NCT03084315

Changes in Biomarkers Associated With Use of Electronic Cigarettes

Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.

Detailed description

This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.

Conditions

• Biomarkers

Interventions

Type	Name	Description
DEVICE	E-Cig Zero Nicotine	E-Cig Zero Nicotine
DEVICE	E-Cig 24mg Nicotine	E-Cig 24mg Nicotine

Timeline

• Start date: 2016-11-15
• Primary completion: 2019-03-08
• Completion: 2019-03-08
• First posted: 2017-03-20
• Last updated: 2021-08-26
• Results posted: 2020-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study