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

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 study is testing if the medication Mirtazapine can help people with opioid use disorder reduce their methamphetamine use while they receive standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Washington State University (Academic / other)
• Locations: 1 site (Spokane, Washington)
• Trial ID: NCT06323837 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a verified diagnosis of methamphetamine use disorder who are enrolled in medication-assisted treatment for opioid use disorder.

Not a fit: Patients with serious chronic illnesses likely to progress during the trial or those with acute illnesses requiring prolonged medical care may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients struggling with methamphetamine use in the context of opioid use disorder.

How similar studies have performed: Other studies have shown promising results using Mirtazapine for treating methamphetamine use, suggesting this approach may be effective.

Eligibility criteria

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 this trial is running

Spokane, Washington

• Spokane Treatment Center — Spokane, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Sterling M McPherson, PhD — Washington State University
• Study coordinator: Abigail L Bowen, MS

Conditions Stimulant Use Disorder