Bupropion in the Treatment of Methamphetamine Dependence

• Sponsor: University of Nebraska (Other)
• Overall Status: Completed
• CT.gov ID: NCT00572234
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Use Disorder	Drug: bupropion SR	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bupropion in the Treatment of Methamphetamine Dependence
• Actual Study Start Date: Aug 31, 2007
• Actual Primary Completion Date: Apr 6, 2010
• Actual Study Completion Date: May 20, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic Charities Campus for Hope	Omaha	Nebraska	United States	68104
2	Omaha Veterans Affairs Medical Center	Omaha	Nebraska	United States	68105

Sponsors and Collaborators

• University of Nebraska

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Grant MD, Principal Investigator, University of Nebraska
• ClinicalTrials.gov Identifier: NCT00572234
• Other Study ID Numbers: 260-07-FB
• First Posted: Dec 12, 2007
• Last Update Posted: Jul 26, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Kathleen Grant MD, Principal Investigator, University of Nebraska: Methamphetamine; Bupropion SR (Sustained Release)
• Additional relevant MeSH terms: Bupropion

Study Results

Participant Flow

Recruitment Details	Dates of recruitment: August 31, 2007 - April 6, 2010 Recruitment from residential substance use disorder treatment programs in Omaha and Lincoln, Nebraska.
Pre-assignment Detail	Initially participants were assigned to one of two randomization pools: one group with and one group without psychoses. However as of January 30, 2009 no participants met criteria for randomization to the psychosis arm of the study and the protocol was changed to remove the psychosis randomization pool.

Arm/Group Title	Receiving Bupropion (Sustain Release) SR	Treatment as Usual
Arm/Group Description	receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, (twice a day) BID	Not receiving bupropion
Period Title: Overall Study
STARTED	19	21
COMPLETED	18	16
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Receiving Bupropion SR	Treatment as Usual	Total
Arm/Group Description	receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, BID	Not receiving bupropion	Total of all reporting groups
Overall Participants	19	21	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (10.9)	34 (7.7)	34 (9.3)
Sex: Female, Male (Count of Participants)
Female	11 57.9%	10 47.6%	21 52.5%
Male	8 42.1%	11 52.4%	19 47.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Analyses were per protocol and based on number of participants enrolled in study who were not withdrawn from the study.

Arm/Group Title	Receiving Bupropion SR	Treatment as Usual
Arm/Group Description	receiving bupropion SR 12 week course of bupropion SR 150 mg, BID bupropion SR: 12 week course of bupropion SR 150 mg, BID	Not receiving bupropion
Measure Participants	19	21
Mean (Standard Deviation) [days]	5.6 (1.9)	6.0 (1.3)

Adverse Events

Arm/Group Title	Receiving Bupropion SR		Treatment as Usual
Arm/Group Description	receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, BID		Not receiving bupropion
All Cause Mortality
	Receiving Bupropion SR		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Serious Adverse Events
	Receiving Bupropion SR		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Receiving Bupropion SR		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.