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Completed

NCT Number: NCT02020005

Evaluation of Cessation Preferences of Menthol Smoker

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Primary outcomes

  1. Product preference for nicotine replacement

    Time frame: 6 weeks

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

Secondary outcomes

  1. Nicotine content preference

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Evaluation of Cessation Preferences of Menthol Smokers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2013
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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