Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Cigarette choice
研究概览
简要总结
The purpose of this study is to evaluate reactions to, and choices to self-administer, cigarette smoke with varying nicotine content among low-frequency, non-dependent adolescent/young adult smokers between the ages of 15-25 years.
详细描述
Participants will undergo three sessions in which their reactions to fixed doses of smoke from investigational cigarettes with three different nicotine contents (15.8 mg/gram of tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •between the ages of 15-25
- •use nicotine or tobacco products between 1-15 days/month for at least 6 months
- •smokes at least 5 cigarettes/month
- •no unstable or significant medical or psychiatric conditions
- •breath alcohol value=0.000
- •able to provide contact information for two individuals who can corroborate smoking status
排除标准
- •use of illegal drugs as measured by urine drug screen (excluding THC)
- •serious quit attempt in the past 3 months
- •plans to quit smoking in the next 2 months
- •current use of nicotine replacement therapy or other tobacco cessation products
- •inability to attend all required experimental sessions
- •blood pressure >160/100 mmHg
- •pregnant, trying to become pregnant, or breastfeeding
结局指标
主要结局
Cigarette choice
时间窗: 30 minutes after sampling all 3 study cigarettes
Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke.
Subjective reactions to fixed doses of tobacco smoke
时间窗: Immediately after puff administration of each study cigarette
Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes
次要结局
- Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration(Immediately after puff administration of each study cigarette)
- Smoking topography - interpuff interval(During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes))
- Smoking topography - number of puffs(During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes))
- Mood and Affect(Immediately after puff administration of each study cigarette)