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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00687713
First received: May 29, 2008
Last updated: December 22, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Methamphetamine Dependence
Drug: Bupropion
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Abstinence [ Time Frame: Weeks 11 and 12 ]

Secondary Outcome Measures:
  • Overall Reduction of Use (Sustained Abstinence) [ Time Frame: 21 days ]

Enrollment: 200
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687713

Locations
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
Matrix Institute
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
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Study Chair: Jurij Mojsiak National Institute on Drug Abuse (NIDA)
  More Information

Publications:
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00687713     History of Changes
Other Study ID Numbers: MDS Bupropion Meth 0001 
Study First Received: May 29, 2008
Results First Received: December 22, 2016
Last Updated: December 22, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Methamphetamine
Bupropion
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 20, 2017