Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
Recruiting
Phase 4
Interventional Study
Post Operative Pain
Spinal Surgery
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 72
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 120 (estimated)
- Sponsor
- The Cleveland Clinic · Other
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About This Trial
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 e…
Trial Locations
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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
Contacts