[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610335":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Single dose of methadone","ACTIVE_COMPARATOR","Single dose of methadone administered at induction of anesthesia",[13],"Drug: Single dose of methadone",{"label":15,"type":16,"description":17,"interventionNames":18},"Split dose of methadone","EXPERIMENTAL","Split dose of methadone post cardiopulmonary bypass",[19],"Drug: Split dose of methadone",{"label":21,"type":16,"description":22,"interventionNames":23},"Balanced split dose of methadone","Balanced split dose of methadone post cardiopulmonary bypass",[24],"Drug: Balanced split dose of methadone",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Single dose of methadone 0.3 mg\u002Fkg actual body weight (max 30 mg) administered at induction of anesthesia",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Split dose of methadone 0.2 mg\u002Fkg actual body weight at induction and 0.1 mg\u002Fkg actual body weight post cardiopulmonary bypass",[15],{"type":27,"name":21,"description":35,"armGroupLabels":36,"otherNames":30},"Balanced split dose of methadone 0.15 mg\u002Fkg actual body weight at induction and 0.15 mg\u002Fkg actual body weight post cardiopulmonary bypass",[21],[38],{"name":39,"affiliation":5,"role":40},"Ettore Crimi, MD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","336-716-4498","ettore.crimi@advocatehealth.org",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Lynnette Harris, BSN","336-716-8791","lynnette.harris@advocatehealth.org",[51],{"facility":5,"status":30,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Winston-Salem","North Carolina","27157","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.24422,36.09986,{"lat":61,"lon":60},[64,68],{"name":65,"role":43,"phone":66,"phoneExt":30,"email":67},"Lynnette Harris, BSN, RN","336-306-0778","Lynnette.Harris@Advocatehealth.org",{"name":39,"role":40,"phone":30,"phoneExt":30,"email":30},{"type":70,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100610335","phase-4-methadone-pharmacokinetics-in-cardiac-surgery-100610335",false,"NCT07226245","Methadone Pharmacokinetics in Cardiac Surgery","Evaluating Pharmacokinetics of Three Methadone Dosing Strategies During Cardiac Surgery With Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Elective cardiac surgery requiring median sternotomy and cardiopulmonary bypass (CABG, valve, combined CABG\u002Fvalve surgeries)\n* Anticipated extubation within 12 hours postoperatively\n* No prior opioid use within 30 days of surgery\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Severe liver or kidney dysfunction (Child-Pugh class B\u002FC, eGFR \\\u003C30 mL\u002Fmin\u002F1.73m², creatinine \\>2 mg\u002FdL, dialysis)\n* Allergy to methadone or fentanyl\n* Use of CYP3A4 inducers (rifampin, phenytoin, carbamazepine), CYP3A4 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole), SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine)\n* Body mass index \\>40 kg\u002Fm²\n* Corrected QT interval interval \\>500 milliseconds\n* Intubation anticipated \\>12 hours\n* History of illicit drug use or alcohol or opioid abuse use disorder within last 12 months\n* Mechanical circulatory support, heart transplant, deep hypothermic circulatory arrest procedures\n* Left Ventricular Ejection Fraction \\\u003C30%\n* Pulmonary disease requiring oxygen therapy\n* Preoperative inotropic support or intra-aortic balloon pump\n* Emergency surgery\n* Postoperative regional anesthesia\n* Hemofiltration during cardiopulmonary bypass","ALL","18 Years","70 Years",{"count":82,"type":83},69,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Cardiac surgery frequently leads to significant postoperative pain, with multiple different drug regimens being utilized (both opioid and non-opioid) in an attempt to alleviate this surgical pain. Methadone is currently one of the drugs that is being utilized to help control the pain. It can be given during and\u002For after surgery. This study hopes to identify the optimal dose of methadone to use to treat this surgical pain.",[89],"Postoperative Pain Management",[91,92,93,94,95],"methadone pharmacokinetics","cardiac surgery","pain management","cardiac surgery recovery","methadone","NOT_YET_RECRUITING","2026-05-22",{"date":99,"type":100},"2026-05-26","ACTUAL",{"date":102,"type":83},"2026-09",{"date":104,"type":83},"2026-12-30",{"name":5,"class":6},1]