Evaluation of Cessation Preferences of Menthol Smoker

NCT ID: NCT02020005

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

non-flavored 2mg nicotine gum

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.

Group Type: EXPERIMENTAL

Non-flavored 2mg nicotine gum

Intervention Type: OTHER

non-flavored 4mg nicotine gum

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.

Group Type: EXPERIMENTAL

Non-flavored 4mg nicotine gum

Intervention Type: OTHER

mint-flavored 2mg nicotine gum

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.

Group Type: EXPERIMENTAL

Mint-flavored 2mg nicotine gum

Intervention Type: OTHER

mint-flavored 4mg nicotine gum

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.

Group Type: EXPERIMENTAL

Mint-flavored 4mg nicotine gum

Intervention Type: OTHER

non-flavored nicotine inhaler

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.

Group Type: EXPERIMENTAL

Non-flavored nicotine inhaler

Intervention Type: OTHER

mint-flavored inhaler

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.

Group Type: EXPERIMENTAL

Mint-flavored nicotine ihaler

Intervention Type: OTHER

Interventions

Non-flavored 2mg nicotine gum

Intervention Type: OTHER

Non-flavored 4mg nicotine gum

Intervention Type: OTHER

Mint-flavored 2mg nicotine gum

Intervention Type: OTHER

Mint-flavored 4mg nicotine gum

Intervention Type: OTHER

Non-flavored nicotine inhaler

Intervention Type: OTHER

Mint-flavored nicotine ihaler

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kola Okuyemi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2013NTLS014

Identifier Type: -

Identifier Source: org_study_id

NCT01978197

Identifier Type: -

Identifier Source: nct_alias