Methamphetamine DependencePhase 2NCT00687713
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
A Phase 2 study testing Bupropion in people with Methamphetamine Dependence, run by National Institute on Drug Abuse (NIDA) at 12 sites in United States.
Trial summary
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Dependence
- 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
- 200 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2008to May 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI
- Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained
- Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method
- Must be willing and able to comply with study procedures
- Must be able to verbalize and understand consent forms and provide written informed consent
- Must be seeking treatment for methamphetamine dependence
Who cannot join
- Please contact study site for more information
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Iowa Luther Hospital
Des Moines, Iowa, 50316
Pacific Addiction Research Center - U of Hawaii
Honolulu, Hawaii, 96817
U of Kansas Medical Center
Kansas City, Missouri, 64131
UCLA Integrated Substance Abuse Program
Los Angeles, California, 90025
New York University
New York, New York, 10010
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
University of Texas Health Science At San Antonio
San Antonio, Texas, 78229-3900
South Bay Treatment Center
San Diego, California, 92115
Addiction and Pharmacology Research Laboratory
San Francisco, California, 94110
Friends Research Institute
Torrance, California, 90502
Matrix Institute
Woodland Hills, California, 91364
About this study
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.
Read the detailed description
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.
It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.
- Conditions
- Methamphetamine Dependence
- Being tested
- Bupropion, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. Receives: Drug: Bupropion |
| Placebo | Placebo comparator | Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Showing Abstinence
The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.
Measured: Weeks 11 and 12
Secondary outcomes (1)
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jurij Mojsiak, Study chair, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687713
- Sponsor's protocol ID
- MDS Bupropion Meth 0001
- Status last verified
- Feb 2017
- First submitted
- 29 May 2008
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7.
PubMed 25818061
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00687713
- Acronym / sponsor ID
- MDS Bupropion Meth 0001
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.
Detailed description
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.
It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Active comparator | Drug: BupropionSubjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI
- Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained
- Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method
- Must be willing and able to comply with study procedures
- Must be able to verbalize and understand consent forms and provide written informed consent
Key exclusion criteria (1 listed)
- Please contact study site for more information
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 |
|---|---|---|
| Bupropion150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper. | Drug | Bupropion |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Number of Subjects Showing Abstinence
Time frame: Weeks 11 and 12
The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.
1 secondary outcome
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25818061Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7.
- Individual participant dataSharing planned: No
Related trials for Methamphetamine Dependence
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Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
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Glutide for Ending Methamphetamine
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Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
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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.
Jurij Mojsiak study chair
National Institute on Drug Abuse (NIDA)
12 sites 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 Dependence, run by National Institute on Drug Abuse (NIDA) at 12 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 6 inclusion and 1 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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 15 Feb 2017). 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?
Number of Subjects Showing Abstinence (time frame: Weeks 11 and 12). 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 NCT00687713, 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 21 Mar 2017.