Naloxone to TReatment Entry in the Emergency Setting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Treatment entry
研究概览
简要总结
The study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.
详细描述
Randomized controlled trial. Subjects are included if they are being treated by an ambulance in the Malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. Subjects are randomized by ambulance staff to either an active intervention, or a control condition:
Intervention: A telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study.
Control: No telephone alert signal is sent, and the active outreach procedure is not carried out. Ambulance staff hand over written information to the individual about how she/he can apply actively for treatment.
Primary outcome is entry into formal assessment and treatment of the substance use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent
排除标准
- •patients unable to understand study information and to provide informed consent
结局指标
主要结局
Treatment entry
时间窗: Two weeks
Entry into formal assessment for evidence-based treatment of opioid use disorder
次要结局
- Treatment outcome (quality of life)(3, 6, 12, 24 and 36 months)
- Treatment outcome (self-report)(3, 6, 12, 24 and 36 months)
- Treatment outcome (urinalysis)(3, 6, 12, 24 and 36 months)
- Treatment retention(3, 6, 12, 24 and 36 months)
- Treatment outcome (hair analysis)(3 months)
研究者
Anders C Håkansson
MD, PhD
Region Skane