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NCT04317053 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by NYU Langone Health.

Completed
Registry status
NA
Development phase
253
Enrollment target

NCT04317053: Completed NA study, sponsored by NYU Langone Health.

NCT04317053 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 253 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04317053, a NA study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
NA
Development phase
253 participants
Enrollment target

Study 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. 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL RELAY

Trial Details

FieldValue
Enrollment Target 253 participants
Start Date 2020-10-08
Est. Completion 2023-07-01
Phase NA
NYU Langone Health

1,164 total trials

What the finished NCT04317053 record still lists

NCT04317053 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 1 intervention - of which RELAY is the first listed.

NCT04317053 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04317053 about?

NCT04317053 is a clinical study titled "Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program". 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 ...

What is the current status of trial NCT04317053?

This trial is currently completed. It is a NA study. The enrollment target is 253 participants. The study started on 2020-10-08. Estimated completion is 2023-07-01.

What interventions are being tested in trial NCT04317053?

The interventions under investigation include: RELAY (BEHAVIORAL).

Who is sponsoring clinical trial NCT04317053?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04317053's enrollment target sits among peer trials

253 407th of 2000 higher than 1,594 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04317053, the US trial registry maintained by the National Library of Medicine. NCT04317053 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.