Effects of E-Cigarette Flavors on Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change Score in Liking/Wanting of E-cigarette
研究概览
简要总结
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.
详细描述
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.
As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21-34 years or 35 -50 years
- •Able to read and write
- •Smoking >/= 1 cigarettes or cigars/day
- •Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
- •Not seeking treatment to stop smoking
排除标准
- •Daily use of other drugs including prescribed psychoactive drugs
- •Any significant current medical or psychiatric condition
- •Known hypersensitivity to propylene glycol
- •Pregnant or lactating females
研究组 & 干预措施
Low nicotine, tobacco
6 mg nicotine combined with tobacco flavored e-juice
干预措施: Nicotine (Drug)
Low nicotine, tobacco
6 mg nicotine combined with tobacco flavored e-juice
干预措施: Flavor (Drug)
Low nicotine, menthol
6 mg nicotine combined with menthol flavored e-juice
干预措施: Nicotine (Drug)
Low nicotine, menthol
6 mg nicotine combined with menthol flavored e-juice
干预措施: Flavor (Drug)
Low nicotine,cherry
6 mg nicotine combined with cherry flavored e-juice
干预措施: Nicotine (Drug)
Low nicotine,cherry
6 mg nicotine combined with cherry flavored e-juice
干预措施: Flavor (Drug)
High nicotine, tobacco
18 mg nicotine combined with tobacco flavored e-juice
干预措施: Nicotine (Drug)
High nicotine, tobacco
18 mg nicotine combined with tobacco flavored e-juice
干预措施: Flavor (Drug)
High nicotine, menthol
18 mg nicotine combined with menthol flavored e-juice
干预措施: Nicotine (Drug)
High nicotine, menthol
18 mg nicotine combined with menthol flavored e-juice
干预措施: Flavor (Drug)
High Nicotine, cherry
18 mg nicotine combined with cherry flavored e-juice
干预措施: Nicotine (Drug)
High Nicotine, cherry
18 mg nicotine combined with cherry flavored e-juice
干预措施: Flavor (Drug)
Low Nicotine, Vanilla
6 mg nicotine combined with vanilla flavored e-juice
干预措施: Nicotine (Drug)
Low Nicotine, Vanilla
6 mg nicotine combined with vanilla flavored e-juice
干预措施: Flavor (Drug)
High Nicotine, Vanilla
18 mg nicotine combined with vanilla flavored e-juice
干预措施: Nicotine (Drug)
High Nicotine, Vanilla
18 mg nicotine combined with vanilla flavored e-juice
干预措施: Flavor (Drug)
结局指标
主要结局
Change Score in Liking/Wanting of E-cigarette
时间窗: Baseline (+10 minutes) to end of lab session (+40 minutes)
The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)
次要结局
未报告次要终点
