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Behavioral Intervention

RELAY for Opioid Overdose

Phase 3

Waitlist Available

Led By Kelly Doran, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 12

Awards & highlights

Study Summary

This trial will compare the effects of two different programs on people who have overdosed on opioids. 350 people will be enrolled and randomly assigned to either the "site-directed care" program or the "Relay-peer-delivered OD education and treatment linkage" program. The outcomes will be measured for 12 months to see which program is more effective in preventing subsequent opioid-related problems.

Eligible Conditions

Opioid Overdose

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of opioid-related adverse events

Secondary outcome measures

Number of ED Visits for other (non-OD) substance use reasons

Number of Emergency Deparment (ED) visits for any cause

Number of Opioid-Related ED Visits

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Relay program (peer navigation)Experimental Treatment1 Intervention

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.

Group II: Site-Directed Care (SDC)Active Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RELAY

2020

Completed Phase 3

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,155 Total Patients Enrolled

1 Trials studying Opioid Overdose

333 Patients Enrolled for Opioid Overdose

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,479 Total Patients Enrolled

Kelly Doran, MDPrincipal InvestigatorNew York University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the potential risks associated with RELAY?

"RELAY is a Phase 3 trial, which means that while there is data supporting efficacy, there is also multiple rounds of data supporting safety. As such, our team at Power has given it a score of 3 for safety."

Answered by AI

Are individuals of all ages welcome in this clinical trial?

"Patients that wish to be considered for this clinical trial must be between the ages of 18 to 99. If an applicant is under 18 or over 65, there are other trials that might be more appropriate."

Answered by AI

How can I become a participant in this experiment?

"In order to be selected for this study, individuals must have overdosed on drugs and be between 18 and 99 years old. Currently, the 247th participant is being recruited."

Answered by AI

Are recruitment efforts for this research still ongoing?

"This particular clinical trial is not currently recruiting patients, as reflected in the data from clinicaltrials.gov. The study was originally posted on October 8th, 2020 and was last updated on July 6th, 2022. There are, however, 16 other trials that are actively looking for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04317053.