[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610014":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":52,"responsibleParty":73,"collaborators":46,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":46,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":55,"whyStopped":46,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methadone Group","ACTIVE_COMPARATOR","Patients randomized to receive post operative methadone",[13],"Drug: Methadone",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients randomized to receive (blinded) placebo","PLACEBO_COMPARATOR","Patients will receive post operative placebo",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methadone","Patients randomized to receive (blinded) methadone: 5 mg twice daily on postoperative (post-op) days 1 and 2 followed by 5 mg daily on postop days 3, 4, and 5.",[9],[27],"Methadone (Blinded) Group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Patients randomized to receive (blinded) placebo will receive placebo twice daily on day 1 and day 2 and once daily on day 3, 4 and 5. Patients taking preoperative opioids will return to baseline opioid schedule after surgery.",[15],[33],"Placebo (Blinded) Group",[35,38],{"name":36,"affiliation":5,"role":37},"Shobana Rajan, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Andra Duncan, MD","STUDY_CHAIR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Stephanie Stoianoff, MBA","CONTACT","12164440231",null,"stoians@ccf.org",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Sandra Durbin, CLPN, CCRP","216-269-4073","durbins@ccf.org",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-81.69541,41.4995,{"lat":65,"lon":64},[68,70,71],{"name":43,"role":44,"phone":69,"phoneExt":46,"email":47},"216-444-0231",{"name":49,"role":44,"phone":46,"phoneExt":46,"email":51},{"name":72,"role":37,"phone":46,"phoneExt":46,"email":46},"Shobana Rajan, M",{"type":74,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100610014","phase-4-methadone-to-reduce-chronic-opioid-use-after-major-spine-surgery-the-mend-pilot-feasibility-study-100610014",false,"NCT07222072","Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study","MEND","Inclusion Criteria:\n\n* Adult ≥ 18 years of age\n* Scheduled for multilevel lumbar and\u002For thoracic spine fusion (primary or revision)\n\nExclusion Criteria:\n\n* \\\u003C18 or \\>72 Years of age\n* Body Mass Index \\>40\n* Known allergy to methadone\n* Pregnant females\n* Non-English-speaking patients",true,"ALL","18 Years","72 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","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.",[94,95],"Post Operative Pain","Spinal Surgery",[23,97,98],"non-opioid","spinal surgery","2025-12-15",{"date":101,"type":102},"2025-12-17","ACTUAL",{"date":104,"type":102},"2025-11-15",{"date":106,"type":88},"2028-10",{"name":5,"class":6},1]