Trial · NCT03492099
Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
NCT03492099, Phase 2, Completed, Johns Hopkins University; results first posted 2020-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessing the Safety of Buprenorphine in People With Sickle Cell Disease. Trials, record NCT03492099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03492099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
- NCT number
- NCT03492099
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Sickle Cell Disease
- Interventions
- buprenorphine
- First posted
- 2018-04-10
- Last updated
- 2022-04-25
- Results first posted
- 2020-10-01
- Limitations and caveats
The study was not randomized nor controlled. The participant pool was limited to those patients who consented to have their data reported; and among those prospectively enrolled, to those who accepted induction. In addition, not all inductions followed the same procedure. In particular, those that were performed inpatient might have a number of biases in patient selection and capacity to detect adverse events.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment | 72 hours after buprenorphine initiation | 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. |
| 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 | 6 months pre BUP induction, 6 months post BUP induction | Change 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. |
| Secondary | Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score | COWS score at BUP induction, COWS score at the end of the first day of induction | 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). |
| Secondary | Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction | 6 months after induction | After 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment | 72 hours after buprenorphine initiation | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | 6 months pre BUP induction, 6 months post BUP induction | acute care visits per patient | MEAN | |
| SECONDARY | Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score | COWS score at BUP induction, COWS score at the end of the first day of induction | 38 out of 43 patients had complete pre-induction COWS data 37 out of 43 patients had complete post-induction COWS data | score on a scale | MEAN |
| SECONDARY | Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction | 6 months after induction | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment | Buprenorphine Arm | 1 | Participants | ||
| 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 | Buprenorphine Arm | Number of Acute Visits per patient 6 months prior to BUP induction | 11.86 | Standard Deviation 11.92 | acute care visits per 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 | Buprenorphine Arm | Number of Acute Visits per patient 6 months post BUP induction | 3.35 | Standard Deviation 3.79 | acute care visits per patient |
| Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score | Buprenorphine Arm | COWS score at BUP induction | 8.92 | Standard Deviation 3.8 | score on a scale |
| Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score | Buprenorphine Arm | COWS score at the end of the first day of induction | 3.32 | Standard Deviation 2.46 | score on a scale |
| Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction | Buprenorphine Arm | 38 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine Arm | 47 | |
| Overall Study | COMPLETED | Buprenorphine Arm | 43 | |
| Overall Study | NOT COMPLETED | Buprenorphine Arm | 4 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Opioid Withdrawal | Psychiatric disorders | Buprenorphine Arm | 2 | 47 | 2 |
| other | Body Pain | Musculoskeletal and connective tissue disorders | Buprenorphine Arm | 2 | 47 | 2 |
| other | Neck Swelling | General disorders | Buprenorphine Arm | 1 | 47 | 1 |
| other | Tongue numbness | General disorders | Buprenorphine Arm | 1 | 47 | 1 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Buprenorphine Arm | 1 | 47 | 1 |
| other | Headache | General disorders | Buprenorphine Arm | 1 | 47 | 1 |
| other | Hyperglycemia | Endocrine disorders | Buprenorphine Arm | 1 | 47 | 1 |
| other | Nausea | Gastrointestinal disorders | Buprenorphine Arm | 1 | 47 | 1 |
| serious | Hospitalization | Nervous system disorders | Buprenorphine Arm | 1 | 47 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine Arm | 0 | 47 |
| Total, other adverse events | Buprenorphine Arm | 9 | 47 |
| Total, serious adverse events | Buprenorphine Arm | 1 | 47 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03492099
GET https://conductscience.org/api/trials/v1/NCT03492099/registered