Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program

Browse trials for

• Opiate Overdose 73

Opiate Overdose

73 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's enrollment of 253 is above the median of 160 across 53 interventional studies indexed under Opiate Overdose.

Lead sponsor

NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.

Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.

Study arms

• No intervention
  Site-Directed Care (SDC)

  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.

• Experimental
  Relay program (peer navigation)

  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.

  Behavioral: RELAY

Interventions

• BehavioralRELAY

  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.

Primary outcomes

1. 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.

   Time frame: Up to Month 12

Secondary outcomes

1. 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.

   Time frame: Up to Month 3

2. 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.

   Time frame: Baseline

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.

   Time frame: Month 1

4. 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.

   Time frame: Month 3

5. 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.

   Time frame: Month 6

6. Time to Next Opioid-Involved Overdose

   Time to next opioid-involved overdose from the time of baseline, by self-report.

   Time frame: Up to Month 6

7. 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.

   Time frame: Up to Month 12

8. 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.

   Time frame: Up to Month 12

9. Number of Opioid Overdose-Related ED Visits

   Frequency of ED visits for opioid overdose will be measured, using administrative data

   Time frame: Up to Month 12

10. 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.

    Time frame: Month 1

11. 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.

    Time frame: Month 3

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.

    Time frame: Month 6

Baseline characteristics

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 41649817 ↗
• Doran 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 documents

• Protocol and statistical analysis plan · Jan 17, 2023
• Informed consent form · Feb 11, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months following article publication and ending 6 years after any reporting, publication, or presentation.

Access criteria: The investigator who proposed to use the data. Upon reasonable request. Upon request, study investigators will provide the research dataset to qualified investigators under a Data Use Agreement (DUA) that will require approval of the study Principal Investigators and each of the primary research team participating agencies (NYU and NYC Department of Health and Mental Hygiene).