Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

Locations

1 United States site

Age

> 18 Years

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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.

participation requirements

– 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

– Have greater than 5 acute care visits in the last 6 months or have daily pain of 7 or
higher on the Visual Analog Scale despite chronic opioid therapy.

– Able to provide consent

– Has medical insurance

participation restrictions

– Acute vaso-occlusive crisis on day of or day prior to buprenorphine initiation

– Use of methadone as long acting opioid (due to prolonged half-life and limited data in
other populations)

– Use of illicit drugs as documented by urine toxicology screen (except for THC)

– Pregnancy

– Acute or severe bronchial asthma

– Hypersensitivity to buprenorphine or any component of the product

– Medical disorder, condition, or history that in the investigator’s judgement would
impair the patient’s ability to participate or complete this study or render the
patient to be inappropriate for enrollment.

Locations

  • Baltimore, Maryland, United States, Johns Hopkins Hospital, 21205