NCT06110546

Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids

Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids, a Randomized Trial (IMPACTOR Study)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge

Conditions

• Effect of Methadone on the Duration on Mechanical Ventilation

Interventions

Type	Name	Description
DRUG	Methadone group	Participants will be started on Methadone 5mg, 10mg or 15mg every 8 hours depending on Fentanyl drip rate (0-100mcg/hr, 100-200mcg/hr or \>200mcg/hr) or hydromorphone drip rate (0-1.5mg/hr, 1.5-3mg/hr, or \>3mg/hr).
DRUG	Usual care	Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols

Timeline

• Start date: 2024-02-18
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2023-10-31
• Last updated: 2025-08-01
• Results posted: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study