[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sickle-cell-hemoglobin-c-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sickle-cell-hemoglobin-c-disease":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":5},"100654456","phase-1-buprenorphine-for-the-management-of-pain-in-children-with-sickle-cell-disease-100654456",false,"NCT07799571","Buprenorphine for the Management of Pain in Children With Sickle Cell Disease","Inclusion Criteria:\n\n* SCD diagnosis (confirmed by Hemoglobin electrophoresis prior to consent)\n* 12-22 years of age who present for acute sickle cell pain crisis\n* Weight \\> 50kg\n* Negative pregnancy test during index admission for patients of childbearing potential\n\nExclusion Criteria:\n\n* Patient refusal to participate\n* Hypersensitivity (e.g. anaphylaxis) to buprenorphine\n* Lack of informed consent or assent\n* \\\u003C 12 years of age\n* Weight \\\u003C 50kg\n* Significant respiratory depression\n* Presence of gastrointestinal obstruction, including paralytic ileus\n* History of seizures\n* Presence of shock physiology\n* Severe hepatic impairment (Child-Pugh score of C or worse)\n* Concurrent benzodiazepine or sedative hypnotics unless use is chronic (patients on a benzodiazepine or sedative-hypnotic for ≥30 days prior to admission may be enrolled with enhanced monitoring; newly initiated agents during the admission are exclusionary)\n* Concurrent strong CYP3A4 inhibitors\u002Finducers\n* Current Monoamine Oxidase Inhibitor (MAOI) use or use within 14 days\n* Active breastfeeding","ALL","12 Years","22 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn whether a single dose of buccal buprenorphine (BELBUCA) is safe when used in place and\u002For with full agonist opioids that would otherwise be started during a sickle cell pain crisis admission, in adolescents and young adults (ages 12-22) with sickle cell disease (SCD) who are hospitalized for acute pain.\n\nThe main questions it aims to answer are:\n\n* Is a single dose of buccal buprenorphine, given at doses between 75 and 450 micrograms, safe in this population?\n* Does buccal buprenorphine reduce the amount of full agonist opioid pain medicine participants need through their patient-controlled analgesia (PCA) pump, and does it change pain scores?\n* Are participants and their care team satisfied with pain management when buccal buprenorphine is used?\n* What are the pharmacokinetic properties (how the body absorbs, distributes, and clears the drug) of buccal buprenorphine in this age group?\n\nThis is a single-arm, open-label, dose-escalation study: every participant receives buccal buprenorphine, and there is no placebo or separate comparison group. Instead, researchers will compare each participant's own opioid use and pain scores in the 8 hours before receiving buccal buprenorphine to the 8 hours afterward, to see whether the dose reduces the need for additional opioid pain medicine.\n\nParticipants will:\n\n* Be treated first with standard-of-care patient-controlled analgesia (PCA) pain medicine (hydromorphone) during the early, acute-stabilization phase of their hospital stay.\n* Once their pain is stable and they meet criteria to transition to oral opioids, as would happen under usual care, they will receive a single dose of buccal buprenorphine instead, at a dose (75, 150, 300, or 450 micrograms) assigned according to a dose-escalation design.\n* Continue to have access to demand-only PCA pain medicine for breakthrough pain after the study dose.\n* Undergo continuous monitoring of heart rate, oxygen level, and carbon dioxide level, plus pain and sedation checks every 4 hours, for 48 hours after the dose.\n* Have blood samples collected, only when blood is already being drawn for clinical care, to help study how the body processes the drug.\n* Complete a brief satisfaction survey about their pain management after the dose.\n* Be contacted by phone or telehealth, and have their medical record reviewed, 30 days after the dose to check for any safety concerns.",[26,27,28,29,30,31,32],"Sickle Cell Disease (SCD)","Sickle Cell Disease Vaso-occlusive Crisis","Sickle Cell Anemia Crisis","Sickle Cell Anemia in Children","Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)","Sickle Cell Hemoglobin C Disease","Pain Crisis",[34,35,36,37,38,32,39,40,41,42,43,44,45,46,47,48,49,50],"Sickle Cell Disease","Sickle Cell Anemia","Vaso-Occlusive Crisis","Vaso-Occlusive Episode","Acute Pain","Buprenorphine","Buccal Buprenorphine","BELBUCA","Partial Opioid Agonist","Opioid-Sparing","Hydromorphone","Bayesian Optimal Interval Design","Phase 1 Trial","Adolescent","Pediatric","Young Adult","Pharmacokinetics","NOT_YET_RECRUITING","2026-08-28",{"date":54,"type":55},"2026-09-02","ACTUAL",{"date":57,"type":20},"2026-10",{"date":59,"type":20},"2032-10",{"name":61,"class":62},"Natasha Archer","OTHER","Sickle Cell-hemoglobin C Disease"]