EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study

BACKGROUND: Electronic cigarettes (e-cigarettes) are becoming increasinglypopular with smokers worldwide. Users report buying them to help quit smoking, toreduce cigarette consumption, to relieve tobacco withdrawal symptoms, and tocontinue having a 'smoking' experience, but with reduced health risks. Researchon e-cigarettes is urgently needed in order to ensure that the decisions ofregulators, healthcare providers and consumers are based on science. MethodsECLAT is a prospective 12-month randomized, controlled trial that evaluatessmoking reduction/abstinence in 300 smokers not intending to quit experimentingtwo different nicotine strengths of a popular e-cigarette model ('Categoria';Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100)received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges;GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The studyconsisted of nine visits during which cig/day use and exhaled carbon monoxide(eCO) levels were measured. Smoking reduction and abstinence rates werecalculated. Adverse events and product preferences were also reviewed.RESULTS: Declines in cig/day use and eCO levels were observed at each studyvisits in all three study groups (p<0.001 vs baseline), with no consistentdifferences among study groups. Smoking reduction was documented in 22.3% and10.3% at week-12 and week-52 respectively. Complete abstinence from tobaccosmoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. Asubstantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants' perceptionand acceptance of the product under investigation was satisfactory.CONCLUSION: In smokers not intending to quit, the use of e-cigarettes, with orwithout nicotine, decreased cigarette consumption and elicited enduring tobaccoabstinence without causing significant side effects.TRIAL REGISTRATION: ClinicalTrials.gov NCT01164072 NCT01164072.