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

What this Trial Is About

This research aims to evaluate the feasibility and safety of using oral methadone after spine surgery to reduce long-term opioid use. Researchers are conducting a randomized, triple-blinded, placebo-controlled pilot trial called the MEND trial to gather early data on methadone's effects on opioid use three months after surgery. The study addresses the significant issue of opioid dependence following spine surgery, which carries high risks of prolonged opioid use and related complications. Participants are assigned to one of two groups: one receiving oral methadone and the other a placebo. Patients in the methadone group will take 5 mg twice daily on the first two postoperative days, then 5 mg once daily on days 3 through 5. Those in the placebo group will receive placebo doses on the same schedule. Patients who were using opioids before surgery will return to their usual opioid regimen after surgery. The study monitors the impact of this treatment during the postoperative period. Throughout the study, participants' willingness to join, provider engagement, protocol adherence, and follow-up completion will be assessed at various time points up to 90 days after surgery. Researchers will also track cardiac rhythm abnormalities and respiratory adverse events for up to 18 months. The main goal is to estimate the reduction in opioid use three months post-surgery. Participants will undergo regular assessments and monitoring to collect these data during the trial period, which may last up to several years.

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