Recruiting
Phase 1
Phase 2

Buprenorphine with Telehealth

Sponsor:

University of Alabama at Birmingham

Code:

NCT06593093

Conditions

Opioid Use Disorder

Opioid Overdose

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

a bundled intervention

control group

Study Details

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

Study ID

NCT06593093

Start date

Feb 13, 2025

Status verified date

Feb, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. discharged from the ED and inpatient settings at the UAB hospital
2. 19 years or older (the age of majority in Alabama);
3. diagnosis of OUD and experiencing opioid overdose in the last 12 months;
4. prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
5. English speaking;
6. not actively psychotic and suicidal, or cognitively impaired.
7. Patients who are admitted to the hospital from the ED will be eligible for enrollment.

Exclusion Criteria:

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

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: phase 1

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.

experimental: phase 2- experimental

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.

placebo comparator: phase 2- control

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.

Interventions

a bundled intervention

a bundled intervention, including peer support, buprenorphine (ranging from 4mg-24mg, oral, daily), telehealth, and community-based addiction programs.

control group

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

Primary outcome measure

  • participant retention rate [ Time Frame: 1 month and 3 months post ED discharge ]
  • buprenorphine adherent rate [ Time Frame: 1 month and 3 months post ED discharge ]
  • linkage rate to addiction treatment programs [ Time Frame: 1 month and 3 months post ED discharge ]

Central Contacts and Locations

Central contacts

Li Li, MD;PhD

2059346269liyli@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Li Li, MD;PhD

2059346269liyli@uabmc.edu

Principal Investigator:

Li Li, MD;PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Emergency department
  • post discharge
  • buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-23.