A Bundled Intervention to End Opioid Overdoses

NCT07485335 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: DA062351NIH
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Opioid Overdose

Keywords

Emergency department; post discharge; buprenorphine; peer support specialist; telehealth

Outcome Measures

Primary Outcomes (7)

• participant retention rate

  measure the total number of participants who complete 1- month and 3-month treatment in the study

  1 month and 3 months post hospital discharge

• buprenorphine adherence rate

  checking prescription rate and patients' self report of their taking medication

  1 month and 3 months post ED discharge

• linkage rate to addiction treatment programs

  patients' self report and reports from addiction treatment programs

  1 month and 3 months post hospital discharge

• Frequency of Repeat Opioid Overdose

  Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital

  Monitored quarterly throughout the R33 study period beyond the 3-month intervention

• Healthcare Utilization (Hospital Revisit Rates)

  Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital

  Monitored quarterly throughout the R33 study period beyond the 3-month intervention

• Adherence to Peer Support Specialist Contact

  Rate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact

  Throughout the 12-week intervention period post hospital discharge

• Opioid Overdose Death

  Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital

  Monitored quarterly throughout the R33 study period beyond the 3-month intervention

Secondary Outcomes (9)

• Childhood Trauma Questionnaire (CTQ)

  [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]

• Overdose Risk Scale (ORISK)

  [Time Frame: Baseline, 1-month and 3-month post hospital discharge]

• Patient Satisfaction Scale (PSS)

  [Time Frame: Baseline, 1-month and 3-month post hospital discharge]

• Credibility and Expectancy Questionnaire (CEQ)

  [Time Frame: 1-month and 3-month post hospital discharge]

• Barratt Impulsiveness Scale (BIS)

  [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]

Study Arms (2)

Experimental (Bundled Intervention)

EXPERIMENTAL

Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after Emergency Department (ED)/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month 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.

Other: Bundled intervention (Experimental); Drug: Buprenorphine (Experimental); Behavioral: Scheduled Peer Support Specialist (Experimental); Other: Telemedicine Buprenorphine Treatment

Control (Usual Care)

PLACEBO COMPARATOR

Participants randomized to the control group will receive the usual care established at University of Alabama at Birmingham (UAB) Hospital. Current usual care 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 complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month 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.

Other: control group

Interventions

Bundled intervention (Experimental) OTHER

a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.

Experimental (Bundled Intervention)

control group OTHER

participants will not be intervened with this bundled treatment, but continue the usual care that has been established at University of Alabama at Birmingham (UAB) hospital

Control (Usual Care)

Buprenorphine (Experimental) DRUG

Participants in the experimental arm will receive buprenorphine treatment for opioid use disorder, including buprenorphine/naloxone (sublingual film or tablet), buprenorphine (sublingual tablet), or buprenorphine extended-release, as determined by the study physician via telehealth. Medication will be provided for the duration of the 12-week intervention period. Participants without insurance or who are underinsured will be provided medication at no cost to ensure equitable access.

Experimental (Bundled Intervention)

Scheduled Peer Support Specialist (Experimental) BEHAVIORAL

Participants in the experimental arm will be introduced to a peer support specialist prior to hospital discharge. Peer support specialists, who have lived experience with substance use disorder and recovery, will provide ongoing support throughout the 12-week intervention period. Specialists will assist participants in navigating and attending community-based addiction treatment resources, including buprenorphine clinics and substance use treatment programs. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources.

Experimental (Bundled Intervention)

Telemedicine Buprenorphine Treatment OTHER

Participants in the experimental arm will receive telehealth-enabled services throughout the 12-week intervention period. Addiction physicians will conduct virtual visits to evaluate, prescribe, and manage buprenorphine for opioid use disorder. Peer support specialists will maintain scheduled contact with participants via telehealth to provide ongoing support and monitor participant progress. Follow-up assessments at 1 and 3 months will be completed remotely via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment.

Experimental (Bundled Intervention)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• discharged from the ED and inpatient settings at the UAB hospital
• years or older (the age of majority in Alabama);
• diagnosis of OUD and experiencing opioid overdose in the last 12 months;
• prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
• 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.

You may not qualify if:

• living in a restricted environment (e.g., prison or jail facility, etc.);
• currently enrolled in other clinical studies;
• anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
• known allergic reaction to buprenorphine;
• critically ill or injured;
• females with pregnancy (they are anticipated to request a higher level of care).
• living outside of Alabama

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose; Emergencies

Interventions

Control Groups; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Li Li, MD;PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Li, MD;PhD

CONTACT

2059346269; liyli@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)