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临床试验/NCT04405414
NCT04405414已完成不适用

Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 746 人开始时间: 2020年5月6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
746
试验地点
1
主要终点
Prevalence of CBD users

研究概览

简要总结

Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis, is used in many over-the-counter products in France. Some painful patients or patients suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are no data available for patients in algology and addictology, particularly with regard to the prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the use of a substance with a therapeutic purpose but outside a medical framework and without monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main objective of the study is therefore to assess the prevalence of CBD users in algology and addictology departments. Secondary objectives are to characterize the use of CBD as well as the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive substances use or current drug treatments and the drug liking of CBD.

详细描述

Physicians from algology and addictology departments will propose the study to all patients who meet the inclusion criteria during a medical consultation (in hospitalization or ambulatory care). If the patient agrees to participate, the non-opposition will be collected and the physician will complete a short form with sociodemographic data, medical history and contact details of the patient.

The form will be transmitted securely to the research staff that will perform a unique research evaluation face to face (when the patient is still hospitalized and available) or by phone (when the patient is not available during hospitalization or no longer hospitalized or in case of ambulatory care). The research evaluation includes data about the frequency and the duration of the use of all substances (CBD included) in the last 12 months and the frequency of current drug treatments. For patients with CBD use in the last 12 months, additional data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD.

A descriptive analysis will be carried out. The CBD user group and the CBD non-user group will be compared on all the variables collected. A multivariate analysis will be carried out in order to identify factors associated to CBD use in algology and addictology patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Minimum age of 18 years
  • Patients for whom hospital specialists in algology or addictology have been requested (for hospitalized or ambulatory cares) during the inclusion period.
  • Giving oral non opposition to participate.

排除标准

  • Adults under guardianship or curator
  • Patients unable to respond to the research evaluation (cerebral function disorder, difficulty to understand, read or write French language).

结局指标

主要结局

Prevalence of CBD users

时间窗: through study completion, an average of 2 year

For all patients included in the study, the use of CBD during the last 12 months (yes or no) will be collected.

次要结局

  • Characterization of CBD users(through study completion, an average of 2 year)
  • Impact of the use of CBD(through study completion, an average of 2 year)
  • Characterization of the use of CBD(through study completion, an average of 2 year)
  • CBD drug-liking(through study completion, an average of 2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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