Opioid UseSOONERNCT04740099
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
A study testing SOONER Video & Kit in people with Opioid Use and Opioid-Related Disorders, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid-Related Disorders, Opioid Withdrawal
- What is being tested?
- SOONER Video & Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M6G3L8
About this study
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.
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
- Being tested
- SOONER Video & Kit, Standard of Care
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOONER Video & KitOther
Also called SOONER Naloxone kit
A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
Standard of CareOther
Also called Community Based Naloxone training referral
A handout including a map and list of locations offering this service.
| Study group | Role | What they receive |
|---|---|---|
| SOONER Training (Intervention) | Experimental | Arm receives video training and kit designed by SOONER team. Receives: Other: SOONER Video & Kit |
| Standard of care training (control) | Other | Participant referred to standard of care (community based Naloxone training) Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-14 days after enrolment
Secondary outcomes (8)
Performance on basic resuscitation skill: Recognize the Emergency
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: Position the Victim
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: Activate emergency medical services
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: Administer Naloxone
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: Hand placement
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: chest compressions
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: continue compressions until end of simulation
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.
Measured: 4-14 days after enrolment
Performance on basic resuscitation skill: order of operations
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.
Measured: 4-14 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: The study never started due to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Public Health, Ontario College of Art and Design (OCAD), University of Toronto
- Responsible party
- Sponsor
- Investigators
- Carol Strike, PhD, Principal investigator, University of TorontoAaron Orkin, MD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740099
- Sponsor's protocol ID
- 19-169
- Acronym
- SOONER
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04740099
- Acronym / sponsor ID
- SOONER / 19-169
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose, Education, Resusitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started due to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Toronto Public Health, Ontario College of Art and Design (OCAD), University of Toronto
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.
| Arm | Type | Receives |
|---|---|---|
| SOONER Training (Intervention) | Experimental | Other: SOONER Video & KitArm receives video training and kit designed by SOONER team. |
| Standard of care training (control) | Other | Other: Standard of CareParticipant referred to standard of care (community based Naloxone training) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOONER Video & KitAlso: SOONER Naloxone kitA brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic. | Other | SOONER Training (Intervention) |
| Standard of CareAlso: Community Based Naloxone training referralA handout including a map and list of locations offering this service. | Other | Standard of care training (control) |
Primary outcome
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.
8 secondary outcomes
Performance on basic resuscitation skill: Recognize the Emergency
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: Position the Victim
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: Activate emergency medical services
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: Administer Naloxone
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: Hand placement
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: chest compressions
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: continue compressions until end of simulation
Time frame: 4-14 days after enrolment
Performance on basic resuscitation skill: order of operations
Time frame: 4-14 days after enrolment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Strike, PhD principal investigator
University of Toronto
Aaron Orkin, MD study chair
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOONER Video & Kit in people with Opioid Use and Opioid-Related Disorders, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfactory basic life support performance (time frame: 4-14 days after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.