Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study

Abstract

BackgroundCigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated.MethodsIn this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.ResultsSustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5%) participants; their median of 25 cigs/day decreasing to 6 cigs/day (p < 0.001). Sustained 80% reduction was shown in 5/40(12.5%) participants; their median of 30 cigs/day decreasing to 3 cigs/day (p = 0.043). Sustained smoking abstinence at week-24 was observed in 9/40(22.5%) participants, with 6/9 still using the e-Cigarette by the end of the study. Combined sustained 50% reduction and smoking abstinence was shown in 22/40 (55%) participants, with an overall 88% fall in cigs/day. Mouth (20.6%) and throat (32.4%) irritation, and dry cough (32.4%) were common, but diminished substantially by week-24. Overall, 2 to 3 cartridges/day were used throughout the study. Participants' perception and acceptance of the product was good.ConclusionThe use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597).

Characteristics of e-cigarette users and their perceptions of the benefits, harms and risks of e-cigarette use: survey results from a convenience sample in Ottawa, Canada

“…sore/dry mouth or throat and cough) are often reported in the literature. 14,17,28,29 This finding is not surprising as aerosol propylene glycol and glycerin, the primary ingredients of e-liquid, are associated with mouth and throat irritation. It is possible that these side effects would eventually diminish (half the participants had been using e-cigarettes for at most 14 months at the time of the survey).…”

“…It is possible that these side effects would eventually diminish (half the participants had been using e-cigarettes for at most 14 months at the time of the survey). 16,29 Some respondents reported potentially more serious health effects-4 noted heart palpitations and 3 reported chest pain. In a summary of adverse events potentially related to e-cigarettes, Chen 28 noted that chest pain and rapid heartbeat have been reported to the Food and Drug Administration.…”

Acute electronic cigarette use: nicotine delivery and subjective effects in regular users

“…Whilst surveys and small scale clinical studies suggest successful replacement of smoking with e-cigarettes due to the presence of nicotine (Dawkins et al, 2013;Etter & Bullen, 2011;Polosa et al, 2011;Siegel, Tanwar & Wood, 2011), effects of vaping on blood nicotine levels are relatively unexplored. In the current study, a significant increase in plasma nicotine level was observed 10 mins after taking 10 puffs on the e-cigarette (from 0.74 ng/ml to 6.77 ng/ml).…”

“…Whilst surveys of users and small scale clinical studies suggest their potential for smoking cessation and harm 4 reduction (Caponneto et al, 2013;Dawkins et al, 2013;Etter & Bullen, 2011;Polosa et al, 2011) their ability to deliver nicotine is under-explored.…”

The Regulatory Challenge of Electronic Cigarettes

“…7,8 However, longitudinal analysis using population-level data found no difference in quit rates between e-cigarette users and nonusers. 9 Controlled clinical trials and populationlevel observational cohort studies are needed to establish the utility of these cigarettes to facilitate smoking cessation.…”