A pharmacokinetic study to examine nicotine delivery from e cigarettes and a conventional cigarette in healthy subjects during a brief period of ad libitum use
Keywords:E-cigarette, Nicotine, Pharmacokinetics
Background: Smoking is a leading cause of numerous human disorders including lung cancer, chronic obstructive pulmonary disease, and atherosclerotic cardiovascular disease. Nicotine is primarily responsible for the addictive properties of cigarette smoking whereas other chemical constituents of the cigarette smoke are considered responsible for disease development. Electronic cigarettes (e-cigarettes) deliver a vapour containing nicotine and which is considered to contain significantly less chemical toxicants compared to cigarette smoke. This study will investigate nicotine delivery from a novel e-cigarette device and compare it to that from both a commercially-available e-cigarette and a combustible cigarette.
Methods: This study will examine nicotine pharmacokinetics in subjects while either smoking a cigarette or using one of 5 different e-cigarettes for up to 5 minutes ad libitum. The study is a single-centre, randomised controlled clinical study with a crossover design. Subjects of either gender will be aged 22–55 years (minimum legal smoking age in CA plus 1 year) and a verified smoking status (assessed by exhaled breath CO and urinary cotinine levels). Subjects will be judged to be healthy by medical history, physical examination, vital signs, ECG and clinical biochemistry tests. The primary objectives are to characterize the kinetics of nicotine absorption into the blood of subjects using different e-cigarettes or smoking a cigarette; and to compare nicotine delivery from different e-cigarettes with one another and with that from a conventional cigarette.
Conclusions: Data from this study will advance our scientific understanding of the pharmacokinetics of nicotine in smokers who use different types of e-cigarettes.
International Agency for Research on Cancer. IARC handbooks on cancer prevention, volume 11, Reversal of risk after quitting smoking. Lyon: International Agency for Research on Cancer, 2017.
Doll R, Peto R, Wheatley K, Gray R, Sutherland I. Mortality in relation to smoking: 40 years' observations on male British doctors. BMJ. 1994;309:901-11.
Stratton K, Shetty P, Wallace R, Bondurant S (eds.) Clearing the smoke: assessing the science base for tobacco harm reduction. Washington, DC: Institute of Medicine, National Academy Press, 2001.
Perfetti TA, Rodgman A. The Complexity of Tobacco and Tobacco Smoke. Beitrage Tabakforschung Int. 2011;24:215–32.
Lunell E, Molander L, Ekberg K, Wahren. Site of nicotine absorption from a vapour inhaler – comparison with cigarette smoking. Eur J Clinical Pharmacol. 2000;55:737-741.
Digard H, Proctor C, Kulasekaran A, Malmqvist U, Richter A. Determination of nicotine absorption from multiple tobacco products and nicotine gum. Nicotine Tob Res. 2013;15:255–61.
Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control. 2010;19:98-103.
Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014;23:133-9.
McRobbie H, Phillips A, Goniewicz ML, Smith KM, Knight-West O, Przulj D, et al. Effects of switching to electronic cigarettes with and without concurrent smoking on exposure to nicotine, carbon monoxide, and acrolein. Cancer Prev Res. 2015;8:873-8.
McNeil A, Brose LS, Calder R, Hitchman SC. E-cigarettes: an evidence update A report commissioned by Public Health England, 2015. Available at https://www.gov.uk/government/ uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf. Accessed on 21 September 2017.
Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016.
Brown J, Beard E, Kotz D, Michie S, West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction. 2014;109:1531-40.
Brose LS, Hitchman SC, Brown J, West R, McNeill A. Is the use of electronic cigarettes while smoking associated with smoking cessation attempts, cessation and reduced cigarette consumption? A survey with a 1-year follow-up. Addiction. 2015;110:1160-8.
Zhu S-H, Zhuang Y-L, Wong S, Cummins SE, Tedeschi GJ. E-cigarette use and associated changes in population smoking cessation: evidence from US current population surveys. BMJ. 2017;358:3262.
Nides MA, Leischow SJ, Bhatter M, Simmons M2.. Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system. Am J Health Behav. 2014;38:265-74.
Fearon IM, Eldridge A, Gale N, Shepperd CJ, McEwan M, Camacho OM et al. E-cigarette Nicotine Delivery: Data and Learnings from Pharmacokinetic Studies. Am J Health Behav. 2017;41:16-32.