Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change score in Liking/wanting of the e-cigarette
研究概览
简要总结
This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 20 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-20 years
- •Able to read and write
- •Urine cotinine levels of >250 ng/ml at screening appointment
- •Use of e-cigarettes in the past month
- •May or may not currently smoke traditional cigarettes
排除标准
- •Seeking smoking cessation treatment
- •Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
- •Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
- •Current or past history of psychosis or other psychiatric diagnosis such as major depression
- •Any significant current medical condition
研究组 & 干预措施
E-cigarette flavor
In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.
干预措施: Nicotine (Drug)
E-cigarette flavor
In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.
干预措施: Experimental Flavor (Other)
Menthol Flavor
In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.
干预措施: Nicotine (Drug)
Menthol Flavor
In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.
干预措施: Menthol Flavor (Other)
No Flavor
In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.
干预措施: Nicotine (Drug)
结局指标
主要结局
Change score in Liking/wanting of the e-cigarette
时间窗: Baseline (+10 minutes) to end of lab session (+40 minutes)
The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session
次要结局
- Change score in rating of coolness(Baseline (+10 minutes) to end of lab session (+40 minutes))
- Number of puffs(End of ad-lib lab session 4 (+40 minutes))
- Change score in rating of total sensation(Baseline (+10 minutes) to end of lab session (+40 minutes))
- Change score in rating of sweetness(Baseline (+10 minutes) to end of lab session (+40 minutes))
- Change score in Tobacco Craving(Baseline (+10 minutes) to end of lab session (+40 minutes))
- E-cigarette value(Baseline (+10 minutes) to end of lab session (+40 minutes))
- Change score in rating of harshness/irritation(Baseline (+10 minutes) to end of lab session (+40 minutes))
- Change score in rating of sourness(End of lab session (+40 minutes))
- Change score in rating of fruitiness(Baseline (+10 minutes) to end of lab session (+40 minutes))