Recruiting

Buprenorphine with Telehealth

Sponsor:

University of Alabama at Birmingham

Code:

NCT07485335

Conditions

Opioid Use Disorder

Opioid Overdose

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Bundled intervention (Experimental)

control group

Buprenorphine (Experimental)

Scheduled Peer Support Specialist (Experimental)

Telemedicine Buprenorphine Treatment

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

NCT07485335

Start date

Sep 7, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 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

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental (Bundled Intervention)

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.

placebo comparator: Control (Usual Care)

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.

Interventions

Bundled intervention (Experimental)

a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to 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 University of Alabama at Birmingham (UAB) hospital

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.

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.

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.

Primary outcome measure

  • participant retention rate [ Time Frame: 1 month and 3 months post hospital discharge ]
  • buprenorphine adherence 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 hospital discharge ]
  • Frequency of Repeat Opioid Overdose [ Time Frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention ]
  • Healthcare Utilization (Hospital Revisit Rates) [ Time Frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention ]
  • Adherence to Peer Support Specialist Contact [ Time Frame: Throughout the 12-week intervention period post hospital discharge ]
  • Opioid Overdose Death [ Time Frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention ]

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

Oct 1, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.