The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes.

Objectives: In this paper, we characterize the nicotine delivery profile of a variable voltage, tank-style electronic nicotine delivery system (ENDS). Methods: Ten cigarette smokers (8 men, 2 women) completed this within-subject study assessing effects of 2 device power settings (15 W, 45 W) and 3 liquid nicotine concentrations (0, 3, and 6 mg/ml) using a tank-style ENDS. Participants completed one directed (10 puffs) and one ad libitum use period for each condition, with blood sampled throughout. Results: Plasma nicotine concentration did not increase significantly at 15 W regardless of liquid nicotine concentration. At 45 W, mean plasma nicotine increased (not significantly compared to 0 mg/ml) from 2.24 ng/ml (SD = 0.2) at baseline to 3.4 ng/ml (SD = 0.6) in the 3 mg/ml condition. In the 6 mg/ml, 45 W condition, mean plasma nicotine increased significantly (compared to 0 mg/ml) from 2.0 ng/ml (SD=0) at baseline to 5.96 ng/ml (SD = 1.3) after 10 puffs. In general, puf duration and volume decreased as device power and nicotine concentration increased. Conclusions: Despite using a variable wattage, tank-style device, nicotine delivery was minimal. These results, when combined with results from other studies using tank-style devices, highlight ENDS performance heterogeneity. Regulation may play a role in standardizing ENDS nicotine delivery.

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Part Two: Pharmacokinetic Evaluation of E-Liquid Flavors of Vuse Solo Electronic Nicotine Delivery System, An Unblinded, Parallel, Randomized Study To Assess Nicotine Uptake In Smokers

10.21203/rs.3.rs-1061045/v1 ◽

2021 ◽

Author(s):

Kyung Soo Hong ◽

Patricia DeLuca ◽

Tao Jin ◽

Bobbette A. Jones ◽

Paul Nelson ◽

...

Keyword(s):

Delivery System ◽

Human Subjects ◽

Randomized Study ◽

Maximum Plasma ◽

Investigational Product ◽

Time Curve ◽

Blood Samples ◽

Nicotine Concentration ◽

Nicotine Delivery ◽

Ad Libitum

Abstract This paper reports the findings of a randomized nicotine pharmacokinetic (PK) study of a closed electronic nicotine delivery system (ENDS). The study evaluated four flavor variants of Vuse Solo ENDS where subjects used their randomized investigational product (IP) for 10 minutes ad libitum and blood samples were collected for PK assessments that included maximum plasma nicotine concentration (Cmax) and area under the nicotine concentration-vs-time curve up to 60 minutes (AUCnic0–60). Baseline-adjusted mean Cmax ranged from 6.53 to 8.21 ng/mL, and mean AUCnic0–60 ranged from 206.87 to 263.52 ng*min/mL for all ENDS IPs. Results for Cmax and AUCnic0-60 values were consistent among the ENDS IP flavor variants tested and results indicate that flavors did not affect nicotine uptake in human subjects.

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Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum and comparator electronic nicotine delivery system

Drug and Alcohol Dependence ◽

10.1016/j.drugalcdep.2020.108441 ◽

2020 ◽

Vol 217 ◽

pp. 108441

Author(s):

Nicholas I. Goldenson ◽

August R. Buchhalter ◽

Erik M. Augustson ◽

Mark L. Rubinstein ◽

Dennis Van Hoof ◽

...

Keyword(s):

Delivery System ◽

Abuse Liability ◽

Nicotine Gum ◽

Nicotine Delivery

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Abuse liability assessment of the JUUL system in four flavors relative to combustible cigarette, nicotine gum and a comparator electronic nicotine delivery system among adult smokers

Drug and Alcohol Dependence ◽

10.1016/j.drugalcdep.2020.108395 ◽

2020 ◽

Vol 217 ◽

pp. 108395

Author(s):

Nicholas I. Goldenson ◽

August R. Buchhalter ◽

Erik M. Augustson ◽

Mark L. Rubinstein ◽

Jack E. Henningfield

Keyword(s):

Delivery System ◽

Abuse Liability ◽

Nicotine Gum ◽

Nicotine Delivery

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Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol

BMJ Open ◽

10.1136/bmjopen-2018-023850 ◽

2018 ◽

Vol 8 (10) ◽

pp. e023850

Author(s):

Catherine S Wall ◽

Rose S Bono ◽

Rebecca C Lester ◽

Cosima Hoetger ◽

Thokozeni Lipato ◽

...

Keyword(s):

Clinical Laboratory ◽

Subjective Effects ◽

Latin Square ◽

Abuse Liability ◽

Smoke Inhalation ◽

Nicotine Concentration ◽

The Past ◽

The Usa ◽

Behavioural Economic ◽

Scientific Meetings

IntroductionIn the USA, Food and Drug Administration regulations prohibit the sale of flavoured cigarettes, with menthol being the exception. However, the manufacture, advertisement and sale of flavoured cigar products are permitted. Such flavourings influence positive perceptions of tobacco products and are linked to increased use. Flavourings may mask the taste of tobacco and enhance smoke inhalation, influencing toxicant exposure and abuse liability among novice tobacco users. Using clinical laboratory methods, this study investigates how flavour availability affects measures of abuse liability in young adult cigarette smokers. The specific aims are to evaluate the effect of cigar flavours on nicotine exposure, and behavioural and subjective measures of abuse liability.Methods and analysesParticipants (projected n=25) are healthy smokers of five or more cigarettes per day over the past 3 months, 18–25 years old, naive to cigar use (lifetime use of 50 or fewer cigar products and no more than 10 cigars smoked in the past 30 days) and without a desire to quit cigarette smoking in the next 30 days. Participants complete five laboratory sessions in a Latin square design with either their own brand cigarette or a session-specific Black & Mild cigar differing in flavour (apple, cream, original and wine). Participants are single-blinded to cigar flavours. Each session consists of two 10-puff smoking bouts (30 s interpuff interval) separated by 1 hour. Primary outcomes include saliva nicotine concentration, behavioural economic task performance and response to various questionnaire items assessing subjective effects predictive of abuse liability. Differences in outcomes across own brand cigarette and flavoured cigar conditions will be tested using linear mixed models.Ethics and disseminationThe Virginia Commonwealth University Institutional Review Board approved the study (VCU IRB: HM20007848). Dissemination channels for study findings include scientific journals, scientific meetings, and policy briefs.Trial registration numberNCT02937051.

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An Experimental Test of the Relationship between Electronic Nicotine Delivery System Use and Alcohol Consumption

Alcoholism Clinical and Experimental Research ◽

10.1111/acer.14566 ◽

2021 ◽

Author(s):

Alexandra R. Hershberger ◽

Amanda Studebaker ◽

Zachary T. Whitt ◽

Mark Fillmore ◽

Christopher W. Kahler ◽

...

Keyword(s):

Alcohol Consumption ◽

Delivery System ◽

Experimental Test ◽

Nicotine Delivery ◽

System Use ◽

The Relationship

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Electronic nicotine delivery system reduces exposure to tobacco‐related carcinogens

Cancer ◽

10.1002/cncr.33863 ◽

2021 ◽

Vol 127 (18) ◽

pp. 3280-3281

Author(s):

Mary Beth Nierengarten

Keyword(s):

Delivery System ◽

Nicotine Delivery

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A Descriptive Analysis of Transitions from Smoking to Electronic Nicotine Delivery System (ENDS) Use: A Daily Diary Investigation

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126301 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6301

Author(s):

Tamlin S. Conner ◽

Jiaxu Zeng ◽

Mei-Ling Blank ◽

Vicky He ◽

Janet Hoek

Keyword(s):

Delivery System ◽

Descriptive Analysis ◽

Daily Diary ◽

Extended Period ◽

Dual Use ◽

Quit Attempt ◽

Quit Smoking ◽

Nicotine Delivery ◽

Study Participants ◽

Tobacco Usage

Objectives: We aimed to examine patterns in smoking and electronic nicotine delivery system (ENDS) use over an extended period of time (up to 20 weeks) in people who smoked and who had never previously made a successful quit attempt using an ENDS. Design and setting: We conducted a longitudinal mixed-methods study in Dunedin, New Zealand, during 2018 and 2019. Participants: Purposively selected participants (N = 45; age (≥18 years), gender, ethnicities, cigarettes/day) who wished to quit smoking. Interventions: Participants were provided with a second-generation ENDS device (vape pen or starter “tank” device) at the start of their quit attempt, and asked to complete smartphone-based daily diary surveys assessing smoking and ENDS use. Outcome measures: Sunburst plots and a sequence plot were used to describe weekly and daily patterns of smoking and ENDS use (smoking only, ENDS use only, dual use, abstinent). Results: The most frequently reported movements among participants, classified according to their study week behaviour, occurred between dual use and exclusive ENDS use (and vice versa). A smaller group reported moving from dual use to exclusive smoking (and often back to dual use), and a small number reported moving between abstinence and different ENDS and smoked tobacco usage behaviours. Data visualisations focussing on those participants who had provided data during each of weeks 9–12 indicate that only a minority reported sustained dual use; instead, most participants indicated varied smoked tobacco and ENDS use, which included periods of dual use. Conclusions: The considerable variety observed within and between study participants suggests that high variability is typical rather than exceptional. Transitions from smoking to ENDS use may involve considerable periods of dual use, which is likely to be dynamic and potentially sustained over several months.

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