Evaluation of Cessation Preferences of Menthol Smokers

Not Applicable

Completed

• Conditions: Smoking Cessation

• 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

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Product preference for nicotine replacement	6 weeks	To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.

Secondary Outcome Measures

Name	Time	Method
Nicotine content preference	6 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