Trial Outcomes & Findings for Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit (NCT NCT02025855)
NCT ID: NCT02025855
Last Updated: 2025-12-05
Results Overview
The time to extubation will be calculated and compared for both groups.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Up to 14 days
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Methadone
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
7 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 14.9 • n=37 Participants
|
37 years
STANDARD_DEVIATION 17.2 • n=37 Participants
|
47 years
STANDARD_DEVIATION 19.4 • n=74 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=37 Participants
|
5 participants
n=37 Participants
|
9 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysThe time to extubation will be calculated and compared for both groups.
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Time to Extubation
|
10 Days
Interval 6.75 to 14.0
|
4 Days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to 14 daysCumulative doses of opioids will be collected and converted to morphine equivalents for analysis.
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Cumulative Opioid Consumption
|
473.5 mg morphine equivalents
Interval 400.0 to 943.0
|
561 mg morphine equivalents
Interval 514.0 to 2372.0
|
SECONDARY outcome
Timeframe: Up to 14 daysLevels of pain and sedation will be assessed per institutional policy, which utilizes the Motor Agitation Assessment Scale (MAAS). Average daily scores will be collected and compared for each group. The MAAS is scored from 0 (patient unresponsive) to 6 (dangerously agitated, uncooperative patient).
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Level of Sedation
|
3 score on a scale
Interval 3.0 to 3.0
|
3 score on a scale
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 14 daysQTc intervals will be calculated and documented at baseline and every 24 hours after to ensure it does not become prolonged. These values will be compared between groups by taking the median of the baseline and daily values.
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Corrected QT Interval
|
437 ms
Interval 430.0 to 439.0
|
457 ms
Interval 450.0 to 465.0
|
SECONDARY outcome
Timeframe: Up to 14 daysThe number of doses of antipsychotic medications will be collected and compared as a surrogate marker for presumed delirium.
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Cumulative Antipsychotic Use
|
0 doses
Interval 0.0 to 2.25
|
0 doses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 14 daysDoses of all benzodiazepines will be collected and compared between groups to determine if methadone reduces consumption.
Outcome measures
| Measure |
Methadone
n=4 Participants
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
Methadone
|
Placebo
n=5 Participants
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.
Placebo
|
|---|---|---|
|
Cumulative Benzodiazepine Consumption
|
260 mg midazolam
Interval 119.0 to 408.0
|
445 mg midazolam
Interval 252.9 to 580.0
|
Adverse Events
Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place