Healthy Volunteers Clinical Trial
Official title:
An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers
The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers. Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.
Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially. ;
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