Bupropion in the Treatment of Methamphetamine Dependence

Condition(s) targeted: Methamphetamine Use Disorder

Intervention: bupropion SR (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Kathleen M Grant, MD, Principal Investigator, Affiliation: Omaha Veterans Affairs Medical Center

Overall contact:
Stephanie G Kelley, BS, Phone: 4023468800, Ext: 4347, Email: stephanie.kelley2@va.gov

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.

Official title: Bupropion in the Treatment of Methamphetamine Dependence

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

Primary outcome: Estimate the treatment effect of bupropion for methamphetamine (meth) dependence.

Secondary outcome:

Compare methamphetamine treatment outcomes between white and non-white participants.

Compare methamphetamine treatment outcomes between white and non-white participants.

Assess safety of bupropion in the treatment of persons with meth dependence with and without meth-related psychosis.

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.

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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

Stephanie G Kelley, BS, Phone: 4023468800, Ext: 4347, Email: stephanie.kelley2@va.gov

Omaha Veterans Affairs Medical Center, Omaha, Nebraska 68105, United States; Recruiting

Catholic Charities Campus for Hope, Omaha, Nebraska 68104, United States; Recruiting

Starting date: June 2007
Ending date: June 2009
Last updated: December 11, 2007