High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients
2 other identifiers
interventional
140
1 country
1
Brief Summary
This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 23, 2025
October 1, 2025
3.4 years
October 17, 2022
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program.
7 days post-ED visit
Secondary Outcomes (12)
Percentage of days with opioid abstinence (Trial 1)
at day 7
Percentage of days with opioid use (Trial 1)
7 days post-ED
Percentage of days with opioid use (Trial 2)
30 days post-ED
Daily assessment of opioid use (Trial 1)
Days 1-7 after enrollment
Change in number of times opioids used (Trial 1)
induction through 7 days
- +7 more secondary outcomes
Study Arms (2)
Buprenorphine Standard Dose
ACTIVE COMPARATORThe standard arm will receive an induction dose of 12mg of buprenorphine (BUP) split as 8mg at time=0 and 4mg at time=30-60 min.
Buprenorphine High Dose
EXPERIMENTALThe experimental arm tests the safety and tolerability of 32mg of BUP split as 16mg at time=0 and 16mg at time=30-60 min as an induction dose.
Interventions
32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose
12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose
Eligibility Criteria
You may qualify if:
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
- Treated in the ED during screening hours
- Meet DSM-5 diagnostic criteria for moderate to severe OUD
- Clinical Opioid Withdrawal Score (COWS) score ≥ 8
- Urine toxicology positive for fentanyl
- Able to speak English or Spanish sufficiently to understand study procedures
You may not qualify if:
- UDS positive for methadone.
- Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing
- Have an unstable medical or psychiatric condition including suicidality requiring hospitalization
- Require ongoing opioids for pain management
- Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible
- Be a prisoner or in custody at the time of the index visit
- Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.
- Unable to provide one additional point of contact other than themselves
- Unwilling to follow study procedures
- Have prior enrollment in the current study
- Have a known allergy or hypersensitivity to BUP
- Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA)
- Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration
- Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers University Hospital
Newark, New Jersey, 07103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ethan Cowan, MD, MS
The Rutgers Addiction Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In trial 1 neither the investigator nor the participant will be blinded to group assignment. In Trial 2, participants, Investigators and site personnel with the exception of the investigational drug pharmacist will be blinded to group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 21, 2022
Study Start
April 6, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Beginning upon acceptance for publication and ending 5 years following article publication.
- Access Criteria
- deidentified individual patient data (IPD) will be shared with researchers who provide a methodologically sound proposal for the purpose of achieving aims in the approved proposal. Proposals should be directed to ethan.cowan@mountsinai.org.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. This study will share deidentified individual participant data that underlie the results that are reported. The data intended for broader use will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.