This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest: 1. What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use? 2. What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products? 3. Beyond nicotine, what other constituents enhance addictive properties?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
381
Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette
UCONN Health Center
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
Time frame: 12 weeks
Toxicant Exposure
Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and urine carcinogens and other tobacco specific nitrosamines.
Time frame: 12 weeks
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Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.