Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.
Assess the influence of nicotine flux and nicotine form on subjective effects. At AUB, the investigators will assess subjective effects (e.g. product liking, nicotine craving) and puffing topography for 130 participants who will undergo 5 ENDS use sessions (combinations 1-5) consisting of 2 bouts (10 puffs + 60min ad libitum) with 2 fluxes (16 and 32μg/s) x 2 forms (protonated, freebase) and a 0 nicotine condition. In addition, the investigators will use a state-of-the-art device to sample in situ a fraction of the aerosol generated during each puff to verify actual nicotine flux and form, and measure exposure to pulmonary toxicants (carbonyls). The investigators hypothesize that increasing nicotine flux and protonated nicotine will result in greater reductions of nicotine craving, and lower puffing intensity and carbonyl exposure. In addition, 10 participants that completed the five use sessions will attend the lab for one additional visit with the aim of determining the influence of puff-by-puff variation of ENDS power and liquid composition on puffing behavior and sensory effects. During this visit participants will complete three directed puffing bouts (10 puffs). In each bout, participants will alternate puffs between two identical ENDS devices differing by a single design factor (combinations 6-8).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
130
30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated
30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated
30/70 PG/VG ratio with nicotine concentration 4mg/ml free base
30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase
30/70 PG/VG ratio with nicotine concentration 0mg/ml (placebo)
30/70 PG/VG ratio with nicotine concentration 0mg/ml
e-liquid 7: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 8: 30/70 PG/VG ratio with nicotine concentration 8mg/ml protonated
e-liquid 9: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 10: 70/30 PG/VG ratio with nicotine concentration 4mg/ml protonated
American University of Beirut
Beirut, Lebanon
Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures
The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. 10 Items are rated on a five-point scale (Poor=1, Fair=2, Good=3, Very good=4, Excellent=5) with higher scores indicating higher activity.
Time frame: Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence
The corresponding 4-item E-Cigarette Dependence Scale that assesses dependence on ENDS. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Almost Always=5) with higher scores indicating higher activity.
Time frame: Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence
The corresponding 4-item Combustible cigarette Dependence Scale that assesses nicotine dependence for daily and nondaily smokers. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Always=5) with higher scores indicating higher activity.
Time frame: Visit 1 - Before starting the first session
Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence
The Fagerstrom Test of Nicotine Dependence questionnaires that assesses nicotine dependence on ENDS. General questions not based on a scale.
Time frame: Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale
Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-100, not at all - extremely), with higher scores indicating higher effects.
Time frame: Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale
Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) (0-100, most disliked sensation imaginable - most liked sensation imaginable), with higher scores indicating higher effects.
Time frame: Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect
The Drug Effect Questionnaire (DEQ) will measure acute effects consisting of seven items: drug strength, high, feeling stimulated, good effects, bad effects, wanting more drugs, and drug liking and this will be assessed on a subjective scale (0-100, not at all-extremely), with higher scores indicating higher effects.
Time frame: Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges
Smoking urges will be assessed by the smoking urges questionnaire on a subjective scale (0-100, Strongly disagree - strongly agree) with higher scores indicating higher urges.
Time frame: Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami
The Hughes-Hatsukami Withdrawal Questionnaire (HHWQ) will be assessed by the Hughes and Hatsukami 1986 questionnaire on a subjective scale (0-100, Not at all - extremely).
Time frame: Up to 180 minutes
Puff Duration
Measured topography Average Puff Duration (sec).
Time frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Flow rate
Measured topography Average Flow rate (LPM).
Time frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Puff Interval
Measured topography Average Inter Puff Interval (sec).
Time frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Number of Puffs
Measured topography Total Number of Puffs (puffs).
Time frame: Will be measured during the approximately 60-minute, ad lib use bout
Liquid consumed
Liquid consumption for each participant use session will be determined by pre- and post-weighing the ENDS device tank (g/session).
Time frame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Carbonyl compound yield
Total Carbonyls Compounds will be quantified (microg/session).
Time frame: Will be measured after the 60-minute, ad lib use bout
Nicotine flux
Nicotine flux will be quantified (mg/sec).
Time frame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Sensory Feedback - Perceived Mouthful
The perceived mouthful will be assessed using the following question: "How would you rate the amount of smoke filling your mouth during the puff you just smoked?". A subjective visual analog scale will be used (1-5, barely any smoke- a lot of smoke) with higher scores indicating higher mouthful.
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Time frame: Will be measured during the approximately 5-minute, 10-puff use bout
Sensory feedback - Perceived Draw Effort
The perceived draw effort will be assessed using the following question: " How would you rate the effort needed to draw the puff you just smoked?". A subjective visual analog scale will be used (1-5, easy- hard) with higher scores indicating harder draw effort.
Time frame: Will be measured during the approximately 5-minute, 10-puff use bout