A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
25
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
Christchurch Clinical Studies Trust Ltd
Christchurch, New Zealand
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.
Time frame: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
Time frame: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax (Maximum measured plasma concentration over the duration of the measurement interval.
Time frame: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
Time frame: 48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Tmax(Time of the maximum measured plasma concentration over the duration of the measurement interval. If the maximum value occurs at more than one time point within the time span specified, Tmax is defined as the first time point with this value
Time frame: 48 days
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Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
Measure exhaled Carbon Monoxide change in all product administration periods
To estimate change in exhaled carbon monoxide (CO) for 8 E-cigarettes/cigarettes Products, in all product administration periods under 2 different delivery (10 puff and ad-libitum) conditions. Exhaled CO will be measured 5-15 minutes prior to initiation of the first inhalation, and up to 15 minutes after the collection of the 30 minute PK sample
Time frame: 48 days
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
To characterize measures of subjective effects with use of 8 E-cigarettes/cigarettes Products under 2 different delivery (10 puff and ad-libitum) conditions using a modified Product Evaluations Scale questionnaire using scale below after collection of the 30-minute PK sample and exhaled CO measurement. Change in Evaluation: 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, 7= extremely Four multi- item subscales will be derived from "Satisfaction" (questions 1, 2, 3, and 12); "Psychological Reward" (questions 4 through 8); "Aversion" (questions 9, 10, 16, and 18) and "Relief" (questions 11, 13, 14, 15, and reversed for question 19) and single questions 17 and 20 will be summarized.
Time frame: 48 days
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
To characterize consumptions of 8 E-cigarettes/cigarettes products within-each and between-all delivery conditions (10 puffs versus ad-libitum puffs), by collecting total number of puffs.
Time frame: 48 days