Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

This is a descriptive, pilot study to assess the safety of converting a subset of adult
sickle cell patients who are on effective disease modifying therapy (on high dose oral
opioids who are unable to wean off opioids) and who continue to have frequent acute visits
where parenteral opioids are administered to convert all opioid treatments to buprenorphine.
Quality of life will be assessed using the Adult Sickle Cell Quality of life Measurement tool
(ASCQ-Me), the Brief Pain Inventory (BPI), two Patient-Reported Outcomes Measurement
Information System (PROMIS) surveys (short-form Pain Interference and Physical Function), and
frequency of acute pain visits.

Buprenorphine is a partial mu-agonist and kappa antagonist and has a high affinity for the mu
receptors with an elimination half-life of 28-37 hours for the sublingual administration. The
lower risk for misuse, diminished withdrawal symptoms and cravings for opioids as well as the
reduced risk of overdose make it an appealing alternative. Recent data on successful
conversion for patients with chronic pain show a decrease in pain scores and increase in
quality of life measurements after the beginning buprenorphine therapy for more than two
months.

The first dose will be determined for each patient by a physician to ensure that the dosage
of buprenorphine will be appropriate given the patient's current opioid dosage. There is the
risk of withdrawal induced vaso-occlusive crisis (VOC).

Within 30 days prior to conversion to buprenorphine, a patient will take the ASCQ-Me, BPI,
and two PROMIS surveys. Twenty-four hours prior to conversion, the patient will stop all
opioid intake. The day of conversion, the patient will take a Clinical Opiate Withdrawal
Scale (COWS) survey to determine whether they are in withdrawal. If so, the patient will
begin buprenorphine conversion. They will also retake the aforementioned quality of life
surveys. The patient will return on days 1, 14, 30, 90, and 180 to be evaluated.

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.