Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: bupropion SR
  • 12 week course of bupropion SR 150 mg, BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • receiving bupropion SR
• No Intervention: 2

Primary Measures

• Estimate the treatment effect of bupropion for methamphetamine (meth) dependence.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• Compare methamphetamine treatment outcomes between white and non-white participants.
  • Time Frame: 6 months
    Safety Issue?: No
• Compare methamphetamine treatment outcomes between white and non-white participants.
  • Time Frame: 6 months
    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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Nebraska

Overall Clinical Trial Officials and Contacts

Kathleen M Grant, MD Principal Investigator Omaha Veterans Affairs Medical Center  

Overall Contact: Stephanie G Kelley, BS 4023468800 stephanie.kelley2@va.gov

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00572234

Study ID Number: 260-07-FB

ClinicalTrials.gov Identifier: NCT00572234

Health Authority: United States: Institutional Review Board