NCT06323837

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

• Stimulant Use Disorder

Interventions

Type	Name	Description
DRUG	Mirtazapine	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.
DRUG	Placebo	Placebo to match.

Timeline

• Start date: 2024-06-17
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-03-21
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study