The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Blood Alcohol Concentration
研究概览
简要总结
The purpose of this research study is to determine if ethanol-containing e-cigarettes impact ethanol breath, blood or oral fluid 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
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •e-cigarette users
- •alcohol consumers
- •willing to provide informed consent
- •able to attend the lab sessions as needed
- •agree to use designated products according to study protocol.
排除标准
- •- Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
结局指标
主要结局
Blood Alcohol Concentration
时间窗: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Blood alcohol concentration (BAC) level was determined 6 times over 6 hours to assess for changes in BAC from use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Breath Alcohol Concentration
时间窗: Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Breath Alcohol Concentration (BrAC) was assessed 12 times over 6 hours to determine changes in BrAC from the use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Oral Fluid Alcohol Concentration (OFAC)
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Oral fluid alcohol concentration (OFAC) was assessed 9 times over 6 hours to determine changes in OFAC from the use of an e-cigarette containing ethanol compared to use of an e-cigarette without ethanol.
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
时间窗: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
时间窗: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
时间窗: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethyl sulfate was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
时间窗: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
时间窗: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
时间窗: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
时间窗: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl sulfate was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
时间窗: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking.
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
时间窗: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
次要结局
- Horizontal Gaze Nystagmus(Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).)
- Walk and Turn Test(Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).)
- One Leg Stand Test(Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).)