Observation for Opioid Use Disorder in Emergency Departments
Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
This study is testing whether longer observation visits in the emergency department can help people with untreated opioid use disorder get better results compared to standard emergency care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 6 sites (Newark, New Jersey and 5 other locations) |
| Trial ID | NCT05064826 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial aims to compare the effectiveness of standard emergency department (ED) visits versus extended observation visits for patients with untreated opioid use disorder (OUD). Patients presenting to participating EDs will be randomized to receive either standard care or enhanced care through ED observation. The study will utilize clinical protocols for managing OUD with medications for opioid use disorder (MOUD) and will assess patient outcomes at the index visit, as well as at 30 and 90 days post-visit. Additionally, patient data will be matched with Medicaid claims for comprehensive analysis and quality measure development.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of non-medical opioid use who are not currently receiving formal addiction treatment.
Not a fit: Patients currently incarcerated or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the management and outcomes for patients with opioid use disorder in emergency settings.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing opioid use disorder in emergency settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Exclusion Criteria: * 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 this trial is running
Newark, New Jersey and 5 other locations
- Rutgers University-University Hospital — Newark, New Jersey, United States (Recruiting)
- NYULH-Brooklyn — Brooklyn, New York, United States (Not_yet_recruiting)
- Northwell Health - Long Island Jewish Medical Center — New Hyde Park, New York, United States (Recruiting)
- Bellevue — New York, New York, United States (Recruiting)
- NYULH-Tisch — New York, New York, United States (Not_yet_recruiting)
- Northwell Health - Staten Island University Hospital — Staten Island, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ryan McCormack, MD — NYU Langone Health
- Study coordinator: Ryan McCormack, MD
- Email: Ryan.McCormack@nyulangone.org
- Phone: 212-263-2863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.