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Mirtazapine for Methamphetamine Use in Opioid Use Disorder Patients

This study is testing if a medication called mirtazapine can help people who are receiving treatment for opioid use disorder to stop using methamphetamine. Researchers want to see if mirtazapine can increase the number of days you stay abstinent from methamphetamine. You might be able to join if you are 18 or older, are already getting treatment for opioid use disorder at specific clinics in Oregon or Spokane, WA, and have a diagnosis of methamphetamine use disorder. The study will enroll about 60 participants. The study's success will be measured by how many more days participants stay free from methamphetamine, as shown by urine tests, over a period of 2 to 22 weeks. The current recruitment status is unclear.

Study design
This is a Phase 2 study that will randomly assign participants to receive either mirtazapine or a placebo (an inactive substance) without knowing which one they are getting. About 60 people are planned to participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for their methamphetamine abstinence through urine tests from week 2 to week 22.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06323837

Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington State University
~60 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:MirtazapinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinanalysis Verified Increased Days of MA Abstinence
Measured over Weeks 2 to Week 22

Conditions

Stimulant Use Disorder

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NCT06323837

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Spokane Treatment Center

    Spokane, Washingtonno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sterling M McPherson, PhD · PRINCIPAL_INVESTIGATOR · Washington State University

Who to contact

Research Coordinator
[email protected]
(509) 638-2376
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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),
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.

What this trial measures

  • Urinanalysis Verified Increased Days of MA AbstinenceWeeks 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.