MethamphetaminePhase 2BUP PGxNCT00833443
Study of Medical Treatment for Methamphetamine Addiction
A Phase 2 study testing Bupropion in people with Methamphetamine and Amphetamine Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Currently there are no medications approved for the treatment of methamphetamine addiction. Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for the treatment of depression and for cigarette smoking cessation but is not approved by the FDA for the treatment of methamphetamine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine, Amphetamine Dependence, Pharmacogenetics
- What is being tested?
- Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- meet DSM-IV criteria for methamphetamine dependence;
- seeking treatment for MA problems;
- specific range of methamphetamine use in the 30 days prior to study entry;
- willing and able to comply with study procedures, including genotyping;
- willing and able to provide written informed consent;
- if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.
Who cannot join
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID or a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID;
- currently on prescription medication that is contraindicated for use with bupropion;
- have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
- have a history of alcohol dependence within the past three years;
- have a history of a seizure disorder;
Show all 10Show fewer
- have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
- have a history of anorexia or bulimia;
- have current hypertension uncontrolled by medication, or any other circumstances that, in the opinion of the investigators, would compromise participant safety;
- have a history of sensitivity to bupropion.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Clinical Research Site 910 Vine St
Los Angeles, California, 90038
About this study
Official title: Pharmacogenomics and Medication Development for Methamphetamine Dependence
Currently there are no medications approved for the treatment of methamphetamine addiction. Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for the treatment of depression and for cigarette smoking cessation but is not approved by the FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that bupropion may help people receiving treatment for methamphetamine addiction to reduce or to stop their methamphetamine use. But results of these studies also suggest that bupropion may help certain groups of patients more than others, such as men versus women and light versus heavy methamphetamine users, although the reasons for this difference are not known. One possibility is that a person's genetic make up may influence whether or not they respond to treatment with bupropion for methamphetamine addiction.
The purpose of the study is to determine if bupropion is can help people reduce or stop their methamphetamine use and to investigate whether genetic variations influence whether people respond to treatment with bupropion for methamphetamine addiction, which may help doctors and patients better decide if treatment with bupropion will be beneficial or not. To identify possible genetic variations that influence response to bupropion, we will perform genetic tests on blood or saliva specimens from participants receiving treatment with either bupropion or placebo (which is a pill that contains no medication) in conjunction with standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use, as assessed with urine drug screens, among participants receiving bupropion versus those receiving placebo to determine if bupropion helps people to reduce or stop their methamphetamine use. We will then compare the results of the genetic tests among participants who respond and who do not respond to bupropion. In addition, since the amount of methamphetamine a person uses was associated with response to bupropion in preliminary studies, we will also compare the results of genetic testing among persons with heavy versus light methamphetamine use before entering treatment.
Results of this study have the potential to provide insights into the biology of methamphetamine addiction and help increase the understanding of how bupropion works. This information could be useful to develop effective medications for methamphetamine addiction and to improve the ability of clinicians to provide treatment to patients with methamphetamine addiction.
- Conditions
- Methamphetamine, Amphetamine Dependence, Pharmacogenetics, Methamphetamine Dependence, Substance Abuse
- Being tested
- Bupropion
- Keywords
- Methamphetamine, Addiction, Pharmacogenomics, Amphetamine, Bupropion, Meth, Crank, Crystal
- Medical subject headings
- Amphetamine-Related Disorders, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban, Wellbutrin
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. Receives: Drug: Bupropion |
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effectiveness Score
The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
Measured: 12 weeks
End of Treatment Methamphetamine Abstinence
Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)
Measured: 12 weeks
Secondary outcomes (1)
Treatment Retention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionJul 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MethamphetamineStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Keith Heinzerling, University of California, Los Angeles
- Investigators
- Keith G Heinzerling, MD MPH, Principal investigator, UCLA Dept of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833443
- Sponsor's protocol ID
- KH_K23
- Other IDs
- P50DA018185, K23DA023558, DPMC
- Acronym
- BUP PGx
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2009
- Last updated
- 26 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heinzerling KG, Swanson AN, Hall TM, Yi Y, Wu Y, Shoptaw SJ. Randomized, placebo-controlled trial of bupropion in methamphetamine-dependent participants with less than daily methamphetamine use. Addiction. 2014 Nov;109(11):1878-86. doi: 10.1111/add.12636. Epub 2014 Aug 5.
PubMed 24894963
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics and Medication Development for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00833443
- Acronym / sponsor ID
- BUP PGx / KH_K23
- Conditions
- Methamphetamine, Amphetamine Dependence, Pharmacogenetics, Methamphetamine Dependence, Substance Abuse
- Keywords
- Methamphetamine, Addiction, Pharmacogenomics, Amphetamine, Bupropion, Meth, Crank, Crystal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently there are no medications approved for the treatment of methamphetamine addiction. Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for the treatment of depression and for cigarette smoking cessation but is not approved by the FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that bupropion may help people receiving treatment for methamphetamine addiction to reduce or to stop their methamphetamine use. But results of these studies also suggest that bupropion may help certain groups of patients more than others, such as men versus women and light versus heavy methamphetamine users, although the reasons for this difference are not known. One possibility is that a person's genetic make up may influence whether or not they respond to treatment with bupropion for methamphetamine addiction.
The purpose of the study is to determine if bupropion is can help people reduce or stop their methamphetamine use and to investigate whether genetic variations influence whether people respond to treatment with bupropion for methamphetamine addiction, which may help doctors and patients better decide if treatment with bupropion will be beneficial or not. To identify possible genetic variations that influence response to bupropion, we will perform genetic tests on blood or saliva specimens from participants receiving treatment with either bupropion or placebo (which is a pill that contains no medication) in conjunction with standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use, as assessed with urine drug screens, among participants receiving bupropion versus those receiving placebo to determine if bupropion helps people to reduce or stop their methamphetamine use. We will then compare the results of the genetic tests among participants who respond and who do not respond to bupropion. In addition, since the amount of methamphetamine a person uses was associated with response to bupropion in preliminary studies, we will also compare the results of genetic testing among persons with heavy versus light methamphetamine use before entering treatment.
Results of this study have the potential to provide insights into the biology of methamphetamine addiction and help increase the understanding of how bupropion works. This information could be useful to develop effective medications for methamphetamine addiction and to improve the ability of clinicians to provide treatment to patients with methamphetamine addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Active comparator | Drug: BupropionBupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. |
| Sugar Pill | Placebo comparator | Drug: Bupropion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older;
- meet DSM-IV criteria for methamphetamine dependence;
- seeking treatment for MA problems;
- specific range of methamphetamine use in the 30 days prior to study entry;
- willing and able to comply with study procedures, including genotyping;
Key exclusion criteria (10 listed)
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID or a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID;
- currently on prescription medication that is contraindicated for use with bupropion;
- have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
- have a history of alcohol dependence within the past three years;
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 |
|---|---|---|
| BupropionAlso: Zyban, WellbutrinBupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks. | Drug | Bupropion, Sugar Pill |
Primary outcome
Treatment Effectiveness Score
Time frame: 12 weeks
The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
End of Treatment Methamphetamine Abstinence
Time frame: 12 weeks
Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)
1 secondary outcome
Treatment Retention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24894963Heinzerling KG, Swanson AN, Hall TM, Yi Y, Wu Y, Shoptaw SJ. Randomized, placebo-controlled trial of bupropion in methamphetamine-dependent participants with less than daily methamphetamine use. Addiction. 2014 Nov;109(11):1878-86. doi: 10.1111/add.12636. Epub 2014 Aug 5.
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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.
Keith G Heinzerling, MD MPH principal investigator
UCLA Dept of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion in people with Methamphetamine and Amphetamine Dependence, run by University of California, Los Angeles at 1 site 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 7 inclusion and 10 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 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2014). 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?
Treatment Effectiveness Score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833443, which also lists 1 linked publication.
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 26 Feb 2014.