Evaluation of Cessation Preferences of Menthol Smokers

Smoking Cessation Clinical Trial

Official title:

Evaluation of Cessation Preferences of Menthol Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978197
• Other study ID #: RC 2013-0003
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2013
• Last updated: April 27, 2015
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• self-identified African American or Black race (mixed race including black also eligible)

• aged 18 to 75

• high school diploma or General Educational Development (GED) certificate

• smoked at least 5 cigarettes daily for the past year

• smokes >80% menthol cigarettes

• in stable good physical health

Exclusion Criteria:

• recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-IV criteria

• contraindications for nicotine gum or e-cigarette use, such as mouth sores or significant dental or jaw problems

• currently using other tobacco or nicotine products other than cigarettes

• currently pregnant or nursing

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

Intervention

Drug:
• Menthol nicotine polacrilex gum 2 mg

• Menthol nicotine polacrilex gum 4 mg

• Nicotine polacrilex gum 2 mg

• Nicotine polacrilex gum 4 mg

• Menthol electronic cigarette

• Regular electronic cigarette

Locations

Country	Name	City	State
United States	University of Minnesota, Delaware Clinical Research Unit	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Clearway MN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants choosing each product	The number of participants who choose to use each of the six different smoking cessation aids for the two week period in which participants will attempt to quit smoking	Week 3	No
Primary	Participants' ranking of products	At the end of the sampling period participants will rank products from one to six according to which ones they liked best.	Week 3	No
Secondary	Factors influencing product choice	We will do logistic regression analysis to determine the influence of product characteristics (type, flavor, nicotine content) and individual characteristics (age, gender, baseline nicotine dependence) on product choice.	Week 3	No