Methamphetamine Use DisorderNCT00572234
Bupropion in the Treatment of Methamphetamine Dependence
A study testing bupropion SR in people with Methamphetamine Use Disorder, run by University of Nebraska at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- bupropion SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2007to 20 May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Catholic Charities Campus for Hope
Omaha, Nebraska, 68104
Veterans Affairs Medical Center, Omaha
Omaha, Nebraska, 68105
About this study
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.
Read the 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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- bupropion SR
- Keywords
- Methamphetamine, Bupropion SR (Sustained Release)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion SRDrug
12 week course of bupropion SR 150 mg, BID
| Study group | Role | What they receive |
|---|---|---|
| Receiving Bupropion SR | Experimental | receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day) Receives: Drug: bupropion SR |
| Treatment as Usual | No intervention | Not receiving bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed Methamphetamine use at weeks 12 and 24, week 24 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study start31 Aug 2007
- Primary completion6 Apr 2010
- Study completion20 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen M Grant, MD, Principal investigator, Veterans Affairs Medical Center, Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572234
- Sponsor's protocol ID
- 0260-07-FB
- Status last verified
- Sep 2023
- First submitted
- 11 Dec 2007
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion in the Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00572234
- Acronym / sponsor ID
- 0260-07-FB
- Conditions
- Methamphetamine Use Disorder
- Keywords
- Methamphetamine, Bupropion SR (Sustained Release)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 31 Aug 2007 (actual)
- Primary completion
- 6 Apr 2010 (actual)
- Study completion
- 20 May 2011 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving Bupropion SR | Experimental | Drug: bupropion SRreceiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day) |
| Treatment as Usual | No intervention | –Not receiving bupropion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion SR12 week course of bupropion SR 150 mg, BID | Drug | Receiving Bupropion SR |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Grant, MD principal investigator
Veterans Affairs Medical Center, Omaha
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupropion SR in people with Methamphetamine Use Disorder, run by University of Nebraska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence. (time frame: Assessed Methamphetamine use at weeks 12 and 24, week 24 reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.