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

Opioid Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03570099
• Other study ID #: 2018/300
• Status: Active, not recruiting
• Start date: June 11, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opioid Abuse
• Opioid-Related Disorders

Intervention

Drug:
• Naloxone Nasal Spray
Naloxone Nasal Spray will be distributed at the addiction centres.

Other:
• Historical control cohort
Historical data will be retrieved from quality registries.

Locations

Country	Name	City	State
Sweden	Malmö Addiction Center	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	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).	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	Respiratory rate of ambulance-attended opioid overdose survivors in the general population	Respiratory rate (breaths per minute) registered in ambulance.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	Heart rate of ambulance-attended opioid overdose survivors in the general population	Heart rate (beats per minute) of opioid overdose survivors registered in ambulance.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	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.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	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.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	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.	5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Secondary	All cause mortality in included patients	Number of deaths will be collected from national and regional registries.	3 years
Secondary	Overdose mortality in included patients	Overdose mortality in included patients. Number of deaths will be collected from national and regional registries.	3 years
Secondary	Retention in naloxone program	Retention in naloxone program - number of patients.	3 years
Secondary	Incidence of witnessing opioid overdoses	Number of incidences of witnessing opioid overdoses.	3 years
Secondary	Incidence in naloxone use and bystander CPR	Number of incidences of naloxone use and bystander CPR.	3 years