NCT07222072 Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
| NCT ID | NCT07222072 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-11-15 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adult ≥ 18 years of age * Scheduled for multilevel lumbar and/or thoracic spine fusion (primary or revision) Exclusion Criteria: * \<18 or \>72 Years of age * Body Mass Index \>40 * Known allergy to methadone * Pregnant females * Non-English-speaking patients
Contact & Investigator
Shobana Rajan, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07222072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 72 Years, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07222072 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07222072 currently recruiting?
Yes, NCT07222072 is actively recruiting participants. Contact the research team at stoians@ccf.org for enrollment information.
Where is the NCT07222072 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07222072 clinical trial?
NCT07222072 is sponsored by The Cleveland Clinic. The principal investigator is Shobana Rajan, MD at The Cleveland Clinic. The trial plans to enroll 120 participants.