NCT02048852

Manipulating Tobacco Constituents in Female Menthol Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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?

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Reduced Nicotine Content- Non Menthol	Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
OTHER	Reduced Nicotine Content- Menthol	Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
OTHER	Conventional Nicotine Content- Menthol	Allow own brand of Conventional Nicotine-Menthol Cigarette
OTHER	Conventional Nicotine Content- Non Menthol	Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-03-01
• Completion: 2020-07-01
• First posted: 2014-01-29
• Last updated: 2021-03-19

Locations

2 sites across 1 country: United States