Clinical trial NCT04740099: Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
Official title: Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER): Randomized Trial and Embedded Qualitative Study to Compare the Effectiveness of point-of Care Overdose Education and Naloxone Distribution Versus Referral to an Existing Community Program in the Management of Simulated Opioid-associated Resuscitative Emergencies.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use
Opioid-Related Disorders
Opioid Withdrawal
Opioid Overdose
Education
Resusitation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Public Health
name: Ontario College of Art and Design (OCAD)
name: University of Toronto
First posted: 2021-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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?


Eligibility criteria: 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.

Primary outcomes:
measure: Satisfactory basic life support performance
timeFrame: 4-14 days after enrolment
Secondary outcomes:
measure: Performance on basic resuscitation skill: Recognize the Emergency
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: Position the Victim
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: Activate emergency medical services
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: Administer Naloxone
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: Hand placement
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: chest compressions
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: continue compressions until end of simulation
timeFrame: 4-14 days after enrolment
measure: Performance on basic resuscitation skill: order of operations
timeFrame: 4-14 days after enrolment
Other outcomes:
measure: Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours
timeFrame: 4-14 days after enrolment
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital, Unity Health Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Carol Strike, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Aaron Orkin, MD
role: STUDY_CHAIR
References: