Opioid Use DisorderED-LINC2NCT05327166
The Emergency Department Longitudinal Integrated Care
A study testing ED-LINC in people with Opioid Use Disorder, run by University of Washington at 1 site in United States.
Trial summary
Collaborative care is a comprehensive patient-centered model of healthcare delivery targeting behavioral health or substance use that stems from the chronic disease management framework. 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?
- ED-LINC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2022to 31 Dec 2026
- 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
- Aged 18 years or older
- Moderate or Severe OUD based on the Structured Clinical Interview for DSM Disorders (SCID)
- Currently have a phone or method of contact
- Able to provide a phone number and one additional piece of contact information
Who cannot join
- Incarcerated or under arrest
- Non-English speaking
- Live beyond a 50 mile radius of Harborview Medical Center
- Require active resuscitation in the ED or other clinical area at the time of Research Assistant (RA) approach
- Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
- Are in the ED or hospital for a primary psychiatric emergency such as suicidal ideation or attempt and require emergent evaluation by a Psychiatrist
Show all 9Show fewer
- Receiving chronic opioid therapy (COT) defined as prescription opioids for most days out of the last 90 days for a chronic pain condition
- In the ED for sexual assault
- Enrolled or eligible for state-funded or hospital-funded care coordination program based on high utilization of the ED
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: The Emergency Department Longitudinal Integrated Care Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity From the ED
Collaborative care is a comprehensive patient-centered model of healthcare delivery targeting behavioral health or substance use that stems from the chronic disease management framework. The intervention being tested ('Emergency Department Longitudinal Integrated Care' or ED LINC) derives from the collaborative care model and has demonstrated feasibility in previous studies.
This study expands on the model to test the effectiveness of the ED-LINC intervention when compared with usual care. The study team primarily hypothesizes that patients randomized to the ED-LINC intervention, when compared to patients randomized to usual care, will demonstrate: 1) significant reductions in self-report illicit opioid use, 2) significant increases in initiation and retention of medications for opioid use disorder, and 3) significant reductions in ED utilization.
Read the detailed description
This is a randomized clinical trial designed to test the effectiveness of the multi-component ED-LINC intervention. Patients with moderate or severe OUD seeking medical care at 2 EDs in Seattle, Washington, who provide informed consent will be randomized to the ED-LINC intervention (n=250) or usual care control (n=250) conditions.
ED-LINC will include: 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to medications for opioid use disorder (MOUD) using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for approximately 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. This intervention will use the Emergency Department Information Exchange (EDIE) to re-engage patients with subsequent ED visits.
This study team developed the 'Emergency Department Longitudinal Integrated Care 2.0' intervention or 'ED-LINC' for patients with OUD to be initiated from the ED. In prior work, ED-LINC was feasible and retention in the study was high in both an intervention arm and a usual care control arm. Additionally, participants randomized to the ED-LINC arm were satisfied and acceptability of the intervention was high. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care and will acknowledge the longitudinal care required for opioid use disorder and related substance abuse, mental health and medical comorbidity.
- Conditions
- Opioid Use Disorder
- Being tested
- ED-LINC
- Keywords
- collaborative care, opioid use disorder (OUD), substance use disorder
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-LINCOther
Also called Collaborative Care
The ED-LINC intervention provides 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants assigned to this arm will receive usual care. |
| ED-LINC Intervention | Experimental | Patients assigned to the ED-LINC intervention will receive 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. Receives: Other: ED-LINC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Illicit Opioid Use Over Time
To compare self-reported past-30 day illicit opioid use using the validated self-report measure of timeline followback (TLFB) in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit.
Measured: Baseline ED visit and 1, 3, 6 and 12-months after ED visit
Initiation of Medications for OUD
To compare the frequency of initiation of medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.
Measured: 12 months
Change in Emergency Department visits
To compare changes over time in Emergency Department visits in subjects receiving usual care or ED-LINC intervention; Emergency Department visits will be measured by the Emergency Department Information Exchange (an automated health information exchange) that caputures population-level Emergency Department utilization for all enrolled participants.
Measured: Index Emergency Department visit to 12-months followup
Secondary outcomes (11)
Intervention effect when associated with Methamphetamine use
Explore the impact of methamphetamine use, as measured by the timeline follow-back (TLFB) which is a validated patient self-report measure of days of methamphetamine use over a 30 day-period, on intervention treatment effects.
Measured: Index Emergency Department visit to 12-months followup
Time to Initiation of MOUD
To compare time to initiation of medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit.
Measured: 12 months
Engagement in Medications for OUD
To compare the frequency of engagement in medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC over the course of the year after the index Emergency Department visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.
Measured: 12 months
Retention in Medications for OUD
To compare the frequency of retention in medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.
Measured: 12 months
Intervention effect when associated depression
Explore the impact of depression in the past 30-days as measured by self-report PHQ-9 at baseline on intervention treatment effects.
Measured: Index Emergency Department visit to 12-months followup
Intervention effect when associated anxiety
Explore the impact of anxiety in the past 30-days as measured by self-report GAD-7 at baseline on intervention treatment effects.
Measured: Index Emergency Department visit to 12-months followup
Intervention effect when associated PTSD
Explore the impact of PTSD in the past 30-days as measured by self-report PCL-C at baseline on intervention treatment effects.baseline on intervention treatment effects.
Measured: Index Emergency Department visit to 12-months followup
Intervention effect when associated current pain
Explore the impact of pain in the past week as measured by the self-report 3-item PEG at baseline on intervention treatment effects.
Measured: Index Emergency Department visit to 12-months followup
Intervention effect when patient has exposure to MOUD in prior 12 months
Explore the impact of any past 12-month MOUD exposure prior to enrollment where MOUD includes buprenorphine, methadone and/or naltexone assessed from review of medical records, using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD obtained at baseline on the intervention treatment effect.
Measured: Index Emergency Department visit to 12-months followup
Intervention effect by sex
Explore the impact of patient sex as measured by patient self-report at baseline on intervention treatment effects
Measured: Index Emergency Department visit to 12-months followup
Intervention effect when patient reports using illicit fentanyl at baseline
Explore the impact of fentanyl use as measured by any patient self-report fentanyl use in the past 30-days at baseline on the intervention treatment effect
Measured: Index Emergency Department visit to 12-months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start12 Apr 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (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 WashingtonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either usual care (n=250) or ED-LINC intervention (n=250). Patients assigned to the ED-LINC intervention will receive 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lauren Whiteside, University of Washington
- Investigators
- Lauren K Whiteside, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327166
- Sponsor's protocol ID
- STUDY00012599
- Other IDs
- R01DA051462
- Acronym
- ED-LINC2
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emergency Department Longitudinal Integrated Care Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity From the ED
- ClinicalTrials.gov ID
- NCT05327166
- Acronym / sponsor ID
- ED-LINC2 / STUDY00012599
- Conditions
- Opioid Use Disorder
- Keywords
- collaborative care, opioid use disorder (OUD), substance use disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Apr 2022 (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.
Collaborative care is a comprehensive patient-centered model of healthcare delivery targeting behavioral health or substance use that stems from the chronic disease management framework. The intervention being tested ('Emergency Department Longitudinal Integrated Care' or ED LINC) derives from the collaborative care model and has demonstrated feasibility in previous studies.
This study expands on the model to test the effectiveness of the ED-LINC intervention when compared with usual care. The study team primarily hypothesizes that patients randomized to the ED-LINC intervention, when compared to patients randomized to usual care, will demonstrate: 1) significant reductions in self-report illicit opioid use, 2) significant increases in initiation and retention of medications for opioid use disorder, and 3) significant reductions in ED utilization.
Detailed description
This is a randomized clinical trial designed to test the effectiveness of the multi-component ED-LINC intervention. Patients with moderate or severe OUD seeking medical care at 2 EDs in Seattle, Washington, who provide informed consent will be randomized to the ED-LINC intervention (n=250) or usual care control (n=250) conditions.
ED-LINC will include: 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to medications for opioid use disorder (MOUD) using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for approximately 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. This intervention will use the Emergency Department Information Exchange (EDIE) to re-engage patients with subsequent ED visits.
This study team developed the 'Emergency Department Longitudinal Integrated Care 2.0' intervention or 'ED-LINC' for patients with OUD to be initiated from the ED. In prior work, ED-LINC was feasible and retention in the study was high in both an intervention arm and a usual care control arm. Additionally, participants randomized to the ED-LINC arm were satisfied and acceptability of the intervention was high. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care and will acknowledge the longitudinal care required for opioid use disorder and related substance abuse, mental health and medical comorbidity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either usual care (n=250) or ED-LINC intervention (n=250). Patients assigned to the ED-LINC intervention will receive 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants assigned to this arm will receive usual care. |
| ED-LINC Intervention | Experimental | Other: ED-LINCPatients assigned to the ED-LINC intervention will receive 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Moderate or Severe OUD based on the Structured Clinical Interview for DSM Disorders (SCID)
- Currently have a phone or method of contact
- Able to provide a phone number and one additional piece of contact information
Key exclusion criteria (9 listed)
- Incarcerated or under arrest
- Non-English speaking
- Live beyond a 50 mile radius of Harborview Medical Center
- Require active resuscitation in the ED or other clinical area at the time of Research Assistant (RA) approach
- Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
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 |
|---|---|---|
| ED-LINCAlso: Collaborative CareThe ED-LINC intervention provides 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. | Other | ED-LINC Intervention |
Primary outcome
Change in Illicit Opioid Use Over Time
Time frame: Baseline ED visit and 1, 3, 6 and 12-months after ED visit
To compare self-reported past-30 day illicit opioid use using the validated self-report measure of timeline followback (TLFB) in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit.
Initiation of Medications for OUD
Time frame: 12 months
To compare the frequency of initiation of medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.
Change in Emergency Department visits
Time frame: Index Emergency Department visit to 12-months followup
To compare changes over time in Emergency Department visits in subjects receiving usual care or ED-LINC intervention; Emergency Department visits will be measured by the Emergency Department Information Exchange (an automated health information exchange) that caputures population-level Emergency Department utilization for all enrolled participants.
11 secondary outcomes
Intervention effect when associated with Methamphetamine use
Time frame: Index Emergency Department visit to 12-months followup
Time to Initiation of MOUD
Time frame: 12 months
Engagement in Medications for OUD
Time frame: 12 months
Retention in Medications for OUD
Time frame: 12 months
Intervention effect when associated depression
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect when associated anxiety
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect when associated PTSD
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect when associated current pain
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect when patient has exposure to MOUD in prior 12 months
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect by sex
Time frame: Index Emergency Department visit to 12-months followup
Intervention effect when patient reports using illicit fentanyl at baseline
Time frame: Index Emergency Department visit to 12-months followup
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 10 Dec 2025.
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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. This study is not recruiting at the moment.
Lauren K Whiteside, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-LINC in people with Opioid Use Disorder, run by University of Washington 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Illicit Opioid Use Over Time (time frame: Baseline ED visit and 1, 3, 6 and 12-months after ED visit). The study lists 3 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 10 Dec 2025.