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).
Highlights
Cigarette smoking is a tough addiction to break
Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40 (32.5%) participants, with a median of 25 cig/day (IQR 20, 30) decreasing significantly to 6 cig/day (IQR 5, 6)(p < 0.001)
Overall, combined sustained 50% reduction and smoking abstinence was shown in 22/40 (55%) participants, with a median of 25 cig/day (IQR 20, 30) decreasing significantly to 3 cig/day (IQR 0, 6)(p < 0.001), which is equivalent to an overall 88% reduction
Summary
Cigarette smoking is a tough addiction to break. improved approaches to smoking cessation are necessary. With well over one billion smokers’ worldwide, cigarette smoking is a global epidemic that poses a substantial health burden and costs [1]. There is little doubt that currently-marketed smoking cessation products increase the chance of committed smokers to stop smoking, they reportedly lack high levels of efficacy, especially in the real life setting [8]. This is known to reflect the chronic relapsing nature of tobacco dependence, the need for novel and effective approaches to smoking cessation interventions is beyond doubt
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