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Behavioural Intervention

Bundled Intervention for Opioid Overdose

Phase 1 & 2
Waitlist Available
Led By Li Li, MD;PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of OUD and experiencing opioid overdose in the last 12 months
19 years or older (the age of majority in Alabama)
Must not have
Anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month and 3 months post ed discharge

Summary

This trial aims to address the high number of opioid overdose deaths in the US, especially among patients discharged from the emergency department. The study will test a combined intervention involving telehealth, peer support, b

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, interventions like buprenorphine can cause symptoms such as dizziness, sleepiness, nausea, and potential dependency or withdrawal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have opioid use disorder and had an overdose in the past year.
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I am 19 years old or older.
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I am not experiencing severe mental health issues like psychosis or suicidal thoughts.
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I started buprenorphine in the emergency department and agree to keep taking it after I leave.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I expect to be on opioids other than buprenorphine for more than three months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 3 months post ed discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month and 3 months post ed discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
buprenorphine adherent rate
linkage rate to addiction treatment programs
participant retention rate

Trial Design

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 Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,568 Previous Clinical Trials
3,285,413 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,635 Previous Clinical Trials
2,304,969 Total Patients Enrolled
Li Li, MD;PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
~127 spots leftby Nov 2030
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