Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- THC (Tetrahydrocannabinol)
研究概览
简要总结
The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).
The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subjects without protection by a legal regime (guardianship, trusteeship)
- •Subjects affiliated to an appropriate social security system
- •Subjects must sign an informed consent form
- •Inclusion Criteria for Group 1:
- •Subjects must have the CHS diagnosis confirmed
- •Inclusion Criteria for Group 2:
- •Subjects must be chronic cannabis consumers and never had CHS
排除标准
- •Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
结局指标
主要结局
THC (Tetrahydrocannabinol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-COOH (11-nor-9-carboxy-Δ⁹-tétrahydrocannabinol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
CBN (Cannabinol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS (see details below for exogenous cannabinoids)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
CBD (Cannabidiol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
CBG (Cannabigerol)
时间窗: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
次要结局
未报告次要终点