CLINICAL TRIAL PUBLISHED
Results of Dr. Polosa’s Randomized Clinical Trial Published
A team of Italian researchers, directed by Dr. Riccardo Polosa of the University of Catania (Sicily, IT), has published the results of a one-year randomized clinical trial to determine whether electronic cigarettes (e-cigarettes) could help unwilling-to-quit smokers to reduce the number of cigarettes they smoke. Study results were announced at press conference in Boston on June 25.
Even though the goal of the study was smoking reduction, 8.7% of subjects stopped smoking altogether, and an additional 10% reduced the number of cigarettes smoked by 50% of more.
At the Boston press conference, CASAA was represented by president, Elaine Keller, who spoke about the concept of harm reduction — substituting low-risk products for smoking — as well as on consumer viewpoints on FDA regulation of e-cigarettes. CASAA recruited two vapers from the Boston area, Jamie Richard, and Demetra Shelton, who each spoke about the effect e-cigarettes have had on their health.
Dr. Michael Siegel of Boston University School of public health helped to arrange the venue for the press conference. He was also a speaker.
The study, called ECLAT by the researchers, recruited 300 Italian smokers who wanted to cut down on their smoking, but not quit altogether. Subjects were randomly assigned to one of three treatment groups. received a free electronic cigarette kit and cartridges with different dosage of nicotine depending on the study group to which they were assigned. Group A received cartridges containing a total of 7.2 mg nicotine cartridges for 12 weeks; Group B received a 6-week supply of 7.2 mg nicotine cartridges followed by a further 6-week supply of cartridges containing a total of 5.4 mg; Group C received no-nicotine cartridges for 12 weeks.
The research included 9 visits in a year, during which general health conditions, levels of exhaled carbon monoxide, psycho-behavioral characteristics of the smoker and product satisfaction level, were evaluated. There were no serious side effects and the researchers documented a general improvement in health.
After the initial 12-week period participants were informed that no more cartridges would be provided by the investigators, but they were advised to continue using their e-cigarette if they wish to do so. Smoking abstinence rates at 12 weeks were 11%, 17%, and 4% for the three treatment groups. At week 52, the rates were 13%, 9%, and 4%. Those who reduced their number of cigarettes per day by 50% or more were 26%, 20%, and 21% at week 12, and 10%, 9%, and 12% at week 52.
CASAA Scientific Director Carl V Phillips observes that this validates a theory about product substitution that he has acted upon since before e-cigarettes were available: ”If a smoker can be persuaded to just substitute a low-risk alternative for just a few weeks — be that on a bet or as part of a study — there is a good chance that he will choose to stick with it, even though he was not considering switching in the first place.”