Buprenorphine for Pain in Sickle Cell Disease

NA
Overseen ByNatasha Archer, MD
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Natasha Archer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NA

Natasha Archer, MD

Principal Investigator

Dana-Farber/Boston Children's Cancer and Blood Disorders Center

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults ages 12-22 with sickle cell disease who are hospitalized for a pain crisis. Participants must be stable enough to switch from IV to oral pain medicine. People with certain other health issues or allergies may not qualify.

Inclusion Criteria

Weight greater than 50kg
Negative pregnancy test during index admission for patients of childbearing potential
I am between 12 and 22 years old and have a sickle cell pain crisis.
See 1 more

Exclusion Criteria

I have had a severe allergic reaction to buprenorphine.
Weight less than 50kg
Active breastfeeding
See 11 more

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine Buccal Film [Belbuca]

Trial Overview

The study tests if a single dose of buccal buprenorphine (Belbuca), given by mouth, is safe and effective in reducing the need for other opioid pain medicines during sickle cell pain crises. All participants receive the drug; their own before-and-after results are compared.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Buccal Buprenorphine (Dose-Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Natasha Archer

Lead Sponsor