This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.
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Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1)
Timeframe: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine pharmacokinetics: Time to maximum blood level (Tmax) (Study 1)
Timeframe: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine pharmacokinetics: Area under the curve (AUC) (Study 1)
Timeframe: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine metabolism (Study 1)
Timeframe: At 60 minutes after the start of each puffing session
Reactive oxygen species (ROS) (Study 1)
Timeframe: Up to 2 years
Nicotine toxicity measures (Study 1)
Timeframe: Up to 2 years
In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1)
Timeframe: Up to 2 years
In vitro nicotine toxicity measures: Cytotoxicity (Study 1)
Timeframe: Up to 2 years
In vitro nicotine toxicity measures: Senescence (Study 1)
Timeframe: Up to 2 years
In vitro nicotine toxicity measures: RNA sequencing (Study 1)
Timeframe: Up to 2 years
Nicotine yield (Study 1)
Timeframe: Up to 2 years
Modified Cigarette Evaluation Questionnaire (mCEQ)(Study 1)
Timeframe: Study visits 2 through 9
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Timeframe: Study visits 2 through 9
Drug Effects/Liking Questionnaire (DEQ)(Study 1)
Timeframe: Study visits 2 through 9
Minnesota Nicotine Withdrawal Scale (MNWS)(Study 1)
Timeframe: Study visits 2 through 9
Puffing topography: Puff count (Study1)
Timeframe: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Average puff duration (Study1)
Timeframe: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: inter-puff interval (Study1)
Timeframe: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Flow rate (Study1)
Timeframe: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Volume (Study1)
Timeframe: 60 minute puffing session at each of the 8 study lab visits
General Labeled Magnitude Scale (gLMS) (Study 2)
Timeframe: 1 six hour lab visit
Labeled Hedonic Scale (LHS) (Study 2)
Timeframe: 1 six hour lab visit
Sensory Attributes (Study 2)
Timeframe: 1 six hour lab visit
Overall acceptance: Industry-designed Thermometer Rating Scale (Study 2)
Timeframe: 1 six hour lab visit