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NOT YET RECRUITING
NCT07485335
PHASE4

A Bundled Intervention - Phase 2

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: Implementation and Effectiveness Testing of a Bundled Post-Hospital Intervention for Non-fatal Opioid Overdoses

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-09-07

Completion Date

2030-09-30

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

OTHER

Bundled intervention (Experimental)

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

OTHER

control group

participants will not be intervened with this bundled treatment, but continue the usual care that has been established at UAB hospital

DRUG

Buprenorphine (Experimental)

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.

BEHAVIORAL

Scheduled Peer Support Specialist (Experimental)

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.

OTHER

Telemedicine Buprenorphine Treatment

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.

Locations (1)

UAB

Birmingham, Alabama, United States