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New treatment option for Stimulant Use Disorder
Official title Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
ClinicalTrials.gov ID: NCT06323837
What this study is testing
What is Mirtazapine?
Mirtazapine is an investigational medicine, being studied as a potential treatment for stimulant use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Suicide attempt in the last 2 years
- Moderate or severe liver disease (AST, ALT, and total bilirubin \>= 5 times upper limit of normal),
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Spokane, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.