Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit

Riccardo Polosa, Pasquale Caponnetto, Marilena Maglia, Jaymin B Morjaria, Cristina Russo, Riccardo Polosa, Pasquale Caponnetto, Marilena Maglia, Jaymin B Morjaria, Cristina Russo

Abstract

Background: Electronic cigarettes (e-Cigs) are an attractive long-term alternative nicotine source to conventional cigarettes. Although they may assist smokers to remain abstinent during their quit attempt, studies using first generation e-Cigs report low success rates. Second generation devices (personal vaporisers - PVs) may result in much higher quit rates, but their efficacy and safety in smoking cessation and/or reduction in clinical trials is unreported.

Method: We conducted a prospective proof-of-concept study monitoring modifications in smoking behaviour of 50 smokers (unwilling to quit) switched onto PVs. Participants attended five study visits: baseline, week-4, week-8, week-12 and week-24. Number of cigarettes/day (cigs/day) and exhaled carbon monoxide (eCO) levels were noted at each visit. Smoking reduction/abstinence rates, product usage, adverse events and subjective opinions of these products were also reviewed.

Results: Sustained 50% and 80% reduction in cigs/day at week-24 was reported in 15/50 (30%) and 7/50 (14%) participants with a reduction from 25cigs/day to 6cigs/day (p < 0.001) and 3cigs/day (p < 0.001), respectively. Smoking abstinence (self-reported abstinence from cigarette smoking verified by an eCO ≤10 ppm) at week-24 was observed in 18/50 (36%) participants, with 15/18 (83.3%) still using their PVs at the end of the study. Combined 50% reduction and smoking abstinence was shown in 33/50 (66%) participants. Throat/mouth irritation (35.6%), dry throat/mouth (28.9%), headache (26.7%) and dry cough (22.2%) were frequently reported early in the study, but waned substantially by week-24. Participants' perception and acceptance of the products was very good.

Conclusion: The use of second generation PVs substantially decreased cigarette consumption without causing significant adverse effects in smokers not intending to quit.

Trial registration: (ClinicalTrials.gov Identifier: NCT02124200).

Figures

Figure 1
Figure 1
E-cigarettes are battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette designed for the purpose of providing inhaled doses of nicotine by way of a vaporized solution to the respiratory system. These devices provide a flavor and physical sensation similar to that of inhaled tobacco smoke, while no smoke or combustion is actually involved in its operation. For the purpose of the current study, E-cigarettes can be distinct in first generation (A) and second generation devices (B). First-generation devices, generally mimic the size and look of conventional cigarettes and consist of small lithium batteries and cartomizers (i.e. cartridges, which are usually prefilled with a liquid that bathes the atomizer); their batteries may be disposable (to be used once only) or rechargeable. Second-generation devices, consist mainly of higher-capacity (larger) rechargeable lithium batteries and atomizers with the ability to refill them with liquid (sold in separate vials). In the most recent atomizers you can simply change the atomizer head (resistance and wick) while keeping the body of the atomizer, thus reducing the operating costs. They do not resemble conventional cigarettes.
Figure 2
Figure 2
Recruitment and flow of subjects within the study. A total of 72 subjects with specifically predefined smoking criteria (smoking ≥15 cig/day for at least 10 years) responded to the advert; of these, 9 subjects were not included in the study because they spontaneously seek assistance with quitting (these were then invited to attend the local smoking cessation clinic, which offers standard support with cessation counselling and pharmacotherapy for nicotine dependence). The remaining 63 subjects consented to participate into the study; of these, 13 were not considered eligible because of the exclusion criteria. In the end, 50 volunteers were included in the study and were issued with a second generation PV kit with a full supply of tobacco aroma e-liquid containing 9 mg/ml nicotine. By the end of the study, a total of 12 subjects were lost to follow-up due to failure of attending their control visits. Overall 38 participants were available for analyses at week-24 follow-up visit.
Figure 3
Figure 3
Changes in the mean (±SD) number of conventional cigarettes use per day for each study subgroups throughout the study.
Figure 4
Figure 4
Changes in the mean (±SD) exhaled carbon monoxide (ppm) for each study subgroups throughout the study.
Figure 5
Figure 5
Changes in the mean (±SD) daily e-Liquid consumption per day (mLs/day) for each study subgroups throughout the study.

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Pre-publication history
    1. The pre-publication history for this paper can be accessed here:

Source: PubMed

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