Efficiency and Safety of an Electronic Cigarette as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study
A new study from PLOS One, recently demonstrated that e-cigarettes hold promise in serving as a means for reducing the number of cigarettes smoked, and can lead to enduring tobacco abstinence as has also been shown with the use of FDA-approved smoking-cessation medications.
In view of the fact that subjects in this study had no immediate intention of quitting, the reported overall abstinence rate of 8.7% at 52-week was remarkable. In comparison, in a study of varenicline in smokers that were motivated to quit, the group treated with 1.0 mg twice per day experienced a 52-week quit rate of 14.4% versus 4.9% in the control group.
Moreover, these positive results were obtained together with an important reduction in frequency of reported symptoms. Although, these data are promising, they are not definitive and more research about long term safety of these products is still required.
Study Design
The study is a three-arms double-blind, controlled, randomized, clinical trial designed to assess the efficacy and safety of ‘Categoria’ e-cigarette loaded with 7.2 mg nicotine and 5.4 mg nicotine cartridges in comparison to no-nicotine cartridges. At baseline, participants were randomized into three separate study groups. The randomization sequence was computer generated by using blocks size of 15 with an allocation ratio of 5:5:5 for each of the three study conditions (A, B, and C). Participants randomized in study group A received 12 weeks supply of 7.2 mg nicotine cartridges; those in study group B, two 6-week supplies of cartridges, one of the 7.2 mg nicotine cartridges and a further 6 weeks with supply of 5.4 mg nicotine cartridges; participants in study group C received 12 weeks supply of no-nicotine cartridges (i.e. control). Blinding was ensured by the identical external appearance of the cartridges. The hospital pharmacy was in charge of randomization and packaging of the cartridges. A prospective evaluation of efficacy and safety was repeated at two additional follow up visits at 24- and 52-weeks. Thus the study consisted of a total of nine visits: a baseline visit and eight follow up visits (at week-2, week-4, week-6, week-8, week-10, week-12, week-24 and week-52).
You can see the full study report here: Efficiency and Safety of an Electronic Cigarette as Tobacco Cigarettes Substitute
