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NCT02025855 · ClinicalTrials.gov registry record · Phase 4
Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit
A Phase 4 study, sponsored by Henry Ford Health System.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT02025855: Clinical Trial Phase 4 study, sponsored by Henry Ford Health System.
NCT02025855 is a Phase 4 study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02025855, a Phase 4 study, was terminated before completion, sponsored by Henry Ford Health System.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if administering methadone to mechanically ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated within 48 hours of their admission. Patients meeting enrollment criteria will be randomly assigned to receive methadone or placebo in addition to standard care. Methadone is a long acting pain medication that is approved by the Food and Drug Administration (FDA) to manage withdrawal from opioids and moderate to severe pain. Both of these indications are a frequent concern for critically ill patients that require mechanical ventilation. These patients often require intravenous (IV) opioids to manage the pain they experience due to their illness, procedures, and mechanical ventilation. During this time patients can develop physical dependence, which leads to withdrawal symptoms when the opioids are stopped or the dose is reduced. These symptoms can include agitation, pain, diarrhea and several others. Currently this is managed by a slow reduction in the dose of the IV opioid, but this can lead to prolonged time on mechanical ventilation, which has been associated with increased morbidity. Administering oral methadone to patients experiencing withdrawal symptoms has been shown to reduce and even eliminate these symptoms in the outpatient setting. This should also benefit patients in the ICU experiencing withdrawal from intravenous opioids required during their stay. It may allow for the other opioids to be discontinued more quickly, allowing for a shorter duration of mechanical ventilation. The level of pain and sedation will be assessed between groups randomized to either methadone or placebo in addition to current intravenous sedative and analgesic agents. The duration of mechanical ventilation will be assessed between both groups. Opioid withdrawal symptoms may manifest or be mistaken for delirium sy
Primary Outcome
The time to extubation will be calculated and compared for both groups.
Interventions
- DRUG Placebo
- DRUG Methadone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
Why NCT02025855 stopped before completion
NCT02025855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02025855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02025855 about?
NCT02025855 is a clinical study titled "Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit". The purpose of this study is to determine if administering methadone to mechanically ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated within 48 hours of their admis...
What is the current status of trial NCT02025855?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2014-01. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02025855?
The interventions under investigation include: Placebo (DRUG), Methadone (DRUG).
Who is sponsoring clinical trial NCT02025855?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02025855's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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