Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05064826
Study type Interventional
Source NYU Langone Health
Contact Ryan McCormack, MD
Phone 212-263-2863
Email Ryan.McCormack@nyulangone.org
Status Recruiting
Phase Early Phase 1
Start date April 21, 2022
Completion date July 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT05304364 - Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160) Phase 1
Completed NCT03831971 - The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers Phase 1