Bupropion in the Treatment of Methamphetamine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Nebraska

December 11, 2007
December 12, 2007
January 14, 2010
June 2007
September 2010   (Final data collection date for primary outcome measure)
Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00572234 on Archive Site
  • 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 ]
Same as current
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Bupropion in the Treatment of Methamphetamine Dependence
Bupropion in the Treatment of Methamphetamine Dependence
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Methamphetamine Use Disorder
Drug: bupropion SR
12 week course of bupropion SR 150 mg, BID
  • Experimental: 1
    receiving bupropion SR
    Intervention: Drug: bupropion SR
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Kathleen M. Grant, MD, Omaha Veterans Affairs Medical Center
University of Nebraska
Not Provided
Principal Investigator: Kathleen M Grant, MD Omaha Veterans Affairs Medical Center
University of Nebraska
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP