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

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), January 2009

First Received: May 29, 2008 Last Updated: January 26, 2009 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 18 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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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:	150
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bupropion 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
2: Placebo Comparator	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
Must report using methamphetamine for 18 or less days during the 30 day period prior to the start orf screening 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
Addiction Phrmacology Research Laboratory	Recruiting
San Fransisco, California, United States, 94110
Contact: Gannt Galloway, Pharm.D. 415-641-3370
Principal Investigator: Gannt Galloway, Pharm.D.
UCLA Integrated Substance Abuse Program	Recruiting
Los Angeles, California, United States, 90025
Contact: Richard A Rawson, Ph.D. 310-267-5020
Principal Investigator: Richard A Rawson, Ph.D.
United States, New York
New York University	Recruiting
New York, New York, United States, 10010
Contact: Malcolm Reid, Ph.D. 212-686-7500
Principal Investigator: Malcolm Reid, Ph.D.
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robert Malcolm, MD 843-792-5214
Principal Investigator: Robert Malcolm, M.D.
United States, Texas
University of Texas Health Science At San Antonio	Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: John D Roache, Ph.D. 210-562-5401
Principal Investigator: John D. Roache, Ph.D.

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

More Information

No publications provided

Responsible Party:	National Institute on Drug Abust (NIDA) ( Liza Gorgon )
Study ID Numbers:	MDS Bupropion Meth 0001
Study First Received:	May 29, 2008
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00687713 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Pharmacologic Actions

Methamphetamine
Autonomic Agents
Therapeutic Uses
Bupropion
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010