Trial Outcomes & Findings for Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids (NCT NCT06110546)
NCT ID: NCT06110546
Last Updated: 2025-08-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
from day of intubation to day 5
Results posted on
2025-08-01
Participant Flow
Of the 2 participants enrolled, 1 withdrew before randomization.
Participant milestones
| Measure |
Methadone Group
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids
Baseline characteristics by cohort
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
|
Cause of Lung Injury
Pneumonia
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Cause of Lung Injury
Aspiration
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Cause of Lung Injury
Non-pulmonary Sepsis
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Cause of Lung Injury
Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Cause of Lung Injury
Other Causes
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Weight
|
129.9 Kilograms
n=99 Participants
|
—
|
129.9 Kilograms
n=206 Participants
|
|
Duration on ventilator at time of randomization
|
78 hours
n=99 Participants
|
—
|
78 hours
n=206 Participants
|
PRIMARY outcome
Timeframe: from day of intubation to day 5Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
Number of Participants on Methadone That Get Extubated
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission)Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From time of admission to ICU to time of discharge from ICU (about 27 days after admission)Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
ICU Length of Stay
|
27 days
|
—
|
SECONDARY outcome
Timeframe: end of ICU stay (up to about 27 days after admission)Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
ICU Mortality
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: from time to admission to time of discharge from hospital (about 27 days after admission)Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
Hospital Length of Stay
|
27 days
|
—
|
SECONDARY outcome
Timeframe: end of hospital stay (up to about 27 days after admission )Population: 0 participants were randomized to the non-methadone group arm.
Outcome measures
| Measure |
Methadone Group
n=1 Participants
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).
|
Non-Methadone Group
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
|
|---|---|---|
|
Hospital Mortality.
|
0 Participants
|
—
|
Adverse Events
Methadone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Methadone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pascal Kingah, MD,MPH
The University of Texas Health Science Center at Houston
Phone: 713-500-6828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place