ED Observation for Opioid Use Disorder
Running, not enrolling · Not applicable
Conditions studied: Opioid Use Disorder
In brief
This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU).
Key facts
- Study ID
- NCT05064826
- Run by
- NYU Langone Health
- People needed
- 170
- Starts
- 2022-04-21
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is 18 years of age or older
- Is able to speak English sufficiently to understand study procedures
- Has a history of non-medical opioid use
- Is a potential candidate for ED-based MOUD treatment initiation and referral at the site as confirmed by clinical staff
- s not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
- Is willing to receive either standard ED care or enhanced ED care in EDOU depending on random assignment
- Presents to the ED during study screening hours
You may not qualify if…
- Unwilling or unable to provide written/electronic informed consent/HIPAA Authorization for research procedures, including research visits at baseline and Day 30 and Day 90, and/or consent for the release of health records and data matching for a period of 2 years following enrollment and 1 year prior to enrollment.
- Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
- Presents from a medical-based extended care facility (e.g., skilled nursing facility)
- Previous participation in the current study
- Inadequate locator information (unable or unwilling to provide one unique mean of contact).
- Has acute, severe medical, psychiatric, or concurrent substance use problem or meets other criteria that would exclude the patient (clinically) from placement in EDOU according to EDOU placement clinical protocols.
Where it is running
- Rutgers University-University Hospital — Newark, New Jersey, United States
- NYULH-Brooklyn — Brooklyn, New York, United States
- Northwell Health - Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Bellevue — New York, New York, United States
- NYULH-Tisch — New York, New York, United States
- Northwell Health - Staten Island University Hospital — Staten Island, New York, United States
Full record on ClinicalTrials.gov
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