ED Observation for Opioid Use Disorder

NCT05064826 | Active Not Recruiting

• 2 other identifiers: 20-0195119-A0-00-1002485
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief 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

Opioid Use Disorder

Outcome Measures

Primary Outcomes (5)

• Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)

  Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/Emergency Department Observation (Units) (EDOU) visit. This measure will be abstracted from the health record primarily.

  Week 1 (~7-10 days)

• Proportion of participants who receive ED-initiated or ED-expedited BUP

  Receipt of ED-initiated/expedited BUP will be operationally defined to include the provision of a specific "warm" referral or transfer of care to a provider, clinic, or treatment setting with the capacity to administer and/or prescribe BUP within 24 hours of completion of the ED/EDOU visit. Eligible transition of care will be will described further in the Manual of Operations (MOP) and will include direct transport or handoff to an outpatient provider immediately from the ED, provision of an appointment within 24 hours (with a specific time and location), transfer to general inpatient or inpatient OUD/addiction treatment. Neither confirmation of a completed appointment (i.e., patient shows up and is seen) nor receipt of BUP at the dedicated follow-up appointment will be required as the patient and treating provider may elect to treat with alternative regimes (e.g., methadone, naltrexone). This measure will be abstracted from the health record primarily.

  Week 1 (~7-10 days)

• Proportion of participants who receive ED-initiated or ED-expedited Medications for Opioid Use Disorder (MOUD)

  Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone.

  Week 1 (~7-10 days)

• The proportion of participants who are successfully linked to formal addiction treatment within one week following the completion of their index ED/EDOU visit

  Successful linkage to formal addiction treatment will be defined as confirmed attendance at formal addiction treatment for OUD following completion of the ED/EDOU visit. Formal addiction treatment will be those treatments consistent with the American Society of Addiction Medicine's (ASAM) level of care (1-4) and will include a range of clinical settings, including office-based providers of BUP or naltrexone, Opioid Treatment Programs (OTPs), intensive outpatient, inpatient, or residential treatments. Means of confirmation will include direct contact with the facility and/or treating clinician or other objective means (e.g., medical record review).

  Week 1 (~7-10 days)

• The proportion of participants who are confirmed to be engaged in formal addiction treatment for OUD on the 30th day following the completion of their index ED/EDOU visit

  Engagement in treatment for OUD will be defined as confirmed enrollment in formal addiction treatment for OUD on the 30th day following completion of the ED/EDOU visit. Attendance at two or more visits for formal addiction treatment within the 30-day period also constitutes engagement.

  Day 30

Secondary Outcomes (18)

• Change in number of days of opioid and other drug use

  Baseline, Day 30

• Change in number of days of opioid and other drug use

  Day 30, Day 90

• Change in proportion of participants who tested positive for illicit opioids/substances

  Baseline, Day 30

• Change in proportion of participants who tested positive for illicit opioids/substances

  Day 30, Day 90

• Change in number of overdose events and risk behaviors

  Baseline, Day 30

Study Arms (2)

Standard visit

NO INTERVENTION

Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.

Extended visit with Observation

EXPERIMENTAL

Participants will have extended Emergency Department visit by having an observation (which could be up to 23 hours) time in addition to the standard ED visit. In addition, information will be gathered about about the participants, use of opioids, healthcare visits, the quality of health, life, and treatment, and other topics. Urine or saliva or both may also be collected.

Other: Observation

Interventions

Observation OTHER

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)

Extended visit with Observation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (6)

Rutgers University-University Hospital

Newark, New Jersey, 07103, United States

Location

NYULH-Brooklyn

Brooklyn, New York, 11220, United States

Location

Northwell Health - Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Bellevue

New York, New York, 10016, United States

Location

NYULH-Tisch

New York, New York, 10016, United States

Location

Northwell Health - Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Ryan McCormack, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 1, 2021
• Study Start: April 21, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to ryan.mccormack@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (6)