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

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid Abuse

Intervention / Treatment
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* Drug: Naloxone Nasal Spray
* Other: Historical control cohort


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Naloxone cohort<br>The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program. | Drug: Naloxone Nasal Spray<br>* Naloxone Nasal Spray will be distributed at the addiction centres.<br>|
| Historical control cohort<br>Data from the historical control cohort will be collected from national registries years 2013-2017. | Other: Historical control cohort<br>* Historical data will be retrieved from quality registries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| All cause mortality in included patients | Number of deaths will be collected from national and regional registries. | 3 years | 
| Overdose mortality in included patients | Overdose mortality in included patients. Number of deaths will be collected from national and regional registries. | 3 years | 
| Retention in naloxone program | Retention in naloxone program - number of patients. | 3 years | 
| Incidence of witnessing opioid overdoses | Number of incidences of witnessing opioid overdoses. | 3 years | 
| Incidence in naloxone use and bystander CPR | Number of incidences of naloxone use and bystander CPR. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid overdose, mortality, naloxone, substance use disorder, prevention