A Phase 4 interventional study of Bundled intervention (Experimental) and control group in Opioid Use Disorder and Opioid Overdose, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
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 Helping to End Addiction Long-term (HEAL) Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the United States. 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 R33 phase, participants will be enrolled and randomized to either the intervention group (N=80) or the usual care group (UC) (N=80). Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied. Randomization will be computer-generated using permuted blocks and will be stratified by age, sex at birth, ethnicity, comorbid diseases, and recruitment site (inpatient unit or emergency department) to ensure balanced allocation across groups. This study is open-label; participants and study staff will not be blinded to treatment assignment. In the intervention group, peers and physicians will provide the same intervention to patients as in the R61 phase, including peer support specialists meeting participants prior to ED discharge, scheduled telehealth contact throughout the 12-week period, and physician-led buprenorphine prescribing and management via telehealth. 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. Patients in the usual care group will receive the standard care that has been established at the ED, including ED-initiated buprenorphine, and a list of community-based substance treatment programs and buprenorphine clinics at ED discharge. However, no further intervention will be provided in the usual care group. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through Research Electronic Data Capture (REDCap), with reminder messages sent twice daily for 5 days prior to each assessment. Primary outcomes will be increased treatment uptake and retention after ED discharge, and reduced opioid overdoses and ED revisits, compared to the usual care group. 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 planned enrollment of 160 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 →
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Exclusion Criteria:
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.
Other: Bundled intervention (Experimental) · Drug: Buprenorphine (Experimental) · Behavioral: Scheduled Peer Support Specialist (Experimental) · Other: Telemedicine Buprenorphine Treatment
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.
Other: control group
a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.
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
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.
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.
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.
participant retention rate
measure the total number of participants who complete 1- month and 3-month treatment in the study
Time frame: 1 month and 3 months post hospital discharge
buprenorphine adherence rate
checking prescription rate and patients' self report of their taking medication
Time frame: 1 month and 3 months post ED discharge
linkage rate to addiction treatment programs
patients' self report and reports from addiction treatment programs
Time frame: 1 month and 3 months post hospital discharge
Frequency of Repeat Opioid Overdose
Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Healthcare Utilization (Hospital Revisit Rates)
Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Adherence to Peer Support Specialist Contact
Rate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact
Time frame: Throughout the 12-week intervention period post hospital discharge
Opioid Overdose Death
Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Childhood Trauma Questionnaire (CTQ)
Participant quality of life will be assessed using validated self-reported survey min: 25, max: 125 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Overdose Risk Scale (ORISK)
Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 24 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month and 3-month post hospital discharge]
Patient Satisfaction Scale (PSS)
Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 64 (higher=better)
Time frame: [Time Frame: Baseline, 1-month and 3-month post hospital discharge]
Credibility and Expectancy Questionnaire (CEQ)
Participant quality of life will be assessed using validated self-reported surveys. min: 6, max: 27 (higher=better)
Time frame: [Time Frame: 1-month and 3-month post hospital discharge]
Barratt Impulsiveness Scale (BIS)
Participant mental health status will be assessed using validated self-report surveys. min: 24, max: 96 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Generalized Anxiety Disorder 7 (GAD-7)
Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 21 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Patient Health Questionnaire 9 (PHQ-9)
Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 27 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Opioid Craving Scale (Craving)
Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 30 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Pittsburgh Sleep Quality Index (PSQI)
Participant mental health status will be assessed using validated self-reported survey. min: 0, max: 21 (higher=worse)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Plan to share: No — Individual participant data (IPD) will not be shared. Study data will be made available in aggregate, de-identified form only. This approach was adopted due to the sensitive nature of the study population (individuals with opioid use disorder in emergency department settings), re-identification risks inherent to this population, and restrictions under the IRB protocol and participant consent agreements. Aggregate findings will be disseminated through peer-reviewed publication and may be made available through NIH-designated channels consistent with HEAL Initiative data sharing requirements.
No publications or documents are linked to this record.
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 ↗
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Studies of the drug tested here: Buprenorphine
University of Alabama at Birmingham →