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

Conditions

• Pain Crisis
• Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
• Sickle Cell Anemia Crisis
• Sickle Cell Anemia in Children
• Sickle Cell Disease (SCD)
• Sickle Cell Disease Vaso-occlusive Crisis
• Sickle Cell Hemoglobin C Disease

Eligibility Criteria

Sex

ALL

Age

12 Years - 22 Years

Healthy Volunteers

Not accepted

Interventions

• Buprenorphine Buccal Film [Belbuca] — DRUG
  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.

Study Details

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.

Key Dates

First listed

Sep 2, 2026

Start date

Oct 31, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2031

Completion

Oct 31, 2032

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Buccal Buprenorphine (Dose-Escalation)
  Participants receive standard-of-care demand-and-continuous hydromorphone PCA during acute stabilization (Phase 1). Once transition-readiness criteria are met (Phase 2), the continuous PCA infusion is discontinued and, after a minimum one-hour equilibration period, participants receive a single buccal dose of buprenorphine (75, 150, 300, or 450 mcg, depending on dose-escalation cohort assignment per the BOIN design) in place of the oral opioid that would otherwise be started, while continuing demand-only PCA for breakthrough pain.

Primary Outcome Measure

Incidence of Protocol-Defined Safety Events [ Time Frame: Within the 48-hour observation window following study drug (buccal buprenorphine) administration ]

Central Contacts

• Natasha Archer, MD
  617-632-5508
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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