Buprenorphine film for pain in young people with sickle cell disease
Tests buprenorphine in young people with sickle cell disease hospitalized for pain.
Plain-language title generated from the registry record
Registry title: Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 22 years old?
Source: NCT07799571, who can take part
Where in United States
- Boston Children's HospitalBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Natasha Archer
- Trial code
- NCT07799571
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
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.
Inclusion: 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: 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); Concurrent strong CYP3A4 inhibitors/inducers; Current Monoamine Oxidase Inhibitor (MAOI) use or use within 14 days; Hypersensitivity (e.g. anaphylaxis) to buprenorphine; History of seizures; Severe hepatic impairment (Child-Pugh score of C or worse); < 12 years of age; Patient refusal to participate; Lack of informed consent or assent; Weight < 50kg; Significant respiratory depression; Presence of gastrointestinal obstruction, including paralytic ileus; Presence of shock physiology; Active breastfeeding.