[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545429":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":48,"responsibleParty":68,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Epidiolex (cannabidiol)","EXPERIMENTAL","Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.",[13],"Drug: Epidiolex",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.",[19],"Drug: Placebo oral solution",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Epidiolex","150mg of Epidiolex",[9],[27],"Cannabidiol Oral Solution",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo oral solution","150mg of Placebo oral solution",[15],[15],[34],{"name":35,"affiliation":5,"role":36},"Patrick McCulloch, MD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Haley M Goble, MPH, CRCC","CONTACT","7134413930",null,"hmgoble@houstonmethodist.org",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"David N Armond, BS","3462380206","dnarmond@houstonmethodist.org",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Houston Methodist Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-95.36327,29.76328,{"lat":61,"lon":60},[64,66],{"name":65,"role":40,"phone":41,"phoneExt":42,"email":43},"Haley M Goble, MHA, CRCC",{"name":67,"role":36,"phone":42,"phoneExt":42,"email":42},"Patrick C McCulloch, MD",{"type":36,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Patrick McCulloch,MD","The John S. Dunn Chair in Orthopedic Surgery","100545429","phase-1-cbd-for-pain-following-orthopedic-shoulder-surgery-100545429",false,"NCT06381791","CBD for Pain Following Orthopedic Shoulder Surgery","Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial","CBD","Inclusion Criteria:\n\n* Above the age of 18 years old\n* Undergoing a rotator cuff repair surgery\n* Receiving standard anesthesia during surgery\n* If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.\n\nExclusion Criteria:\n\n* Under the age of 18 years old\n* History of revision shoulder arthroplasty\n* History of liver disease or impairment\n* Are currently taking valproate or clobazam\n* Are currently taking a moderate\u002Fstrong CYP3A4 or CYP2C19 inhibitor\n* Are currently taking a strong CYP3A4 or CYP2C19 inducer\n* Are currently taking narcotics\n* History of substance\u002Falcohol abuse\n* Those currently or previously under the care of a pain management specialist\n* History of marijuana\u002Fcannabidiol (not including topical) regular use within the past 6 months\n* Allergy related to cannabidiol\n* Allergy related to sesame seeds\n* Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)\n* If you are taking any medications with known risks for suicidal behavior and ideation\n* If you have a diagnosed psychiatric disorder\n* If you are untreated for a diagnosed sleeping disorder\n* If you are actively breastfeeding\n* Patients currently taking central nervous system (CNS) depressants\n* Patients currently taking other drugs with known hepatotoxicity\n* Vulnerable populations.\n\nPatients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.","ALL","18 Years",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.\n\nResearchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.\n\nParticipants will:\n\n* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.\n* Complete two short surveys. Once before surgery and once after.\n* Have bloodwork tested after surgery",[90,91],"Shoulder Osteoarthritis","Rotator Cuff Injuries",[77,93,23],"Cannabidiol","2026-04-15",{"date":96,"type":97},"2026-04-16","ACTUAL",{"date":99,"type":97},"2024-05-24",{"date":101,"type":83},"2027-12-30",{"name":5,"class":6},1]