Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-72
SponsorThe Cleveland Clinic
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 effects of methadone at 3 months after spine surgery.
Eligibility criteria
Qualifiers
Adult ≥ 18 years of age
Scheduled for multilevel lumbar and/or thoracic spine fusion (primary or revision)
Disqualifiers
<18 or >72 Years of age
Body Mass Index >40
Known allergy to methadone
Pregnant females
Trial design
Treatments tested in this trial
- Methadone
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov