ED Observation for Opioid Use Disorder

NCT05064826 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-12-31

No results posted yet for this 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).

Conditions

Interventions

OTHER

Observation

Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED. Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry)

Sponsors & Collaborators

Principal Investigators

  • Ryan McCormack, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2025-06-01
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064826 on ClinicalTrials.gov