Opioid Use DisorderNCT05064826
ED Observation for Opioid Use Disorder
A study testing Extended Visit with Observation and Standard ED Visit in people with Opioid Use Disorder, run by NYU Langone Health at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Extended Visit with Observation and Standard ED Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Apr 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NYULH-Brooklyn
Brooklyn, New York, 11220
Northwell Health - Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Bellevue
New York, New York, 10016
NYULH-Tisch
New York, New York, 10016
Rutgers University-University Hospital
Newark, New Jersey, 07103
Northwell Health - Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
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).
Read the detailed 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Extended Visit with Observation, Standard ED Visit
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Visit with ObservationOther
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)
Standard ED VisitOther
Standard visit
| Study group | Role | What they receive |
|---|---|---|
| Standard visit | Active comparator | Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours. Receives: Other: Standard ED Visit |
| 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. Receives: Other: Extended Visit with Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 30
Secondary outcomes (18)
Change in number of days of opioid and other drug use
Measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation.
Measured: Baseline, Day 30
Change in number of days of opioid and other drug use
Measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation.
Measured: Day 30, Day 90
Change in proportion of participants who tested positive for illicit opioids/substances
Measured: Baseline, Day 30
Change in proportion of participants who tested positive for illicit opioids/substances
Measured: Day 30, Day 90
Change in number of overdose events and risk behaviors
Measured: Baseline, Day 30
Change in number of overdose events and risk behaviors
Measured: Day 30, Day 90
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status between 0 (dead) and 1 (full health).
Measured: Baseline, Day 30
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status between 0 (dead) and 1 (full health).
Measured: Day 30, Day 90
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.
Measured: Baseline, Day 30
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.
Measured: Day 30, Day 90
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27.
Measured: Baseline, Day 30
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27.
Measured: Day 30, Day 90
Change in score on Treatment Effectiveness Assessment (TEA) Scale
Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment.
Measured: Baseline, Day 30
Change in score on Treatment Effectiveness Assessment (TEA) Scale
Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment.
Measured: Day 30, Day 90
Change in proportion of participants who reported treatment satisfaction
Measured: Baseline, Day 30
Change in proportion of participants who reported treatment satisfaction
Measured: Day 30, Day 90
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Self reported by participants.
Measured: Baseline, Day 30
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Self reported by participants.
Measured: Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start21 Apr 2022
- Primary completion1 Jun 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan McCormack, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064826
- Sponsor's protocol ID
- 20-01951
- Other IDs
- 5R33DA049265-03
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
- ClinicalTrials.gov ID
- NCT05064826
- Acronym / sponsor ID
- 20-01951
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard visit | Active comparator | Other: Standard ED VisitParticipants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours. |
| Extended visit with Observation | Experimental | Other: Extended Visit with ObservationParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Visit with ObservationEmergency 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) | Other | Extended visit with Observation |
| Standard ED VisitStandard visit | Other | Standard visit |
Primary outcome
Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)
Time frame: Week 1 (~7-10 days)
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.
Proportion of participants who receive ED-initiated or ED-expedited BUP
Time frame: Week 1 (~7-10 days)
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.
Proportion of participants who receive ED-initiated or ED-expedited Medications for Opioid Use Disorder (MOUD)
Time frame: Week 1 (~7-10 days)
Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone.
The proportion of participants who are successfully linked to formal addiction treatment within one week following the completion of their index ED/EDOU visit
Time frame: Week 1 (~7-10 days)
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).
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
Time frame: Day 30
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.
18 secondary outcomes
Change in number of days of opioid and other drug use
Time frame: Baseline, Day 30
Change in number of days of opioid and other drug use
Time frame: Day 30, Day 90
Change in proportion of participants who tested positive for illicit opioids/substances
Time frame: Baseline, Day 30
Change in proportion of participants who tested positive for illicit opioids/substances
Time frame: Day 30, Day 90
Change in number of overdose events and risk behaviors
Time frame: Baseline, Day 30
Change in number of overdose events and risk behaviors
Time frame: Day 30, Day 90
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
Time frame: Baseline, Day 30
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
Time frame: Day 30, Day 90
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Time frame: Baseline, Day 30
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Time frame: Day 30, Day 90
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
Time frame: Baseline, Day 30
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
Time frame: Day 30, Day 90
Change in score on Treatment Effectiveness Assessment (TEA) Scale
Time frame: Baseline, Day 30
Change in score on Treatment Effectiveness Assessment (TEA) Scale
Time frame: Day 30, Day 90
Change in proportion of participants who reported treatment satisfaction
Time frame: Baseline, Day 30
Change in proportion of participants who reported treatment satisfaction
Time frame: Day 30, Day 90
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Time frame: Baseline, Day 30
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
Time frame: Day 30, Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan McCormack, MD principal investigator
NYU Langone Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Visit with Observation and Standard ED Visit in people with Opioid Use Disorder, run by NYU Langone Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP) (time frame: Week 1 (~7-10 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.