Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02)

Study evaluating pharmacokinetics of methadone administered through IV to healthy adults

Summary

This study will evaluate how healthy adults process methadone administered through IV. It is needed to determine the optimal dose of methadone and to understand variations in drug disposition. Methadone is already approved by the U.S. Food and Drug Administration for treatment of pain management and Opioid Use Disorder (OUD) in adults. Results from MTH02 will help update information on dosing methadone for adults, and they will lay the foundation for studies to label methadone for treating acute pain and OUD in children.

 

Publications

 

OVERVIEW

Status:
Enrollment completed

ClinicalTrials.gov identifier:
NCT05425420

Principal Investigator:
Kanecia Zimmerman, MD, MPH
Duke University School of Medicine Department of Pediatrics; Duke Clinical Research Institute

NEWS

  • PTN Enrolls Participants in Methadone Study for Adults
    The Pediatric Trials Network (PTN) has enrolled the first participants in a study titled Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02). This study will evaluate how healthy adults process methadone administered through IV. It is essential for determining the optimal dose of methadone and to understand variations in ...