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Evaluation of Cessation Preferences of Menthol Smokers

Not Applicable
Completed
Conditions
Smoking Cessation
Interventions
Other: Mint-flavored nicotine ihaler
Other: Non-flavored 2mg nicotine gum
Other: Mint-flavored 4mg nicotine gum
Other: Mint-flavored 2mg nicotine gum
Other: Non-flavored 4mg nicotine gum
Other: 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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
mint-flavored inhalerMint-flavored nicotine ihalerAll 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 gumNon-flavored 2mg nicotine gumAll 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 gumMint-flavored 4mg nicotine gumAll 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 gumMint-flavored 2mg nicotine gumAll 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 gumNon-flavored 4mg nicotine gumAll 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 inhalerNon-flavored nicotine inhalerAll 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
NameTimeMethod
Product preference for nicotine replacement6 weeks

To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.

Secondary Outcome Measures
NameTimeMethod
Nicotine content preference6 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

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