Pharmacokinetic and subjective assessment of prototype JUUL2 electronic nicotine delivery system in two nicotine concentrations, JUUL system, IQOS, and combustible cigarette

Goldenson, Nicholas I.; Augustson, Erik; Chen, Joey; Shiffman, Saul

doi:10.1007/s00213-022-06100-0

Cited by 15 publications

(11 citation statements)

References 37 publications

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“…Cigarettes and HTP 1 both reduced cravings [ 28 ]. The manufacturer of the pod e-cigarette has tested different versions of their e-cigarette in comparison with HTP 1 and cigarettes in smokers (half of them being ever-users of electronic nicotine delivery systems) in two sets: controlled (10 puffs, 30 s intervals, 3 s puff duration, 32 participants) and ad libitum (over 10 min, 30 participants) [ 26 ]. The controlled use yielded similar results to the ones presented herein, with C max values of 24.83 ng/mL and 13.68 ng/mL for cigarettes and HTP 1, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Two Different Heated Tobacco Products vs. Cigarettes: Comparison of Nicotine Delivery and Subjective Effects in Experienced Users

Vukas,

Mallock-Ohnesorg,

Rüther

et al. 2023

Toxics

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Heated tobacco products (HTPs) produce aerosol using a different mechanism than tobacco cigarettes, leading to lower emissions of some harmful substances, but also of nicotine as reported by some independent studies. Lower nicotine delivery could lead to compensatory puffing when product use does not sufficiently satisfy cravings. Thus, this three-arm crossover study was conducted to characterize the potential of two different HTPs to deliver nicotine and satisfy cravings compared with conventional cigarettes in users who had already switched to HTPs. Fifteen active, non-exclusive HTP users consumed the study products according to a pre-directed puffing protocol. At predetermined time points, venous blood was sampled and the subjective effects of consumption were assessed. Nicotine delivery by both HTPs was comparable, but significantly lower than that by conventional cigarettes, suggesting a lower addictive potential. Cravings were reduced by all products, with no statistically significant differences between them, despite the different nicotine deliveries. This indicated that HTPs do not necessarily need high nicotine deliveries with high addictive potential, as are characteristic of tobacco cigarettes. These results were followed up on with an ad libitum use study.

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Section: Discussionmentioning

confidence: 99%

“…Nicotine delivery of HTPs has mostly been studied by product manufacturers [ 23 , 24 , 25 , 26 ], and only a few studies on HTP 1 have been published without conflicts of interest [ 27 , 28 ]. To the best of our knowledge, the two HTPs discussed herein have not yet been compared with each other in a single kinetic study.…”

Section: Introductionmentioning

confidence: 99%

Two Different Heated Tobacco Products vs. Cigarettes: Comparison of Nicotine Delivery and Subjective Effects in Experienced Users

Vukas,

Mallock-Ohnesorg,

Rüther

et al. 2023

Toxics

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“…Multiple factors contributed to the high quit rate observed among IQOS-HTP and JustFog-EC users: (1) participants were keen to switch to combustion-free NDAs; (2) personalized motivational counseling was administered by psychologists proficient in both smoking cessation and harm reduction at each study visit; (3) top selling products in their respective category (ie, JustFog for ECs and IQOS for HTPs) were given for free in the study and most participants found these products appealing; (4) study products had a pharmacokinetic profile of nicotine uptake mimicking that of conventional cigarettes [ 36 , 37 ]; (5) participants perceived the study products as less harmful than their own cigarettes; and (6) regular use of study products relieved cigarette-induced symptoms and improved exercise tolerance.…”

Section: Discussionmentioning

confidence: 99%

Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial

Caponnetto¹,

Campagna²,

Maglia³

et al. 2023

JMIR Public Health Surveill

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Background People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. Objective We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. Methods We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide–confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. Results A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. Conclusions Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. Trial Registration ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748

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“…Particularly, puff duration is a primary determinant of the quantity of emissions generated 27,66,67 although other parameters such as puff volume may also have an influence, 68 and it has also been reported that the impact of changing topography on emissions is not uniform and may vary depending on the toxicant being assessed. 69 While more intense puffing on e-cigarettes can increase the aerosol mass of nicotine and give rise to more cigarette-like performance, which could increase the ability of e-cigarettes to act as a substitute for conventional cigarettes, [70][71][72] it can also increase the levels of any harmful toxicants within the e-cigarette emissions. For this reason, utilising puffing topography information collected from users is likely to support the generation of a more accurate assessment of likely nicotine uptake/ exposure and to facilitate a stronger toxicological risk assessment for the use of a given e-cigarette.…”

Section: How Can Puff Topography Inform Emissions Testing?mentioning

confidence: 99%

E‐cigarette puffing topography: The importance of assessing user behaviour to inform emissions testing

Wadkin¹,

Allen²,

Fearon

2022

Drug Testing and Analysis

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Analysis of the chemical composition of e‐cigarette emissions is an important step in determining whether e‐cigarettes offer both individual and population‐level harm reduction potential. Commonly, e‐cigarette emissions for chemical analysis are collected when using e‐cigarettes according to standardised puffing regimens, such as those recommended by the International Organization for Standardization (ISO) or the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA). While the use of such standard puffing regimens affords a degree of uniformity between studies and are also recommended by regulatory authorities who require the submission of e‐cigarette emissions data to make decisions regarding allowing a product to be commercially marketed, the standardised regimens do not necessarily reflect human puffing behaviour. This can lead to under‐ or over‐estimating real‐world emissions from e‐cigarettes and inaccuracy in determining their harm reduction potential. In this review, we describe how human puffing behaviour (topography) information can be collected both in the clinical laboratory and in the real world using a variety of different methodologies. We further discuss how this information can be used to dictate e‐cigarette puffing regimens for collecting emissions for chemical analyses and how this may lead to better predictions both of human yields of e‐cigarette emissions constituents and of risk assessments to predict e‐cigarette tobacco harm reduction potential.

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Pharmacokinetic and subjective assessment of prototype JUUL2 electronic nicotine delivery system in two nicotine concentrations, JUUL system, IQOS, and combustible cigarette

Cited by 15 publications

References 37 publications

Two Different Heated Tobacco Products vs. Cigarettes: Comparison of Nicotine Delivery and Subjective Effects in Experienced Users

Two Different Heated Tobacco Products vs. Cigarettes: Comparison of Nicotine Delivery and Subjective Effects in Experienced Users

Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial

E‐cigarette puffing topography: The importance of assessing user behaviour to inform emissions testing

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