Interview by Paul Bergen
Dr. Riccardo Polosa graciously agreed to discuss the findings in his latest research on smokers enrolled in a smoking cessation study testing the effectiveness of e-cigarettes (both nicotine and non-nicotine) for quitting smoking.
PLB: Perhaps one of the most intriguing aspects of this study is selecting individuals who were not planning on quitting, using a product intended for nicotine maintenance rather than cessation and still achieving a quit rate competitive with cessation therapies given to people who want to quit. Leaving aside the idea (which you bring up in the paper) that there may have been people unintentionally predisposed to quitting enrolled in the study, apart from the product (e-cigarettes) one could ask: is the intention to quit perhaps less important than we think it is?
RP: This is likely to be correct. For many smokers (probably even more so for those who, despite the intense tobacco control policy adopted in the US, are still smoking - the so called hard core smokers) intention to quit is not the main reason why they would switch to an E-cigarette. It is a known fact that many smokers enjoy smoking and the main reason for trying and adopting these products is to perpetuate their smoking behavior, without having to worry or to feel guilty about the harmful effect of tobacco smoke.
The corollary of this is that, the more similar is the behavioral and sensorial experience of tobacco smoking reproduced by vaping, the more likely smokers will switch and adopt E-cigarettes long term. It is interesting to note how product development and public health actually coincide in this case! This is also supported by the observation that in the ECLAT study abstinence rates remain pretty stable at each study visits throughout the whole 52-week period. This is something you do not normally observe in a typical smoking cessation study, where quit rates tend to progressively decline in the first few months before plateauing.
Beside the need to perpetuate a behavior, I believe that the element of curiosity also played an important role in switching and initially adopting the e-cig in the ECLAT study. Please note that when we started recruiting in early 2010 these products were virtually unknown by the general public in Italy (awareness has increased exponentially since then, and these products today are generally well-known).
PLB: There is this myth circulating that everyone who smokes wants to quit. Obviously the fact that so many people still smoke belies that. The great thing about e-cigarettes is that they are safe enough (and safer than some recommended cessation routes such as varenicline) that quitting or not becomes more an issue of whether the user wants to rather than a health concern. If we accept that there is little difference between continuing to use nicotine or not and no stated intention of quitting, why do you think people did quit?
RP: I thank you for giving me the opportunity of expanding a few important concepts that could not be addressed in the journal article due to editorial space limitations. In our study, switching to e-cigs resulted in complete smoking abstinence in about 10% of smokers not intending to quit; of these only 26.9% were still using the product by the end of the observational period. Thus, 73.1% of regular e-cig users ended up quitting vaping as well. Probably, the fact that participants were not supplied with the product beyond the 12-week intervention phase of the study and that its commercial availability during the extension phase was poor has produced an unexpected effect. Many regular vapers confronted with the situation of not being supplied with (or able to acquire) the product, rather than relapsing in tobacco smoking realized to be strong enough to free themselves also from the behavioral component of smoking that was being reproduced by vaping the product under investigation (not that surprising, considering that the product under investigation was underperforming by today’s e-cig standards). In this regard, the product under investigation was not very 'addictive' and in fact, given the population under investigation, was instrumental to beating participants smoking addiction/behavior.
As I said earlier we cannot exclude that there may have been people unintentionally predisposed to quitting enrolled in the study. For these individuals the e-cig might have facilitated a lingering need for a change in behavior. E-cig might have been stimulated subconsciously progression through the stages of change (from pre-contemplation to contemplation to determination to action - i.e. quitting).
PLB: In general you found that reduction rates seemed roughly the same for all groups (high, medium and no nicotine vaping) but quit rates were higher for the high nicotine e-cigarette users. This ends up in a bit of ambiguity since the no nicotine group liked their product the least and many of the subjects in that group also did not like the flavor. They could have lower quit levels because they did not like them or because they weren’t getting as much nicotine. So either you need to meet the user drug need or at least you need to make the product quite attractive.
RP: Quit rates were consistently lower for the no nicotine study group, with no substantial difference between high and medium nicotine groups (this is also supported by the finding that saliva cotinine levels were similar in both groups). A problem in the study was that the poor taste of the no nicotine product (we were not aware of this when we commenced the study). We believe that sensorial factors rather than the absence of nicotine have driven down success rates in this subgroup. As always the truth stands in the middle. There are different smokers’ phenotypes; those who are addicted to nicotine ('medicated' by nicotine) on an extreme end and those who smoke for the pleasure of smoking (sensorial, behavioral, social factors) on the opposite end, with a variety of mixed phenotypes in between. For those in need of their daily dose of nicotine it is best to invest on high-performance products that are able to satisfy their personal need of nicotine. For those who enjoy smoking is best to ensure a product that satisfies their psycho-sensorial components, especially those related to taste.
PLB: I also found it interesting that 1) that there were complaints about the brand used and yet 2) people would still recommend them to other smokers. As to the first part, I think that a problem with any study in this area that attempts to standardize the product aspect will run up against individual preferences that could affect successful quitting. In the real world vapers explore brands until the find one they like and sometimes they abandon the idea because of a first experience with something that did not meet their expectations. Having an adlib approach to the use is superior to most cessation studies but can you imagine having a preliminary phase where participants tried a number of different brands to find one that tasted good and in general met their definition of a “good smoke”?
RP: We are not reinventing the wheel. ECLAT is an important study, but it has its own limitations (drawbacks). Nonetheless, we can learn a lot when we consider that these limitations may form the basis for future E-cig related research. Indeed, those who relapsed (probably we have also to include many lost to follow ups) seem to have returned to their own tobacco brand because of a first experience with something that did not meet their expectations. Furthermore, we have submitted for publication a 24-month follow up study of our first pilot exploring real world attitudes of vapers failing entry products and switching to intermediate level products. My research team at the University of Catania is now collecting evidence that individual sensorial expectations are critical for improving success rates in E-cig clinical trials. Therefore, we have designed study protocols that include a run-in phase in which participants could try different brands/models/aroma so that they can adopt the one they considered their personal best, before being formally enrolled in the trial. That is what I call personalized 'medicine' applied to e-cig clinical research!
PLB: And as to the second point, it was reported that even people who did not have the best experience still recommended the brand to smokers they knew. I don’t know if that is typical behavior among to be quitters of other methods, but it does indicate that one person being exposed to e-cigarettes might end up with someone else quitting.
As a quit method they have built in advertising in that you can see them as opposed to just about every other method. Ultimately it does seem to say that even people who were not happy with their e-cigarette still liked the basic idea of it.
RP: Yes, it was surprising to see that even people who did not have the best experience with the e-cig were still recommending the electronic product to other smokers. Trends in the product perception scoring may follow different trajectory at different time points and it is possible that scoring at later time points (smoker’s preference was only assessed at week-12, -24 and -52) may not reflect early (positive) perception of the product. This may in part explain the discrepancy. It is also possible, as you suggest, that even users who were not happy with the product under investigation still liked the basic idea of it and recognized the potential for other types of smokers (i.e. social smokers vs chain smokers). Last but not least, there might be a psychological component that can explain this discrepancy. Generally quitting is contagious in the sense that if a smoker quit by a method, whatever it is, almost always tries to involve other smokers to use the same strategy. However, the opposite is also true: if I fail with that method I would still recommend it to prove that also other smokers will equally fail.
PLB: You make the comment that “e-cigarettes [help reduce] cigarette consumption and elicits enduring tobacco abstinence without causing significant side effects in individuals unable or not wishing to quit can be seen as an emerging novel approach to tobacco harm reduction...these products may also be attractive in managing smokers who are not ready to repeat a quit attempt and decline further assistance after relapse”.
If I understand you correctly you mean that e-cigarettes are successful in helping people quit precisely because it does not feel like quitting. And of interest is the idea that a bad quitting experience could forestall future quitting attempts. Again this could be an argument for making nicotine alternatives as attractive as possible.
RP: Spot on! E-cigs encourage smokers to spontaneously do something good for their health. An efficient, attractive, adequately priced, and widely available product has the potential of becoming a major strategic weapon for the success in the fight against tobacco worldwide.
PLB: You also mention something that I did see crop up elsewhere in that a number of people who switched from smoking to vaping ended up quitting nicotine altogether. (And in a group that was never intending to quit.) Though we accept that nicotine is important to the experience, could it be that once you have a attractive enough substitute (like the smoke, the nicotine, essentially the same experience) but with a little difference that separates you from the previous behavior that you are freer to pursue abstinence? I do know that in my own experience having tobacco in the vicinity felt more compelling to me than having an e-cigarette around like I do now. This is purely anecdotal but I suspect it has something to do with breaking from the one burning unit to the whenever and however many puffs experience. The burning unit seems to be almost a demand in comparison to the e-cigarette invitation.
RP: In principle we all agree that traditional cigarettes are more efficient in term of nicotine release and also more attractive for some sensorial aspects associated with tobacco taste. However, typically the act of smoking is also often coupled with the sense of guilt that derives from the knowledge that smoking and combustion are bad for someone’s health. A much safer product that can reproduce the experience of “smoking without smoking” is a revolutionary opportunity for smokers that now can pursue abstinence without giving up the pleasure that derives from their smoking behavior. That is why I am convinced that with the development of newer more attractive products that can replicate a personalized smoking experience will make important weapons for the success in the fight against tobacco.
PLB: You note that “those who abstained completely from tobacco from the beginning of the study were more likely to stay quit at subsequent follow-ups, whereas those who at first became reducers (dual users) were more likely to relapse later on in the study”. Do you think that perhaps those who switched over at once were those “unintentionally ready to quit”?
RP: Although, we cannot exclude that those who switched over at once were those “unintentionally ready to quit”, I believe that a better explanation for this phenomenon is that immediate adaptation and regular use of the product under investigation empowered e-cig users to gain the necessary confidence to do something good for their health (i.e. stay quit long term). Conversely, the reason for reducers (dual users) being more likely to relapse later on in the study was mainly associated with the poor adaptation with the model under investigation.
Conversely, the reason for reducers (dual users) being more likely to relapse later on in the study was mainly associated with the poor adaptation (i.e. unsatisfactory smoker’s preference for the product) with the model under investigation.
PLB: One thing that crossed my mind as I read the study is that this is all good news even though anti-nicotine groups could seize on the fact that some relapsed. My view is that even if most people ended up still smoking a little or ended up for some reason relapsing years later that at least during this period they were not smoking. Those dual users cut down their cigarettes whenever they were vaping instead. In a sense it does not matter if they are a perfect solution - all that matters is that they help somewhat.
RP: I could not agree more! In spite of the fact that the product under investigation (2009) was quite underperforming by current (2013) standards, it was clearly helpful to smokers. This has to be considered in view of the notion that for smokers not able or not interested in quitting smoking cessation specialists do not have anything better to offer. Hence, ECLAT’s findings indicate that the glass is half full, not half empty and that the ecig is a friend, not an enemy.
PLB: Thank you for your time Dr. Polosa.