Manipulating Tobacco Constituents in Male Menthol Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
研究概览
简要总结
This study examines the potential effect of reducing nicotine content or menthol or both in men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
详细描述
The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •smoking at least 5 menthol cigarettes daily for the last year;
- •able to speak, read and understand English;
- •male age 18 -45 years of age;
- •stable residence;
- •not intending to quit smoking within the next 6 weeks.
排除标准
- •unstable psychiatric disorder (Psychiatric symptoms reported that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.);
- •substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week;
- •history of cardiovascular disease;
- •current blood clot in arms or legs;
- •blood pressure >160/100;
- •unstable medical problems which may include but are not limited to immune system disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems, substance abuse or dependence that would limit patients ability to follow experimental protocol
- •Serious quit attempts in the last 3 months;
- •regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
- •currently using nicotine replacement or other tobacco cessation products
结局指标
主要结局
Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
时间窗: Baseline, 6 weeks, and 12 weeks
Data analyses will include subjects from this study matched to female subjects from the parent study.
次要结局
- Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).(Baseline, 6 weeks, and 12 weeks)
- Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.(Baseline)
- Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).(Baseline, 6 weeks, and 12 weeks)
- Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)(Baseline, 6 weeks, and 12 weeks)