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

Trial Summary

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.

What data supports the effectiveness of the treatment A Bundled Intervention for opioid overdose?

Research shows that training family members to manage heroin overdoses and administer naloxone (a medication that reverses opioid overdoses) can improve their knowledge and attitudes, which may help prevent fatal overdoses. Additionally, behavioral interventions have been pilot tested to reduce opioid overdoses among high-risk individuals, suggesting that similar approaches could be effective. ^{1 2 3 4 5}

How is the Bundled Intervention treatment for opioid overdose different from other treatments?

The Bundled Intervention for opioid overdose is unique because it combines multiple strategies to address the risk of subsequent overdoses, potentially including education, naloxone distribution, and linking individuals to treatment, rather than focusing solely on abstinence or a single approach. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Li Li, MD;PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Out-of-hospital treatment of opioid overdoses in an urban setting. [2022]

3. Ireland 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Training family members to manage heroin overdose and administer naloxone: randomized trial of effects on knowledge and attitudes. [2014]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A scoping review of post opioid-overdose interventions. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. [2018]