Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overdose mortality in the general population
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects treated at the Addiction centres of Skåne County
- •signed informed consent
排除标准
- •subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties
研究组 & 干预措施
Prospective Naloxone cohort
The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.
干预措施: Naloxone Nasal Spray (Drug)
Historical control cohort
Data from the historical control cohort will be collected from national registries years 2013-2017.
干预措施: Historical control cohort (Other)
结局指标
主要结局
Overdose mortality in the general population
时间窗: 5 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.
次要结局
- Need of ambulance transport to hospital of ambulance-attended opioid overdose survivors in the general population(5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020))
- Overdose mortality in included patients(3 years)
- Retention in naloxone program(3 years)
- Incidence of witnessing opioid overdoses(3 years)
- Incidence in naloxone use and bystander CPR(3 years)
- Reaction level of ambulance-attended opioid overdose survivors in the general population(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(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(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(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(5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020))
- All cause mortality in included patients(3 years)