Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Liking/effect score of the e-cigarette
研究概览
简要总结
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.
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
- •Cigarette smoker
- •Use of e-cigarettes in the past 30 days
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
Low Dose Nicotine
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: Nicotine (Drug)
Tobacco Flavor
In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: Low Dose Menthol (Other)
Tobacco Flavor
In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: High Dose Menthol (Other)
Low Dose Nicotine
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: Low Dose Menthol (Other)
Low Dose Nicotine
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: High Dose Menthol (Other)
High Dose Nicotine
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: Nicotine (Drug)
High Dose Nicotine
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: Low Dose Menthol (Other)
High Dose Nicotine
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
干预措施: High Dose Menthol (Other)
结局指标
主要结局
Liking/effect score of the e-cigarette
时间窗: Every 30 min for 120 min during lab session
The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor.
次要结局
- Change scores from baseline in Nicotine Withdrawal(Every 30 min for 120 min during lab session)
- Maximum value of money at which the e-cigarette is chosen over money(Every 30 min for 120 min during lab session)
- Change scores from baseline in Tobacco Craving(Every 30 min for 120 min during lab session)