High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED) (NCT05589181) | Clinical Trial Compass
RecruitingPhase 3
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
United States140 participantsStarted 2023-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
Timeframe: 7 days post-ED visit
Trial details
NCT IDNCT05589181
SponsorRutgers, The State University of New Jersey