Bundled Intervention for Opioid Overdose

(B-CARE Trial)

Overseen By Li Li, MD;PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Alabama at Birmingham

Must be taking: Buprenorphine

Must not be taking: Other opioids

Disqualifiers: Living in restricted environment, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent repeat opioid overdoses after patients leave the emergency department. It combines telehealth, peer support, medication (buprenorphine, an opioid addiction treatment), and connections to ongoing treatment to determine if this package reduces overdose deaths. Individuals who have experienced an opioid overdose in the past year and are willing to continue treatment after leaving the hospital might be suitable candidates. Participants will complete surveys during the trial to help researchers assess the program's effectiveness. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to continue taking buprenorphine after leaving the emergency department. If you are expected to take other prescribed opioids for more than three months, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telehealth combined with buprenorphine (a medication for opioid addiction) is generally well-received by patients. Studies have found that individuals receiving buprenorphine via telehealth perform as well as, if not better than, those receiving it in person. This indicates that telehealth does not increase risk.

Buprenorphine has been widely used and studied, and it is known to help individuals with opioid use disorder. Although no treatment is without risk, buprenorphine is considered safe and has FDA approval for treating opioid addiction.

Support from someone who has faced similar challenges can be very beneficial. This type of peer support is generally viewed as helpful rather than risky.

Overall, the combined approach—including telehealth, peer support, buprenorphine, and connections to additional addiction treatment programs—aims to provide a comprehensive and safe method for those recovering from an opioid overdose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the bundled intervention for opioid overdose because it combines several supportive elements not typically offered together in standard care. Unlike usual treatments that might only offer medication or referrals, this approach integrates peer support, buprenorphine treatment, and telehealth, all starting soon after an emergency department discharge. This comprehensive package aims to provide continuous support and easier access to addiction treatment, potentially improving outcomes by addressing multiple needs simultaneously. The use of telehealth and peer support is particularly innovative, as it offers ongoing connection and encouragement, which might enhance recovery success rates.

What evidence suggests that this bundled intervention is effective for reducing opioid overdoses?

Research has shown that medications like buprenorphine and methadone reduce the risk of overdose and the need for emergency care due to opioids. Studies also find that telehealth, which involves receiving health services online or by phone, helps individuals adhere to their medication plans for opioid addiction. In this trial, participants in the experimental arms will receive a bundled intervention that includes telehealth, peer support, buprenorphine treatment, and connections to long-term addiction programs. This combined approach aims to provide comprehensive support after leaving the emergency department, potentially reducing overdose deaths. Project POINT, a program based in emergency departments, successfully helped individuals who survived an opioid overdose by offering a mix of support and treatment plans. These findings suggest that such a bundled intervention can effectively lower the chances of repeat overdoses. ^{1 2 3 6 7}

Who Is on the Research Team?

Li Li, MD;PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced an opioid overdose and are discharged from the emergency department. It aims to help them avoid repeat overdoses and reduce mortality by increasing treatment uptake post-discharge.

Inclusion Criteria

Patients who are admitted to the hospital from the ED will be eligible for enrollment

I have opioid use disorder and had an overdose in the past year.

English speaking

Exclusion Criteria

Critically ill or injured

Living in a restricted environment (e.g., prison or jail facility, etc.)

Currently enrolled in other clinical studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a bundled intervention including peer support, buprenorphine treatment, and telehealth for 3 months post-ED discharge

12 weeks

Daily contact in Week 1, twice in Week 2, weekly thereafter

Follow-up

Participants are monitored for treatment uptake and retention, and reduction in opioid overdoses and ED revisits

3 months

Surveys at 1-month and 3-month intervals

Extension

Participants may continue to engage in community-based treatment programs for continuity of care

What Are the Treatments Tested in This Trial?

Interventions

• A Bundled Intervention

Trial Overview

The study tests a bundled intervention after ED discharge, which includes telehealth services, support from peers who have had similar experiences, medication (buprenorphine), and connections to ongoing care.

How Is the Trial Designed?

Group I: phase 2- experimental Experimental Treatment 1 Intervention

Participants will be enrolled the same way as in phase 1. After their enrollment, participants will be randomized to either the experimental (bundled intervention) group or the control (usual care group). Bundled intervention will have the same components as in the phase 1, including peer support, buprenorphine treatment, and telehealth up to 3 months after ED/hospital discharge, and linkage to definitive addiction treatment programs. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.

Group II: phase 1 Experimental Treatment 1 Intervention

After completing screening questions and obtaining consent, eligible participants will complete their baseline procedures and measures. All participants will then start the experimental, i.e., bundled intervention, the first week after their ED discharge, including peer support service and buprenorphine treatment with addiction physicians using telehealth. Each participant will be in the study for 3 months. During the study period, participants will be sent survey links to their cell phones and/or emails to complete self-report questionnaires via the Research Electronic Data Capture (REDCap) at 1-month and 3-month for follow-up assessments. Peers will remind the participants to complete the survey.

Group III: phase 2- control Placebo Group 1 Intervention

Participants who are randomized to the control group will receive the usual care that has been established in the ED at UAB hospital. The current usual care at the UAB ED includes a thorough assessment, buprenorphine initiation as appropriate, peer referral, and a written list of buprenorphine clinics. Participants will also receive information about community-based substance use treatment programs. However, these services are at the participant's own discretion to navigate and attend after ED discharge. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A training program on take-home naloxone (THN) significantly improved overdose-related knowledge and attitudes among family members of heroin users, with trained participants showing a mean knowledge increase of 4.08 points on the Opioid Overdose Knowledge Scale compared to the control group.

The benefits of THN training were retained after 3 months, as evidenced by a higher percentage of trained individuals witnessing and managing overdoses, with naloxone being administered in 8 out of 13 overdose incidents during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training family members to manage heroin overdose and administer naloxone: randomized trial of effects on knowledge and attitudes. Williams, AV., Marsden, J., Strang, J.[2014]

Patients who experienced a non-fatal opioid overdose (NFOO) have a 7.2% risk of experiencing another overdose within a year, with opioid use disorder (OUD) significantly increasing this risk by 51%.

Following an NFOO, there was a notable increase in the utilization of outpatient substance use services (5.94%) and buprenorphine treatment (1.29%), highlighting the need for improved access to treatment for patients at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of substance use disorders in experiencing a repeat opioid overdose, and substance use treatment patterns among patients with a non-fatal opioid overdose. Karmali, RN., Ray, GT., Rubinstein, AL., et al.[2021]

About half of heroin/opiate users have experienced an overdose, and the majority of drug-related deaths are linked to heroin/opiate use, highlighting the urgent need for effective interventions.

High-risk periods for overdose, particularly after prison release or treatment discharge, have been identified, and training peers and family members to administer naloxone could significantly improve response rates in overdose situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Death matters: understanding heroin/opiate overdose risk and testing potential to prevent deaths. Strang, J.[2021]

A performance improvement project involving 47 opioid-dependent inpatients and their families showed that overdose prevention training significantly increased their ability to recognize an opioid overdose and their comfort in assisting during an overdose situation.

Despite 32% of family members being aware of a prior overdose, the training highlighted the importance of naloxone education and harm reduction strategies, suggesting that such programs are beneficial and should be integrated into residential treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. Pade, P., Fehling, P., Collins, S., et al.[2018]

The REBOOT intervention, a motivational interviewing program, significantly reduced the likelihood of opioid overdose events among high-risk individuals, with a 38% lower risk of any overdose compared to standard treatment.

Participants in the REBOOT group experienced fewer overdose events overall, with a reduction of 54% in the number of overdoses, demonstrating the intervention's efficacy in preventing overdoses without affecting opioid use or naloxone carriage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. Coffin, PO., Santos, GM., Matheson, T., et al.[2018]

In a study of 726 presumed opioid overdose patients treated by emergency medical services, 94% responded positively to naloxone, indicating its high efficacy in reversing opioid overdoses in an out-of-hospital urban setting.

Most patients (80%) who had an initial blood pressure received naloxone intramuscularly, and the response rates were similar for both intramuscular and intravenous administration, demonstrating that naloxone is effective regardless of the route of delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-hospital treatment of opioid overdoses in an urban setting. Sporer, KA., Firestone, J., Isaacs, SM.[2022]

A scoping review identified 27 post-overdose intervention programs in the US, with 9 operating from emergency departments and 18 providing support through various community-based methods, highlighting the diverse approaches to care after a nonfatal opioid overdose.

Despite the emergence of these programs, there is significant variability in their components and follow-up strategies, and more research is needed to evaluate their effectiveness and establish best practices for reducing the risk of subsequent overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of post opioid-overdose interventions. Bagley, SM., Schoenberger, SF., Waye, KM., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06593093

Study Details | NCT06593093 | A Bundled Intervention

However, it remains untested if a bundled intervention of telehealth, peers, buprenorphine, and linkage to definitive addiction programs can increase treatment ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/9513197

Project POINT: Effectiveness and Scalability of an Overdose ...

Planned Outreach, Intervention, Naloxone, and Treatment (POINT) is an emergency department (ED)-based outreach program for engaging opioid overdose survivors ...

3.

withpower.com

withpower.com/trial/bundled-intervention-for-opioid-overdose-629b5

Bundled Intervention for Opioid Overdose (B-CARE Trial)

What data supports the effectiveness of the treatment A Bundled Intervention for opioid overdose? Research shows that training family members to manage ...

4.

health.ny.gov

health.ny.gov/health_care/medicaid/ebbrac/2025/docs/2025-07_hlth_tech_assessment.pdf

Treatment of Opioid Use Disorder Delivered Exclusively by ...

Treatment exclusively by telehealth was associated with adherence to prescribed medications for OUD in studies, but only 1 trial reported ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ...

Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

6.

reporter.nih.gov

reporter.nih.gov/project-details/10985969

Telehealth for Opioid Use Disorder in Vulnerable Settings

Repeated studies find remote treatment with buprenorphine to be as good—and often better—than in-person treatment as usual. Research also calls attention to ...

7.

phti.org

phti.org/wp-content/uploads/sites/3/2025/09/PHTI-Virtual-OUD-Solutions-Assessment-Report.pdf

Virtual Opioid Use Disorder Solutions

Access to buprenorphine- based treatment has improved outcomes, and broad dissemination of Naloxone has begun to reduce deaths from overdose; however ...