RecruitingPhase 1/2

A Bundled Intervention

United States190 participantsStarted 2025-02-13

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. discharged from the ED and inpatient settings at the UAB hospital
✓. 19 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.

Exclusion criteria

✕. 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

What they're measuring

participant retention rate

Timeframe: 1 month and 3 months post ED discharge

buprenorphine adherent rate

Timeframe: 1 month and 3 months post ED discharge

linkage rate to addiction treatment programs

Timeframe: 1 month and 3 months post ED discharge

Trial details

NCT IDNCT06593093

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-11-30

Contact for this trial

Li Li, MD;PhD

2059346269 liyli@uabmc.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials

Plain-language summary

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. discharged from the ED and inpatient settings at the UAB hospital
✓. 19 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.

Exclusion criteria

✕. 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