NCT07485335 · University of Alabama at Birmingham
A Bundled Intervention to End Opioid Overdoses
(B-CARE)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Bundled intervention (Experimental)
a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.
OTHER
control group
participants will not be intervened with this bundled treatment, but continue the usual care that has been established at University of Alabama at Birmingham (UAB) hospital
DRUG
Buprenorphine (Experimental)
Participants in the experimental arm will receive buprenorphine treatment for opioid use disorder, including buprenorphine/naloxone (sublingual film or tablet), buprenorphine (sublingual tablet), or buprenorphine extended-release, as determined by the study physician via telehealth. Medication will be provided for the duration of the 12-week intervention period. Participants without insurance or who are underinsured will be provided medication at no cost to ensure equitable access.
BEHAVIORAL
Scheduled Peer Support Specialist (Experimental)
Participants in the experimental arm will be introduced to a peer support specialist prior to hospital discharge. Peer support specialists, who have lived experience with substance use disorder and recovery, will provide ongoing support throughout the 12-week intervention period. Specialists will assist participants in navigating and attending community-based addiction treatment resources, including buprenorphine clinics and substance use treatment programs. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources.
OTHER
Telemedicine Buprenorphine Treatment
Participants in the experimental arm will receive telehealth-enabled services throughout the 12-week intervention period. Addiction physicians will conduct virtual visits to evaluate, prescribe, and manage buprenorphine for opioid use disorder. Peer support specialists will maintain scheduled contact with participants via telehealth to provide ongoing support and monitor participant progress. Follow-up assessments at 1 and 3 months will be completed remotely via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment.
Primary outcome measures
participant retention rate
Time frame: 1 month and 3 months post hospital discharge
measure the total number of participants who complete 1- month and 3-month treatment in the study
buprenorphine adherence rate
Time frame: 1 month and 3 months post ED discharge
checking prescription rate and patients' self report of their taking medication
linkage rate to addiction treatment programs
Time frame: 1 month and 3 months post hospital discharge
patients' self report and reports from addiction treatment programs
Frequency of Repeat Opioid Overdose
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Healthcare Utilization (Hospital Revisit Rates)
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital
Adherence to Peer Support Specialist Contact
Time frame: Throughout the 12-week intervention period post hospital discharge
Rate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact
Opioid Overdose Death
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- living in a restricted environment (e.g., prison or jail facility, etc.);
- currently enrolled in other clinical studies;
- anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
- known allergic reaction to buprenorphine;
- critically ill or injured;
- females with pregnancy (they are anticipated to request a higher level of care).
- living outside of Alabama
Where
- Birmingham, Alabama
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations