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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03570099
Enrollment
2000
Registered
2018-06-26
Start date
2018-06-11
Completion date
2023-07-01
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Abuse

Keywords

opioid overdose, mortality, naloxone, substance use disorder, prevention

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.

Interventions

Naloxone Nasal Spray will be distributed at the addiction centres.

OTHERHistorical control cohort

Historical data will be retrieved from quality registries.

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* subjects treated at the Addiction centres of Skåne County * signed informed consent

Exclusion criteria

* subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties

Design outcomes

Primary

MeasureTime frameDescription
Overdose mortality in the general population5 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

MeasureTime frameDescription
Respiratory rate of ambulance-attended opioid overdose survivors in the general population5 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 population5 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 population5 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 population5 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 care5 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.
Reaction level of ambulance-attended opioid overdose survivors in the general population5 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).
Overdose mortality in included patients3 yearsOverdose mortality in included patients. Number of deaths will be collected from national and regional registries.
Retention in naloxone program3 yearsRetention in naloxone program - number of patients.
Incidence of witnessing opioid overdoses3 yearsNumber of incidences of witnessing opioid overdoses.
Incidence in naloxone use and bystander CPR3 yearsNumber of incidences of naloxone use and bystander CPR.
All cause mortality in included patients3 yearsNumber of deaths will be collected from national and regional registries.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026