RECRUITING

Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment

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Conditions

Stimulant Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-17
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06323837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery \& Treatment Center/clinics in Spokane, WA.
  2. * Verification of a DSM-5104 diagnosis of an methamphetamine (MA) use disorder (i.e. mild, moderate, or severe),
  3. * Aged 18+ years,
  4. * Ability to provide written informed consent,
  5. * Demonstration of 78% adherence rate during the induction period and
  6. * Provision of at least one MA positive urinalysis at baseline or during induction.
  7. * 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.
  8. * No current acute illness requiring prolonged medical care.
  9. * No serious chronic illnesses that are likely to progress clinically during trial participation.
  10. * 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.
  1. * Inability to demonstrate competency to provide informed consent because of cognitive or psychiatric disorders or limited English proficiency,
  2. * Prior diagnosis of dementia,
  3. * Medically or psychiatrically unsafe to participate as determined by Dr. Layton (Medical Director),
  4. * 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
  5. * Suicide attempt in the last 2 years
  6. * Moderate or severe liver disease (AST, ALT, and total bilirubin \>= 5 times upper limit of normal),
  7. * Impaired renal function (estimated GFR \<40 ml/min),
  8. * Current severe cocaine, amphetamine, or alcohol use disorder as defined by DSM-5 criteria which Drs Layton and McPherson deem their participation as unsafe.
  9. * History of bipolar disorder or psychotic disorder, as determined by Structured Clinical Interview for DSM Disorders (SCID,
  10. * 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.
  11. * Taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamine oxidase inhibitor,
  12. * Prescribed MZP in the least year, or
  13. * History of violent criminal behavior or being on parole,.
  14. * Currently pregnant or intending to become pregnant,.
  15. * Final determination of eligibility will be made by Dr. Layton in consultation with the PI.

Contacts and Locations

Study Contact

Abigail L Bowen, MS
CONTACT
(425) 736-1354
abigail.bowen@wsu.edu
Serena M McPherson, BA
CONTACT
(509) 324 7459
s.mcpherson@wsu.edu

Principal Investigator

Sterling M McPherson, PhD
PRINCIPAL_INVESTIGATOR
Washington State University

Study Locations (Sites)

Spokane Treatment Center
Spokane, Washington, 99208
United States

Collaborators and Investigators

Sponsor: Washington State University

  • Sterling M McPherson, PhD, PRINCIPAL_INVESTIGATOR, Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-06-17
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Stimulant Use Disorder