Trial Outcomes & Findings for Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (NCT NCT03492099)
NCT ID: NCT03492099
Last Updated: 2022-04-25
Results Overview
Data will be collected on need for hospitalization within 72 hours of conversion due to withdrawal induced vaso-occlusive crisis (VOC). If 2 out of the first 5 patients require hospitalization within 72 hours of conversion the study will be stopped and we will assess what changes need to be made in the protocol to decrease the risk of hospitalization triggered by the conversion.
COMPLETED
PHASE2
47 participants
72 hours after buprenorphine initiation
2022-04-25
Participant Flow
Participant milestones
| Measure |
Buprenorphine Arm
This is the main and only arm of the study. This was an observational trial in which patients who were converted to buprenorphine had data collected on hospital utilization before and after conversion to buprenorphine and filled out surveys listed in secondary outcomes.
buprenorphine: As this was part of clinical care individual dosages were dependent on prior opioid exposure and patient characteristics.
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|---|---|
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Overall Study
STARTED
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47
|
|
Overall Study
COMPLETED
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43
|
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Buprenorphine Arm
n=47 Participants
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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47 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Age, Continuous
|
38 years
STANDARD_DEVIATION 10.25 • n=99 Participants
|
|
Sex: Female, Male
Female
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29 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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18 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 72 hours after buprenorphine initiationData will be collected on need for hospitalization within 72 hours of conversion due to withdrawal induced vaso-occlusive crisis (VOC). If 2 out of the first 5 patients require hospitalization within 72 hours of conversion the study will be stopped and we will assess what changes need to be made in the protocol to decrease the risk of hospitalization triggered by the conversion.
Outcome measures
| Measure |
Buprenorphine Arm
n=43 Participants
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment
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1 Participants
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SECONDARY outcome
Timeframe: 6 months pre BUP induction, 6 months post BUP inductionChange in the number of acute care visits per subject in the 6 months prior to BUP induction and in the 6 months post to BUP induction will be observed by comparing the mean number of acute care visits per patient- either to Emergency Department (ED) or to Sickle Cell Infusion Center - in the six months prior to BUP induction and in the six months post to BUP induction.
Outcome measures
| Measure |
Buprenorphine Arm
n=43 Participants
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
|
|---|---|
|
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
Number of Acute Visits per patient 6 months prior to BUP induction
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11.86 acute care visits per patient
Standard Deviation 11.92
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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
Number of Acute Visits per patient 6 months post BUP induction
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3.35 acute care visits per patient
Standard Deviation 3.79
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SECONDARY outcome
Timeframe: COWS score at BUP induction, COWS score at the end of the first day of inductionPopulation: 38 out of 43 patients had complete pre-induction COWS data 37 out of 43 patients had complete post-induction COWS data
Change in severity of opiate withdrawal will be observed by comparing the mean COWS score at BUP induction and 1 day post induction. All patients will be in opiate withdrawal at the time of buprenorphine induction and at the end of the first day of induction. The level of withdrawal will be measured by the COWS score, an 11-item scale designed to be administered by a clinician. The score ranges from 0-4 (no withdrawal), 5-12 (mild withdrawal), 13-24 (moderate withdrawal), 25-36 (severe withdrawal), and 36-48 (most severe withdrawal).
Outcome measures
| Measure |
Buprenorphine Arm
n=38 Participants
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score
COWS score at BUP induction
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8.92 score on a scale
Standard Deviation 3.8
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Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score
COWS score at the end of the first day of induction
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3.32 score on a scale
Standard Deviation 2.46
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SECONDARY outcome
Timeframe: 6 months after inductionAfter induction, clinical team will continue to follow up with patients to see if they would like to continue buprenorphine therapy during the next 6 months after induction. The date of discontinuation and the reason why will be recorded. The number of participants reported in the outcome is the number of participants that continued buprenorphine therapy 6 months after induction.
Outcome measures
| Measure |
Buprenorphine Arm
n=43 Participants
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction
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38 Participants
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Adverse Events
Buprenorphine Arm
Serious adverse events
| Measure |
Buprenorphine Arm
n=47 participants at risk
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Nervous system disorders
Hospitalization
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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Other adverse events
| Measure |
Buprenorphine Arm
n=47 participants at risk
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.
buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
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|---|---|
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Psychiatric disorders
Opioid Withdrawal
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4.3%
2/47 • Number of events 2 • Within 72 hours of induction
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Musculoskeletal and connective tissue disorders
Body Pain
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4.3%
2/47 • Number of events 2 • Within 72 hours of induction
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General disorders
Neck Swelling
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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General disorders
Tongue numbness
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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Respiratory, thoracic and mediastinal disorders
Pneumonia
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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General disorders
Headache
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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Endocrine disorders
Hyperglycemia
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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Gastrointestinal disorders
Nausea
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2.1%
1/47 • Number of events 1 • Within 72 hours of induction
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Additional Information
Dr. Sophie Lanzkron
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place