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

September 28, 2022 updated by: Unity Health Toronto

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.

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6G3L8
        • St. Michael's Hospital, Unity Health Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOONER Training (Intervention)
Arm receives video training and kit designed by SOONER team.
Other: SOONER Video & Kit
A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
Other Names:
  • SOONER Naloxone kit
Other: Standard of care training (control)
Participant referred to standard of care (community based Naloxone training)
Other: Standard of Care
A handout including a map and list of locations offering this service.
Other Names:
  • Community Based Naloxone training referral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satisfactory basic life support performance
Time Frame: 4-14 days after enrolment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance on basic resuscitation skill: Recognize the Emergency
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: Position the Victim
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: Activate emergency medical services
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: Administer Naloxone
Time Frame: 4-14 days after enrolment
Skill performance on device preparation and correct administration will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: Hand placement
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: chest compressions
Time Frame: 4-14 days after enrolment
Skill performance (rate and depth of chest compressions) will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: continue compressions until end of simulation
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment
Performance on basic resuscitation skill: order of operations
Time Frame: 4-14 days after enrolment
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians. Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
4-14 days after enrolment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours
Time Frame: 4-14 days after enrolment

The questionnaires were developed for the Toronto Public Health OEND program evaluation using data points from other overdose education and naloxone distribution programs and from the validated Opioid Overdose Knowledge and Attitudes Scales (OOKS and OOAS). We also included relevant questions from a national survey of injection drug users (ITRACK, Health Canada) and the CAMH Monitor conducted by the Centre for Addiction and Mental Health (CAMH). The questionnaire items include:

  1. Demographics: age, gender, ethnicity, housing status, and neighbourhood
  2. Prescription medications
  3. Opioid and non-opioid drug use in past 4 weeks: drug, amount, route, frequency
  4. Drug use setting: where and with whom opioids were used
  5. Periods of abstinence
  6. Use of prevention strategies, and speaking to others about overdose or overdose response
  7. Knowledge of overdose and naloxone use
  8. Status of naloxone kit
  9. Willingness and confidence to respond to overdose
4-14 days after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toronto
Toronto Public Health
Ontario College of Art and Design (OCAD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carol Strike, PhD, University of Toronto
  • Study Chair: Aaron Orkin, MD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All publications will indicate that original de-identified study data and statistical coding is available upon request from the Steering Committee. This information and will be shared freely with corresponding scholars and the public, on request.

IPD Sharing Time Frame

Available on an ongoing basis upon request

IPD Sharing Access Criteria

At the discretion of the research team

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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