ED Observation for Opioid Use Disorder

Last updated: March 26, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Observation

Clinical Study ID

NCT05064826
20-01951
19-A0-00-1002485
  • Ages 18-100
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 thesite as confirmed by clinical staff

  • s not receiving MOUD through ongoing formal addiction treatment or pain managementat the time of index ED visit

  • Is willing to receive either standard ED care or enhanced ED care in EDOU dependingon random assignment

  • Presents to the ED during study screening hours

Exclusion

Exclusion Criteria:

  • Unwilling or unable to provide written/electronic informed consent/HIPAAAuthorization 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 matchingfor 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 courtof 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 nursingfacility)

  • Previous participation in the current study

  • Inadequate locator information (unable or unwilling to provide one unique mean ofcontact).

  • Has acute, severe medical, psychiatric, or concurrent substance use problem or meetsother criteria that would exclude the patient (clinically) from placement in EDOUaccording to EDOU placement clinical protocols.

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: Observation
Phase:
Study Start date:
April 21, 2022
Estimated Completion Date:
July 31, 2026

Study Description

In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures.

Connect with a study center

  • Rutgers University-University Hospital

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • NYULH-Brooklyn

    Brooklyn, New York 11220
    United States

    Site Not Available

  • Northwell Health - Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Bellevue

    New York, New York 10016
    United States

    Active - Recruiting

  • NYULH-Tisch

    New York, New York 10016
    United States

    Site Not Available

  • Northwell Health - Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.