Amphetamine-Related DisordersPhase 2NCT01888835
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
A Phase 2 study testing Mirtazapine in people with Amphetamine-Related Disorders, run by Phillip Coffin, MD, MIA at 1 site in United States.
Trial summary
The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive… Read more about this study
- Who is it for?
- Ages 18 to 69 years, men only
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- born male, or born female and does not identify as female;
- reports anal sex with men in the prior three months while under the influence of meth;
- diagnosed with meth dependence by SCID;
- interested in stopping or reducing meth use;
- at least one meth-positive urine during screening and run-in period;
- no current acute illness requiring prolonged medical care;
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- no serious chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and adhere to visit schedule;
- age 18-69 years;
- baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history
- current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load < 200 copies/mL
- text-capable cell phone or access to email
Who cannot join
- Evidence of current major depression by SCID;
- history of bipolar disorder or psychotic disorder, as determined by SCID;
- known allergy or previous adverse reaction to mirtazapine;
- taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
- moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal);
- impaired renal function (estimated GFR <40 ml/min);
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- currently participating in another research study;
- pending legal proceedings with high risk for incarceration during the time of planned study participation;
- any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Use Research Unit
San Francisco, California, 94102
About this study
Official title: Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up
The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Mirtazapine, Placebo
- Keywords
- HIV, sexual behavior
- Medical subject headings
- Amphetamine-Related Disorders, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called Remeron
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Active comparator | mirtazapine 30 mg orally per day Receives: Drug: Mirtazapine |
| Placebo | Placebo comparator | placebo (30 mg) orally per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of methamphetamine-positive urine tests
To determine the efficacy of mirtazapine vs placebo at 12 weeks and 24 weeks of treatment plus counseling, and to determine whether efficacy is sustained for an additional 12 weeks after discontinuation of treatment and counseling (weeks 24 to 36).
Measured: weekly for 9 months
Secondary outcomes (1)
Sexual risk (see description)
To assess if the intervention reduces HIV risk behaviors, including number of male sex partners, number of male anal sex partners with whom meth is used and episodes of unprotected anal sex with serodiscordant partners.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amphetamine-Related DisordersStudies 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, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phillip Coffin, MD, MIA
- Sponsor type
- Other government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Phillip O Coffin, M.D., Principal investigator, San Francisco Department of Public HealthSteven L Batki, M.D., Principal investigator, University of California, San FranciscoEmily Behar, Study director, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888835
- Sponsor's protocol ID
- 1R01DA034527
- Other IDs
- R01DA034527
- Status last verified
- Mar 2018
- First submitted
- 25 Jun 2013
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coffin PO, Santos GM, Hern J, Vittinghoff E, Walker JE, Matheson T, Santos D, Colfax G, Batki SL. Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):246-255. doi: 10.1001/jamapsychiatry.2019.3655.
PubMed 31825466
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up
- ClinicalTrials.gov ID
- NCT01888835
- Acronym / sponsor ID
- 1R01DA034527
- Conditions
- Amphetamine-Related Disorders
- Keywords
- HIV, sexual behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Phillip Coffin, MD, MIAOther government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Active comparator | Drug: Mirtazapinemirtazapine 30 mg orally per day |
| Placebo | Placebo comparator | Drug: Placeboplacebo (30 mg) orally per day |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- born male, or born female and does not identify as female;
- reports anal sex with men in the prior three months while under the influence of meth;
- diagnosed with meth dependence by SCID;
- interested in stopping or reducing meth use;
- at least one meth-positive urine during screening and run-in period;
Key exclusion criteria (9 listed)
- Evidence of current major depression by SCID;
- history of bipolar disorder or psychotic disorder, as determined by SCID;
- known allergy or previous adverse reaction to mirtazapine;
- taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
- moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal);
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 |
|---|---|---|
| MirtazapineAlso: Remeron | Drug | Mirtazapine |
| Placebo | Drug | Placebo |
Primary outcome
Number of methamphetamine-positive urine tests
Time frame: weekly for 9 months
To determine the efficacy of mirtazapine vs placebo at 12 weeks and 24 weeks of treatment plus counseling, and to determine whether efficacy is sustained for an additional 12 weeks after discontinuation of treatment and counseling (weeks 24 to 36).
1 secondary outcome
Sexual risk (see description)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Derived from this study: PubMed 31825466Coffin PO, Santos GM, Hern J, Vittinghoff E, Walker JE, Matheson T, Santos D, Colfax G, Batki SL. Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):246-255. doi: 10.1001/jamapsychiatry.2019.3655.
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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.
Phillip O Coffin, M.D. principal investigator
San Francisco Department of Public Health
Steven L Batki, M.D. principal investigator
University of California, San Francisco
Emily Behar study director
San Francisco Department of Public Health
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 Mirtazapine in people with Amphetamine-Related Disorders, run by Phillip Coffin, MD, MIA 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 12 inclusion and 9 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 13 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 methamphetamine-positive urine tests (time frame: weekly for 9 months). 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 NCT01888835, 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 13 Mar 2018.