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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving Bupropion SR | Experimental | receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day) |
|
| Treatment as Usual | No Intervention | Not receiving bupropion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupropion SR | Drug | 12 week course of bupropion SR 150 mg, BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Grant, MD | Veterans Affairs Medical Center, Omaha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic Charities Campus for Hope | Omaha | Nebraska | 68104 | United States | ||
| Veterans Affairs Medical Center, Omaha |
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.
Dates of recruitment: August 31, 2007 - April 6, 2010 Recruitment from residential substance use disorder treatment programs in Omaha and Lincoln, Nebraska.
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| ID | Title | Description |
|---|---|---|
| FG000 | Receiving Bupropion (Sustain Release) SR | receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, (twice a day) BID |
| FG001 | Treatment as Usual | Not receiving bupropion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receiving Bupropion SR | receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, BID |
| BG001 | Treatment as Usual | Not receiving bupropion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyses were per protocol and based on number of participants enrolled in study who were not withdrawn from the study. | Posted | Mean | Standard Deviation | days | Assessed Methamphetamine use at weeks 12 and 24, week 24 reported |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receiving Bupropion SR | receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, BID |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Grant | University of Nebraska Medical Center | 402-995-4347 | kathleen.grant2@va.gov |
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| Omaha |
| Nebraska |
| 68105 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Treatment as Usual | Not receiving bupropion | 0 | 16 | 0 | 16 | 0 | 16 |
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