Abstract

BackgroundThis randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette.MethodsFive e-cigarettes with different e-liquid formulations containing 1.6 % and 2.4 % nicotine and a conventional tobacco cigarette were randomized among 24 subjects under two exposure sessions consisting of a 30-min controlled and a one-hour ad lib use period to assess plasma nicotine levels, impacts on smoking urge and adverse events. The 30-min controlled use session comprised an intensive use of the e-cigarettes with a total of 50 puffs taken every 30 s for comparison to a single conventional cigarette having a typical machine-measured nicotine yield (~0.8 mg). Ad lib product use conditions provided insight into more naturalistic product use behaviors and their accompanying smoking urge reductions. Adverse events (AEs) were assessed by the Principal Investigator.ResultsSignificant (p < 0.05) increases in plasma nicotine concentrations occurred within 10 min of controlled e-cigarette use and significant (p < 0.001) reductions from baseline smoking urge were observed within 5 min. E-cigarette and cigarette nicotine plasma levels were comparable for up to one hour of use. After both sessions (90 min), nicotine exposure was the highest for the cigarette, with all e-cigarettes showing 23 % to 53 % lower plasma concentrations. During controlled use, peak reduction in smoking urge for e-cigs occurred later than for the cigarette. After completion of both sessions, significant smoking urge reduction persisted for most of the tested e-cigarettes, albeit at levels lower than that provided by the tobacco cigarette. Nicotine content, vehicle differences, and the presence of menthol did not significantly affect smoking urge reduction by the e-cigarettes. No subjects were discontinued due to AEs. The most frequently reported AEs events included cough, throat irritation, headache, and dizziness.ConclusionsBlood plasma nicotine levels obtained from short-term use of e-cigarettes containing 1.6 % and 2.4 % nicotine were significant, but lower than those of conventional tobacco cigarettes, yet the reduction in craving symptoms were broadly comparable. The types of AEs were consistent with other research studies of longer duration that have reported that use of e-cigarettes by adult smokers is well-tolerated.Trial Registrationhttp://ClinicalTrials.gov identifier: NCT02210754. Registered 8 August 2014.

Highlights

  • This randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette

  • The secondary objectives were to assess the tolerability and any adverse events associated with the study products following short-term use under intensive controlled use conditions, as well as under more natural ad-lib use conditions

  • The mean puff counts were fairly comparable across products, averaging between 49.5 and 60.3, with the highest and lowest mean puff counts again noted with the 1.6 % nicotine products

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Summary

Introduction

This randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette. More recent studies have reported that experienced subjects using later-generation e-cigarettes containing 9 to 24 mg/mL of nicotine attain significant increases in plasma nicotine concentrations over baseline values that can be similar to those obtained from conventional cigarette smoking [9,10,11]. These results suggest that an acclimation to the product may be necessary for naïve smokers to become familiar with the characteristics of the specific e-cigarettes in order to effectively use them in a subjectively enjoyable manner. This is quite consistent with a perspective that the substantial sensory and behavioral aspects of cigarette smoking that are mimicked by e-cigarettes may provide meaningful relief of the cigarette cravings commonly reported by abstinent smokers

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