Evaluation of Cessation Preferences of Menthol Smokers

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