Manipulating Tobacco Constituents in Female Menthol Smokers
- Conditions
- Nicotine Dependence
- Registration Number
- NCT02048852
- Lead Sponsor
- UConn Health
- Brief Summary
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.
- Detailed Description
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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 381
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. 12 weeks Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
- Secondary Outcome Measures
Name Time Method Toxicant Exposure 12 weeks 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.
Trial Locations
- Locations (2)
UCONN Health Center
🇺🇸Farmington, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
UCONN Health Center🇺🇸Farmington, Connecticut, United States