Bupropion in the Treatment of Methamphetamine Dependence - Full Text View

Sponsor:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00572234

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 Bupropion hydrochloride Bupropion Amphetamine Methamphetamine

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
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

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

Sponsors and Collaborators

University of Nebraska

Investigators

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:

Methamphetamine
Amphetamine
Bupropion
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012