Stimulant Use DisorderPhase 2MIRROMNCT06323837
Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
A Phase 2 study testing Mirtazapine in people with Stimulant Use Disorder, run by Washington State University at 1 site in United States.
Trial summary
This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stimulant Use Disorder
- What is being tested?
- Mirtazapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery \& Treatment Center/clinics in Spokane, WA.
- Verification of a DSM-5104 diagnosis of an methamphetamine (MA) use disorder (i.e. mild, moderate, or severe),
- Aged 18+ years,
- Ability to provide written informed consent,
- Demonstration of 78% adherence rate during the induction period and
- Provision of at least one MA positive urinalysis at baseline or during induction.
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- Baseline complete blood cell count (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.
- No current acute illness requiring prolonged medical care.
- No serious chronic illnesses that are likely to progress clinically during trial participation.
- Vital signs are within the normal ranges (i.e., Blood pressure: 90/60 mm Hg to 120/80 mm Hg; breathing: 12-18 breaths per minute; pulse: 60-100 beats per minute; temperature: 97.8 - 99.1 degrees Fahrenheit.
Who cannot join
- Inability to demonstrate competency to provide informed consent because of cognitive or psychiatric disorders or limited English proficiency,
- Prior diagnosis of dementia,
- Medically or psychiatrically unsafe to participate as determined by Dr. Layton (Medical Director),
- Documented suicide attempt in the past 30 days and/or serious suicide intention or plan as assessed by the Structured Clinical Interview for DSM-5 (SCID-5; clinical trials version)105
- Suicide attempt in the last 2 years
- Moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal),
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- Impaired renal function (estimated GFR <40 ml/min),
- Current severe cocaine, amphetamine, or alcohol use disorder as defined by DSM-5 criteria which Drs Layton and McPherson deem their participation as unsafe.
- History of bipolar disorder or psychotic disorder, as determined by Structured Clinical Interview for DSM Disorders (SCID,
- Currently taking 1) any type of opioid use disorder medication other than methadone or buprenorphine/naloxone, or 2) phenytoin, carbamazepine, or another inducer of hepatic metabolism (such as rifampicin) and CYP enzyme inhibitor cimetidine.
- Taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamine oxidase inhibitor,
- Prescribed MZP in the least year, or
- History of violent criminal behavior or being on parole,.
- Currently pregnant or intending to become pregnant,.
- Final determination of eligibility will be made by Dr. Layton in consultation with the PI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spokane Treatment Center
Spokane, Washington, 99208
Rachel Ryan, BS
About this study
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial (RCT) to Evaluate the Ability of Mirtazapine (MZP) to Increase Methamphetamine (MA) Abstinence Among Treatment-seeking Medication for Opioid Use Disorder (MOUD) Adults
This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).
The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods.
- Conditions
- Stimulant Use Disorder
- Being tested
- Mirtazapine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
This is a Phase 2, randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of mirtazapine (MZP) to increase methamphetamine (MA) abstinence among treatment-seeking medication for opioid use disorder (MOUD) adults.
PlaceboDrug
Placebo to match.
| Study group | Role | What they receive |
|---|---|---|
| MZP+TAU | Experimental | Mirtazapine + Treatment as Usual Receives: Drug: Mirtazapine |
| PLO+TAU | Placebo comparator | Placebo + Treatment as Usual Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinanalysis Verified Increased Days of MA Abstinence
Determine if participants randomized to the MZP+TAU arm use less MA compared to those assigned to the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate significantly increased rates of biochemically verified MA abstinence relative to those in the PLO+TAU arm across the 10-week treatment period and 3-month follow-up periods.
Measured: Weeks 2 to Week 22
Secondary outcomes (1)
Actigraphy Verified Improved Sleep Patterns
Determine if participants randomized to the MZP+TAU arm demonstrate improvements in sleep compared to those assigned to the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate improvements in objectively verified sleep relative to the PLO+TAU arm across the 10-week treatment and 3-month follow-up periods.
Measured: Week 2 to Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start17 Jun 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant Use DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sterling McPherson, Washington State University
- Investigators
- Sterling M McPherson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323837
- Sponsor's protocol ID
- 20383
- Acronym
- MIRROM
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial (RCT) to Evaluate the Ability of Mirtazapine (MZP) to Increase Methamphetamine (MA) Abstinence Among Treatment-seeking Medication for Opioid Use Disorder (MOUD) Adults
- ClinicalTrials.gov ID
- NCT06323837
- Acronym / sponsor ID
- MIRROM / 20383
- Conditions
- Stimulant Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- 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.
This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).
The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MZP+TAU | Experimental | Drug: MirtazapineMirtazapine + Treatment as Usual |
| PLO+TAU | Placebo comparator | Drug: PlaceboPlacebo + Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery \& Treatment Center/clinics in Spokane, WA.
- Verification of a DSM-5104 diagnosis of an methamphetamine (MA) use disorder (i.e. mild, moderate, or severe),
- Aged 18+ years,
- Ability to provide written informed consent,
- Demonstration of 78% adherence rate during the induction period and
Key exclusion criteria (15 listed)
- Inability to demonstrate competency to provide informed consent because of cognitive or psychiatric disorders or limited English proficiency,
- Prior diagnosis of dementia,
- Medically or psychiatrically unsafe to participate as determined by Dr. Layton (Medical Director),
- Documented suicide attempt in the past 30 days and/or serious suicide intention or plan as assessed by the Structured Clinical Interview for DSM-5 (SCID-5; clinical trials version)105
- Suicide attempt in the last 2 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 |
|---|---|---|
| MirtazapineThis is a Phase 2, randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of mirtazapine (MZP) to increase methamphetamine (MA) abstinence among treatment-seeking medication for opioid use disorder (MOUD) adults. | Drug | MZP+TAU |
| PlaceboPlacebo to match. | Drug | PLO+TAU |
Primary outcome
Urinanalysis Verified Increased Days of MA Abstinence
Time frame: Weeks 2 to Week 22
Determine if participants randomized to the MZP+TAU arm use less MA compared to those assigned to the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate significantly increased rates of biochemically verified MA abstinence relative to those in the PLO+TAU arm across the 10-week treatment period and 3-month follow-up periods.
1 secondary outcome
Actigraphy Verified Improved Sleep Patterns
Time frame: Week 2 to Week 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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.
Sterling M McPherson, PhD principal investigator
Washington State University
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 Stimulant Use Disorder, run by Washington State University 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator ((509) 638-2376, wsu.appl@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinanalysis Verified Increased Days of MA Abstinence (time frame: Weeks 2 to Week 22). 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 2 Jul 2026.