Trial Outcomes & Findings for Buprenorphine Loading in the Emergency Department (NCT NCT04283500)

Last Updated: 2024-04-15

Results Overview

This will be measured by the proportion of participants who report Successful Rapid Induction. Participants will receive a loading dose of BUP SL 32mg in the ED without experiencing a clinically significant serious and/or severe adverse event (AE) related to the intervention - specifically, the receipt of a dose of BUP SL greater than 8mg during the Index ED visit. Successful rapid induction is defined only by the outcome of the participant's visit, and not by any following research visits.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Day 0

Results posted on

2024-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	BUP Treatment Arm Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Overall Study STARTED	15
Overall Study Completed Day 0	14
Overall Study Completed Day 1	14
Overall Study Completed Day 2	13
Overall Study Completed Day 3	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	BUP Treatment Arm Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Overall Study Lost to Follow-up	8
Overall Study Withdrawn by study team prior to intervention for not meeting post-enrollment inclusion criteria	1

Baseline Characteristics

Buprenorphine Loading in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BUP Treatment Arm n=14 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Age, Continuous	40.4 years STANDARD_DEVIATION 4.06 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	7 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Outcome measures
Measure	BUP Treatment Arm n=14 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Number of Participants With Successful Rapid Induction	14 Participants

SECONDARY outcome

Timeframe: Index ED Visit 1(Day 0)

The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. The tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of withdrawal and monitor these symptoms over time. The summed score can be used to help clinicians determine the stage or severity of withdrawal and assess the level of physical dependence on opioids. The total score ranges from 0 to 48. The interpretation of scores is as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Outcome measures

Outcome measures
Measure	BUP Treatment Arm n=14 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Opioid Withdrawal at Conclusion of Index Visit as Measured by the Clinical Opiate Withdrawal Scale (COWS)	1 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Day 1 (24 hours)

Participants who had suppression of opioid withdrawal within 24 hours of receipt of buprenorphine at the index visit as measured by having none of the following: 1) having a COWS score of \>7 at the Day 1 research visit, 2) having objective signs of opioid withdrawal as assessed by a medical clinician, or 3) participant self-report of opioid use to treat opioid withdrawal.

Outcome measures

Outcome measures
Measure	BUP Treatment Arm n=14 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Number of Participants With Withdrawal Suppresion at Day 1 (24 Hours)	9 Participants

SECONDARY outcome

Timeframe: Day 2

Participants who had suppression of opioid withdrawal within 48 hours of receipt of buprenorphine at the index visit as measured by having none of the following: 1) having a COWS score of \>7 at the Day 1 research visit, 2) having objective signs of opioid withdrawal as assessed by a medical clinician, or 3) participant self-report of opioid use to treat opioid withdrawal.

Outcome measures

Outcome measures
Measure	BUP Treatment Arm n=12 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Number of Participants With Withdrawal Suppresion by Day 2	6 Participants

SECONDARY outcome

Timeframe: Day 3

Participants who had suppression of opioid withdrawal within 72 hours of receipt of buprenorphine at the index visit as measured by having none of the following: 1) having a COWS score of \>7 at the Day 1 research visit, 2) having objective signs of opioid withdrawal as assessed by a medical clinician, or 3) participant self-report of opioid use to treat opioid withdrawal.

Outcome measures

Outcome measures
Measure	BUP Treatment Arm n=12 Participants Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Number of Participants With Withdrawal Suppression on Day 3	4 Participants

Adverse Events

BUP Treatment Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BUP Treatment Arm n=14 participants at risk Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records. Buprenorphine Naloxone: Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • 1 month systematic - standard questionnaire and medical record review

Additional Information

Ryan McCormack

NYU Langone Health

Phone: 2122632862

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place