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

Study acronym: MEND
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Start date changed from estimate of Dec 1, 2025 to Nov 15, 2025
    • Site contact updated
    v4
  2. Primary endpoints: 4 to 5v3 Show 4 more changesShow less
    • Start date: Nov 3, 2025 to Dec 1, 2025
    • Eligibility criteria revised
    • Secondary endpoints revised (3)
    • Site contact updated
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2025 to Nov 3, 2025
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07222072
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Post Operative Pain, Spinal Surgery
Related terms Postoperative Pain
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov