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临床试验/NCT04211077
NCT04211077已完成不适用

Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 273,221 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273,221
试验地点
1
主要终点
Suicidal Risk Factors Associated with Opioid Analgesics Use

研究概览

简要总结

There is an increase in prescriptions for analgesics opioids and overdose mortality in France.

In the United States, the consumption of opioid analgesics is associated with excess mortality, especially suicide. In France, the investigator team showed retrospectively a link between history of suicide attempt (SA) and use of analgesics in general elderly population.

It is important to determine if there is a link between the prescription of opioid analgesics and suicide attempts, in a longitudinal study in general population.

The originality of the project lies in:

  • the absence of a French epidemiological study on the link between opioid analgesics and suicide attempt / mortality despite the context of "opioid crisis",
  • taking into account the terms of consumption of care

详细描述

Main objective:

To estimate the relative risk (Odds ratio) of SA associated with exposure to opioid analgesics in a case-crossover design study

Secondary objectives:

  1. To Compare the profile of subjects who attempted suicide versus subjects who had an accidental drug intoxication with opioids vs subjects who did not attempt suicide or did not have an accidental overdose with opioid analgesics (case-control design)
  2. To Evaluate the dose-effect of opioid analgesics on the risk of SA (case-control and case-crossover design).
  3. To Identify changes in care consumption (medical consultations, co-prescriptions, changes in analgesic doses) in the 3 months preceding a SA in patients who received at least one prescription for opioid analgesics in the same period.

The Database is retrospective (2012-2017) Two methods will be used

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Suicidal Risk Factors Associated with Opioid Analgesics Use

时间窗: 1 year

Occurrence of a suicide attempt

次要结局

  • Socio-demographic characteristics (potential risk factor)(1 year)
  • Psychotropic use (potential risk factor)(1 year)
  • Comorbidities (potential risk factor)(1 year)
  • Nomadism indicator (potential risk factor)(1 year)
  • Delay between first prescription of opioid analgesics and occurrence of suicide attempt(1 year)
  • Care consumption (potential risk factor)(1 year)
  • Other analgesic use (potential risk factor)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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