Actively Recruiting
Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
Led by Washington State University · Updated on 2025-03-04
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery & Treatment Center/clinics in Spokane, WA.
- Verified DSM-5 diagnosis of methamphetamine use disorder (mild, moderate, or severe).
- Age 18 years or older.
- Ability to provide written informed consent.
- Demonstrated at least 78% adherence during the induction period.
- Provided at least one methamphetamine positive urine test at baseline or during induction.
- Baseline blood tests without clinically significant abnormalities as determined by clinician.
- No current acute illness requiring prolonged medical care.
- No serious chronic illnesses likely to worsen during trial participation.
- Vital signs within normal ranges (blood pressure, breathing rate, pulse, temperature).
You will not qualify if you...
- Inability to provide informed consent due to cognitive, psychiatric, or language issues.
- Prior diagnosis of dementia.
- Medically or psychiatrically unsafe to participate as determined by study medical director.
- Documented suicide attempt in past 30 days or serious suicidal intention or plan.
- Suicide attempt in last 2 years.
- Moderate or severe liver disease.
- Impaired kidney function (estimated GFR <40 ml/min).
- Current severe cocaine, amphetamine, or alcohol use disorder deemed unsafe for participation.
- History of bipolar or psychotic disorder.
- Taking opioid use disorder medications other than methadone or buprenorphine/naloxone.
- Taking certain medications affecting liver metabolism or antidepressants within past 30 days.
- Prescribed mirtazapine within the past year.
- History of violent criminal behavior or on parole.
- Currently pregnant or intending to become pregnant.
- Final eligibility decided by study medical director in consultation with principal investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spokane Treatment Center
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
A
Abigail L Bowen, MS
CONTACT
S
Serena M McPherson, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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