Phase 2
Completed N=47
Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
Source: ClinicalTrials.gov NCT03492099 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Oct 2020
Primary outcomePrimary: Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment |
1 | — |
| SECONDARY Change in the Number of Acute Care Visits Per Subject in the 6 Months Prior to Buprenorphine (BUP) Induction and in the 6 Months Post to BUP Induction |
11.86; 3.35 | — |
| SECONDARY Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score |
8.92; 3.32 | — |
| SECONDARY Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction |
38 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03492099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.