Bupropion in the Treatment of Methamphetamine Dependence

NCT ID: NCT00572234

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-05-20

Brief Summary

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.

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.

Conditions

Methamphetamine Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Receiving Bupropion SR

receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day)

Group Type: EXPERIMENTAL

bupropion SR

Intervention Type: DRUG

12 week course of bupropion SR 150 mg, BID

Treatment as Usual

Not receiving bupropion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

bupropion SR

12 week course of bupropion SR 150 mg, BID

Intervention Type: DRUG

Eligibility 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 Internal Review Board (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 (monoamine oxidase) 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen M Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs Medical Center, Omaha

Locations

Catholic Charities Campus for Hope

Omaha, Nebraska, United States

Veterans Affairs Medical Center, Omaha

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0260-07-FB

Identifier Type: -

Identifier Source: org_study_id