Trial intelligence / Profile preview

Mirtazapine for Methamphetamine Abstinence in MOUD Adults

NCT06323837Phase 2

Key facts

Status
Recruiting
Start
Jun 2024
Primary completion
Dec 2026
Countries
1
Sponsor
Washington State University
Modality
Small Molecules
Conditions
methamphetamine use disorder (MUD)
01

Overview

Phase 2, randomised, double-blind trial in methamphetamine use disorder (MUD) comparing Mirtazapine + Treatment as Usual with Placebo + Treatment as Usual (2 arms). Primary endpoint: Urinanalysis Verified Increased Days of Methamphetamine Abstinence at 22 weeks. Started Jun 2024; status: recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Mirtazapine + Treatment as Usual

    Mirtazapine + Treatment as Usual

  • Placebo + Treatment as Usual

    Placebo + Treatment as Usual

03

Who it enrols

Adults with methamphetamine use disorder currently receiving medication for opioid use disorder (methadone or buprenorphine/naloxone), with a positive MA urinalysis, excluding those with severe psychiatric, hepatic, or renal conditions.

04

Endpoints

Primary

  • Urinanalysis Verified Increased Days of Methamphetamine Abstinence

Secondary

  • Actigraphy Verified Improved Sleep Patterns

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