Adults 18 to 99, any sex, with Opioid Overdose. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Opioid-related Adverse EventsPrimary· 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.
Group
Value
95% CI
Site-Directed Care (SDC)
4.15
± 9.58
Relay Program (Peer Navigation)
3.24
± 4.76
Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)Secondary· Up to Month 3
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.
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.
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.
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.
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.
Group
Value
95% CI
Site-Directed Care (SDC)
3.77
± 6.14
Relay Program (Peer Navigation)
6.46
± 8.13
Time to Next Opioid-Involved OverdoseSecondary· Up to Month 6
Time to next opioid-involved overdose from the time of baseline, by self-report.
Group
Value
95% CI
Site-Directed Care (SDC)
68.0
± 49.3
Relay Program (Peer Navigation)
57.8
± 51.4
Number of Emergency Deparment (ED) Visits for Any CauseSecondary· Up to Month 12
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.
Group
Value
95% CI
Site-Directed Care (SDC)
6.73
± 12.9
Relay Program (Peer Navigation)
6.28
± 8.85
Number of ED Visits for Other (Non-OD) Substance Use ReasonsSecondary· Up to Month 12
Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.
Group
Value
95% CI
Site-Directed Care (SDC)
2.98
± 8.62
Relay Program (Peer Navigation)
2.26
± 4.03
Number of Opioid Overdose-Related ED VisitsSecondary· Up to Month 12
Frequency of ED visits for opioid overdose will be measured, using administrative data
Group
Value
95% CI
Site-Directed Care (SDC)
0.402
± 1.28
Relay Program (Peer Navigation)
0.376
± 0.964
Percentage of Participants Who Self-Report Opioid-Involved OverdoseSecondary· Month 1
Includes non-fatal overdose that did or did not result in an ED visit, by self report.
Group
Value
95% CI
Site-Directed Care (SDC)
11.3
Relay Program (Peer Navigation)
16.7
Percentage of Participants Who Self-Report Opioid-Involved OverdoseSecondary· Month 3
Includes non-fatal overdose that did or did not result in an ED visit, by self report.
Group
Value
95% CI
Site-Directed Care (SDC)
24.3
Relay Program (Peer Navigation)
31.6
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 25 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04317053.