A Phase 4 interventional study of a bundled intervention, including peer support specialist, buprenorphine, physician care, and telehealth in Opioid Use Disorder and Opioid Overdose, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
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.
This study is supported by the HEAL Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the U.S. and are particularly concentrated among patients after emergency department (ED) discharge. Medications for opioid use disorder (MOUDs), including buprenorphine, are the most effective treatments for opioid use disorder (OUD) as MOUD reduce opioid-related overdoses and deaths. Despite this, less than 30% patients with OUD are treated with MOUDs. Furthermore, adequate treatment with MOUD can be more difficult in certain patient population, i.e., patients with nonfatal opioid overdoses after ED discharge. This patient population also accounts for substantial health care utilization, frequent ED visits, and the largest at-risk group for repeat overdoses and even deaths. Many barriers, including patients' stigma on MOUDs, lack of appropriate monitoring and support, difficulty in navigating community-based treatment programs and being connected with buprenorphine clinics for continuity of care, have been identified as contributors to poor treatment uptake post-ED discharge. These barriers present a pressing need to develop novel treatment modules. Peer support models and telehealth have been successful in improving service provision and increasing treatment uptake in substance use disorders. However, it remains untested if a bundled intervention of telehealth, peers, buprenorphine, and linkage to definitive addiction programs can increase treatment uptake in this particular population. Thus, the purpose of this proposal is to test this bundled intervention specifically focusing on patients with OUD and nonfatal opioid overdoses post-ED discharge. In the R61 phase, 30 patients with OUD and opioid overdoses in the past 12 months will be enrolled from the University of Alabama at Birmingham Hospital when participants are discharged from the ED. Following ED discharge, peers will contact patients daily in Week 1 post-ED discharge, twice in Week 2, and weekly thereafter for 12 weeks using telehealth. Physicians will continue prescribing buprenorphine. Peers will also motivate and assist participants to engage in community-based treatment programs for continuity of care after intervention is completed. Primary outcomes are the feasibility and acceptability of this bundled intervention. Secondary outcomes include treatment uptake, repeat overdose, and healthcare utilization (opioid overdose related-ED revisits after the initial ED encounter). As of now, we have successfully completed the R61 phase enrollment and data collection. We are working on data clean and analysis, as well as data dissemination. This is part of a two phases study, R61 and R33. The R61 milestones for progression to the R33 phase is based on whether: 1) start-up activities are completed; 2) enrollment is completed; 3) intervention is implemented and primary outcome measures are met, and 4) Stakeholder Advisory Board is formed. We have successfully completed all listed milestones and we are ready to progress to the next phase, R33, to conduct a RCT to test this bundled intervention's effectiveness and efficacy. If successful, this project will lay the groundwork for a multi-site trial to validate the treatment and to identify actual implementation and sustainability barriers and best practices.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 30 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Opiate Overdose, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 Qualtrics at 1-month and 3-month for follow-up assessments. Peers will remind the participants to complete the survey. Peers will also assist the participants to enter a definitive addiction treatment program, including buprenorphine or addiction clinic for continuity of care.
Drug: a bundled intervention, including peer support specialist, buprenorphine, physician care, and telehealth
a bundled intervention, including peer support, buprenorphine (ranging from 4mg-24mg, oral, daily, or sublocade), physician care, telehealth, and community-based addiction programs. Participants are enrolled 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 complete baseline surveys on the day of informed consent. Participants are sent survey links to their cell phones and emails to complete self-report questionnaires via Qualtrics at 1- and 3-month follow-up assessments. Participants are reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments. Peers assist the participants to enter a definitive addiction treatment, including buprenorphine clinic.
Participant Enrollment and Retention Rates
measure the feasibility of recruitment
Time frame: 1 month and 3 months post enrollment
Number of Participants With Buprenorphine Adherence
checking buprenorphine adherence rate
Time frame: 3 months post ED discharge
Linkage Rate to Addiction Treatment Programs
patients' self report
Time frame: 3 months post ED discharge
Repeat Non-fatal Opioid Overdose
participants' repeat non-fatal opioid overdose one year after the initial ED enrollment
Time frame: up to 1 year after enrollment date
Total ED Revisits and Readmissions
monitor participants' total (opioid overdose related ED revisits and readmissions after initial ED encounter)
Time frame: up to 1 year after the enrollment date
Have completed 30 participants enrollment as planned
| Milestone | R61 Phase (Only 1 Arm) |
|---|---|
| Started | 30 |
| Start-up activities are completed | 30 |
| Completed | 24 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 6 |
measure the feasibility of recruitment
| Participants | Phase 1 (Only 1 Arm) |
|---|---|
| 1-month | 24 |
| 3-month | 24 |
checking buprenorphine adherence rate
| Participants | Buprenorphine Adherence Rate |
|---|---|
| Number of Participants With Buprenorphine Adherence | 24 |
patients' self report
| Participants | Linkage Rate to Addiction Treatment Program |
|---|---|
| Linkage Rate to Addiction Treatment Programs | 12 |
participants' repeat non-fatal opioid overdose one year after the initial ED enrollment
| Participants | Repeat Non-fatal Overdose |
|---|---|
| Repeat Non-fatal Opioid Overdose | 5 |
monitor participants' total (opioid overdose related ED revisits and readmissions after initial ED encounter)
| Participants | Healthcare Utilization |
|---|---|
| Total ED Revisits and Readmissions | 8 |
Collected over from the enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 (Only 1 Arm) | 0/30 (0%) | 5/30 (16.7%) | 0/30 (0%) |
| Event | Phase 1 (Only 1 Arm) |
|---|---|
| non-fatal opioid overdosesGeneral disorders | 5/30 |
| Age, Continuous(years) | R61 Phase (Only 1 Arm) (the First Phase in a Two-phases Study) |
|---|---|
| Mean | 38 ± 8 |
| Sex: Female, Male(Participants) | R61 Phase (Only 1 Arm) (the First Phase in a Two-phases Study) |
|---|---|
| Female | 13 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | R61 Phase (Only 1 Arm) (the First Phase in a Two-phases Study) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | R61 Phase (Only 1 Arm) (the First Phase in a Two-phases Study) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The study team will share our pooled participants data using: Conference presentations; Publications; A press release; sharing with other emergency departments across the U.S; prepare and submit subsequent grants to communicate the results of this study and to facilitate broad implementation activities; the results of this study also will be posted publicly via ClinicalTrials.gov.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: we plan to disseminate our data as soon as possible
Access criteria: any interested researchers are able to access the IPD and supporting information under the guidelines from the NIH/NIDA
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →