Bupropion in the Treatment of Methamphetamine Dependence

September 21, 2023 updated by: University of Nebraska
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 Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receiving Bupropion SR
receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day)
12 week course of bupropion SR 150 mg, BID
No Intervention: Treatment as Usual
Not receiving bupropion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.
Time Frame: Assessed Methamphetamine use at weeks 12 and 24, week 24 reported
The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.
Assessed Methamphetamine use at weeks 12 and 24, week 24 reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2007

Primary Completion (Actual)

April 6, 2010

Study Completion (Actual)

May 20, 2011

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimated)

December 12, 2007

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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