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Methadone tested to shorten time on breathing machines in ICU

NCT ID NCT02025855

Symptom relief Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving methadone to ICU patients on breathing machines could help them get off the ventilator faster. Patients who needed strong painkillers were given either methadone or a placebo. The trial was stopped early and only included 9 people, so no firm conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methadone
What this could lead to
If it worked, this approach could help ICU patients on breathing machines get off the ventilator sooner, reducing complications.
What could go wrong
The trial was terminated early with only 9 participants, so results are very limited. Methadone can also cause dangerous heart rhythm changes in rare cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

9 people

The number who actually took part.

Start date

Jan 2014

Finished

Oct 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Mechanically ventilated patients with opioid consumption greater than or equal to 1,200 mcg of fentanyl or equivalent consumption of another opioid per day during the first 48 hours of intubation. Exclusion Criteria: * Allergy to methadone * Admitted for head injury * Admitted for seizure * Seizure during admission, prior to enrollment * Subjects at high risk for developing a prolonged corrected QT (QTc) interval * Gastric residual volume ≥200 mL * Suspected obstruction or ileus * Nausea and vomiting * Recent abdominal surgery * Active upper or lower gastrointestinal bleeding * Active order for no medications by mouth or Total parenteral nutrition (TPN) * Pregnancy * Subjects receiving neuromuscular blocker infusions * Subjects taking antipsychotics at baseline

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Conditions

The condition(s) this trial relates to.

delirium opiate dependence substance withdrawal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delirium Opioid use, unspecified with withdrawal Opioid-induced disorders

Contacts and locations

Locations

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

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