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Can a single buprenorphine dose tame sickle cell pain?

NCT ID NCT07799571

Symptom relief Sponsor: Natasha Archer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a single dose of buprenorphine, given as a film inside the cheek, is safe and helps control pain in adolescents and young adults with sickle cell disease who are hospitalized for a pain crisis. Participants receive one dose of buprenorphine instead of starting oral opioids, while still having access to their usual pain pump for breakthrough pain. Researchers compare each person's opioid use and pain scores in the 8 hours before and after the dose to see if buprenorphine reduces the need for additional opioids. The study also monitors safety closely and checks satisfaction with pain management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine buccal film (Belbuca)
What this could lead to
If it works, this could offer a safer way to manage sickle cell pain crises, reducing reliance on stronger opioids and their side effects.
What could go wrong
This is an early, small dose-escalation study, so safety and effectiveness are not yet proven. Buprenorphine can cause sedation or breathing problems, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 22 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Acute Pain Hemoglobin SC Disease sickle cell disease sickle cell-hemoglobin c disease syndrome Vaso-Occlusive Crises

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02215, United States

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