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

Unity Health Toronto

Status: Withdrawn

Conditions: Opioid Withdrawal; Education; Opioid Overdose; Resusitation; Opioid-Related Disorders; Opioid Use

Treatments: Other: Standard of Care; Other: SOONER Video & Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04740099

19-169

Details and patient eligibility

About

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 resuscitation training and naloxone distribution reduce resuscitation failures in a simulated overdose even, in comparison with standard-of-care referral to a local OEND program, within 14 days post-intervention? Can an integrated participant recruitment and retention strategy recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition rates 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?

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. adults ≥16 years of age, and

2. 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:

   1. has a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day);
   2. has required emergency care for opioid overdose previously;
   3. 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;
   4. uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting;
   5. has a history of non-medical opioid use who are being released from prison;
   6. 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.
   7. 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 criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

SOONER Training (Intervention)

Experimental group

Description:

Arm receives video training and kit designed by SOONER team.

Treatment:

Other: SOONER Video & Kit

Standard of care training (control)

Other group

Description:

Participant referred to standard of care (community based Naloxone training)

Treatment:

Other: Standard of Care