Evaluation of Cessation Preferences of Menthol Smokers
- Conditions
- Smoking Cessation
- Interventions
- Other: Mint-flavored nicotine ihalerOther: Non-flavored 2mg nicotine gumOther: Mint-flavored 4mg nicotine gumOther: Mint-flavored 2mg nicotine gumOther: Non-flavored 4mg nicotine gumOther: Non-flavored nicotine inhaler
- Registration Number
- NCT02020005
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description mint-flavored inhaler Mint-flavored nicotine ihaler 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. non-flavored 2mg nicotine gum 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. mint-flavored 4mg nicotine gum 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. mint-flavored 2mg nicotine gum 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. non-flavored 4mg nicotine gum 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. non-flavored nicotine inhaler 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.
- Primary Outcome Measures
Name Time Method Product preference for nicotine replacement 6 weeks To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.
- Secondary Outcome Measures
Name Time Method Nicotine content preference 6 weeks To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.
Trial Locations
- Locations (1)
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States