Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
The Cleveland Clinic
120 participants
Nov 15, 2025
INTERVENTIONAL
Conditions
Summary
The investigators propose a randomized, triple-blinded (patients, investigators, outcomes assessors), placebo-controlled pilot feasibility trial (Methadone to End Narcotic Dependence, MEND trial) to assess the feasibility and safety of postoperative oral methadone in patients undergoing spine surgery and collect preliminary data to inform a larger clinical trial that will test the opioid-sparing effects of methadone at 3 months after spine surgery.
Eligibility
Inclusion Criteria2
- Adult ≥ 18 years of age
- Scheduled for multilevel lumbar and/or thoracic spine fusion (primary or revision)
Exclusion Criteria5
- <18 or >72 Years of age
- Body Mass Index >40
- Known allergy to methadone
- Pregnant females
- Non-English-speaking patients
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Interventions
Patients randomized to receive (blinded) methadone: 5 mg twice daily on postoperative (post-op) days 1 and 2 followed by 5 mg daily on postop days 3, 4, and 5.
Patients randomized to receive (blinded) placebo will receive placebo twice daily on day 1 and day 2 and once daily on day 3, 4 and 5. Patients taking preoperative opioids will return to baseline opioid schedule after surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07222072