500 Participants Needed

ED-LINC for Opioid Use Disorder

(ED-LINC2 Trial)

LA
Overseen ByLayla A Anderson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new healthcare approach called ED-LINC (Emergency Department Longitudinal Integrated Care) to assist individuals with opioid use disorder. The goal is to determine if this method reduces illegal opioid use, encourages adherence to treatment medications, and decreases emergency room visits. Participants will receive either usual care or the ED-LINC intervention, which includes overdose education and ongoing support. Individuals who have struggled with opioid use for some time and can be contacted by phone may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to contribute to innovative care strategies for opioid use disorder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving chronic opioid therapy, you are not eligible to participate.

What prior data suggests that the ED-LINC intervention is safe?

Research has shown that the ED-LINC program, designed to manage opioid use disorder, was tested in a small study. In this trial, researchers randomly assigned 40 patients to either the ED-LINC program or the usual care. The results indicated that patients in the ED-LINC group experienced no more side effects than those in the usual care group. Additionally, the study successfully followed over 80% of participants for up to 6 months. This suggests that ED-LINC is safe and well-tolerated by patients, with no major safety issues reported.12345

Why are researchers excited about this trial?

Researchers are excited about the ED-LINC intervention for opioid use disorder because it offers a comprehensive approach that goes beyond typical treatments like medication-assisted therapies (e.g., methadone, buprenorphine). Unlike standard care, ED-LINC includes personalized overdose education and a brief bedside intervention aimed at boosting motivation to seek outpatient care. It also employs a patient-centered decision support tool for medication-assisted treatment, along with proactive and ongoing care management. This holistic approach is designed to not only address opioid use but also tackle related health issues, potentially leading to more sustained recovery outcomes.

What evidence suggests that the ED-LINC intervention is effective for opioid use disorder?

Research has shown that the ED-LINC program is designed to assist people with opioid addiction, starting in the emergency room. In this trial, participants will receive either the ED-LINC intervention or usual care. An initial study found that patients who received ED-LINC did not use heroin less than those who received regular care. However, the program includes valuable features such as education on preventing overdoses and motivational talks to encourage further treatment. It also provides a plan for ongoing care, which is crucial for those dealing with opioid issues. While early results show limited effects on drug use, the program’s comprehensive support system could enhance treatment involvement and care.12367

Who Is on the Research Team?

LK

Lauren K Whiteside, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate or severe opioid use disorder (OUD) who have a phone and can provide contact information. It's not for those in other care programs, incarcerated individuals, non-English speakers, people living far from Harborview Medical Center, or patients needing urgent psychiatric help.

Inclusion Criteria

I can provide a phone number and another way to contact me.
Moderate or Severe OUD based on the Structured Clinical Interview for DSM Disorders (SCID)
I have a phone or another way to be contacted.

Exclusion Criteria

Require active resuscitation in the ED or other clinical area at the time of Research Assistant (RA) approach
I am in the hospital for a mental health crisis needing urgent psychiatric evaluation.
Enrolled or eligible for state-funded or hospital-funded care coordination program based on high utilization of the ED
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ED-LINC intervention, including overdose education, motivational bedside intervention, and a patient-centered approach to MOUD, with longitudinal care management for approximately 3 months

12 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months
4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • ED-LINC
Trial Overview The study tests 'Emergency Department Longitudinal Integrated Care' (ED-LINC), which aims to improve outcomes for OUD patients. It compares ED-LINC's effectiveness against usual care in reducing illicit opioid use, increasing treatment retention, and decreasing emergency department visits.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ED-LINC InterventionExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

Emergency department-based peer support programs are effective in connecting individuals with opioid use disorder (OUD) to medication and recovery services, showing promise in addressing the opioid crisis.
The integration of peer support varies across programs, affecting how peers are alerted to potential patients and how they engage with them, highlighting the need for consistent reporting on these methods in future evaluations.
Emergency department-based peer support for opioid use disorder: Emergent functions and forms.McGuire, AB., Powell, KG., Treitler, PC., et al.[2021]
Out of 394 emergency department patients with untreated moderate to severe opioid use disorder, only 15.2% were actively seeking a referral to substance use treatment, indicating a significant gap in treatment engagement.
Patients seeking treatment referrals were less likely to test positive for amphetamines and methamphetamines, suggesting that those with fewer concurrent substance use issues may be more inclined to seek help for their opioid use disorder.
Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment.Coupet, E., D'Onofrio, G., Chawarski, M., et al.[2022]
The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.
Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.
Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs.Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

Citations

The Emergency Department Longitudinal Integrated Care ...The research team conducted a pilot pragmatic clinical trial that randomized 40 patients presenting to a single ED to a collaborative care intervention.
Emergency Department Longitudinal Integrated CareED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder. Official Title. A Longitudinal Collaborative Care ...
A pilot randomized clinical trialIn this limited pilot, patients receiving ED-LINC had no difference in past 30-day heroin use compared to usual care. Abstract. Introduction. Opioid use ...
Project Details - NIH RePORTERThe Emergency Department Longitudinal Integrated Care (ED-LINC) Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity from the ED.
The Emergency Department Longitudinal Integrated CareED-LINC will include: 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient- ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34952745/
The Emergency Department Longitudinal Integrated Care (ED ...The pilot study achieved >80% follow-up rates at 1, 3, and 6 months. In adjusted longitudinal mixed model regression analyses, no statistically significant ...
The Emergency Department Longitudinal Integrated Care | ...ED-LINC will include: 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to ...
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