Clinical trial NCT03570099: Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Official title: Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Abuse
Keywords: opioid overdose
mortality
naloxone
substance use disorder
prevention
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overdose mortality in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary outcomes:
measure: Reaction level of ambulance-attended opioid overdose survivors in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: Respiratory rate of ambulance-attended opioid overdose survivors in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: Heart rate of ambulance-attended opioid overdose survivors in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: Naloxone or other antidot administered by ambulance staff to ambulance-attended opioid overdose survivors in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: Need of ambulance transport to hospital of ambulance-attended opioid overdose survivors in the general population
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: Incidence of opioid overdoses attended by ambulance or emergency hospital care
timeFrame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
measure: All cause mortality in included patients
timeFrame: 3 years
measure: Overdose mortality in included patients
timeFrame: 3 years
measure: Retention in naloxone program
timeFrame: 3 years
measure: Incidence of witnessing opioid overdoses
timeFrame: 3 years
measure: Incidence in naloxone use and bystander CPR
timeFrame: 3 years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Center
Study officials:
affiliation: Region Skåne
name: Ulf Malmqvist, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Troberg K, Isendahl P, Blome MA, Dahlman D, Hakansson A. Protocol for a multi-site study of the effects of overdose prevention education with naloxone distribution program in Skane County, Sweden. BMC Psychiatry. 2020 Feb 7;20(1):49. doi: 10.1186/s12888-020-2470-3.