Evaluation of Cessation Preferences of Menthol Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Product preference for nicotine replacement
研究概览
简要总结
The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified as African American or Black;
- •Aged 18 years or older;
- •High school graduate or GED;
- •Smoking at least 10 cigarettes daily for the past year;
- •Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;
- •Good physical health (no unstable medical condition);
- •No contraindications for nicotine inhaler or gum use, such as mouth sores or significant dental or jaw problems;
- •Stable, good health.
排除标准
- •Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- •Currently using other tobacco or nicotine products other than cigarettes;
- •Pregnant or nursing.
研究组 & 干预措施
non-flavored 2mg nicotine gum
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Non-flavored 2mg nicotine gum (Other)
non-flavored 4mg nicotine gum
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Non-flavored 4mg nicotine gum (Other)
mint-flavored 2mg nicotine gum
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Mint-flavored 2mg nicotine gum (Other)
mint-flavored 4mg nicotine gum
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Mint-flavored 4mg nicotine gum (Other)
non-flavored nicotine inhaler
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Non-flavored nicotine inhaler (Other)
mint-flavored inhaler
All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.
干预措施: Mint-flavored nicotine ihaler (Other)
结局指标
主要结局
Product preference for nicotine replacement
时间窗: 6 weeks
To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.
次要结局
- Nicotine content preference(6 weeks)