Opioid Use DisorderPhase 4B-CARENCT07485335
A Bundled Intervention to End Opioid Overdoses
A Phase 4 study testing Bundled intervention (Experimental), Buprenorphine (Experimental) and Scheduled Peer Support Specialist (Experimental) in people with Opioid Use Disorder and Opioid Overdose, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Overdose
- What is being tested?
- Bundled intervention (Experimental), Buprenorphine (Experimental) and Scheduled Peer Support Specialist (Experimental)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2026to 30 Sep 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB
Birmingham, Alabama, 35294
Li Li, MD;PhD, 2059346269, liyli@uabmc.edu
Li Li, MD;PhD
About this study
Official title: Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge
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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder, Opioid Overdose
- Being tested
- Bundled intervention (Experimental), control group, Buprenorphine (Experimental), Scheduled Peer Support Specialist (Experimental), Telemedicine Buprenorphine Treatment
- Keywords
- Emergency department, post discharge, buprenorphine, peer support specialist, telehealth
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled intervention (Experimental)Other
a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.
control groupOther
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)Drug
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)Behavioural
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Bundled Intervention) | Experimental | 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. Receives: Other: Bundled intervention (Experimental); Drug: Buprenorphine (Experimental); Behavioral: Scheduled Peer Support Specialist (Experimental); Other: Telemedicine Buprenorphine Treatment |
| Control (Usual Care) | Placebo comparator | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
participant retention rate
measure the total number of participants who complete 1- month and 3-month treatment in the study
Measured: 1 month and 3 months post hospital discharge
buprenorphine adherence rate
checking prescription rate and patients' self report of their taking medication
Measured: 1 month and 3 months post ED discharge
linkage rate to addiction treatment programs
patients' self report and reports from addiction treatment programs
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Secondary outcomes (9)
Childhood Trauma Questionnaire (CTQ)
Participant quality of life will be assessed using validated self-reported survey min: 25, max: 125 (higher=worse)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start7 Sep 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Li Li, University of Alabama at Birmingham
- Investigators
- Li Li, MD;PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485335
- Sponsor's protocol ID
- IRB-300016289
- Other IDs
- R33DA062351-02
- Acronym
- B-CARE
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge
- ClinicalTrials.gov ID
- NCT07485335
- Acronym / sponsor ID
- B-CARE / IRB-300016289
- Conditions
- Opioid Use Disorder, Opioid Overdose
- Keywords
- Emergency department, post discharge, buprenorphine, peer support specialist, telehealth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Experimental (Bundled Intervention) | Experimental | Other: Bundled intervention (Experimental), Drug: Buprenorphine (Experimental), Behavioral: Scheduled Peer Support Specialist (Experimental), Other: Telemedicine Buprenorphine TreatmentParticipants 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. |
| Control (Usual Care) | Placebo comparator | Other: control groupParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundled intervention (Experimental)a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs. | Other | Experimental (Bundled Intervention) |
| control groupparticipants 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 | Other | Control (Usual Care) |
| 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. | Drug | Experimental (Bundled Intervention) |
| 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. | Behavioural | Experimental (Bundled Intervention) |
| Telemedicine Buprenorphine TreatmentParticipants 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. | Other | Experimental (Bundled Intervention) |
Primary outcome
participant retention rate
Time frame: 1 month and 3 months post hospital discharge
measure the total number of participants who complete 1- month and 3-month treatment in the study
buprenorphine adherence rate
Time frame: 1 month and 3 months post ED discharge
checking prescription rate and patients' self report of their taking medication
linkage rate to addiction treatment programs
Time frame: 1 month and 3 months post hospital discharge
patients' self report and reports from addiction treatment programs
Frequency of Repeat Opioid Overdose
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Healthcare Utilization (Hospital Revisit Rates)
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital
Adherence to Peer Support Specialist Contact
Time frame: Throughout the 12-week intervention period post hospital discharge
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
Opioid Overdose Death
Time frame: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
9 secondary outcomes
Childhood Trauma Questionnaire (CTQ)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Overdose Risk Scale (ORISK)
Time frame: [Time Frame: Baseline, 1-month and 3-month post hospital discharge]
Patient Satisfaction Scale (PSS)
Time frame: [Time Frame: Baseline, 1-month and 3-month post hospital discharge]
Credibility and Expectancy Questionnaire (CEQ)
Time frame: [Time Frame: 1-month and 3-month post hospital discharge]
Barratt Impulsiveness Scale (BIS)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Patient Health Questionnaire 9 (PHQ-9)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Opioid Craving Scale (Craving)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Pittsburgh Sleep Quality Index (PSQI)
Time frame: [Time Frame: Baseline, 1-month, and 3-month post hospital discharge]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Opioid Use Disorder
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Active, not recruiting
Facilitating Opioid Care Connections
Opioid Court Model, Medication to Treat Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Li, MD;PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bundled intervention (Experimental), Buprenorphine (Experimental) and Scheduled Peer Support Specialist (Experimental) in people with Opioid Use Disorder and Opioid Overdose, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Li, MD;PhD (2059346269, liyli@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participant retention rate (time frame: 1 month and 3 months post hospital discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.