Bupropion in the Treatment of Methamphetamine Dependence

NCT00572234 | Completed Results DMC

• 1 other identifier: 0260-07-FB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Methamphetamine Use Disorder

Keywords

Methamphetamine; Bupropion SR (Sustained Release)

Outcome Measures

Primary Outcomes (1)

• Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.

  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

Study Arms (2)

Receiving Bupropion SR

EXPERIMENTAL

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

Drug: bupropion SR

Treatment as Usual

NO INTERVENTION

Not receiving bupropion

Interventions

bupropion SR DRUG

12 week course of bupropion SR 150 mg, BID

Receiving Bupropion SR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Catholic Charities Campus for Hope

Omaha, Nebraska, 68104, United States

Location

Veterans Affairs Medical Center, Omaha

Omaha, Nebraska, 68105, United States

Location

Results Point of Contact

• Title: Kathleen Grant
• Organization: University of Nebraska Medical Center

kathleen.grant2@va.gov

402-995-4347

Study Officials

• Kathleen M Grant, MD

  Veterans Affairs Medical Center, Omaha

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: August 31, 2007
• Primary Completion: April 6, 2010
• Study Completion: May 20, 2011
• Last Updated: October 10, 2023
• Results First Posted: July 26, 2019

Record last verified: 2023-09

Locations

US (2)