A Bundled Intervention to End Opioid Overdoses (NCT07485335) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Bundled Intervention to End Opioid Overdoses
United States160 participantsStarted 2026-09-07
Plain-language summary
Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.
Who can participate
Age range
19 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
. discharged from the ED and inpatient settings at the UAB hospital
. 19 years or older (the age of majority in Alabama);
. diagnosis of OUD and experiencing opioid overdose in the last 12 months;
. prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
. English speaking;
. not actively psychotic and suicidal, or cognitively impaired.
. Patients who are admitted to the hospital from the ED will be eligible for enrollment.
Exclusion criteria
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.
1This trial is testing a bundled approach — combining buprenorphine with peer support specialists and linkage to addiction treatment — so can you help me understand how that package compares to what you'd recommend for me right now as standard care?
2Since this is a Phase 4 trial, which means the individual treatments involved have already been approved, what does that mean for what's already known about safety, and are there any new or unknown risks specific to the way these treatments are being combined here?
3One of the main things being measured is whether people actually stay in the program and keep taking buprenorphine — what happens to my care if I struggle with adherence during the trial, and would I lose access to treatment?
4The trial isn't recruiting yet, so realistically how long might it be before I could even consider enrolling, and given my situation, should we start something now rather than waiting?
5The study is specifically tracking repeat overdoses and overdose deaths as outcomes — what does that tell us about how serious my risk level needs to be to make this trial worth considering over other options you might already have available for me?
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
participant retention rate
Timeframe: 1 month and 3 months post hospital discharge
2
buprenorphine adherence rate
Timeframe: 1 month and 3 months post ED discharge
3
linkage rate to addiction treatment programs
Timeframe: 1 month and 3 months post hospital discharge
4
Frequency of Repeat Opioid Overdose
Timeframe: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
5
Healthcare Utilization (Hospital Revisit Rates)
Timeframe: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
6
Adherence to Peer Support Specialist Contact
Timeframe: Throughout the 12-week intervention period post hospital discharge
7
Opioid Overdose Death
Timeframe: Monitored quarterly throughout the R33 study period beyond the 3-month intervention