A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhaltion of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
67
Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
Vince & Associates Clinical Research
Overland Park, Kansas, United States
To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. Baseline adjustments to the (non-adjusted) PK endpoints will also be presented.
Time frame: 7 days
To assess exhaled carbon monoxide [CO] following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum
Exhaled CO levels will be measured using a Bedfont Micro+ Smokerlyzer or similar device and levels at Screening and after product use will be assessed.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using the "modified Product Evaluation Scale (mPES)"
Change in Evaluation; Scale: 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" (items 1, 2, 3, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9, 10, 16, and 18); and "Relief" (item 11, 13, 14, 15, and reversed for item 19) and single items 17 and 20 will be summarized.
Time frame: 7 Days
To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Time frame: 7 Days
To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Time frame: 7 Days
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Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
Treatment with usual brand cigarette (10 puffs).
To assess the safety and tolerability of short-term use of four JUUL 5% ENDS.
Number of participants with Adverse Events associated with use of JUUL 5% Device will be described by individual listings and frequency tables.
Time frame: 7 Days
To characterize product use of four JUUL 5% ENDS during controlled use sessions.
All product use data will be summarized using descriptive statistics. The difference in weight pre- and post- product use of each JUUL product and comparator e-cigarettes will be summarized.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Intent to Use Again Questionnaire.
The Intent to Use Again questionnaire will be assessed using a 100 mm bipolar VAS
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Nicotine Withdrawal Questionnaire.
The nicotine withdrawal will be assessed using a 100mm visual analog scale (VAS)
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Direct Effect Questionnaire.
Product direct effect will be assessed using a 100 mm VAS
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Liking Questionnaire.
Product liking will be assessed using a 100 mm VAS
Time frame: 7 Days