Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Buprenorphine

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

• 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

Exclusion Criteria:

• 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.