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

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: Participant, Care Provider, Investigator Primary Purpose: Treatment
Official Title:	Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Metamfetamine Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


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:

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.


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:	February 14, 2017
Individual Participant Data
Plan to Share IPD:	No

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 28, 2017