Opioid OverdoseNCT04317053
Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
A study testing RELAY in people with Opioid Overdose, run by NYU Langone Health at 1 site in United States.
Trial summary
The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- RELAY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years)
- English- or Spanish-speaking
- Patient at a participating ED with nonfatal opioid OD.
- Currently residing in NYC
Who cannot join
- Unable to provide informed consent
- Currently incarcerated, currently living in another controlled environment prohibiting research contacts, or currently in police custody
- Known to be currently pregnant
- Already participating in the study (patients will only be enrolled into the study once)
- Already actively engaged in the Relay program (within the 90-day program window)
- Speaks only Spanish, at a site and time period when no Spanish-speaking RA is available
Trial locations and contacts
1 site in 1 country.
About this study
The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The proposed randomized controlled trial will evaluate the impact of Relay on preventing subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal opioid OD presenting to one of four participating EDs will be enrolled and randomized to one of two arms: 1) site-directed care (SDC) or 2) Relay-peer-delivered OD education and treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12 months through interviews and administrative health data.
Read the detailed description
Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
- Conditions
- Opioid Overdose
- Being tested
- RELAY
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAYBehavioural
Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
| Study group | Role | What they receive |
|---|---|---|
| Site-Directed Care (SDC) | No intervention | Site-specific existing interventions delivered to patients with OUD as part of ED care. At a minimum SDC arm patients will receive from the study research team OD education and naloxone distribution (OEND), a list of opioid treatment programs, and an informational flyer about Relay. |
| Relay program (peer navigation) | Experimental | Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education. Receives: Behavioral: RELAY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Opioid-related Adverse Events
Opioid-related adverse events includes fatal and non-fatal opioid-involved overdose as well as substance use-related emergency department (ED) visits. ED visits and fatal overdoses in the 12-month period after baseline will be captured in administrative data sources. Other non-fatal opioid-involved overdose events will be captured by self-report in follow-up interviews through six months after baseline, and estimated for the second half of the 12-month follow-up period.
Measured: Up to Month 12
Secondary outcomes (12)
Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)
MOUD is defined as use of methadone, buprenorphine, or naltrexone that is prescribed by an office-based provider or provided by a treatment program as treatment for OUD. Initiation is defined as receiving MOUD within the 90 days following the index visit, for individuals who received no MOUD for at least 2 weeks prior to the index visit.
Measured: Up to Month 3
Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate more prevalent overdose risk behaviors.
Measured: Baseline
Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate more prevalent overdose risk behaviors.
Measured: Month 1
Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate more prevalent overdose risk behaviors.
Measured: Month 3
Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate more prevalent overdose risk behaviors.
Measured: Month 6
Time to Next Opioid-Involved Overdose
Time to next opioid-involved overdose from the time of baseline, by self-report.
Measured: Up to Month 6
Number of Emergency Deparment (ED) Visits for Any Cause
Frequency of ED visits for any cause (including visits that are not substance use-related) will be measured, using administrative data, to assess whether there are differences in overall acute care use representing potentially negative health events.
Measured: Up to Month 12
Number of ED Visits for Other (Non-OD) Substance Use Reasons
Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.
Measured: Up to Month 12
Number of Opioid Overdose-Related ED Visits
Frequency of ED visits for opioid overdose will be measured, using administrative data
Measured: Up to Month 12
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Includes non-fatal overdose that did or did not result in an ED visit, by self report.
Measured: Month 1
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Includes non-fatal overdose that did or did not result in an ED visit, by self report.
Measured: Month 3
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Includes non-fatal overdose that did or did not result in an ED visit, by self report.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start8 Oct 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kelly Doran, MD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317053
- Sponsor's protocol ID
- 19-01547
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2020
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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).
Publications
Doran KM, Welch AE, Kepler KL, Jeffers A, Chambless D, Cowan E, Wittman I, Regina A, Siu K, Bailey VS, Rostam-Abadi Y, Kennedy J, Kunins HV, Gwadz M, Shelley D, Cleland CM, McNeely J. Peer Navigator Intervention and Opioid-Related Adverse Events for Emergency Department Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2555903. doi: 10.1001/jamanetworkopen.2025.55903.
PubMed 41649817Doran KM, Welch AE, Jeffers A, Kepler KL, Chambless D, Cowan E, Wittman I, Regina A, Chang TE, Parraga S, Tapia J, Diaz C, Gwadz M, Cleland CM, McNeely J. Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose. Contemp Clin Trials. 2023 Mar;126:107111. doi: 10.1016/j.cct.2023.107111. Epub 2023 Feb 4.
PubMed 36746325
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
- ClinicalTrials.gov ID
- NCT04317053
- Acronym / sponsor ID
- 19-01547
- Conditions
- Opioid Overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The proposed randomized controlled trial will evaluate the impact of Relay on preventing subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal opioid OD presenting to one of four participating EDs will be enrolled and randomized to one of two arms: 1) site-directed care (SDC) or 2) Relay-peer-delivered OD education and treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12 months through interviews and administrative health data.
Detailed description
Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Site-Directed Care (SDC) | No intervention | –Site-specific existing interventions delivered to patients with OUD as part of ED care. At a minimum SDC arm patients will receive from the study research team OD education and naloxone distribution (OEND), a list of opioid treatment programs, and an informational flyer about Relay. |
| Relay program (peer navigation) | Experimental | Behavioral: RELAYRelay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years)
- English- or Spanish-speaking
- Patient at a participating ED with nonfatal opioid OD.
- Currently residing in NYC
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Currently incarcerated, currently living in another controlled environment prohibiting research contacts, or currently in police custody
- Known to be currently pregnant
- Already participating in the study (patients will only be enrolled into the study once)
- Already actively engaged in the Relay program (within the 90-day program window)
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 |
|---|---|---|
| RELAYRelay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education. | Behavioural | Relay program (peer navigation) |
Primary outcome
Number of Opioid-related Adverse Events
Time frame: Up to Month 12
Opioid-related adverse events includes fatal and non-fatal opioid-involved overdose as well as substance use-related emergency department (ED) visits. ED visits and fatal overdoses in the 12-month period after baseline will be captured in administrative data sources. Other non-fatal opioid-involved overdose events will be captured by self-report in follow-up interviews through six months after baseline, and estimated for the second half of the 12-month follow-up period.
12 secondary outcomes
Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)
Time frame: Up to Month 3
Overdose Risk Behavior Questionnaire Score
Time frame: Baseline
Overdose Risk Behavior Questionnaire Score
Time frame: Month 1
Overdose Risk Behavior Questionnaire Score
Time frame: Month 3
Overdose Risk Behavior Questionnaire Score
Time frame: Month 6
Time to Next Opioid-Involved Overdose
Time frame: Up to Month 6
Number of Emergency Deparment (ED) Visits for Any Cause
Time frame: Up to Month 12
Number of ED Visits for Other (Non-OD) Substance Use Reasons
Time frame: Up to Month 12
Number of Opioid Overdose-Related ED Visits
Time frame: Up to Month 12
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Time frame: Month 1
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Time frame: Month 3
Percentage of Participants Who Self-Report Opioid-Involved Overdose
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41649817Doran KM, Welch AE, Kepler KL, Jeffers A, Chambless D, Cowan E, Wittman I, Regina A, Siu K, Bailey VS, Rostam-Abadi Y, Kennedy J, Kunins HV, Gwadz M, Shelley D, Cleland CM, McNeely J. Peer Navigator Intervention and Opioid-Related Adverse Events for Emergency Department Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2555903. doi: 10.1001/jamanetworkopen.2025.55903.
- Derived from this study: PubMed 36746325Doran KM, Welch AE, Jeffers A, Kepler KL, Chambless D, Cowan E, Wittman I, Regina A, Chang TE, Parraga S, Tapia J, Diaz C, Gwadz M, Cleland CM, McNeely J. Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose. Contemp Clin Trials. 2023 Mar;126:107111. doi: 10.1016/j.cct.2023.107111. Epub 2023 Feb 4.
- 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.
Kelly Doran, MD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAY in people with Opioid Overdose, run by NYU Langone Health at 1 site 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 4 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Opioid-related Adverse Events (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317053, which also lists 2 linked publications.
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 25 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.