Status:

WITHDRAWN

Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)

Lead Sponsor:

Unity Health Toronto

Collaborating Sponsors:

Toronto Public Health

Ontario College of Art and Design (OCAD)

Conditions:

Opioid Use

Opioid-Related Disorders

Eligibility:

All Genders

16+ years

Phase:

NA

Brief Summary

Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resus...

Eligibility Criteria

Inclusion

  • adults ≥16 years of age, and
  • Eligible for overdose education according to criteria adapted from the 2015 American Heart Association Guidelines by meeting any one or more of the following criteria:
  • has a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as \>100mg morphine equivalent per day);
  • has required emergency care for opioid overdose previously;
  • is enrolled in opioid agonist treatment programs, including methadone or buprenorphine maintenance programs, or stopped an opioid agonist treatment program in the last 6 months;
  • uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting;
  • has a history of non-medical opioid use who are being released from prison;
  • is receiving prescription opioid therapy with risk factors for adverse effects, including i. relevant comorbidities, ii. co-prescriptions of benzodiazepines or other sedatives, iii. concomitant ongoing alcohol use, iv. use of prescription opioids not as prescribed.
  • is likely to witness an opioid overdose, defined as anyone who lives with or is in frequent contact with others who use opioids, or who has previously witnessed an opioid overdose.

Exclusion

  • plan to move away from Toronto during the study period
  • have no mode of contact or follow-up,
  • have a community do not resuscitate order,
  • have a terminal illness, end-of-life care, or illness likely to result in death within the study period,
  • are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder), or
  • have insufficient English language skills to participate in the study.

Key Trial Info

Start Date :

December 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2023

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04740099

Start Date

December 1 2021

End Date

March 1 2023

Last Update

October 3 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada, M6G3L8

Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER) | DecenTrialz