Substance AbusePhase 2NCT00318409
Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
A Phase 2 study testing Bupropion in people with Substance Abuse and HIV Infections, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, HIV Infections
- What is being tested?
- Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2007
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-negative by rapid test or able to document HIV infection through healthcare provider's note or documentation of laboratory test;
- Reports anal sex with men in prior 3 months while using meth
- Diagnosed with meth dependence as determined by SCID
- Interested in stopping or reducing meth use
- Meth-positive urine on screening
- No known allergies to bupropion
Show all 9Show fewer
- No current acute illnesses
- Able and willing to provide informed consent and to be followed over a 3-month period
- Baseline CBC and electrolytes within institutional limits.
Who cannot join
- History of seizure
- High risk for seizure, including: recent (last 24 months) head trauma, brain injury or surgery; using theophylline or systemic steroids; prior or current history of anorexia or bulimia; prior or current history of alcohol withdrawal symptoms
- Measured moderate or severe liver disease (LFTs > 3 times normal) or history of chronic liver disease
- Impaired renal function (creatinine clearance < 90 ml/min)
- Evidence of current major depression, as determined by SCID
- Taking anti-depressant medication within last 30 days
Show all 11Show fewer
- Currently on any bupropion-containing regimen
- Currently using or unwilling not to use pseudoephedrine-containing products (causes false + urines for meth use) for trial duration
- Currently taking antiretroviral therapy (ART)
- CD4 count < 200 cells/mm3
- Any condition that, in the principal investigator's judgment, interferes with safe study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health, HIV/AIDS Office
San Francisco, California, 94102
About this study
Official title: Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. No studies have tested the feasibility and acceptability of conducting pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the tolerability of and adherence to medication among these participants.
Read the detailed description
The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population. The MSM meth epidemic, and its link with HIV transmission, underscores the need to pilot test new, innovative modalities to reduce meth use and meth-associated sexual risk behavior. Ultimately, a pharmacologic treatment for meth use may not only serve to improve outcomes among those who are accessing current treatment services, but might also benefit those who are not willing or able to utilize such services. While studies show that MSM who enter substance use treatment decrease both their substance use and sexual risk behavior, current behavioral meth treatment programs report low rates of success in treating meth dependence among MSM. We believe the time has come to test the acceptability of pharmacologic interventions to reduce meth use among MSM, and to assess the feasibility of conducting such trials among sexually active, meth-dependent MSM, whose meth-associated sexual behavior use places them at extraordinarily high risk for transmitting or acquiring HIV. In this pilot study, we will provide meth-dependent MSM with placebo or daily bupropion XL (extended-release), a well-tolerated dopamine agonist that has potential to reduce meth use. The specific aims of this study are:
- To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized, double-blind study of bupropion versus placebo with biologic (urine meth testing) and behavioral (sexual risk) measures.
- To explore the tolerability of bupropion and placebo among meth-dependent MSM, as determined by the number of adverse clinical events in the bupropion and placebo arms.
- To describe the acceptability of bupropion and placebo among meth-dependent MSM, by measuring (via electronic pill caps) medication adherence to bupropion and placebo.
This randomized, double-blind, placebo-controlled, two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo. We will include both HIV- and HIV-INFECTED MSM, because meth use is common in both groups. We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment. Participants will be seen weekly for urine specimen collection and substance-use counseling. Clinical exams, medical history, specimen collection, and behavioral assessments will be performed at baseline and at the 1, 2, and 3 month visits. Interim visits will be scheduled whenever indicated by signs or symptoms. Our decision to maintain participants on 3 months of bupropion is based on the smoking literature, which demonstrated bupropion's efficacy in treating nicotine addiction within similar time periods; we anticipate that any future efficacy trial will maintain participants on bupropion for this duration.
- Conditions
- Substance Abuse, HIV Infections
- Being tested
- Bupropion, Placebo
- Keywords
- Methamphetamine, HIV
- Medical subject headings
- Substance-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Wellbutrin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | buproprion XL 300mg daily Receives: Drug: Bupropion |
| Placebo | Placebo comparator | placebo 300mg daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled
Measured: At Enrollment
Feasibility: Proportion of Scheduled Study Visits Completed
Measured: 12 weeks
Feasibility: Proportion of Urine Samples Collected
Measured: 12 weeks
Feasibility: Participants Who Completed the Trial
Measured: 12 weeks
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
Measured: throughout study
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings
Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.
Measured: 12 weeks
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report
Proportional of reported days taking study drug during the 12 weeks of study.
Measured: 12 weeks
Acceptability: Proportion of Participants Discontinuing Medication in Both Arms
Proportion of participants who discontinued study medication for at least one week prior to study completion.
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 posted26 Apr 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionNov 2007
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 Substance AbuseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Collaborators
- National Institute on Drug Abuse (NIDA), Public Health Foundation Enterprises, Inc.
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Grant Colfax, M.D., Principal investigator, Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318409
- Sponsor's protocol ID
- R21DA021090-1
- Other IDs
- R21DA021090
- Status last verified
- Oct 2014
- First submitted
- 24 Apr 2006
- Last updated
- 17 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Das M, Santos D, Matheson T, Santos GM, Chu P, Vittinghoff E, Shoptaw S, Colfax GN. Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men. AIDS. 2010 Apr 24;24(7):991-1000. doi: 10.1097/qad.0b013e328336e98b.
PubMed 20397286
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.
- ClinicalTrials.gov ID
- NCT00318409
- Acronym / sponsor ID
- R21DA021090-1
- Conditions
- Substance Abuse, HIV Infections
- Keywords
- Methamphetamine, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Collaborators
- National Institute on Drug Abuse (NIDA), Public Health Foundation Enterprises, Inc.
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. No studies have tested the feasibility and acceptability of conducting pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the tolerability of and adherence to medication among these participants.
Detailed description
The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population. The MSM meth epidemic, and its link with HIV transmission, underscores the need to pilot test new, innovative modalities to reduce meth use and meth-associated sexual risk behavior. Ultimately, a pharmacologic treatment for meth use may not only serve to improve outcomes among those who are accessing current treatment services, but might also benefit those who are not willing or able to utilize such services. While studies show that MSM who enter substance use treatment decrease both their substance use and sexual risk behavior, current behavioral meth treatment programs report low rates of success in treating meth dependence among MSM. We believe the time has come to test the acceptability of pharmacologic interventions to reduce meth use among MSM, and to assess the feasibility of conducting such trials among sexually active, meth-dependent MSM, whose meth-associated sexual behavior use places them at extraordinarily high risk for transmitting or acquiring HIV. In this pilot study, we will provide meth-dependent MSM with placebo or daily bupropion XL (extended-release), a well-tolerated dopamine agonist that has potential to reduce meth use. The specific aims of this study are:
- To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized, double-blind study of bupropion versus placebo with biologic (urine meth testing) and behavioral (sexual risk) measures.
- To explore the tolerability of bupropion and placebo among meth-dependent MSM, as determined by the number of adverse clinical events in the bupropion and placebo arms.
- To describe the acceptability of bupropion and placebo among meth-dependent MSM, by measuring (via electronic pill caps) medication adherence to bupropion and placebo.
This randomized, double-blind, placebo-controlled, two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo. We will include both HIV- and HIV-INFECTED MSM, because meth use is common in both groups. We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment. Participants will be seen weekly for urine specimen collection and substance-use counseling. Clinical exams, medical history, specimen collection, and behavioral assessments will be performed at baseline and at the 1, 2, and 3 month visits. Interim visits will be scheduled whenever indicated by signs or symptoms. Our decision to maintain participants on 3 months of bupropion is based on the smoking literature, which demonstrated bupropion's efficacy in treating nicotine addiction within similar time periods; we anticipate that any future efficacy trial will maintain participants on bupropion for this duration.
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: Bupropionbuproprion XL 300mg daily |
| Placebo | Placebo comparator | Drug: Placeboplacebo 300mg daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- HIV-negative by rapid test or able to document HIV infection through healthcare provider's note or documentation of laboratory test;
- Reports anal sex with men in prior 3 months while using meth
- Diagnosed with meth dependence as determined by SCID
- Interested in stopping or reducing meth use
- Meth-positive urine on screening
Key exclusion criteria (11 listed)
- History of seizure
- High risk for seizure, including: recent (last 24 months) head trauma, brain injury or surgery; using theophylline or systemic steroids; prior or current history of anorexia or bulimia; prior or current history of alcohol withdrawal symptoms
- Measured moderate or severe liver disease (LFTs > 3 times normal) or history of chronic liver disease
- Impaired renal function (creatinine clearance < 90 ml/min)
- Evidence of current major depression, as determined by SCID
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: Wellbutrin | Drug | Bupropion |
| Placebo | Drug | Placebo |
Primary outcome
Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled
Time frame: At Enrollment
Feasibility: Proportion of Scheduled Study Visits Completed
Time frame: 12 weeks
Feasibility: Proportion of Urine Samples Collected
Time frame: 12 weeks
Feasibility: Participants Who Completed the Trial
Time frame: 12 weeks
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
Time frame: throughout study
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings
Time frame: 12 weeks
Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report
Time frame: 12 weeks
Proportional of reported days taking study drug during the 12 weeks of study.
Acceptability: Proportion of Participants Discontinuing Medication in Both Arms
Time frame: 12 weeks
Proportion of participants who discontinued study medication for at least one week prior to study completion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20397286Das M, Santos D, Matheson T, Santos GM, Chu P, Vittinghoff E, Shoptaw S, Colfax GN. Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men. AIDS. 2010 Apr 24;24(7):991-1000. doi: 10.1097/qad.0b013e328336e98b.
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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.
Grant Colfax, M.D. principal investigator
Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section
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 Substance Abuse and HIV Infections, run by San Francisco Department of Public Health 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 9 inclusion and 11 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 17 Oct 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 17 Oct 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?
Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled (time frame: At Enrollment). The study lists 8 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 NCT00318409, 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 17 Oct 2014.