Opioid Use DisorderTREATEDNCT06961058
Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department
A study testing referral to telehealth treatment and referral to in person treatment in people with Opioid Use Disorder, run by University of California, Davis at 3 sites in United States.
Trial summary
Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- referral to telehealth treatment and referral to in person treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2025to 1 Sep 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who present to the emergency department and receive buprenorphine (either administered or prescribed) to treat OUD
- do not have an established outpatient clinic where they will get buprenorphine when they leave the emergency department
Who cannot join
- inability to give consent
- patients living in institutions (e.g., nursing homes, prisons)
- unable to complete questionnaires in either English or Spanish
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
El Centro Regional Medical Center Emergency Department
El Centro, California, 92243
Rahul Nene, MD PhD, 760-339-7100, rnene@health.ucsd.edu
- Recruiting
University of California Davis Emergency Department
Sacramento, California, 95817
Meghan Weyrich, MPH, 916-734-7391, masoulsby@health.ucdavis.edu
- Recruiting
Olive View - UCLA Medical Center Emegency Department
Sylmar, California, 91342
Breena Taira, MD MPH, 844-804-0055, btaira@dhs.lacounty.gov
About this study
Official title: In Person vs Telehealth Opioid Use Disorder Treatment After Patients Leave the Emergency Department
Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic.
Researchers will:
Read more
Compare rates of establishing outpatient OUD treatment, how long patients stay on buprenorphine, and patients' experience with care to determine whether patient experiences and outcomes are better for patients referred to telehealth treatment versus patients patients referred to in-person treatment after they leave the emergency department.
Participants will:
Be recruited from 3 different hospital emergency departments.
Answer questionnaires at baseline and then 1, 3, 6, and 9 months after their initial emergency department visit.
Read the detailed description
Buprenorphine is a lifesaving but underused medication for treating opioid use disorder (OUD). Providing buprenorphine for OUD in hospital emergency departments is an evidence-based practice that reduces patients' risk of overdose. Most people with OUD need to stay on buprenorphine for years, yet median buprenorphine adherence is typically less than six months. There is thus a clear need for strategies to increase long term buprenorphine retention, particularly among patients prescribed buprenorphine in emergency departments, who often face barriers when transitioning to outpatient OUD treatment after they leave the emergency department. The practice of providing outpatient OUD treatment via telehealth (e.g., through video or phone visits) was developed years ago to serve rural areas, but it has become much more widely used and accepted across the US since the COVID-19 pandemic. Telehealth OUD treatment may also reduce logistical barriers to treatment (e.g., transportation) and reduce impacts of patient-reported OUD stigma (by reducing in-person visits to addiction clinics). This proposed study will address the following research question: For patients prescribed buprenorphine for OUD in hospital emergency departments and then referred for outpatient buprenorphine treatment, how do rates of establishing outpatient treatment and long-term retention in treatment compare for patients referred to treatment in person (at outpatient clinics or opioid treatment programs) versus treatment via telehealth? The study hypothesis is that rates of engaging with outpatient treatment, long-term buprenorphine retention, and patients' experience with care will be greater for patients referred to telehealth compared to in-person OUD treatment. To test this hypothesis, this project will conduct a pragmatic clinical trial at three emergency departments that participate in "CA Bridge," a statewide California program to encourage substance use treatment in emergency departments. Patients started on buprenorphine for OUD in the emergency department will be recruited and randomized 3:1 to either a random assignment group or a group where patients can choose their outpatient arm assignment. Patients in the random assignment group will be further randomized 1:1 to be referred to either in-person or telehealth outpatient treatment. This 2-step study design allows researchers to estimate both traditional effect sizes and the impact of patient preference on outcomes. Buprenorphine prescribing will be measured using prescription records from California's prescription drug monitoring program; patient questionnaires will be administered at baseline and 1, 3, 6, and 9 months after patients' emergency department visit. Treatment outcomes will be the proportion of patients establishing outpatient OUD treatment (i.e., filling at least one outpatient buprenorphine prescription within 30 days of their emergency department) and cumulative days with an active buprenorphine prescription six months after their emergency department visit (primary outcome). Drug related fatal overdose will be measured using California death certificate data. Subsequent emergency department visits and hospitalizations will be assessed from electronic health records. Patients' experience with care will be measured using AHRQ's Consumer Assessment of Health Providers and Systems Clinician and Group survey version 4.0, which includes questions specific to telehealth encounters. Finally, this study will examine associations between patients' baseline reports of OUD stigma and subsequent treatment outcomes as well as how arm assignment effects this association. Study findings will fill key evidence gaps and directly inform decisions by clinicians and patients about where patients should be referred for outpatient buprenorphine treatment after they leave the emergency department. Compared to the general population with OUD, patients who seek OUD care in the emergency department have higher overdose risk and are disproportionately low-income, non-white, and unstably housed. Thus, improving buprenorphine retention among patients who start treatment in the emergency department also has potential to reduce socioeconomic disparities in OUD treatment and, ultimately, overdose rates. Findings from our study will be immediately applicable to clinicians and patients in the nearly 300 hospital emergency departments across California that participate in the CA Bridge program as well as to hospitals across the country that have implemented emergency department-based OUD treatment programs.
- Conditions
- Opioid Use Disorder
- Being tested
- referral to telehealth treatment, referral to in person treatment
- Keywords
- emergency department, buprenorphine, telehealth, comparative effectiveness
- Medical subject headings
- Opioid-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
referral to telehealth treatmentOther
the intervention tested will be referral to get outpatient treatment via telehealth. Participants in the telehealth arm will receive the intervention.
referral to in person treatmentOther
participants in the in person arm will be referred to in person OUD treatment after they leave the ED
| Study group | Role | What they receive |
|---|---|---|
| in person | Active comparator | Participants will get treatment via CA Bridge, California's statewide program to provide Emergency Department (ED)-based OUD treatment. When clinicians or staff suspect an ED patient may have OUD, they refer the patient to an ED-based counselor who assesses the patient and engages them in OUD care. All patients with OUD get brief counseling and take-home naloxone. Patients willing to start treatment get buprenorphine (via either ED- or home-based induction), a referral for in-person outpatient OUD treatment at a local outpatient clinic or opioid treatment program, and a "bridge" prescription of buprenorphine to last until their first outpatient appointment. CA Bridge counselors maintain contact with patients for up to 30 days to help them establish outpatient care. This is usual care in study hospitals and in the >80% of California hospitals that participate in CA Bridge. Receives: Other: referral to in person treatment |
| telehealth | Experimental | This arm will comprise the same elements as the "in person" arm except that patients will be referred to get outpatient OUD treatment via telehealth (i.e. phone or video visits). Depending on study site and patient insurance, participants will be referred to get treatment at either a clinic associated with their hospital that offers telehealth OUD treatment or from a digital health company that provides on-demand telehealth OUD treatment and support services via video and phone visits. Receives: Other: referral to telehealth treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
buprenorphine retention
cumulative days with an active buprenorphine prescription
Measured: 6 months
Secondary outcomes (7)
buprenorphine retention
cumulative days with an active buprenorphine prescription
Measured: 3 months, 9 months
buprenorphine retention (binary)
active buprenorphine prescription with no gap in coverage >7 days
Measured: 3, 6, 9 months
drug overdose death
death related to overdose
Measured: 1, 3, 6, 9 months
past 30-day opioid use
patient-reported number of days patient used opioids (illicit opioids or prescription opioids for non-medical reasons) during past 30 days
Measured: 1, 3, 6, 9 months
patient experience with care
Access and visit rating subscales of AHRQ CAHPS clinician and group survey
Measured: 1, 3, 6, 9 months
non-fatal overdose
non-fatal overdose related to drug use, assessed from a combination of patient report and hospital electronic health records
Measured: 1, 3, 6, 9 months
establishing outpatient treatment
patients filling at least 1 outpatient buprenorphine prescription within 30 days of their emergency department visit
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start3 Jun 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study will use a two-stage randomization procedure. Patients will first be randomized 3:1 to either a "random assignment" group, which will then be further randomized 1:1 to one of the two arms, or a "patient choice" group. Patients in the "patient choice" group will be assigned to their preferred arm. If patients in this group have no preference, we will randomize them 1:1 to one of the arms. This approach allows estimation of both treatment effects and effects of patient preference on outcomes.
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Aimee Moulin, MD MAS, Principal investigator, University of California, DavisStephen G Henry, MD MSc, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961058
- Sponsor's protocol ID
- 2262435
- Other IDs
- BPS-2023C3-35503
- Acronym
- TREATED
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: sharing is not required by the study funder for this project
Publications
D'Onofrio G, Chawarski MC, O'Connor PG, Pantalon MV, Busch SH, Owens PH, Hawk K, Bernstein SL, Fiellin DA. Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention. J Gen Intern Med. 2017 Jun;32(6):660-666. doi: 10.1007/s11606-017-3993-2. Epub 2017 Feb 13.
PubMed 28194688
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Person vs Telehealth Opioid Use Disorder Treatment After Patients Leave the Emergency Department
- ClinicalTrials.gov ID
- NCT06961058
- Acronym / sponsor ID
- TREATED / 2262435
- Conditions
- Opioid Use Disorder
- Keywords
- emergency department, buprenorphine, telehealth, comparative effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 7 May 2025 (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.
Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic.
Researchers will:
Compare rates of establishing outpatient OUD treatment, how long patients stay on buprenorphine, and patients' experience with care to determine whether patient experiences and outcomes are better for patients referred to telehealth treatment versus patients patients referred to in-person treatment after they leave the emergency department.
Participants will:
Be recruited from 3 different hospital emergency departments.
Answer questionnaires at baseline and then 1, 3, 6, and 9 months after their initial emergency department visit.
Detailed description
Buprenorphine is a lifesaving but underused medication for treating opioid use disorder (OUD). Providing buprenorphine for OUD in hospital emergency departments is an evidence-based practice that reduces patients' risk of overdose. Most people with OUD need to stay on buprenorphine for years, yet median buprenorphine adherence is typically less than six months. There is thus a clear need for strategies to increase long term buprenorphine retention, particularly among patients prescribed buprenorphine in emergency departments, who often face barriers when transitioning to outpatient OUD treatment after they leave the emergency department. The practice of providing outpatient OUD treatment via telehealth (e.g., through video or phone visits) was developed years ago to serve rural areas, but it has become much more widely used and accepted across the US since the COVID-19 pandemic. Telehealth OUD treatment may also reduce logistical barriers to treatment (e.g., transportation) and reduce impacts of patient-reported OUD stigma (by reducing in-person visits to addiction clinics). This proposed study will address the following research question: For patients prescribed buprenorphine for OUD in hospital emergency departments and then referred for outpatient buprenorphine treatment, how do rates of establishing outpatient treatment and long-term retention in treatment compare for patients referred to treatment in person (at outpatient clinics or opioid treatment programs) versus treatment via telehealth? The study hypothesis is that rates of engaging with outpatient treatment, long-term buprenorphine retention, and patients' experience with care will be greater for patients referred to telehealth compared to in-person OUD treatment. To test this hypothesis, this project will conduct a pragmatic clinical trial at three emergency departments that participate in "CA Bridge," a statewide California program to encourage substance use treatment in emergency departments. Patients started on buprenorphine for OUD in the emergency department will be recruited and randomized 3:1 to either a random assignment group or a group where patients can choose their outpatient arm assignment. Patients in the random assignment group will be further randomized 1:1 to be referred to either in-person or telehealth outpatient treatment. This 2-step study design allows researchers to estimate both traditional effect sizes and the impact of patient preference on outcomes. Buprenorphine prescribing will be measured using prescription records from California's prescription drug monitoring program; patient questionnaires will be administered at baseline and 1, 3, 6, and 9 months after patients' emergency department visit. Treatment outcomes will be the proportion of patients establishing outpatient OUD treatment (i.e., filling at least one outpatient buprenorphine prescription within 30 days of their emergency department) and cumulative days with an active buprenorphine prescription six months after their emergency department visit (primary outcome). Drug related fatal overdose will be measured using California death certificate data. Subsequent emergency department visits and hospitalizations will be assessed from electronic health records. Patients' experience with care will be measured using AHRQ's Consumer Assessment of Health Providers and Systems Clinician and Group survey version 4.0, which includes questions specific to telehealth encounters. Finally, this study will examine associations between patients' baseline reports of OUD stigma and subsequent treatment outcomes as well as how arm assignment effects this association. Study findings will fill key evidence gaps and directly inform decisions by clinicians and patients about where patients should be referred for outpatient buprenorphine treatment after they leave the emergency department. Compared to the general population with OUD, patients who seek OUD care in the emergency department have higher overdose risk and are disproportionately low-income, non-white, and unstably housed. Thus, improving buprenorphine retention among patients who start treatment in the emergency department also has potential to reduce socioeconomic disparities in OUD treatment and, ultimately, overdose rates. Findings from our study will be immediately applicable to clinicians and patients in the nearly 300 hospital emergency departments across California that participate in the CA Bridge program as well as to hospitals across the country that have implemented emergency department-based OUD treatment programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study will use a two-stage randomization procedure. Patients will first be randomized 3:1 to either a "random assignment" group, which will then be further randomized 1:1 to one of the two arms, or a "patient choice" group. Patients in the "patient choice" group will be assigned to their preferred arm. If patients in this group have no preference, we will randomize them 1:1 to one of the arms. This approach allows estimation of both treatment effects and effects of patient preference on outcomes.
| Arm | Type | Receives |
|---|---|---|
| in person | Active comparator | Other: referral to in person treatmentParticipants will get treatment via CA Bridge, California's statewide program to provide Emergency Department (ED)-based OUD treatment. When clinicians or staff suspect an ED patient may have OUD, they refer the patient to an ED-based counselor who assesses the patient and engages them in OUD care. All patients with OUD get brief counseling and take-home naloxone. Patients willing to start treatment get buprenorphine (via either ED- or home-based induction), a referral for in-person outpatient OUD treatment at a local outpatient clinic or opioid treatment program, and a "bridge" prescription of buprenorphine to last until their first outpatient appointment. CA Bridge counselors maintain contact with patients for up to 30 days to help them establish outpatient care. This is usual care in study hospitals and in the >80% of California hospitals that participate in CA Bridge. |
| telehealth | Experimental | Other: referral to telehealth treatmentThis arm will comprise the same elements as the "in person" arm except that patients will be referred to get outpatient OUD treatment via telehealth (i.e. phone or video visits). Depending on study site and patient insurance, participants will be referred to get treatment at either a clinic associated with their hospital that offers telehealth OUD treatment or from a digital health company that provides on-demand telehealth OUD treatment and support services via video and phone visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who present to the emergency department and receive buprenorphine (either administered or prescribed) to treat OUD
- do not have an established outpatient clinic where they will get buprenorphine when they leave the emergency department
Key exclusion criteria (3 listed)
- inability to give consent
- patients living in institutions (e.g., nursing homes, prisons)
- unable to complete questionnaires in either English or Spanish
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 |
|---|---|---|
| referral to telehealth treatmentthe intervention tested will be referral to get outpatient treatment via telehealth. Participants in the telehealth arm will receive the intervention. | Other | telehealth |
| referral to in person treatmentparticipants in the in person arm will be referred to in person OUD treatment after they leave the ED | Other | in person |
Primary outcome
buprenorphine retention
Time frame: 6 months
cumulative days with an active buprenorphine prescription
7 secondary outcomes
buprenorphine retention
Time frame: 3 months, 9 months
buprenorphine retention (binary)
Time frame: 3, 6, 9 months
drug overdose death
Time frame: 1, 3, 6, 9 months
past 30-day opioid use
Time frame: 1, 3, 6, 9 months
patient experience with care
Time frame: 1, 3, 6, 9 months
non-fatal overdose
Time frame: 1, 3, 6, 9 months
establishing outpatient treatment
Time frame: 1 month
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 29 Jun 2026.
- Background: PubMed 28194688D'Onofrio G, Chawarski MC, O'Connor PG, Pantalon MV, Busch SH, Owens PH, Hawk K, Bernstein SL, Fiellin DA. Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention. J Gen Intern Med. 2017 Jun;32(6):660-666. doi: 10.1007/s11606-017-3993-2. Epub 2017 Feb 13.
- PCORI (funder) website for this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. sharing is not required by the study funder for this project
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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.
Aimee Moulin, MD MAS principal investigator
University of California, Davis
Stephen G Henry, MD MSc principal investigator
University of California, Davis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing referral to telehealth treatment and referral to in person treatment in people with Opioid Use Disorder, run by University of California, Davis at 3 sites 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 2 inclusion and 3 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Meghan Weyrich, MPH (916-734-7391, masoulsby@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buprenorphine retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961058, which also lists 1 linked publication.
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 29 Jun 2026.