Study Chair: Jurij Mojsiak, National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (ESTIMATE): June 2, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: MDS Bupropion Meth 0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO