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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 is a Phase 4 study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 9 participants.
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
Interventions
- DRUG Placebo
- DRUG Methadone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02025855
The ClinicalTrials.gov registry entry for NCT02025855 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02025855 reports 0 study locations.
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.
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