A multi-national, prospective mixed methods study of the effectiveness of naloxone (including intranasal Nyxoid) administration by lay people in reversing opioid overdose (NalPORS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Overdose
• Additional medical condition(s):
  Opioid Overdose

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  1. To determine the frequency of deaths in the 24 hours or later if information is available subsequent to administration of naloxone by lay-persons to reverse an opioid overdose in the real world. 2. To determine the proportion of naloxone administration with the intention of reversing an opioid overdose by lay persons provided with THN who witness an opioid overdose.
• Outcomes:
  1. frequency of deaths among those witnessing opioid overdose (n=600) 2. Rate of THN administration among those witnessing opioid overdose (n=600), .
• Data analysis plan:
  The administration rate of THN by lay people and the frequency of deaths from the opioid overdose will be estimated as proportions. A Statistical Analysis Plan (SAP) will be developed throughout the study in conjunction with the co-sponsor standard operating procedures and will be approved by the Study Steering Committee (SSC) (see Section 10. Study oversight). The study data will be stratified by participants groups as follows: 1) Patients in treatment for OUD, 2) Participants who use opioids but are not currently in treatment, 3) Friends and family members, 4) Staff working with individuals with OUD. Effective administration rates of THN by lay people will be estimated in each sub-group, as proportions. The outcomes will also be estimated for each THN formulation.