CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
SOONER Training and Naloxone Kit Kit +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03821649
NCT03821649N/ACompleted

Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial

Unity Health Toronto·interventional·Posted Jan 30, 2019·Updated May 23, 2022

In Brief

A clinical study evaluating SOONER Training and Naloxone Kit Kit and Community or Hospital-Based Training for Overdose. Completed, enrolled 90 participants across 4 sites.

Detailed Summary

Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverdose
CountriesCanada

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartJan 23, 2019
Primary CompletionMar 1, 2020
Study CompletionDec 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.4 years ago

Interventions

SOONER Training and Naloxone Kit Kitbehavioral

Participants are shown our unique overdose response education video and given the associated kit to take home.

Community or Hospital-Based Trainingbehavioral

Referral to standard of care for Naloxone training