Buprenorphine Loading in the Emergency Department

NCT04283500 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 19-01700
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Buprenorphine (BUP) is FDA-approved for the treatment of opioid withdrawal and opioid use disorder. Few ED providers have received the necessary DEA registration (aka X waiver) required to prescribe BUP, and urgent appointments to continue ongoing BUP treatment may not be readily available, thus leading to medication discontinuity. A loading dose induction strategy with 32mg of BUP may help effectively link ED patients to outpatient treatment while minimizing known barriers to ED uptake. Administering a "loading dose" of BUP to saturate mu-opioid receptors would extend the duration of action and provide additional time to secure ongoing treatment. Further, BUP's ceiling effect on respiratory depression makes it a remarkably safe drug even at high doses. In recent years, ED providers have begun to incorporate this approach into clinical protocols, however, it has not been formally studied in this clinical setting. The investigator's study represents the necessary step of studying this novel approach in the ED setting to define the parameters for clinical protocols and large-scale studies.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Rapid Induction

  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.

  Day 0

Secondary Outcomes (4)

• Opioid Withdrawal at Conclusion of Index Visit as Measured by the Clinical Opiate Withdrawal Scale (COWS)

  Index ED Visit 1(Day 0)

• Number of Participants With Withdrawal Suppresion at Day 1 (24 Hours)

  Day 1 (24 hours)

• Number of Participants With Withdrawal Suppresion by Day 2

  Day 2

• Number of Participants With Withdrawal Suppression on Day 3

  Day 3

Study Arms (1)

BUP treatment arm

EXPERIMENTAL

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.

Drug: Buprenorphine Naloxone

Interventions

Buprenorphine Naloxone DRUG

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.

Also known as: Suboxone

BUP treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
• Meets DSM-5 criteria for moderate to severe OUD
• Has a positive urine screen for opioids and a negative urine screen for methadone
• Must be experiencing opioid withdrawal with a COWS score ≥8
• Is willing and able to participate in the study and follow study procedures
• Is able to provide adequate and reliable locator information for follow-up
• Has reliable access to a phone

You may not qualify if:

• Is currently engaged in medication treatment for OUD with methadone, BUP, or naltrexone
• Has a urine toxicology test that is positive for methadone or buprenorphine
• Currently requires prescribed opioids for treatment of an ongoing pain condition
• Has a known allergy to BUP
• Is pregnant as determined by urine hCG testing at the index ED visit
• Is breastfeeding as determined by self-report
• Has medical, psychiatric, or concurrent substance use conditions or severe cognitive impairment which might prelude safe participation
• Is a prisoner or in police custody at the time of the index ED visit
• Has previously enrolled in the current study

Sponsors & Collaborators

• NYU Langone Health: lead
• Emergency Medicine Foundation: collaborator

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Ryan McCormack
• Organization: NYU Langone Health

Ryan.McCormack@nyulangone.org

2122632862

Study Officials

• Ryan McCormack, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: November 1, 2020
• Primary Completion: February 25, 2023
• Study Completion: February 25, 2023
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Ryan.McCormack@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)