RecruitingPhase 4NCT07222072

Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study

Sponsor

The Cleveland Clinic

Enrollment

120 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal surgery Post Operative Pain

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

Min Age: 18 YearsMax Age: 72 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methadone and a drug called Placebo for people with post operative pain and spinal surgery. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 72 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethadone

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.

DRUGPlacebo

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.