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Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
Sponsor: The Cleveland Clinic
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.
Key Details
Gender
All
Age Range
18 Years - 72 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-11-15
Completion Date
2028-10
Last Updated
2025-12-17
Healthy Volunteers
Yes
Conditions
Interventions
Methadone
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.
Placebo
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)
Cleveland Clinic
Cleveland, Ohio, United States