Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
- Conditions
- Opioid Abuse
- Interventions
- Other: Historical control cohort
- Registration Number
- NCT03570099
- Lead Sponsor
- Region Skane
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- subjects treated at the Addiction centres of Skåne County
- signed informed consent
- subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Historical control cohort Historical control cohort Data from the historical control cohort will be collected from national registries years 2013-2017. Prospective Naloxone cohort Naloxone Nasal Spray The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
Malmö Addiction Center
🇸🇪Malmö, Sweden