Bundled Intervention for Opioid Overdose

(B-CARE Trial)

LL
Overseen ByLi Li, MD;PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
Must be taking: Buprenorphine
Prior Safety DataThis treatment has passed at least one previous human trial

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 (ED). The bundled intervention includes telehealth (remote medical appointments), peer support, buprenorphine medication, and connections to ongoing care. The goal is to increase treatment participation and reduce opioid overdose deaths. Individuals who have experienced an opioid overdose in the past year, received buprenorphine in the ED, and are willing to continue its use may be suitable for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients, offering a chance to contribute to broader knowledge and potentially improve outcomes for others.

Do I have to stop taking my current medications for the trial?

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 taking other prescribed opioids for more than three months, you cannot participate.

What is the safety track record for this bundled intervention?

Research has shown that the combined approach for preventing opioid overdose, which includes online healthcare, peer support, and buprenorphine treatment, is generally manageable for individuals. Previous studies have found that online healthcare services for opioid use disorder are safe and effective, helping patients adhere better to their treatment plans.

Studies have also demonstrated that using online healthcare to provide buprenorphine, a medication that reduces cravings and withdrawal symptoms from opioids, is effective and safe. No major negative effects were reported, indicating the treatment's safety.

The FDA has already approved buprenorphine for treating opioid use disorder, further supporting its safety. Overall, the components of this combined approach have a strong record of safety.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Bundled Intervention for opioid overdose because it offers a comprehensive approach that combines several support mechanisms. Unlike the standard care, which mainly involves initial buprenorphine treatment and self-navigation through treatment options, the Bundled Intervention integrates scheduled peer support and telehealth consultations with addiction physicians. This method ensures continuous guidance and support up to three months after hospital discharge, aiming to enhance recovery rates and provide a more structured path to long-term addiction treatment. By leveraging technology and peer support, this intervention could significantly improve engagement and outcomes for individuals recovering from opioid overdose.

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

This trial will compare a bundled intervention with usual care for opioid overdose. Research has shown that combining treatments, such as online healthcare services, peer support, and the medication buprenorphine, can aid individuals with opioid addiction. Participants in the experimental group will receive this bundled intervention, which includes scheduled peer support contacts, buprenorphine treatment with addiction physicians via telehealth, and linkage to definitive addiction treatment programs. Studies have found that online healthcare helps individuals adhere to their medication and remain in treatment longer. Peer support effectively increases engagement in recovery and access to services. Buprenorphine is associated with fewer opioid overdoses and serious health issues related to opioids. Together, these treatments aim to encourage more people to begin treatment and prevent repeat overdoses after leaving the emergency room.23467

Who Is on the Research Team?

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Li Li, MD;PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults (19+) in Alabama who speak English, have had an opioid overdose in the past year, were treated and discharged from UAB hospital's emergency or inpatient care, and are willing to continue buprenorphine. People with severe mental illness, pregnancy, certain medical conditions, allergies to buprenorphine, or living outside Alabama can't join.

Inclusion Criteria

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
See 4 more

Exclusion Criteria

Living in a restricted environment (e.g., prison or jail facility, etc.)
Currently enrolled in other clinical studies
I expect to take prescribed opioids (not buprenorphine) for over three months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a bundled intervention including telehealth, peer support, and buprenorphine treatment for 12 weeks

12 weeks
Scheduled telehealth contacts throughout the 12-week period

Follow-up

Participants are monitored for treatment uptake, retention, and opioid overdose events post-intervention

3 months
Follow-up assessments at 1 and 3 months via survey links

Long-term Monitoring

Opioid overdose events and healthcare utilization are monitored quarterly beyond the 3-month intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Bundled Intervention

Trial Overview

The study compares usual care to a bundled intervention that includes telemedicine visits for buprenorphine treatment, scheduled support from peer specialists, and help connecting to ongoing care after leaving the hospital. The goal is to reduce repeat overdoses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental (Bundled Intervention)Experimental Treatment4 Interventions
Group II: Control (Usual Care)Placebo Group1 Intervention

Find a Clinic Near You

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+

Citations

Outcomes for patients receiving telemedicine-delivered ... - PMC

We describe results of a retrospective chart review of 472 patients treated in the program between August 2015 and April 2019.

Retention rates and cost-effectiveness of telehealth vs. in ...

Management of opioid use disorder (OUD) has evolved with integration of telehealth, particularly during COVID-19. This study evaluated effectiveness (retention ...

Bundled Intervention for Opioid Overdose (B-CARE Trial)

This trial tests a new approach to prevent repeat opioid overdoses after patients leave the emergency department. It combines telehealth, peer support, ...

Increased Use of Telehealth Services and Medications for ...

In this national study, researchers analyzed data among two cohorts of Medicare beneficiaries to explore receipt of opioid use disorder-related ...

A Bundled Intervention to End Opioid Overdoses (B-CARE)

Peer support models and telehealth have been successful in improving service provision and increasing treatment uptake in substance use disorders. However, it ...

Response to a peer telehealth intervention for emergency ...

We conducted an interrupted time series (ITS) analysis of ED patients presenting for unintentional opioid overdose or other opioid-related issues.

Virtual Opioid Use Disorder Solutions

Through its rigorous, evidence-based research, PHTI analyzes the clinical benefits and economic impact of digital health solutions.