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Not yet recruitingPhase 1

Buprenorphine for the Management of Pain in Children With Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Phase 3 (Transition off study drug): After the post-dose monitoring and assessment period, the care team and participant jointly decide whether to resume a basal PCA infusion, start a long-acting full agonist oral opioid, continue demand-only PCA or transition to short acting full agonist opioids for the remainder of the hospitalization."
  • "By separating the decision of when to give the study drug (the Phase 2 readiness criteria) from what PCA structure is running at the time of dosing (basal infusion stopped, demand-only continued through dosing), the design allows the pre-dose and post-dose 8-hour opioid-use windows to be measured under identical demand-only PCA conditions."
  • "Approximately 48 hours after the study dose, participants and involved care team members are sent a link to a brief REDCap satisfaction survey, to be completed by the time of hospital discharge."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one dose of buprenorphine (BELBUCA), placed inside the cheek, is safe and helps reduce pain and the need for other opioid pain medicines. It is for people ages 12–22 with sickle cell disease who are in the hospital for a sudden pain crisis. Everyone in the study gets the study medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have sickle cell disease confirmed by a blood test before agreeing to join.
  • Be 12–22 years old and have a sudden sickle cell pain crisis.
  • Weigh more than 50 kilograms (about 110 pounds).
  • Have a negative pregnancy test during this hospital stay if you could become pregnant.

Who can't join

  • Do not want to join, or have not given the required permission to join.
  • Be younger than 12 or weigh less than 50 kilograms (about 110 pounds).
  • Have an allergy to buprenorphine.
  • Have seriously slowed breathing, a blocked bowel, or shock (dangerously low blood flow).
  • Have a history of seizures or severe liver problems.
  • Take certain calming or sleep medicines that were started less than 30 days before admission or during the hospital stay. People taking them for at least 30 days before admission may join with extra monitoring.
  • Take medicines that strongly affect the liver enzyme CYP3A4, which helps process drugs, or take an MAOI (a type of antidepressant) now or within the past 14 days.
  • Be breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 shock physiology * Severe hepatic impairment (Child-Pugh score of C or worse) * 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 * Active breastfeeding

Study sites (1)

MA