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

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT06323837
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stimulant Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mirtazapine — DRUG
    This is a Phase 2, 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.
  • Placebo — DRUG
    Placebo to match.

Study Details

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.

Key Dates

Start date
Jun 17, 2024
Status verified
Feb 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MZP+TAU
    Mirtazapine + Treatment as Usual
  • Placebo Comparator: PLO+TAU
    Placebo + Treatment as Usual

Primary Outcome Measure

Urinanalysis Verified Increased Days of MA Abstinence [ Time Frame: Weeks 2 to Week 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spokane Treatment CenterSpokaneWashington99208
Rachel Ryan, BS

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Spokane Treatment Center· Spokane, WA

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