Effect of Methadone on the Duration on Mechanical VentilationPhase 4IMPACTORNCT06110546
Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids
A Phase 4 study testing Methadone group in people with Effect of Methadone on the Duration on Mechanical Ventilation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Methadone on the Duration on Mechanical Ventilation
- What is being tested?
- Methadone group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2024to 22 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
- Patients infused Fentanyl or Hydromorphone for more than 72 hours
- Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
- Patients hemodynamically stable
- Patients with a failed single or multiple attempts at spontaneous breathing trials
Who cannot join
- Patients with history of opioid drug abuse
- Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
- Patients with cervical spinal cord injury or neuromuscular disease
- Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
- Patients with prolonged QTc interval ≥500
- Patients with prior history of cardiac conduction defects or sudden death
Show all 11Show fewer
- Patients with QTc increase of ≥60 milliseconds above the value of prior EKGs measured during current ICU admission
- Patients with more than 5 days on IV analgesia
- Patients intubated for more than 3 days
- Patients without feeding tubes
- Patients not receiving enteral feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids, a Randomized Trial (IMPACTOR Study)
The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge
- Being tested
- Methadone group, Usual care
- Keywords
- opioids, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone groupDrug
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).
Usual careDrug
Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
| Study group | Role | What they receive |
|---|---|---|
| Methadone group | Experimental | Not described Receives: Drug: Methadone group |
| Non-Methadone group | Active comparator | Not described Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants on Methadone That Get Extubated
Measured: from day of intubation to day 5
Secondary outcomes (5)
Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone
Measured: from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission)
ICU Length of Stay
Measured: From time of admission to ICU to time of discharge from ICU (about 27 days after admission)
ICU Mortality
Measured: end of ICU stay (up to about 27 days after admission)
Hospital Length of Stay
Measured: from time to admission to time of discharge from hospital (about 27 days after admission)
Hospital Mortality.
Measured: end of hospital stay (up to about 27 days after admission )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start18 Feb 2024
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: very low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Effect of Methadone on the Duration on Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Kingah, The University of Texas Health Science Center, Houston
- Investigators
- Pascal Kingah, MD,MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110546
- Sponsor's protocol ID
- HSC-MS-22-0689
- Acronym
- IMPACTOR
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2023
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids, a Randomized Trial (IMPACTOR Study)
- ClinicalTrials.gov ID
- NCT06110546
- Acronym / sponsor ID
- IMPACTOR / HSC-MS-22-0689
- Keywords
- opioids, mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone group | Experimental | Drug: Methadone group |
| Non-Methadone group | Active comparator | Drug: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
- Patients infused Fentanyl or Hydromorphone for more than 72 hours
- Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
- Patients hemodynamically stable
- Patients with a failed single or multiple attempts at spontaneous breathing trials
Key exclusion criteria (11 listed)
- Patients with history of opioid drug abuse
- Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
- Patients with cervical spinal cord injury or neuromuscular disease
- Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
- Patients with prolonged QTc interval ≥500
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone groupParticipants 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). | Drug | Methadone group |
| Usual careParticipants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols | Drug | Non-Methadone group |
Primary outcome
Number of Participants on Methadone That Get Extubated
Time frame: from day of intubation to day 5
5 secondary outcomes
Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone
Time frame: from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission)
ICU Length of Stay
Time frame: From time of admission to ICU to time of discharge from ICU (about 27 days after admission)
ICU Mortality
Time frame: end of ICU stay (up to about 27 days after admission)
Hospital Length of Stay
Time frame: from time to admission to time of discharge from hospital (about 27 days after admission)
Hospital Mortality.
Time frame: end of hospital stay (up to about 27 days after admission )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Kingah, MD,MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone group in people with Effect of Methadone on the Duration on Mechanical Ventilation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants on Methadone That Get Extubated (time frame: from day of intubation to day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.