Using Mirtazapine to treat methamphetamine use in patients with opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effectiveness of Mirtazapine, a unique medication, in reducing methamphetamine use among patients receiving medication-assisted treatment for opioid use disorder. The study will compare outcomes between participants receiving Mirtazapine combined with standard treatment and those receiving a placebo with standard treatment. The primary goal is to achieve higher rates of verified abstinence from methamphetamine and improvements in health-related behaviors over a 10-week period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Spokane Treatment Center
  Spokane, Washington, United States Recruiting

Study contacts

• Principal investigator: Sterling M McPherson, PhD — Washington State University
• Study coordinator: Research Coordinator
• Email: wsu.appl@wsu.edu
• Phone: (509) 638-2376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.