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Could an antidepressant help curb meth use in people treated for opioid addiction?

NCT ID NCT06323837

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This phase 2 trial tests whether mirtazapine, an antidepressant, can help adults who are already receiving medication for opioid use disorder to stop or reduce their methamphetamine use. Participants are randomly assigned to receive either mirtazapine or a placebo for 10 weeks, alongside their usual treatment. The study measures methamphetamine abstinence through urine tests and also tracks sleep improvements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirtazapine
What this could lead to
If it works, mirtazapine could become a new treatment option to help people reduce or stop methamphetamine use while receiving medication for opioid use disorder.
What could go wrong
This is a small, early-phase trial with only 60 participants. The drug may not prove more effective than placebo, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Spokane Treatment Center

    RECRUITING

    Spokane, Washington, 99208, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.