Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder (ADAPT-ED)

February 17, 2026 updated by: Katherine Watkins, RAND
The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable OUD. The trial includes (1) two first stage components: the CA Bridge Model with Substance Use Navigator assisted treatment initiation and linkage to care (SUN) or CA Bridge plus immediate telehealth connection to an outpatient provider (SUN+TeleBridge); (2) a dynamic tailoring variable describing (non) response to the first stage: whether the patient has not filled an outpatient buprenorphine prescription at 30 days or whether the patient returns to the ED with an OUD-related event or self-reports non-adherence to buprenorphine within the first 90 days; (3) two second-stage components for non-responders; either ongoing buprenorphine treatment by an ED-based interim treatment team (ED-ITT) or ED-ITT augmented with behavioral health support (ED-ITT+BHS). First-stage responders will receive no further active intervention unless the participant returns to the ED or notifies the SUN about no longer taking buprenorphine within 90 days of study enrollment.

Hypothesis 1: The investigators hypothesize that the most intensive Adaptive Treatment Strategy (ATS) will lead to (a) more days of buprenorphine use and (b) a longer time to overdose, self-harm, or death compared to the least intensive ATS.

Hypothesis 2: The investigators hypothesize that (a) SUN+TeleBridge in the first stage of the ATS and (b) ED-ITT+BHS in the second stage of the ATS will each lead to more days of buprenorphine use and a longer time to overdose, self-harm, or death within the first 12 months compared to SUN and ED-ITT, respectively, and (c) there is a synergistic positive effect of receiving both SUN+TeleBridge and ED-ITT+BHS on days of buprenorphine use.

Hypothesis 3: The investigators hypothesize that the effect of SUN+TeleBridge versus SUN and the effect of ED-ITT+BHS versus ED-ITT among first stage non-responders will be larger among those with (a) a history of overdose at baseline and (b) co-occurring depression or PTSD at baseline relative to those who do not have either or those conditions.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mariah Kalmin, PhD
  • Phone Number: 6160 310-393-0411
  • Email: mariahk@rand.org

Study Contact Backup

  • Name: P'trice Jones, MS
  • Phone Number: 8416 310-393-0411
  • Email: ptricej@rand.org

Study Locations

  • United States
    • California
      • Colton, California, United States, 92324
        • Recruiting
        • Arrowhead Regional Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presented for ED care at ARMC
  • Age 18 or older
  • Probable OUD diagnosis
  • Speak and understand English or Spanish
  • Have capacity to give informed consent
  • Provide a signed and dated informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SUN with no follow up
In Arm A, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be responders by 90 days and therefore receive no active follow up.
Behavioral: SUN
The SUN helps patients initiate buprenorphine treatment in the hospital, connects patients to follow-up care by facilitating appointments at outpatient clinics, addresses barriers to care, and serves as a resource for patients and clinicians. The SUN also advocates for a harm-reduction culture, models respectful interactions with people who use drugs and provides technical assistance to hospital staff to reduce stigma and discrimination.
Active Comparator: SUN + Telebridge with no follow up
In Arm D, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be responders by 90 days and therefore receive no active follow up.
Behavioral: SUN + Telebridge
TeleBridge consists of an immediate telehealth connection to a buprenorphine provider affiliated with the CA Bridge program who has expertise facilitating pharmacotherapy with individuals with OUD. TeleBridge addresses barriers to initiation of buprenorphine by reducing long wait times and the inability of the outpatient setting to initiate treatment on demand. TeleBridge also eliminates the need for patients to meet system-level requirements (e.g. on time for appointments during working hours while wearing appropriate attire) to obtain follow-up care. TeleBridge is a more resource-intensive form of care because it involves developing formalized relationships with outpatient providers and implementing telehealth protocols. TeleBridge is feasible based on the increased use of telehealth to expand post-ED care pathways.
Active Comparator: SUN followed by ED-ITT
In Arm B, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.
Behavioral: SUN
The SUN helps patients initiate buprenorphine treatment in the hospital, connects patients to follow-up care by facilitating appointments at outpatient clinics, addresses barriers to care, and serves as a resource for patients and clinicians. The SUN also advocates for a harm-reduction culture, models respectful interactions with people who use drugs and provides technical assistance to hospital staff to reduce stigma and discrimination.
Behavioral: ED-ITT
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report nonadherence to the prescribed BUP are considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment by an ED-based interim treatment team (ED-ITT), the SUN and Site PI (an ED physician with expertise in addiction medicine) will meet weekly to review the SUN's caseload, using a patient registry that has been modified for the trial. The registry: 1) prompts/documents proactive SUN outreach up to 3 additional months for non-responders, with an emphasis on prioritizing subsequent outreach to patients who have not yet engaged with outpatient care, or who are at risk of dropping out if the patient have transitioned; and 2) documents when the ED provider prescribes transitional BUP and when the patient would be due for a new prescription.
Active Comparator: SUN followed by ED-ITT + BHS
In Arm C, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
Behavioral: SUN
The SUN helps patients initiate buprenorphine treatment in the hospital, connects patients to follow-up care by facilitating appointments at outpatient clinics, addresses barriers to care, and serves as a resource for patients and clinicians. The SUN also advocates for a harm-reduction culture, models respectful interactions with people who use drugs and provides technical assistance to hospital staff to reduce stigma and discrimination.
Behavioral: ED-ITT + BHS
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report to the SUN nonadherence to the prescribed BUP will be considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment from the ED-ITT+BHS, Behavioral Health Support (BHS) will be added to ED-ITT and include a weekly caseload review with an externally-affiliated psychiatrist with expertise in addiction medicine who will make mental health and substance use treatment recommendations, both pharmacological and behavioral, to the ED provider and SUN for up to 3 months. The consultant may also ask the SUN to do a more detailed behavioral health assessment, if insufficient information is available to make treatment recommendations. All prescriptions will be written by the ED provider.
Active Comparator: SUN + Telebridge followed by ED-ITT
In Arm E, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.
Behavioral: SUN + Telebridge
TeleBridge consists of an immediate telehealth connection to a buprenorphine provider affiliated with the CA Bridge program who has expertise facilitating pharmacotherapy with individuals with OUD. TeleBridge addresses barriers to initiation of buprenorphine by reducing long wait times and the inability of the outpatient setting to initiate treatment on demand. TeleBridge also eliminates the need for patients to meet system-level requirements (e.g. on time for appointments during working hours while wearing appropriate attire) to obtain follow-up care. TeleBridge is a more resource-intensive form of care because it involves developing formalized relationships with outpatient providers and implementing telehealth protocols. TeleBridge is feasible based on the increased use of telehealth to expand post-ED care pathways.
Behavioral: ED-ITT
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report nonadherence to the prescribed BUP are considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment by an ED-based interim treatment team (ED-ITT), the SUN and Site PI (an ED physician with expertise in addiction medicine) will meet weekly to review the SUN's caseload, using a patient registry that has been modified for the trial. The registry: 1) prompts/documents proactive SUN outreach up to 3 additional months for non-responders, with an emphasis on prioritizing subsequent outreach to patients who have not yet engaged with outpatient care, or who are at risk of dropping out if the patient have transitioned; and 2) documents when the ED provider prescribes transitional BUP and when the patient would be due for a new prescription.
Active Comparator: SUN + Telebridge followed by ED-ITT + BHS
In Arm F, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
Behavioral: SUN + Telebridge
TeleBridge consists of an immediate telehealth connection to a buprenorphine provider affiliated with the CA Bridge program who has expertise facilitating pharmacotherapy with individuals with OUD. TeleBridge addresses barriers to initiation of buprenorphine by reducing long wait times and the inability of the outpatient setting to initiate treatment on demand. TeleBridge also eliminates the need for patients to meet system-level requirements (e.g. on time for appointments during working hours while wearing appropriate attire) to obtain follow-up care. TeleBridge is a more resource-intensive form of care because it involves developing formalized relationships with outpatient providers and implementing telehealth protocols. TeleBridge is feasible based on the increased use of telehealth to expand post-ED care pathways.
Behavioral: ED-ITT + BHS
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report to the SUN nonadherence to the prescribed BUP will be considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment from the ED-ITT+BHS, Behavioral Health Support (BHS) will be added to ED-ITT and include a weekly caseload review with an externally-affiliated psychiatrist with expertise in addiction medicine who will make mental health and substance use treatment recommendations, both pharmacological and behavioral, to the ED provider and SUN for up to 3 months. The consultant may also ask the SUN to do a more detailed behavioral health assessment, if insufficient information is available to make treatment recommendations. All prescriptions will be written by the ED provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of days a buprenorphine prescription was filled in the 6 months after enrollment
Time Frame: 6 months from date of enrollment
6 months from date of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to a composite measure of overdose, suicide, self-harm and death
Time Frame: 6 months from date of enrollment
6 months from date of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

Stanford University
Alameda Health System
Arrowhead Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-N0631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All participant data will be destroyed in accordance with RAND Survey Research Group institutional policies (RAND SRG follows Federal guidelines, currently 7 years following study completion).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Use Disorder

Clinical Trials on SUN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe