NCT02592772

Manipulating Tobacco Constituents in Male Menthol Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study examines the potential effect of reducing nicotine content or menthol or both in men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.

Detailed description

The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Reduced Nicotine Non-Menthol (RNC)	Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
OTHER	Reduced Nicotine Menthol (RNC-Men)	Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
OTHER	Conventional Nicotine Non-Menthol (CN)	Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.

Timeline

• Start date: 2016-02-04
• Primary completion: 2019-05-01
• Completion: 2019-06-01
• First posted: 2015-10-30
• Last updated: 2020-04-09

Locations

2 sites across 1 country: United States