Bupropion in the Treatment of Methamphetamine Dependence

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University of Nebraska.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Nebraska

ClinicalTrials.gov Identifier:

NCT00572234

First received: December 11, 2007

Last updated: January 13, 2010

Last verified: January 2010

History of Changes

Purpose

Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number of psychosocial and pharmacological treatments have been studied, no specific treatments for methamphetamine have been identified. This study is a collaborative pre-clinical and clinical partnership examining bupropion in the treatment of methamphetamine dependence.

Condition	Intervention
Methamphetamine Use Disorder	Drug: bupropion SR


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bupropion in the Treatment of 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 University of Nebraska:

Primary Outcome Measures:

Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare methamphetamine treatment outcomes between white and non-white participants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assess safety of bupropion in the treatment of persons with meth dependence with and without meth-related psychosis. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 receiving bupropion SR	Drug: bupropion SR 12 week course of bupropion SR 150 mg, BID
No Intervention: 2

Detailed Description:

Nearly 40% of adults seeking substance use disorders (SUD) treatment in Nebraska report methamphetamine is their drug of choice. In preliminary studies examining bupropion in methamphetamine use, it was well tolerated, reduced craving for methamphetamine and reduced methamphetamine related euphoria. Investigators at the University of Nebraska Medical Center and the University of Nebraska-Lincoln have initiated studies examining bupropion in animals and humans as a potential intervention in addictive disorders. Pre-clinical studies in the Co-Investigator's laboratory were the first to demonstrate the potential utility of bupropion as a pharmacotherapy for methamphetamine use disorders (MUD) while the Principal Investigator studied bupropion as a smoking cessation aid in alcoholics.

The primary goal of this study is to establish an interdisciplinary and translational collaboration to test bupropion in persons in treatment for methamphetamine dependence and to inform pre-clinical studies so as to enhance their practical applicability to clinical settings. The pilot clinical study will examine the treatment effect and safety of a 12 week course of bupropion in persons with methamphetamine use disorder. Concurrently, we will examine the efficacy of bupropion on methamphetamine self-administration in animal models which better simulates clinical approaches.

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patient in the substance use disorder program at either the Omaha VA Medical Center or at Catholic Charities Campus for Hope
diagnosis of methamphetamine dependence as well as presence or history of psychosis based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria (not to include patients in full sustained remission)
provide names, addresses, and phone numbers of at least two collateral informants who can provide information on their methamphetamine and other drug use during follow-up
must sign an informed consent as approved by the UNMC IRB and Catholic Charities Research Committee.

Exclusion Criteria:

a history of severe injury to their brain
advanced cardiac, pulmonary, renal or liver disease
predisposition to seizures
history of bulimia or anorexia nervosa
current diagnosis of major depressive disorder
diagnosis or past history of panic disorders, schizophrenia, or bipolar affective disorder
family history or childhood history of epilepsy or seizures
history of strokes, brain tumors, or bleeding in the brain.
used any psychoactive drug within one week of study entry (two weeks for MAO inhibitors or protriptyline, four weeks for fluoxetine)
currently using any theophylline product (e.g. Theodur)
used an investigational drug in any study within the past four weeks
used a therapeutic course of bupropion SR for > 1 week at any time in the past 12 months or have been evaluated in previous studies examining bupropion SR at anytime
If female, the participant must not be pregnant or breast feeding

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: NCT00572234

Contacts


Contact: Stephanie G Kelley, BS	4023468800 ext 4347	stephanie.kelley2@va.gov

Locations


United States, Nebraska
Catholic Charities Campus for Hope	Recruiting
Omaha, Nebraska, United States, 68104
Omaha Veterans Affairs Medical Center	Recruiting
Omaha, Nebraska, United States, 68105

Sponsors and Collaborators

University of Nebraska

Investigators


Principal Investigator:	Kathleen M Grant, MD	Omaha Veterans Affairs Medical Center

More Information


Responsible Party:	Kathleen M. Grant, MD, Omaha Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00572234 History of Changes
Other Study ID Numbers:	260-07-FB
Study First Received:	December 11, 2007
Last Updated:	January 13, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:


Methamphetamine Bupropion SR

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 September 30, 2016

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