Pain, PostoperativePhase 2NCT03605901
Dosing of Methadone for Spine Surgery
A Phase 2 study testing Standard dosing of methadone and Aliquots of methadone titrated to apnea in people with Pain, Postoperative, run by University of Florida at 1 site in United States.
Trial summary
This study compares two methods of dosing methadone for complex spine cases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Standard dosing of methadone and Aliquots of methadone titrated to apnea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 9 May 2025
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
- At or between the ages 18 to 75 years.
- Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.
Who cannot join
- Methadone or buprenorphine use.
- Morbid obesity with BMI>40 Kg/m2.
- Chronic renal failure with creatinine>2.0 mg/dL.
- Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
- Current or historical alcohol abuse.
- Current or historical drug abuse.
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- Patients with history of prolonged QTc, as defined as a QTc value >450 ms in males and >460 ms in females.
- Patients with ASA status IV or V.
- Surgical diagnosis including spine tumor, infection, or trauma.
- In the Principal Investigator's opinion is not a candidate for the study.
- Unwilling to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
This study compares two methods of dosing methadone for complex spine cases
Read the detailed description
Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.
- Conditions
- Pain, Postoperative
- Being tested
- Standard dosing of methadone, Aliquots of methadone titrated to apnea
- Keywords
- Post-operative pain, Spine surgery, Methadone, Opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dosing of methadoneDrug
Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Aliquots of methadone titrated to apneaDrug
Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing of methadone | Active comparator | Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. Receives: Drug: Standard dosing of methadone |
| Aliquots of methadone titrated to apnea | Experimental | Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. Receives: Drug: Aliquots of methadone titrated to apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop
The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline).
Measured: Postop 24 hours, Postop 48 hours, Postop 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start19 Mar 2019
- Primary completion9 May 2025
- Study completion9 May 2025
Why it stopped: PI left institution.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Seubert, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605901
- Sponsor's protocol ID
- IRB201700673
- Other IDs
- OCR18737
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2018
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PubMed 20418538
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing of Methadone for Spine Surgery
- ClinicalTrials.gov ID
- NCT03605901
- Acronym / sponsor ID
- IRB201700673
- Conditions
- Pain, Postoperative
- Keywords
- Post-operative pain, Spine surgery, Methadone, Opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares two methods of dosing methadone for complex spine cases
Detailed description
Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| Standard dosing of methadone | Active comparator | Drug: Standard dosing of methadoneReceive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
| Aliquots of methadone titrated to apnea | Experimental | Drug: Aliquots of methadone titrated to apneaReceive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
- At or between the ages 18 to 75 years.
- Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.
Key exclusion criteria (11 listed)
- Methadone or buprenorphine use.
- Morbid obesity with BMI>40 Kg/m2.
- Chronic renal failure with creatinine>2.0 mg/dL.
- Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
- Current or historical alcohol abuse.
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 |
|---|---|---|
| Standard dosing of methadoneSubject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. | Drug | Standard dosing of methadone |
| Aliquots of methadone titrated to apneaSubjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. | Drug | Aliquots of methadone titrated to apnea |
Primary outcome
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop
Time frame: Postop 24 hours, Postop 48 hours, Postop 72 hours
The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20418538Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
- Individual participant dataSharing planned: No
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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.
Christoph Seubert, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard dosing of methadone and Aliquots of methadone titrated to apnea in people with Pain, Postoperative, run by University of Florida 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 3 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 23 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Jun 2026). 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?
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop (time frame: Postop 24 hours, Postop 48 hours, Postop 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605901, which also lists 1 linked publication.
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 23 Jun 2026.