SOONER Feasibility Study Protocol

NCT03821649 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition 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 in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.

Conditions

Overdose

Keywords

Education; Naloxone; Opioid; Overdose; Resuscitation

Outcome Measures

Primary Outcomes (2)

• Participant recruitment rate (participants recruited in 4 weeks)

  Approximately 28 participants are recruited within 4 weeks. The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met: (A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.

  4 weeks

• Participant attrition at the underlying study's outcome simulation

  less than 50% attrition at the underlying study's outcome simulation. Primary outcome description: The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met: (A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.

  4-6 weeks

Secondary Outcomes (3)

• Site recruitment rates

  28 days

• Participant retention rates

  4-6 weeks

• Descriptions of study process problems

  4-6 weeks

Study Arms (2)

SOONER Training and Naloxone Kit

EXPERIMENTAL

Participants in this arm will be shown the SOONER overdose response training video at the time of recruitment and given the SOONER Naloxone kit to take home.

Behavioral: SOONER Training and Naloxone Kit Kit

Community or Hospital-Based Training

ACTIVE COMPARATOR

Control arm - participants in this arm will be referred to the standard of care for Naloxone training. This standard of care includes community-based OEND programs and/or an existing hospital-based OEND program..

Behavioral: Community or Hospital-Based Training

Interventions

SOONER Training and Naloxone Kit Kit BEHAVIORAL

Participants are shown our unique overdose response education video and given the associated kit to take home.

SOONER Training and Naloxone Kit

Community or Hospital-Based Training BEHAVIORAL

Referral to standard of care for Naloxone training

Community or Hospital-Based Training

Eligibility Criteria

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

You may not qualify if:

• 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.
• Have no mode of contact or follow-up.
• Plan to move away from Toronto during the study period.
• Have insufficient English language skills to participate in the study.
• Are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder).

Sponsors & Collaborators

• Unity Health Toronto: lead
• OCAD University: collaborator
• Toronto Public Health: collaborator

Study Sites (4)

Inner City Family Health Team

Toronto, Ontario, Canada

Location

St Michael's Hospital Emergency Department

Toronto, Ontario, Canada

Location

St Micheal's Health Centre at 410

Toronto, Ontario, Canada

Location

St Micheal's Hospital Rapid Access Addictions Medicine Clinic

Toronto, Canada

Location

Related Publications (9)

• United Nations Office on Drugs and Crime, World Health Organization. Discussion paper UNODC/WHO 2013: Opioid overdose: preventing and reducing opioid overdose mortality. 2013; Available at: http://www.unodc.org/docs/treatment/overdose.pdf. Accessed 04/23, 2014. Archived by WebCite© at http://www.webcitation.org/6U3qbjl2E)

  BACKGROUND

• Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014 May-Jun;8(3):153-63. doi: 10.1097/ADM.0000000000000034.

  PMID: 24874759 BACKGROUND

• Doyon S, Aks SE, Schaeffer S. Expanding access to naloxone in the United States. J Med Toxicol. 2014 Dec;10(4):431-4. doi: 10.1007/s13181-014-0432-1. No abstract available.

  PMID: 25316516 BACKGROUND

• Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36. doi: 10.1007/s11524-006-9120-z.

  PMID: 17146712 BACKGROUND

• Coffin PO, Fuller C, Vadnai L, Blaney S, Galea S, Vlahov D. Preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in New York City. J Urban Health. 2003 Jun;80(2):288-90. doi: 10.1093/jurban/jtg031.

  PMID: 12791804 BACKGROUND

• Meyers K, Webb A, Frantz J, Randall M. What does it take to retain substance-abusing adolescents in research protocols? Delineation of effort required, strategies undertaken, costs incurred, and 6-month post-treatment differences by retention difficulty. Drug Alcohol Depend. 2003 Jan 24;69(1):73-85. doi: 10.1016/s0376-8716(02)00252-1.

  PMID: 12536068 BACKGROUND

• Parsons JA, Markowitz B, Thomas R, Norris K, Charles M, King C, Sellen K, Campbell DM, Leece P, Klaiman M, Chapman L, Hopkins S, Shahin R, Handford C, Stergiopoulos V, Morrison LJ, Strike C, Orkin AM; SOONER investigators. The opportunity to save a life: A qualitative study of a point-of-care overdose education and naloxone distribution intervention. PLoS One. 2025 Jun 25;20(6):e0326495. doi: 10.1371/journal.pone.0326495. eCollection 2025.

  PMID: 40560908 DERIVED

• Orkin AM, Charles M, Norris K, Thomas R, Chapman L, Wright A, Campbell DM, Handford C, Klaiman M, Hopkins S, Shahin R, Thorpe K, Juni P, Parsons J, Sellen K, Goso N, Hunt R, Leece P, Morrison LJ, Stergiopoulos V, Turner S, Strike C. Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial. Resusc Plus. 2021 May 14;6:100131. doi: 10.1016/j.resplu.2021.100131. eCollection 2021 Jun.

  PMID: 34223388 DERIVED

• Orkin A, Campbell D, Handford C, Hopkins S, Klaiman M, Leece P, Parsons JA, Shahin R, Strike C, Thorpe K, Sellen K, Milos G, Wright A, Charles M, Sniderman R, Morrison L; SOONER Investigators. Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial. BMJ Open. 2019 Nov 12;9(11):e029436. doi: 10.1136/bmjopen-2019-029436.

  PMID: 31722937 DERIVED

MeSH Terms

Conditions

Drug Overdose

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 30, 2019
• Study Start: January 23, 2019
• Primary Completion: March 1, 2020
• Study Completion: December 10, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)