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

NCT ID: NCT04740099

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

SOONER Training (Intervention)

Arm receives video training and kit designed by SOONER team.

Group Type: EXPERIMENTAL

SOONER Video & Kit

Intervention Type: OTHER

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

Standard of care training (control)

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

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

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

Interventions

SOONER Video & Kit

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

Intervention Type: OTHER

Standard of Care

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

Intervention Type: OTHER

Other Intervention Names

SOONER Naloxone kit; Community Based Naloxone training referral

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Toronto Public Health

OTHER_GOV

Sponsor Role: collaborator

Ontario College of Art and Design (OCAD)

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Strike, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Aaron Orkin, MD

Role: STUDY_CHAIR

University of Toronto

Locations

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

19-169

Identifier Type: -

Identifier Source: org_study_id