Bupropion in the Treatment of Methamphetamine Dependence
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ClinicalTrials.gov Identifier: NCT00572234 |
Recruitment Status
: Unknown
Verified January 2010 by University of Nebraska.
Recruitment status was: Recruiting
First Posted
: December 12, 2007
Last Update Posted
: January 14, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Methamphetamine Use Disorder | Drug: bupropion SR | Not Applicable |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
receiving bupropion SR
|
Drug: bupropion SR
12 week course of bupropion SR 150 mg, BID
|
No Intervention: 2 |
- Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ]
- Compare methamphetamine treatment outcomes between white and non-white participants. [ Time Frame: 6 months ]
- Assess safety of bupropion in the treatment of persons with meth dependence with and without meth-related psychosis. [ Time Frame: 6 months ]

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572234
Contact: Stephanie G Kelley, BS | 4023468800 ext 4347 | stephanie.kelley2@va.gov |
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 |
Principal Investigator: | Kathleen M Grant, MD | Omaha Veterans Affairs Medical Center |
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 Key Record Dates |
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 |