Bupropion in the Treatment of Methamphetamine Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00572234
First received: December 11, 2007
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Methamphetamine Use Disorder
Drug: bupropion SR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bupropion in the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Estimate the treatment effect of bupropion for methamphetamine (meth) dependence. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare methamphetamine treatment outcomes between white and non-white participants. [ Time Frame: 6 months ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
receiving bupropion SR
Drug: bupropion SR
12 week course of bupropion SR 150 mg, BID
No Intervention: 2

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572234

Contacts
Contact: Stephanie G Kelley, BS 4023468800 ext 4347 stephanie.kelley2@va.gov

Locations
United States, Nebraska
Omaha Veterans Affairs Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Catholic Charities Campus for Hope Recruiting
Omaha, Nebraska, United States, 68104
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Kathleen M Grant, MD Omaha Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Kathleen M. Grant, MD, Omaha Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00572234     History of Changes
Other Study ID Numbers: 260-07-FB
Study First Received: December 11, 2007
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Methamphetamine
Bupropion SR

Additional relevant MeSH terms:
Methamphetamine
Bupropion
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 24, 2014