[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604337":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":49,"locations":56,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":40,"enrollmentInfo":87,"targetDuration":40,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":103,"whyStopped":40,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dronabinol + Epidiolex Arm","EXPERIMENTAL","Dronabinol (THC) will be dosed every 12 hours. To limit potential adverse effects, the dose of dronabinol will be titrated up gradually over 15 days to a final daily dose of 20 mg (10 mg every 12 hours). This final dosage will be administered twice daily from Day 16 to Week 8.\n\nEpidiolex (CBD) will also be dosed every 12 hours. To limit potential adverse effects, the dose of Epidiolex will be titrated up gradually over 15 days to a final dose of 400 mg every 12 hours. Participants will start off taking 200 mg daily (100 mg every 12 hours) for 5 days, then uptitrate to 400 mg (200 mg every 12 hours) for 5 days, then uptitrate to 600 mg for 5 days (300 mg every 12 hours), and finally 800 mg from day 16 through week 8 (400 mg every 12 hours).",[13,14],"Drug: Dronabinol Capsules","Drug: Epidiolex 100 mg\u002FmL Oral Solution",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo Arm","PLACEBO_COMPARATOR","Placebo Dronabinol capsules will be labeled and identical in appearance to dronabinol capsules. They will be made of pearl capsules filled with lactose by Montefiore's Investigational Drug Pharmacy team.\n\nPlacebo Epidiolex oral solution will be made up of ethanol (79.0 mg\u002FmL), sucralose (0.5 mg\u002FmL), strawberry flavor (0.2 mg\u002FmL), and refined sesame oil (to a volume of 1 mL). This mixture will be identical in appearance, taste, and composition of Epidiolex, except for the active ingredient of pure CBD.",[20,21],"Other: Placebo Dronabinol","Other: Placebo Epidiolex",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Dronabinol Capsules","Dronabinol is a synthetic form of THC. Dronabinol is eliminated in a biphasic manner, with an initial half-life of 25-36 hours.",[9],[29],"Marinol",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Epidiolex 100 mg\u002FmL Oral Solution","Epidiolex is an oral solution (100 mg\u002FmL) which rapidly appears in plasma, reaches peak plasma concentration in 3-4 hours and has a half-life of 18-32 hours.",[9],[35],"Cannabidiol (CBD)",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo Dronabinol","Placebo capsules",[16],null,{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Placebo Epidiolex","Placebo oral solution",[16],[46],{"name":47,"affiliation":5,"role":48},"Deepika Slawek, MD, MPH, MS","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":40,"email":53},"CONTACT","718-920-3786","dslawek@montefiore.org",{"name":55,"role":51,"phone":40,"phoneExt":40,"email":40},"Deepika Slawek",[57],{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Montefiore Health System (Montefiore) Buprenorphine Treatment Network","The Bronx","New York","10467","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-73.86641,40.84985,{"lat":68,"lon":67},[71],{"name":47,"role":51,"phone":52,"phoneExt":40,"email":53},{"type":73,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[75],{"name":76,"class":77},"National Institute on Drug Abuse (NIDA)","NIH","100604337","phase-3-dronabinol-and-epidiolex-to-manage-uncontrolled-residual-symptoms-of-buprenorphine-initiation-trial-100604337",false,"NCT07148206","Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial","DEMURE","Inclusion Criteria:\n\n* Fluency in English and Spanish\n* The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD\n* Newly initiated on buprenorphine within 21 days\n* Positive urine toxicology for opioids other than buprenorphine in the past week OR opioid withdrawal symptoms in the past week based on the Clinical Opioid Withdrawal Scale (COWS) \\>=5\n* Any cannabis use in the past at or after the age of 18 years based on self-report\n\nExclusion Criteria:\n\n* Urine toxicology positive for cannabinoids\n* Inability to provide informed consent\n* Liver tests (AST or ALT) \\>3 times the upper limit of normal, or a history of liver disease\n* Pregnancy or breast\u002Fchest feeding\n* Unstable cardiac disease, history of hypotension or syncope\n* Psychotic disorder, or history of suicidal behavior and\u002For ideation\n* Progressive neurological conditions, frequent falls, or history of epileptic seizures\n* Severe alcohol use disorder, benzodiazepine use disorder or stimulant use disorder\n* Other serious medical conditions that would be a contraindication to THC or CBD use","ALL","18 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \\[THC\\]) and Epidiolex (cannabidiol \\[CBD\\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.",[95],"Opioid Use Disorder",[97,98,35,99,100,101,102],"Buprenorphine","delta-9-Tetrahydrocannabinol (THC)","Cannabinoids","Opioid Use","Opioid Withdrawal","Retention to Treatment","NOT_YET_RECRUITING","2026-06-06",{"date":106,"type":107},"2026-06-09","ACTUAL",{"date":109,"type":89},"2026-10",{"date":111,"type":89},"2028-05",{"name":5,"class":6},1]