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

This study has been completed.

First Received on May 29, 2008. Last Updated on May 23, 2011 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00687713

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 II

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:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Bupropion hydrochloride Bupropion Amphetamine Methamphetamine

U.S. FDA Resources

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

Primary Outcome Measures:

Abstinence [ Time Frame: Weeks 11 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall reduction of use (sustained abstinence) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated 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
Experimental: 1	Drug: Bupropion 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
Placebo Comparator: 2	Other: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

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)

More Information

No publications provided

Responsible Party:	Liza Gorgon, National Institute on Drug Abust (NIDA)
ClinicalTrials.gov Identifier:	NCT00687713 History of Changes
Other Study ID Numbers:	MDS Bupropion Meth 0001
Study First Received:	May 29, 2008
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Bupropion
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012