Bupropion in the Treatment of Methamphetamine Dependence

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Methamphetamine Use Disorder	Drug: bupropion SR	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Bupropion in the Treatment of Methamphetamine Dependence
Study Start Date :	June 2007
Estimated Primary Completion Date :	September 2010
Estimated Study Completion Date :	September 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; receiving bupropion SR	Drug: bupropion SR; 12 week course of bupropion SR 150 mg, BID
No Intervention: 2

Outcome Measures

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Primary Outcome Measures :

1. Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Compare methamphetamine treatment outcomes between white and non-white participants. [ Time Frame: 6 months ]
2. Assess safety of bupropion in the treatment of persons with meth dependence with and without meth-related psychosis. [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	December 12, 2007
Last Update Posted:	January 14, 2010
Last Verified:	January 2010

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