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ED-LINC for Opioid Use Disorder (ED-LINC2 Trial)
N/A
Recruiting
Led By Lauren K Whiteside, MD, MS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline ed visit and 1, 3, 6 and 12-months after ed visit
Awards & highlights
ED-LINC2 Trial Summary
This trial is testing a new way of delivering healthcare targeting behavioral health or substance abuse that has shown promise in earlier studies. The team is testing whether this new way (ED-LINC) is more effective than usual care in reducing self-reported illicit opioid use, increasing use of medications for opioid abuse disorder, and reducing emergency department utilization.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves healthcare delivery rather than medication, typical drug side effects are not expected. However, participants may experience stress or discomfort related to changes in their care routine.
ED-LINC2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
ED-LINC2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline ed visit and 1, 3, 6 and 12-months after ed visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline ed visit and 1, 3, 6 and 12-months after ed visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Emergency Department visits
Change in Illicit Opioid Use Over Time
Initiation of Medications for OUD
Secondary outcome measures
Engagement in Medications for OUD
Intervention effect by sex
Intervention effect when associated PTSD
+8 moreED-LINC2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ED-LINC InterventionExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Participants assigned to this arm will receive usual care.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,752 Previous Clinical Trials
1,839,997 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,622,556 Total Patients Enrolled
Lauren K Whiteside, MD, MSPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a phone number and another way to contact me.I do not speak English.I am 18 years old or older.I am in the hospital for a mental health crisis needing urgent psychiatric evaluation.I am receiving comfort care for a chronic illness like advanced cancer.I have been taking prescribed opioids regularly for the last 3 months for chronic pain.I have a phone or another way to be contacted.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: ED-LINC Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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