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.
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
Patient refusal to participate
Hypersensitivity (e.g. anaphylaxis) to buprenorphine
Lack of informed consent or assent
< 12 years of age
Single group
Buprenorphine Buccal Film [Belbuca]
DrugA 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.
Incidence of Protocol-Defined Safety Events
Safety is defined operationally as the absence of: (1) requirement for transfer to a higher level of care (such as the ICU), acute chest syndrome, stroke, or any acute life-threatening event requiring emergent medical intervention; (2) severe somnolence (Modified Ramsay Sedation Score ≥7) and/or disorientation persisting despite routine efforts to awaken; (3) severe hypoxemia (SpO2 decrease of ≥3-4% from pre-dose SpO2, or \<88%, whichever is lower, despite treatment); (4) severe hypoventilation (respiratory rate \<6 breaths/min or ETCO2/TcCO2 \>65 mmHg for \>5 minutes despite routine efforts to awaken); (5) administration of naloxone for sedation or respiratory depression; (6) any CTCAE v5.0 Grade ≥3 adverse event attributed to the study drug.
Change in Numeric Rating Scale (NRS) Pain Scores
Pain scores over the 8 hours following the buprenorphine dose compared to the average of cumulative dosing in the 8 hours prior to the buprenorphine dose and the 8-hour epoch starting 12 hours after the buprenorphine dose.
Decrement in Cumulative Full-Agonist Opioid (PCA) Consumption
Decrement in cumulative μ-opioid receptor agonist consumption, in weight-scaled IV morphine equivalents, over the 8 hours following the buprenorphine dose compared to the average of the cumulative pain scores in the 8 hours prior to the buprenorphine dose and the 8-hour epoch starting 12 hours after the buprenorphine dose.
Patient/Parent Satisfaction with Pain Management
Patient/parent satisfaction with pain management based on: qualitative report of the patient/parent satisfaction survey; pain and sedation scores; and side-effect profile of the patient.
Plasma Buprenorphine Concentration
Plasma buprenorphine concentration (ng/mL), measured via liquid chromatography-tandem mass spectrometry (LC-MS/MS), using samples collected opportunistically at the time of clinically indicated blood draws. Sample collection time relative to study drug administration will be recorded for use in population pharmacokinetic (PopPK) modeling.
Provider Satisfaction with Pain Management
Provider satisfaction with pain management based on: qualitative report of the Provider satisfaction survey; pain and sedation scores; ease of use/administration; and side-effect profile of the patient. Survey administered 48 hours after study drug administration, to be completed by hospital discharge
Plasma Norbuprenorphine Concentration
Plasma norbuprenorphine concentration (ng/mL), measured via liquid chromatography-tandem mass spectrometry (LC-MS/MS), using samples collected opportunistically at the time of clinically indicated blood draws. Sample collection time relative to study drug administration will be recorded for use in population pharmacokinetic (PopPK) modeling.
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Natasha Archer
Lead sponsor
Boston Children's Hospital
Sponsor institution
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