To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.
This will be a single-center, randomized, open-label, parallel study during which up to 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
210
An electronic cigarette
An electronic cigarette
An electronic cigarette
Clinical Research Consortium (CRC)
Tempe, Arizona, United States
Central Kentucky Research Associates (CKRA)
Lexington, Kentucky, United States
St. Louis Clinical Trials (SLCT)
St Louis, Missouri, United States
Midwest Clinical Research (MCRC)
Dayton, Ohio, United States
Cmax (Maximum baseline-adjusted nicotine plasma concentration)
To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
Time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
AUCnic0-60
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.
Time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
Tmax
Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.
Time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
AUCnic0-15
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
Time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
PLoverall
Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.
Time frame: 13 Minutes
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An electronic cigarette
An electronic cigarette
A combustible cigarette
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, United States