Evaluation of Cessation Preferences of Menthol Smokers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Cessation Preferences of Menthol Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Non-flavored 2mg nicotine gum
* Other: Non-flavored 4mg nicotine gum
* Other: Mint-flavored 2mg nicotine gum
* Other: Mint-flavored 4mg nicotine gum
* Other: Non-flavored nicotine inhaler
* Other: Mint-flavored nicotine ihaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-flavored 2mg nicotine gum<br>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. | Other: Non-flavored 2mg nicotine gum<br> <br> |
| Experimental: non-flavored 4mg nicotine gum<br>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. | Other: Non-flavored 4mg nicotine gum<br> <br> |
| Experimental: mint-flavored 2mg nicotine gum<br>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. | Other: Mint-flavored 2mg nicotine gum<br> <br> |
| Experimental: mint-flavored 4mg nicotine gum<br>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. | Other: Mint-flavored 4mg nicotine gum<br> <br> |
| Experimental: non-flavored nicotine inhaler<br>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. | Other: Non-flavored nicotine inhaler<br> <br> |
| Experimental: mint-flavored inhaler<br>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. | Other: Mint-flavored nicotine ihaler<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product preference for nicotine replacement | To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine content preference | To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol cigarettes, smoking cessation