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Evaluation of Cessation Preferences of Menthol Smoker

Evaluation of Cessation Preferences of Menthol Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02020005
Enrollment
60
Registered
2013-12-24
Start date
2013-09-30
Completion date
2013-12-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

menthol cigarettes, smoking cessation

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.

Interventions

OTHERNon-flavored 2mg nicotine gum
OTHERNon-flavored 4mg nicotine gum
OTHERMint-flavored 2mg nicotine gum
OTHERMint-flavored 4mg nicotine gum
OTHERNon-flavored nicotine inhaler
OTHERMint-flavored nicotine ihaler

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Product preference for nicotine replacement6 weeksTo determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.

Secondary

MeasureTime frameDescription
Nicotine content preference6 weeksTo determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026