Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Sep;14(6):853-861.
doi: 10.1007/s11739-019-02025-3. Epub 2019 Feb 2.

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

Grant O'Connell  1 , John D Pritchard  2 , Chris Prue  2 , Joseph Thompson  2 , Thomas Verron  2 , Donald Graff  3 , Tanvir Walele  4
Affiliations
Randomized Controlled Trial

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

Grant O'Connell et al. Intern Emerg Med. 2019 Sep.

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 myblu 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.

Keywords: Conventional cigarette; E-cigarette; Electronic cigarette; Nicotine delivery; Nicotine lactate; Nicotine salt; Pharmacokinetics.

PubMed Disclaimer

Conflict of interest statement

GOC, JDP, CP, JT, TV and TW are full time employees of the Imperial Brands Group. Celerion has received funding from several e-cigarette/tobacco manufacturers to conduct pharmacokinetic/pharmacodynamic studies of their products with smokers and vapers, as well as biomarker studies on smokers who switch to vaping.

Figures

Fig. 1
Fig. 1
Pharmacokinetic profiles: mean plasma nicotine concentration by investigational product (linear scale) over 30 min
See this image and copyright information in PMC

References

    1. McNeill A, Brose LS, Calder R, Hitchman SC, Hajek P, McRobbie H (2015) E-cigarettes: an evidence update (Public Health England 2015 report). Public Health England
    1. Royal College of Physicians (2016) Nicotine without smoke: tobacco harm reduction. https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-toba.... Accessed Dec 2018
    1. McNeill A, Brose LS, Calder R, Bauld L, Robson D (2018) Evidence review of e-cigarettes and heated tobacco products 2018. A report commissioned by Public Health England. London
    1. McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P. Electronic cigarettes for smoking cessation and reduction. Cochrane Database Syst Rev. 2014;12:CD010216. - PubMed
    1. Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, Stead LF, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2016;9:Cd010216. - PMC - PubMed

Publication types