NCT02048852已完成不适用
Manipulating Tobacco Constituents in Female Menthol Smokers
UConn Health4 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 381
- 试验地点
- 4
- 主要终点
- The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
研究概览
简要总结
This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.
详细描述
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:
- What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use?
- What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products?
- Beyond nicotine, what other constituents enhance addictive properties?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 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
- •female 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 by patient or identified in medical record 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 (based on history and drug and alcohol questionaires) or other heart conditions. The study physician will determine whether a given medical condition is unstable and the appropriateness of study participation for a particular subject;
- •Serious quit attempts in the last 3 months (to ensure stability of smoking);
- •regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
- •Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
- •Pregnant or breastfeeding those planning to become pregnant,and those who are of childbearing potential and are not using an "acceptable form" of birthcontrol such as Depo-provera, Norplant, tubal ligation and barrier methods such as condoms or diaphragm.
结局指标
主要结局
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
时间窗: 12 weeks
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
次要结局
- Toxicant Exposure(12 weeks)
研究者
研究点 (4)
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