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

NCT04740099 | Withdrawn

• 1 other identifier: 19-169
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Satisfactory basic life support performance

  Satisfactory basic life support performance on a standardized high fidelity overdose simulation, as assessed by the consensus of two trained clinicians.

  4-14 days after enrolment

Secondary Outcomes (8)

• Performance on basic resuscitation skill: Recognize the Emergency

  4-14 days after enrolment

• Performance on basic resuscitation skill: Position the Victim

  4-14 days after enrolment

• Performance on basic resuscitation skill: Activate emergency medical services

  4-14 days after enrolment

• Performance on basic resuscitation skill: Administer Naloxone

  4-14 days after enrolment

• Performance on basic resuscitation skill: Hand placement

  4-14 days after enrolment

Other Outcomes (1)

• Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours

  4-14 days after enrolment

Study Arms (2)

SOONER Training (Intervention)

EXPERIMENTAL

Arm receives video training and kit designed by SOONER team.

Other: SOONER Video & Kit

Standard of care training (control)

OTHER

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

Other: Standard of Care

Interventions

SOONER Video & Kit OTHER

A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.

Also known as: SOONER Naloxone kit

SOONER Training (Intervention)

Standard of Care OTHER

A handout including a map and list of locations offering this service.

Also known as: Community Based Naloxone training referral

Standard of care training (control)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Toronto Public Health: collaborator
• Ontario College of Art and Design (OCAD): collaborator
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M6G3L8, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose

Interventions

Receptor Protein-Tyrosine Kinases; Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carol Strike, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Aaron Orkin, MD

  University of Toronto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: February 5, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Available on an ongoing basis upon request
• Access Criteria: At the discretion of the research team

Locations

CA (1)