Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

Overseen by Sophie Lanzkron, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will assess the safety of changing pain medications (opioids) adult sickle cell patients take to another type of medication therapy (buprenorphine). Patients will be asked questions about their quality of life. Other tools for assessment will also be administered.

Research Team

Sophie Lanzkron, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

Sickle Cell Disease, any genotype

On disease modifying therapy (either chronic transfusions or hydroxyurea)

On chronic daily full agonist opioid therapy with doses ranging from 90 to 400 morphine equivalents

Treatment Details

Interventions

• Buprenorphine (Opioid)

Participant Groups

Group I: Buprenorphine Arm Experimental Treatment 1 Intervention

This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution