Natasha Archer
The goal of this clinical trial is to learn whether a single dose of buccal buprenorphine (BELBUCA) is safe when used in place and/or 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. The main questions it aims to answer are: * Is a single dose of buccal buprenorphine, given at doses between 75 and 450 micrograms, safe in this population? * 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? * Are participants and their care team satisfied with pain management when buccal buprenorphine is used? * What are the pharmacokinetic properties (how the body absorbs, distributes, and clears the drug) of buccal buprenorphine in this age group? This 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. Participants will: * Be treated first with standard-of-care patient-controlled analgesia (PCA) pain medicine (hydromorphone) during the early, acute-stabilization phase of their hospital stay. * 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. * Continue to have access to demand-only PCA pain medicine for breakthrough pain after the study dose. * 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. * Have blood samples collected, only when blood is already being drawn for clinical care, to help study how the body processes the drug. * Complete a brief satisfaction survey about their pain management after the dose. * Be contacted by phone or telehealth, and have their medical record reviewed, 30 days after the dose to check for any safety concerns.
Background and Rationale Sickle cell disease (SCD) is an inherited red blood cell disorder that affects more than 100,000 people in the United States and millions worldwide. Recurrent episodes of severe pain, called vaso-occlusive crises (VOC), are the most common reason children and young adults with SCD are hospitalized. These pain episodes are typically treated with opioid pain medicines, most often delivered through a patient-controlled analgesia (PCA) pump that provides a continuous background dose along with patient-activated bolus doses. Full agonist opiods such as hydromorphone and mo…
Inclusion Criteria: * SCD diagnosis (confirmed by Hemoglobin electrophoresis prior to consent) * 12-22 years of age who present for acute sickle cell pain crisis * Weight \> 50kg * Negative pregnancy test during index admission for patients of childbearing potential Exclusion Criteria: * Patient refusal to participate * Hypersensitivity (e.g. anaphylaxis) to buprenorphine * Lack of informed consent or assent * \< 12 years of age * Weight \< 50kg * Significant respiratory depression * Presence of gastrointestinal obstruction, including paralytic ileus * History of seizures * Presence of shoc…
A single buccal dose of buprenorphine (BELBUCA), administered once between 8:00 AM and 3:00 PM on the qualifying study day. Dose is assigned by dose-escalation cohort (75 mcg, 150 mcg, 300 mcg, or 450 mcg) per a Bayesian Optimal Interval (BOIN) design targeting a dose-limiting toxicity rate of 0.25.