Tuesday, February 09, 2010

Reported Results of First Clinical Trial on Electronic Cigarettes Suggest that These Devices are Much Safer than Previously Thought

According to an article on the CNN web site, the results of the first clinical trial of electronic cigarettes are now available and the chief finding is apparently that the electronic cigarettes tested delivered almost no nicotine to users.

According to the article: "'Electronic cigarettes' that vaporize nicotine juice to inhale instead of smoke from burning tobacco do not deliver as promised, according to research at Virginia Commonwealth University. 'They are as effective at nicotine delivery as puffing on an unlit cigarette,' said Dr. Thomas Eissenberg, at the school's Institute for Drug and Alcohol Studies. His study, funded by the federal National Cancer Institute, is the first by U.S. doctors to check the function of so-called 'no-smoke tobacco' devices, which are unregulated in the United States for sale or use." ...

"The latest clinical evidence suggests users are not getting the addictive substance they get from smoking tobacco. 'These e-cigs do not deliver nicotine,' Eissenberg said of the findings he expects to publish in an upcoming issue of Tobacco Control, a product of the British Medical Journal Group. This past summer, Eissenberg recruited smokers without prior experience using e-cigarettes to volunteer to use two popular brands of the devices for a set period. The 16 subjects were regularly measured in a clinical setting for the presence of nicotine in their bodies, their reported craving for conventional cigarettes, and certain physiological effects such as a change in heart rate. 'Ten puffs from either of these electronic cigarettes with a 16 mg nicotine cartridge delivered little to no nicotine,' the study found."

The clinical trial is described here.

The Rest of the Story

If the findings of this study are accurate (and generalizable to other e-cigarette brands), then the major implication of this research is that electronic cigarettes are probably far safer than has previously been thought.

The major health concern related to electronic cigarettes is that they deliver nicotine, which is thought to contribute to cardiovascular disease, especially with long-term exposure. In addition, nicotine is highly addictive and its continued use leads to dependence, which is itself associated with negative consequences.

However, if this new research is accurate, then the main health concern associated with electronic cigarettes is actually much less of a concern than previously thought. If electronic cigarettes do not deliver much nicotine, then the problems associated with long-term exposure to, and dependence to, nicotine are ameliorated and no longer of concern.

In other words, if this research is accurate (and generalizable), then electronic cigarettes may not only be a safer alternative to smoking, they might actually be a safe alternative.

While I think this research demonstrates that at least two brands of electronic cigarettes do not appear to deliver much nicotine, these results conflict with some other laboratory findings, such as the finding that nicotine is present as 1.5% of the components in the vapor of inLife's Regal electronic cigarettes.

Thus, I do not think it is appropriate to conclude that all electronic cigarettes fail to deliver any nicotine.

But even if this research is only partially generalizable, the implications are enormous. Because what this work demonstrates is that it takes very little - if any - nicotine to satisfy the addiction to nicotine of smokers when they are provided with a mechanism that simulates all the other aspects of the smoking behavior.

In other words, if true, this research suggests that electronic cigarettes are really a miraculous innovation: a device that can simulate the smoking experience and get smokers off cigarettes, helping them overcome their nicotine addiction, without actually delivering much nicotine.

It appears that the role of nicotine in addiction to smoking has been exaggerated and that there are behavioral aspects to the addiction that play a very important role. It also appears that there is a very strong placebo effect and that even in the absence of nicotine, if smokers believe they are getting nicotine, it may go a long way towards satisfying their craving and ameliorating their withdrawal symptoms.

This has implications for research into the effectiveness of nicotine replacement products because it suggests that previous research is substantially marred by the failure to blind participants to their status. Subjects receiving placebo likely knew that they were not receiving nicotine; thus, they may easily have been discouraged and gone back to smoking. Even the marginal results of nicotine replacement therapy studies are now thrown into serious question.

Another important implication of this research is that - if generalizable to all e-cigarettes - it essentially eliminates any substantial concern about the health effects of these products on bystanders. With very little nicotine being delivered to the vaper, it is undeniable that there will simply be no significant exposure to nicotine among bystanders. Thus, the assertion of some anti-smoking groups that electronic cigarettes pose a threat to bystanders does not appear to be substantiated.

While we need to await the actual publication of these findings in a peer-reviewed journal, the preliminary indication is that electronic cigarettes are an incredible innovation: they are devices which appear to have great success in getting smokers off of cigarettes, yet they amazingly are able to do so without delivering much nicotine.

It may well be that electronic cigarettes are not dependent upon nicotine for their success. If so, this would mean that vapers could use glycerin or pure propylene glycol cartridges without any nicotine and still have success in overcoming their addiction to cigarettes. This would be truly a remarkable phenomenon, and it would represent an innovation with potentially immense public health benefits.

It would mean that a device which simulates smoking and delivers nothing but vaporized glycerin or propylene glycol could be effective as a smoking cessation aid. It would mean that, for the first time, we have a truly safe and potentially effective alternative to smoking.

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