Bupropion in the Treatment of Methamphetamine Dependence
Recruitment status was Recruiting
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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 |
- Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| 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 Adrenergic Agents Adrenergic Uptake Inhibitors Antidepressive Agents Antidepressive Agents, Second-Generation Autonomic Agents Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents |
Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sympathomimetics Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015