NCT07122349已完成不适用
An Interventional Study to Facilitate the Development of a Cannabis Impairment Detection Device in Adult Cannabis Users
Gaize1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2022年9月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention
研究概览
简要总结
The goal of this study is to develop a cannabis impairment detection device in adult cannabis users. The main question[s] it aims to answer are:
- Is the investigational device accurate and reliable at detecting cannabis impairment?
- is the device safe for the collection of eye movement data from cannabis intoxicated individuals? Participants will be administered a series of Drug Recognition Expert Ocular Tests via the Gaize headset following cannabis consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 19, years or older, having given written informed consent to participate in the research trial and certifying that they will not drive for a period of at least 6 hours post discharge.
- •Having used cannabis at least one time prior
- •Having access to legal cannabis
- •Normal or corrected to normal vision using either glasses or contact lenses, or surgery.
排除标准
- •Enrolled in, or participated in another clinical trial within 30 days before the study
- •Having a prosthetic eye
- •Blood pressure greater than 160/90 mmHg and heart rate greater than 100 bpm.
研究组 & 干预措施
Gaize Device
Experimental
干预措施: Cannabis Impairment Test (Device)
结局指标
主要结局
Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention
时间窗: Immediately after testing.
Number of participants experiencing complications related to the investigational device (headache, dizziness, nausea, etc.)
次要结局
- Drug Recognition Expert Protocol Eye Test Scores(up to 90 minutes)
研究者
研究点 (1)
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