2023-509993-49-00已完成4 期
Nitrous oxide abuse in traffic – A clinical study of the blood concentrations and driving ability during and after short recreational intake.
Koebenhavns Universitet1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年3月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- the blood concentration curve for nitrous oxide following the imitated recreational intake of nitrous oxide
研究概览
简要总结
To determine the pharmacokinetic elimination rates of nitrous oxide from the body as measured in blood samples following short recreational intake.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Holder of a Danish driving license for ≥ 1 year
- •Have ≥ 200 km of driving experience during the last year
- •Informed consent
- •Ability to read and understand Danish
排除标准
- •No visible signs of injuries or conditions that might hinder the use of inhalation device
- •No known medical history or diagnose contra-indicated for the use of the IMP
- •Positive pregnancy test (females only)
- •Failed eyesight tests
- •No major simulator sickness after training
- •Self-reported history of addictive behavior or a former/current regular recreational use of nitrous oxide
结局指标
主要结局
the blood concentration curve for nitrous oxide following the imitated recreational intake of nitrous oxide
the blood concentration curve for nitrous oxide following the imitated recreational intake of nitrous oxide
次要结局
- the driving ability before, during and after imitated recreational intake of nitrous oxide, measured on a medium-fidelity driving simulator
研究者
Brian Schou Rasmussen
Scientific
Koebenhavns Universitet
研究点 (1)
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