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

NCT06110546 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HSC-MS-22-0689
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

opioids; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Participants on Methadone That Get Extubated

  from day of intubation to day 5

Secondary Outcomes (5)

• Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone

  from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission)

• ICU Length of Stay

  From time of admission to ICU to time of discharge from ICU (about 27 days after admission)

• ICU Mortality

  end of ICU stay (up to about 27 days after admission)

• Hospital Length of Stay

  from time to admission to time of discharge from hospital (about 27 days after admission)

• Hospital Mortality.

  end of hospital stay (up to about 27 days after admission )

Study Arms (2)

Methadone group

EXPERIMENTAL

Drug: Methadone group

Non-Methadone group

ACTIVE COMPARATOR

Drug: Usual care

Interventions

Methadone group DRUG

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).

Methadone group

Usual care DRUG

Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols

Non-Methadone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
• Patients infused Fentanyl or Hydromorphone for more than 72 hours
• Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)\>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
• Patients hemodynamically stable
• Patients with a failed single or multiple attempts at spontaneous breathing trials

You may not qualify if:

• Patients with history of opioid drug abuse
• Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
• Patients with cervical spinal cord injury or neuromuscular disease
• Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
• Patients with prolonged QTc interval ≥500
• Patients with prior history of cardiac conduction defects or sudden death
• Patients with QTc increase of ≥60 milliseconds above the value of prior EKGs measured during current ICU admission
• Patients with more than 5 days on IV analgesia
• Patients intubated for more than 3 days
• Patients without feeding tubes
• Patients not receiving enteral feeding

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Pascal Kingah, MD,MPH
• Organization: The University of Texas Health Science Center at Houston

Pascal.L.Kingah@uth.tmc.edu

713-500-6828

Study Officials

• Pascal Kingah, MD,MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: February 18, 2024
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)