Bundled Intervention for Opioid Overdose
(B-CARE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byLi Li, MD;PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Alabama at Birmingham
Must be taking: Buprenorphine
Must not be taking: Other opioids
Disqualifiers: Living in restricted environment, others
Trial Summary
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.
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.
12345How 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.
13567Eligibility 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
+3 more
Exclusion Criteria
Critically ill or injured
Living in a restricted environment (e.g., prison or jail facility, etc.)
Currently enrolled in other clinical studies
+3 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: phase 2- experimentalExperimental Treatment1 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 1Experimental Treatment1 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- controlPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UABBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. [2018]The United States is amidst an opioid epidemic, including synthetic opioids that may result in rapid death, leaving minimal opportunity for bystander rescue. We pilot tested a behavioral intervention to reduce the occurrence of opioid overdose among opioid dependent persons at high-risk for subsequent overdose.
Out-of-hospital treatment of opioid overdoses in an urban setting. [2022]To investigate clinical outcomes in a cohort of opioid overdose patients treated in an out-of-hospital urban setting noted for a high prevalence of i.v. opioid use.
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]A non-fatal opioid overdose (NFOO) increases the risk of another overdose and identifies high-risk patients. We estimated the risk of repeat opioid overdose for patients with and without substance use disorder (SUD) diagnoses and the change in substance use treatment utilization rates associated with the first NFOO.
Training family members to manage heroin overdose and administer naloxone: randomized trial of effects on knowledge and attitudes. [2014]To evaluate a heroin overdose management training programme for family members based on emergency recovery procedures and take-home naloxone (THN) administration.
Death matters: understanding heroin/opiate overdose risk and testing potential to prevent deaths. [2021]To describe work undertaken over a 20-year period, investigating overdose characteristics among survivors, effects of acute heroin administration, clustering of risk of overdose fatality and potential interventions to reduce this fatal outcome.
A scoping review of post opioid-overdose interventions. [2022]Nonfatal opioid overdose is a significant risk factor for subsequent fatal overdose. The time after a nonfatal overdose may provide a critical engagement opportunity to both reduce subsequent overdose risk and link individuals to treatment. Post-overdose interventions have emerged in affected communities throughout the United States (US). The objective of this scoping review is to identify US-based post-overdose intervention models (1) described in peer-reviewed literature and (2) implemented in public health and community settings.
Opioid overdose prevention in a residential care setting: Naloxone education and distribution. [2018]Patients with opioid use disorders are at an increased risk for overdose death if they had a previous overdose, have co-occurring medical and psychiatric comorbidity, and are high-dose opioid users transitioning to relative abstinence or abstinence, i.e., those individuals discharging from drug treatment programs. Despite the success of opioid overdose prevention programs utilizing naloxone, residential substance abuse treatment centers often emphasize abstinence-based care for those suffering from addiction and do not adopt harm reduction approaches such as naloxone education and distribution. This performance improvement project reports the implementation of an opioid overdose prevention program provided to patients and their family members in a residential treatment setting.