Methadone for Pain After Spine Surgery
This study is looking at whether a medication called methadone can help reduce the need for other strong pain medicines (opioids) after major spine surgery. Researchers want to see if giving methadone for a few days after surgery is practical and safe. You could be eligible if you are an adult between 18 and 72 years old and are scheduled for certain types of spine fusion surgery. The study will compare methadone to a placebo (a pill with no medicine) to see how well it works. The main goal for this first study is to check if it's possible to recruit enough participants and if the study procedures can be followed easily. This information will help plan a larger study in the future.
- Study design
- This is a randomized, triple-blinded (you, your doctors, and the people analyzing results won't know if you're getting methadone or placebo), placebo-controlled study with 120 participants.
- What's involved
- You would receive either methadone or a placebo twice daily for two days after surgery, then once daily for three more days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goals for this study are measured at 7 days after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shobana Rajan, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
- Andra Duncan, MD · STUDY_CHAIR · The Cleveland Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility and Acceptability-Participant Willingness/Recruitment7 days
Willingness of participants to be randomized Indicates acceptability of randomization among eligible patients Outcome Measure: % of eligible patient consenting to randomization
- Feasibility and Acceptability-Provider Engagement7 days
Feasibility, acceptability and execution of clinical protocol based on the use of intraoperative IV methadone followed by a postoperative oral methadone regimen following spine surgery will be assessed by yes/no response to the following: Willingness of neurosurgeons/anesthesiologists to buy in to the trial Reflects institutional buy-in and clinical integration potential Outcome Measure: % of surgeons permitting patient enrollment and supporting protocol adherence
- Feasibility and Execution-Protocol Compliance and Execution7 days
Feasibility of clinical protocol based on the use of intraoperative IV methadone followed by a postoperative oral methadone regimen following spine surgery will be assessed by yes/no response to the following: Compliance with the protocol, including specific study related procedures and timepoints specific to medication administration, adverse event reporting and data collection. Demonstrates deliverability and data reliability Outcome Measure: % adherence to all major protocol steps (drug administration, ECGs, AE reporting, opioid data)
- Acceptability and Execution-Baseline Stratification Data18 months
Outcome Measure: % of enrolled patients with prior chronic opioid use
- Feasibility and Execution-Follow-Up Completion90 days
Ability to assess primary endpoint (opioid use at 3 months).Measured by response rates to the telephone survey at 3 months