Professor Riccardo Polosa, MD, PhD, is Director of the Institute for Internal Medicine and Clinical Immunology of the University of Catania – Italy. He is also in charge of the University Centre for Tobacco Research (CPCT – University of Catania) and Honorary Professor of Medicine at Southampton University (UK). He is author of more than 200 peer reviewed articles and books mainly covering respiratory medicine, clinical immunology, and tobacco addiction. He is interviewed here by Paul Bergen from tobaccoharmreduction.org.
Paul: Your recent research (page since removed) (summarised on the Ashtray blog here (page since removed)) exploring e-cigarettes as aids in reducing cigarette smoking has garnered some press. Before we discuss the implications of your research, I have a few questions about the study itself. You had 40 participants who were characterized as “unwilling to quit”. Were they asked to attempt to quit or simply exposed to and provided with e-cigarettes as an additional nicotine source?
Riccardo: The forty volunteers in our study were recruited through advertising in a local newspaper. In the ad, the study was promoted as an opportunity to try out a new, cleaner substitute for tobacco smoking (e-cig) and to monitor its impact on smoking habits. Thus volunteers in the study participated with the intention of trying out something new and not to quit smoking. In fact, although participants were offered free smoking cessation services at any stage of the study, none registered in our centre for canonical smoking cessation services.
Paul: One potential confounder I see is that it has been found that for some people (admittedly just a few) simply being part of a program about smoking (any sort of program) will cause them to reassess their behavior and reduce their smoking? Was the “unwilling to quit” condition a control for this effect?
Riccardo: It is well known that just by asking people about their smoking frequency may increase their likelihood to think about (or revisit earlier thoughts of) quitting and therefore increases their likelihood of quitting. Being part of our study could have caused participants to reassess their behavior and reduce their smoking anyway. However, selecting smokers “unwilling to quit” can be a control for this effect. Furthermore, smokers “unwilling to quit” represent a more relevant target from a public health perspective because of the tobacco harm reduction potential of the e-cig.
Paul. Can you describe what the actual sessions consisted of?
Riccardo: Eligible participants (healthy smokers, 18-60 years old, smoking 15 factory-made cigs/day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days) were invited to our clinic. During the first baseline visit, basic demographic and a detailed smoking history were taken. Additionally, levels of carbon monoxide in exhaled breath were measured. Participants were then given a free e-cigarette kit (Categoria; Arbi Group Srl, Milano, Italy) containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-cigarette. A free supply of 7.4 mg nicotine cartridges (‘Original’ cartridges; Arbi Group Srl, Milano, Italy) was also provided throughout the study and participants were trained on how to load them onto the e-cigarette’s atomizer. Participants were invited to use it whenever they wanted and to attend a four follow up visits at week-4, week-8, week-12 and week-24. At these visits we recorded their exhaled carbon monoxide levels and collected completed study diaries and unused study products.
Paul: I also suspect that the “unwilling to quit” condition might increase the likelihood of the self reporting about smoking behavior to be true. Though these are good test subjects for how well this alternative might work under the worst conditions, I can imagine that this group might include a few people who were determined not to succeed. Do you feel you had a few subjects of that sort?
Riccardo: That is possible. Two individuals in the study repeatedly reported of having heard by word of mouth of extremely serious adverse events in people admitted to a local hospital because of “water in the lung” due to regular e-cig use. Moreover, they used this argument to dissuade other participants from completing our study. We attempted to verify their stories and realized they were mere fabrications. We ignored the motives for their conduct. These two participants were lost to follow up.
Paul: Though any study can be criticized on some basis, this does seem to show that even people who are not thinking of quitting might switch to e-cigarettes (thus reducing their risk without even being motivated to do so)? If they were so unwilling to quit, why do you think that those that switched or quit actually did so?
Riccardo: For some participants, satisfaction from e-cig use was good enough to compensate for their need of own cigarette brand. This by itself can explain the behavior change in the 9 participants (22.5%) who were not smoking at week 24. The replacement of the ritual of smoking gestures, the opportunity to reduce a bad smell, to reduce cost of buying traditional cigarettes, and the perception of an improved general sense of well being might have been responsible for their switching/quitting. In exposure terms, quitting equates to switching to the e-cig.
Paul: You write that mouth and throat irritation, and dry cough, decreased over the months. Do you mean that smoking related effects decreased or that this was the decrease in vaping related effects?
Riccardo: Mouth and throat irritation and dry cough were commonly reported in the initial few weeks of e-cig use, but subsided with time. Some of these effects might have been due to the sensori-motor effect of nicotine or to the non-specific irritant effect of propylene glycol present in the cartridge. It is possible that by avoiding traditional cigarettes the threshold for the reported effects could have been reduced.
Paul: This is a small study and described as a pilot. Are you already engaged in a follow-up to this?
Riccardo: Yes, we are about to collect the 6-month data point of our larger randomized clinical trial, with three hundred volunteers (smokers ‘unwilling to quit’) randomized in three study arms (high, low and no nicotine groups).
Paul: The results are quite positive and agree with what seems to be occurring in the real world. Not only are almost all vapers former smokers but many report not actively trying to quit until they tried e-cigarettes. Any thoughts on that?
Riccardo: The status quo in smoking cessation presents smokers with just two unpleasant alternatives: quit or die. But, there is a third choice for smokers: switching to the e-cig. The use of e-cig allows smokers to introduce nicotine from a much safer source than a lit cigarette and to keep the gestures associated with smoking. Switching to the e-cig may increase smokers’ confidence in making a more important change in their lifestyle – quitting.
Paul: I know that e-cigarettes are legal in Italy (correct me if I am wrong). What is your sense of how many people are using them? Do you see many vendors? Do you see people using them and what is the general reaction in public to them?
Riccardo: In Italy, Categoria e-cigarettes (including those with nicotine) are the only one approved by the Italian Institute of Health. However, precise legislation (particularly in relation to the liquid contained in the e-cig) does not currently exist (neither in Italy nor at a global level) and this will be required at some stage to guarantee the safety of consumers. We are now working towards this direction.
In Italy, smokers appear to be buying them to help quit smoking, to reduce cigarette consumption and to relieve tobacco withdrawal symptoms due to workplace smoking restrictions. Also, a “novelty” effect of this new product must be taken into account, with many smokers willing to show off their new gadget in front of their fellow smokers and to the public. The general reaction to e-cigs is somewhat negative as they are perceived by the public (and by policy makers) as cigarettes substitute. Better information about this product is necessary to ensure widespread adoption.
Paul: Question: Does this mean that Categoria has a monopoly or just that it is the only approved product in the category?
Riccardo: Any e-cigarette suppliers are allowed to do business in Italy but only Categoria has official approval. This was obtained after extensive product testing.
Paul: You have been working in the area of nicotine dependence for some time. What prompted you to investigate e-cigarettes?
Riccardo: For many years several experts in tobacco control and nicotine dependence have been hoping to see a gadget that could deliver nicotine in a safe manner and substitute the behavioral/sensori-motor need for the tobacco cigarette. The e-cigarette has the potential of being such a gadget, because it can give to smokers what they want thanks to the combined effect of hand-to-mouth motion and nicotine. And it is much safer than a lit cigarette. Working in the area of nicotine dependence for many years has convinced me that we, as health professionals, should also take care of the smokers who are unable or unwilling to quit. To this end, the e-cig is an opportunity not to be missed. The urge to better understand the potential of their role in the smoker’s life prompted us to set up a trial to investigate the e-cig.
Paul: Do you see vaping as the best current answer to nicotine dependence of just another alternative?
Riccardo: I think that e-cig is a good solution to reduce the use of traditional cigarettes and their associated risk. Other valid options for tackling nicotine dependence in smokers exist, but it is still a personal choice how to introduce nicotine in his/her body. Each individual smoker should find a best way to reduce or eliminate his or her own smoking. In theory, at least for westernized cultures, vaping is a far better option than smoking. And it could save millions of lives.
Paul: Any additional thoughts on e-cigarettes, smoking or nicotine that you would like to express?
Riccardo: Yes, any further improvement in their manufacturing standards and easy of use will definitely foster a wider adoption of the e-cig and a steeper reduction in smoking prevalence.