Evaluation of Cessation Preferences of Menthol Smokers

University of Minnesota (UMN)

Status: Completed

Conditions: Smoking Cessation

Treatments: Other: Mint-flavored 4mg nicotine gum; Other: Non-flavored 2mg nicotine gum; Other: Non-flavored nicotine inhaler; Other: Mint-flavored 2mg nicotine gum; Other: Non-flavored 4mg nicotine gum; Other: Mint-flavored nicotine ihaler

Study type: Interventional

Funder types: Other

Identifiers

NCT02020005

2013NTLS014

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 6 patient groups

non-flavored 2mg nicotine gum

Experimental group

Description:

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.

Treatment:

Other: Non-flavored 2mg nicotine gum

non-flavored 4mg nicotine gum

Experimental group

Description:

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.

Treatment:

Other: Non-flavored 4mg nicotine gum

mint-flavored 2mg nicotine gum

Experimental group

Description:

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.

Treatment:

Other: Mint-flavored 2mg nicotine gum

mint-flavored 4mg nicotine gum

Experimental group

Description:

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.

Treatment:

Other: Mint-flavored 4mg nicotine gum

non-flavored nicotine inhaler

Experimental group

Description:

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.

Treatment:

Other: Non-flavored nicotine inhaler

mint-flavored inhaler

Experimental group

Description:

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.

Treatment:

Other: Mint-flavored nicotine ihaler