The Impact of Vaping Ethanol in the Evaluation of Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Preliminary breath test for ethanol
研究概览
简要总结
The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.
排除标准
- •Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
- •Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
研究组 & 干预措施
E-cigarette without ethanol, 10 puffs
干预措施: E-cigarette liquid without ethanol, 10 puffs (Other)
E-cigarette with ethanol, 1 puff
干预措施: E-cigarette liquid with ethanol, 1 puff (Other)
E-cigarette without ethanol, 1 puff
干预措施: E-cigarette liquid without ethanol, 1 puff (Other)
E-cigarette with ethanol, 10 puffs
干预措施: E-cigarette liquid with ethanol, 10 puffs (Other)
结局指标
主要结局
Preliminary breath test for ethanol
时间窗: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)
Initial type of breath test used (gives percent blood alcohol concentration)
Standard Field Sobriety Test
时间窗: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)
Test used to determine sobriety
Evidentiary breath test for ethanol
时间窗: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)
Secondary type of breath test used (gives percent blood alcohol concentration)
次要结局
未报告次要终点