An observational study in Opioid Abuse, sponsored by Region Skane. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Region Skane · Observational
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.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 175 across 38 observational studies indexed under Drug Overdose.
Browse Drug Overdose studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of subjects treated at the Addiction centres of Skåne County. Naloxone Nasal Spray will be handed out to these subjects, who must be able to understand the given information about the use of the drug.
Exclusion Criteria:
The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.
Drug: Naloxone Nasal Spray
Data from the historical control cohort will be collected from national registries years 2013-2017.
Other: Historical control cohort
Naloxone Nasal Spray will be distributed at the addiction centres.
Historical data will be retrieved from quality registries.
Overdose mortality in the general population
Overdose mortality deaths 2019-2023 to be compared with historical overdose mortality during 2013-2017. Number of deaths will be collected from national registries.
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Reaction level of ambulance-attended opioid overdose survivors in the general population
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).
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Respiratory rate of ambulance-attended opioid overdose survivors in the general population
Respiratory rate (breaths per minute) registered in ambulance.
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Heart rate of ambulance-attended opioid overdose survivors in the general population
Heart rate (beats per minute) of opioid overdose survivors registered in ambulance.
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Naloxone or other antidot administered by ambulance staff to ambulance-attended opioid overdose survivors in the general population
Naloxone or other antidot, if needed, administered by ambulance staff in opioid overdose survivors.
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Need of ambulance transport to hospital of ambulance-attended opioid overdose survivors in the general population
The need to transport the opioid overdose survivors to hospital - information registered in ambulance.
Time frame: 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
Incidence of opioid overdoses attended by ambulance or emergency hospital care, information registered in ambulance or emergency hospital care.
Time frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
All cause mortality in included patients
Number of deaths will be collected from national and regional registries.
Time frame: 3 years
Overdose mortality in included patients
Overdose mortality in included patients. Number of deaths will be collected from national and regional registries.
Time frame: 3 years
Retention in naloxone program
Retention in naloxone program - number of patients.
Time frame: 3 years
Incidence of witnessing opioid overdoses
Number of incidences of witnessing opioid overdoses.
Time frame: 3 years
Incidence in naloxone use and bystander CPR
Number of incidences of naloxone use and bystander CPR.
Time frame: 3 years
Plan to share: No
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Region Skane