Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

Sponsor

Region Skane (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03570099

Collaborator

(none)

2,000

Enrollment

Location

60.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s. The purpose of the study is to investigate the effects of a Naloxone distribution program in Skåne County. The primary issue is whether the project had an effect on overdose mortality and overdose related injuries.

Condition or Disease	Intervention/Treatment	Phase
Opioid Abuse	Drug: Naloxone Nasal Spray Other: Historical control cohort

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

Actual Study Start Date :

Jun 11, 2018

Actual Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Prospective Naloxone cohort The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.	Drug: Naloxone Nasal Spray Naloxone Nasal Spray will be distributed at the addiction centres.
Historical control cohort Data from the historical control cohort will be collected from national registries years 2013-2017.	Other: Historical control cohort Historical data will be retrieved from quality registries.

Arm

Intervention/Treatment

Prospective Naloxone cohort

The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.

Drug: Naloxone Nasal Spray

Naloxone Nasal Spray will be distributed at the addiction centres.

Historical control cohort

Data from the historical control cohort will be collected from national registries years 2013-2017.

Other: Historical control cohort

Historical data will be retrieved from quality registries.

Outcome Measures

Primary Outcome Measures

Overdose mortality in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Overdose mortality deaths 2019-2023 to be compared with historical overdose mortality during 2013-2017. Number of deaths will be collected from national registries.

Secondary Outcome Measures

Reaction level of ambulance-attended opioid overdose survivors in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Assessment of responsiveness in acute brain disorders using Reaction Level Scale (RLS-85) in ambulance. The RLS scale is graded from 1 (awake, no delayed reaction, oriented) to grade 8 (unconscious, no movements to painful stimuli).
Respiratory rate of ambulance-attended opioid overdose survivors in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Respiratory rate (breaths per minute) registered in ambulance.
Heart rate of ambulance-attended opioid overdose survivors in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Heart rate (beats per minute) of opioid overdose survivors registered in ambulance.
Naloxone or other antidot administered by ambulance staff to ambulance-attended opioid overdose survivors in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Naloxone or other antidot, if needed, administered by ambulance staff in opioid overdose survivors.
Need of ambulance transport to hospital of ambulance-attended opioid overdose survivors in the general population [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
The need to transport the opioid overdose survivors to hospital - information registered in ambulance.
Incidence of opioid overdoses attended by ambulance or emergency hospital care [5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)]
Incidence of opioid overdoses attended by ambulance or emergency hospital care, information registered in ambulance or emergency hospital care.
All cause mortality in included patients [3 years]
Number of deaths will be collected from national and regional registries.
Overdose mortality in included patients [3 years]
Overdose mortality in included patients. Number of deaths will be collected from national and regional registries.
Retention in naloxone program [3 years]
Retention in naloxone program - number of patients.
Incidence of witnessing opioid overdoses [3 years]
Number of incidences of witnessing opioid overdoses.
Incidence in naloxone use and bystander CPR [3 years]
Number of incidences of naloxone use and bystander CPR.