Evaluation of Cessation Preferences of Menthol Smokers

Smoking Cessation Clinical Trial

Official title: Evaluation of Cessation Preferences of Menthol Smokers

Status Completed

Clinical Trial Summary

The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, 1) mint-flavored 2mg nicotine gum ; 2) mint-flavored 4mg nicotine gum; 3) non-flavored 2mg nicotine gum; 4) non-flavored 4mg nicotine gum; 5) mint-flavored electronic cigarette; and 6) non-flavored electronic cigarette. Fifty smokers (all African American menthol smokers) will be recruited for this study. Participants will undergo a baseline assessment followed by a 2-week product sampling phase.

Clinical Trial Description

The Family Smoking Prevention and Tobacco Control Act enacted by the US Congress in 2009 gave the Food and Drug Administration (FDA) the authority to regulate tobacco products. In July 2011, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) submitted its final report that included a recommendation that "removal of menthol cigarettes from the marketplace would benefit public health in the US". Available evidence suggest that a ban on menthol cigarettes from US markets could create a situation in which up to 3 million menthol smokers would be interested in quitting smoking and the majority of whom will be ethnic minorities and other at risk groups including youths, and female smokers. However, little empirical evidence is available to guide treatment options for menthol smokers.

The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, 1) mint-flavored 2mg nicotine gum ; 2) mint-flavored 4mg nicotine gum; 3) non-flavored 2mg nicotine gum; 4) non-flavored 4mg nicotine gum; 5) mint-flavored electronic cigarette; and 6) non-flavored electronic cigarette. Fifty smokers (all African American menthol smokers) will be recruited for this study. Participants will undergo a 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 cessation phase is followed by one week of abrupt withdrawal of the product. We will use the two-way ANOVA by ranks to test differences of rank of choice among the six products. We will use a binary variable to record the product each individual chooses. We will apply a repeated-measures logistic regression with generalized estimating equations (GEE) to identify factors associated with their choice of product.

Dissemination activities will occur at local and national levels. At the local level, study findings will be presented at seminars and conferences at the University of Minnesota (UMN) and the Twin Cities area. We will also work with project staff at ClearWay to identify other relevant policy and community stakeholder audiences across the state especially those serving priority populations. At the national level, abstracts of study findings will be presented at national scientific. The research proposed in the current application is an important step to developing an evidence base for effective smoking cessation treatments for menthol smokers.

Study Assessment Schedule Week 0: Consent, baseline assessment/orientation Week 1: Product sampling Week 2: Product sampling Week 3: Product preference scale, Smoking cessation/using preferred product Week 4: Smoking cessation/using preferred product Week 5: Cessation of all products Week 6: Final visit ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

• NCT number: NCT01978197
• Study type: Interventional
• Source: University of Minnesota - Clinical and Translational Science Institute
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Completion date: December 2013