A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers

Abstract

E-cigarettes containing ‘nicotine salts’ aim to increase smoker’s satisfaction by improving blood nicotine delivery and other sensory properties. Here, we evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. A randomised, open-label, cross-over clinical study was conducted in 15 healthy US adult smokers. Five different e-cigarette products were evaluated consecutively on different days after use of own brand conventional cigarette. Plasma nicotine pharmacokinetics, subjective effects, and tolerability were assessed following controlled use of the products. The rate of nicotine absorption into the bloodstream was comparable from all e-cigarettes tested and was as rapid as that for conventional cigarette. However, in all cases, nicotine delivery did not exceed that of the conventional cigarette. The pharmacokinetic profiles of nicotine salt emissions were also dependent upon the properties of the e-cigarette device. Subjective scores were numerically highest after smoking a conventional cigarette followed by the my blu 40-mg nicotine salt formulation. The rise in nicotine blood levels following use of all the tested e-cigarettes was quantified as ‘a little’ to ‘modestly’ satisfying at relieving the desire to smoke. All products were well tolerated with no notable adverse events reported. These results demonstrate that, while delivering less nicotine than a conventional cigarette, the use of nicotine salts in e-cigarettes enables cigarette-like pulmonary delivery of nicotine that reduces desire to smoke.

Inhalation Toxicology of Vaping Products and Implications for Pulmonary Health

“…The evidence supporting a role for e-cigarettes in smoking cessation/reduction has not been straightforward. One study of 15 individuals, lead by a popular manufacturer of e-cigarettes, observed that the urge to smoke was reduced by e-cigarettes at plasma levels of nicotine that were lower than obtained with conventional cigarettes [29]. Another prospective 6-month study of 40 smokers with no intention of quitting found a sustained 50% reduction in cigarettes/day at week 24 in 13/40 participants and a sustained 80% reduction in 5/40 participants.…”

Trendy e-cigarettes enter Europe: chemical characterization of JUUL pods and its aerosols

“…These latter devices are comparatively simple and easy to use. Pod systems usually contain highly concentrated nicotine salt formulations and have recently been demonstrated to deliver nicotine nearly equally efficient as combustible cigarettes (Bowen and Xing 2014;O'Connell et al 2019). The high nicotine content of up to 5% (approximately 58 mg/mL), the resulting high pH value of the vapor and the high proportion of free-base nicotine would normally lead to airway irritation (Duell et al 2018).…”

Investigating the Attitudes of Adolescents and Young Adults Towards JUUL: Computational Study Using Twitter Data

“…This suggests that nicotine is being absorbed more efficiently through JUUL pods than through combustible cigarettes — likely a result of cigarette nicotine being combusted into sidestream smoke and JUUL pods’ nicotinic formulation [ 13 ]. JUUL pods contain a protonated form of nicotine known as nicotine salts [ 14 ], of which the absorption resembles freebase nicotine seen in cigarettes [ 15 , 16 ] but has a smoother feel when inhaled and does not taste as bitter [ 13 , 17 ].…”