Vansickel, Eissenberg study published

[rolygate]

Electronic Cigarettes: Effective Nicotine Delivery After Acute Administration
Andrea Rae Vansickel, Thomas Eissenberg

Electronic Cigarettes: Effective Nicotine Delivery After Acute Administration

"Conclusions: User experience and/or device characteristics likely influence EC nicotine delivery and other effects. Systematic manipulation of these and other variables could elucidate conditions that produce intended effects."

This study reports that, in contrast to naive users (= beginners) using minis (1st generation devices) of uncertain performance and isolated from advice or support, it can be shown that experienced owners with equipment selected as required, used as required, can achieve satisfactory results. (We haven't seen the full document but this accords with the abstract's Conclusions, and pre-release information as to its content.)

It would be interesting to see the range of plasma nic levels recorded.

 

[dspin]

Thanks for posting Roly

 

[MastiffMike]

So basicly, vaping witout ECF doesn't work! But vaping along with frequent ECF contact is a win-win!

Heck, I coulda told you that!

 

[rothenbj]

Truth from "The Tongue" I don't know how many I've watched start using PVs that I suggested ECF to. Most aren't willing to invest the time and normally don't continue vaping. I'm beginning to believe the long term quit rate wouldn't be much better than Chantix without some education from ECF type interaction. Getting people to realize that nicquid actually tastes much better than cigarette smoke without the health risks is a learning experience, especially with the vast array of products available.

Once you get the right kit and flavors, the thought of actually smoking diminish very rapidly.

 

[MastiffMike]

Well said rothenbj! I think the wealth of info (about not only devices but also flavors, nic levels, usage, etc.) that can be found on ECF is CRITICAL to successfully quitting analogs. Buying a starter kit at the mall may work for a small percentage of people but not many.

Personally I think the go-to starter kit for people should be an adjustable voltage kit with cartos. I know for me 3.2v isn't enough to keep my off the analogs and the hassle of low mAh batteries and dripping isn't real user friendly (especially for a newbie).

But back to the topic... How do we get EVERYONE to visit ECF at least hourly??? Let's hear suggestions people!

 

[rolygate]

@Rothenbj
I believe that motivation and support are needed unless exceptional circumstances exist - which is probably the same for any change of smoking behaviour, whether switching to an alternative like e-cigs or Snus, or quitting. Personally it is hard for me to accept that e-cigs are a magic bullet that, once picked up, somehow convert smokers who have no wish to change and no access to any form of support. It's certainly true this does happen in some cases, but for the majority, I feel that some other contributory factors need to be present.

In my case it took a year because I considered myself a smoker, who enjoyed smoking a small number of cigs a day, and saw no reason to change. Zero motivation in other words. However I did have access to both support and plenty of gear. It took a year; one day I realised that I hadn't smoked in some time, and I didn't really know how long that was exactly. At that point I was a vaper, without having tried or even wanted to convert. I'd still smoke a cigar, but not a cig.

Many smokers are a lost cause as far as vaping goes, because no matter how good the equipment and support is, they actively don't want to change. If someone isn't amenable to persuasion there's no point in wasting time (or useful e-cigs) on them.

 

[dotma]

Well in my case i bought a mall kiosk e cig with a lot of encouragement from my nonsmoking hubs and i found the ECF shortly after that. I know that without knowing that there were so many other bigger and better things out there and exactly how to use them, I would have thought that vaping sucked based on my one experience and probably would have given up.

 

[rolygate]

Thanks to CASAA, who are SRNT members, I have now seen the full study.

For me there are several interesting elements. The peak plasma nic levels seen are over 20ng/ml (and after over an hour's vaping) although most users measured less. All used their own mods / e-cigs and their own liquid, albeit in cartos as that was a requirement of the study. Since they could vape as needed, however they liked, the result is substantially equivalent to real-life use.

Perhaps if allowed to use tanks and liquid feed arrangements, the nic levels would have been a fraction higher. On the other hand, if the vapers tested could have previously experimented at length with the carts/cartos arrangement required, they would then have raised the nic strength of the liquid used, to get the same result. They used, on average, 18mg strength liquid, which we would consider average. There are several strengths available retail above and below that.

This is a useful study which enters into the literature a simple fact that any experienced vaper knows: e-cigarettes work. It has to be remembered, though that something doesn't 'exist' for medics unless doctors have measured it themselves and it has been published.

The whole business of funding a trial, writing the protocols, arranging staff and facilities, running the trials, organising the results, writing up the results, getting the methodology checked and approved, submission for publication, and finally seeing it in print, is a major enterprise. When finally we see something done right, at considerable expense in time and energy, not to mention cost, we should applaud it.

(As a practical-minded person {read: mean} I see one rather nice advantage of this study, for the organisers / grant managers - the subjects brought their own equipment. What a model )

Now we come to the obligatory closing line, so beloved of researchers, and traditionally such agony for us. It often comes in a form such as, "We have thus shown that e-cigarettes work. However further research is needed, and until then, see your doctor for FDA-approved medications if you want to quit". There is so much wrong with that typical finisher that the reader cries with frustration. Luckily, this time, we have been spared too much pain - instead of a 10 on the pain scale we are down to around a 4. This is progress.

"One important potential benefit of EC regulation may be more consistent nicotine delivery, device performance, and cartridge and vapor content."

For medics, this is shows unbelievable restraint. The fact that it is still partly in cloud-cuckoo land is not their fault, they deal with medical matters, not the reality of politics and money. Unfortunately, FDA regulation = removal of as much as possible from the market by any means possible that will survive legal challenge. It's what they're paid to do by their owners.

The perfect result in the FDA's eyes would be three e-cigs left on the market, none of which works properly. Anyway, leaving that aside, it is easy to see a situation in which mini e-cigs are plentiful, and can be shown not to work for beginners, in terms of nicotine delivery. That after all is normal. If in fact 'consistent nicotine delivery' and 'device performance', as measured by plasma nic levels as that is the only viable test, is a regulatory factor in any way, then the current nic strengths in cartos will have to go way up.

If you are selling minis to newbies, and the regulations say you can/should be seeing reasonable plasma nic levels, then 18mg and 24mg refills (1.8% and 2.4%) aren't going to cut the mustard. Not only will you need to supply 36mg (3.6%), but maybe even 48mg (4.8%), in order that the poor device performance plus the poor user technique of naive users does actually produce measurable blood nicotine levels.

Some new users will be OK on 5ng plasma levels, and some will need 30ng/ml. Given there is a factor-10 difference in individual tolerance to nicotine, there will be a percentage of users needing 48mg nic liquid to show any useful range of results, when using a mini e-cig.

 

[rolygate]

[Note: some edits have been made to the above post, from v1, mainly to increase the coverage of certain issues.]

 

[rothenbj]

Funny you would say that Chris because I was that unmotivated smoker, hardcore and committed, in fact. Had my gf not been such a PIA, I'd still be. She kept pushing (very pushy when she gets a bug up) until I did not enough investigation and spent too much money. THEN I found ECF and learned about manual 510s which worked much better.

I then was a smoker like you until six months later, I wanted to stop entirely. ECF was again the source of the answers to my question and led me to snus, the perfect product for me. This site is the proverbial Library of Congress for harm reduction products, if you can just navigate to the right sections.

 

[Bill Godshall]

rolygate wrote:

I believe that motivation and support are needed unless exceptional circumstances exist - which is probably the same for any change of smoking behaviour, whether switching to an alternative like e-cigs or Snus, or quitting.

The folks at USSTC (United States Smokeless Tobacco Company), now owned by Altria, and maker of Skoal (the leading entry brand into the smokeless tobacco category) and Copenhagen moist snuff have been telling me for the past decade that the two most difficult hurdles of getting smokers to try using snuff is overcoming their fear/disgust of the product (that most Americans have been brainwashed to believe), and learning how to properly use the product (as swallowing tobacco juice isn't very pleasant).

The snus products and the pouched products are easier to learn to use, and they create less juice (if used behind upper lip instead of lower lip).

It appears that the two biggest barriers to getting smokers to switch to e-cigarettes are overcoming reluctance to spend the initial cost, and then learning how to use the products.

Recent surveys confirm that a large majority of smokers (and nonsmokers) correctly believe that e-cigarettes are less hazardous than tobacco cigarettes, and that smokers perceive dissolvables as less hazardous than snus, and percieve snus as less hazardous than snuff and chewing tobacco.

 

[sebt]

Thanks for posting this rolygate - fascinating reading.

@Rothenbj
Many smokers are a lost cause as far as vaping goes, because no matter how good the equipment and support is, they actively don't want to change. If someone isn't amenable to persuasion there's no point in wasting time (or useful e-cigs) on them.

I can confirm this from my own experience. Why exactly I had my last cigarette on 2nd February 2012, and not earlier (or later), is a mystery. Why, since then, I haven't had a cigarette, is clear: because of vaping, and the support and enthusiasm I get from participating in this forum. It seems to me that anti-smoking campaigners are seeking that magic bullet that will persuade everyone, immediately, to change; and can use this unrealistic criterion - selectively - to discredit harm-reduction methods such as vaping.

Thanks to CASAA, who are SRNT members, I have now seen the full study.

For me there are several interesting elements. The peak plasma nic levels seen are over 20ng/ml (and after over an hour's vaping) although most users measured less.

How does 20ng/ml compare with levels when smoking an analog? Forgive my ignorance - that study must have been done, somewhere...

If you are selling minis to newbies, and the regulations say you can/should be seeing reasonable plasma nic levels, then 18mg and 24mg refills (1.8% and 2.4%) aren't going to cut the mustard. Not only will you need to supply 36mg (3.6%), but maybe even 48mg (4.8%), in order that the poor device performance plus the poor user technique of naive users does actually produce measurable blood nicotine levels.

This shows how complicated the arguments are. I'm using 12mg juice, after smoking the equivalent of 1-1.5PAD for 22 years. I have no idea what my plasma nic levels are after vaping. Using this measure as the exclusive determinant of "success", my vaping to give up cigarettes might well be classed as a "failure". Ignoring a surely significant fact, not captured by measurement of plasma nic levels: that I haven't used or even wanted an analog since giving up!

E-cigarettes seem sometimes to be damned whatever level of nicotine they deliver.

Either:

a) They're evil druggy devices, delivering that evil drug nicotine in huge doses, which produces or maintains "addictive personalities" (the Health Board chairman in MA wasn't too clear on whether nicotine use makes you an "addictive personality" or whether you were one in the first place - it's a fine point of Calvinist theology...)
or
b) They're ineffective, useless for the purposes of smoking cessation, because they don't deliver any nicotine, or not enough! Perhaps any anecdotal reports of people successfully using them to give up smoking are a cause for alarm. Because surely something as evil as smoking can only be replaced by something equally evil. Ergo there must be something other than nicotine (which we'll get round to detecting at some point, but will content ourselves by just being terrified by for the moment) in e-cigarettes. Some kind of essence of Pure Addictive Evil.

It is good to see something physically measurable being evaluated, and e-cigs showing up well as physically effective, on one physical measure. But in the wider debate, it comes down to the first point quoted above - about smokers' amenability to persuasion - which leads me to think that nothing is, or ever can be, a 100% reliable method of giving up smoking. The established pharmaceuticals don't exactly have a great track record, after all.

At this point in my thinking, IMHO, it seems like a better bet to concentrate on the safety of e-cigarettes, rather than on their effectiveness in helping you to give up smoking. (Although of course I'm living proof of the latter point). Because the latter claim is open to being shot down by regulatory agencies setting the bar impossibly high.

Very thought-provoking. My for the moment...

 

[rolygate]

Sebt - .....it seems like a better bet to concentrate on the safety of e-cigarettes, rather than on their effectiveness in helping you to give up smoking.

The 'efficacy' of e-cigarettes as an aid to 'giving up smoking' is a false construct invented by researchers. People buy e-cigs as a safer replacement for cigarettes, they don't intend to give up inhalation of nicotine. As there are millions using them, with the number currently growing by around 50% per year, they certainly work for that purpose.

The problem for medics is they see everything as a medical issue. If people change to an alternative form of tobacco, it has nothing whatsoever to do with medical or pharmaceutical issues of any kind - it's a consumer decision. The only medical impact is that tobacco alternatives are so safe that it is almost correct to say that anyone using them is one less who will get sick and die.

What all this has got to do with pharmaceutical licensing isn't really clear, as there is no connection. Plenty of people in pharma wish there was, as that would allow them to remove e-cigarettes in order to protect their income; and pharma has millions to spend on this.

 

[rothenbj]

@Sebt - For people like Smokefree New Zealand, clearly ANTZ (Anti-Nicotine & Tobacco Zealots), they have a totally different perspective. I posted this elsewhere but felt it appropriate here. They generated a document in 2006 on Snuff regulation. I found one bullet point quite revealing-

Smokeless tobacco can alternatively be regarded
as a population-level quitting device, that can be
permitted for the five years before and after a
cigarette sales ban, and then withdrawn to avoid
widespread nicotine addiction.

Even after promoting the safest forms of smokeless tobacco to get people to stop smoking, the long term strategy is total elimination of all tobacco/nicotine use. Leave nicotine to the pharma industry to "cure" other nicotine treatable diseases. Perhaps they'll find the best methods to administer their treatments will be with an inhaler device or "medicine" packaged as little pouches under your upper lip. Of course only after "SAFE AND EFFECTIVE" approval from the FDA.

http://www.smokeless.org.nz/snuffregs.pdf

 

[JW50]

Thanks for posting this rolygate - fascinating reading.

...

How does 20ng/ml compare with levels when smoking an analog? Forgive my ignorance - that study must have been done, somewhere...

...
...

At this link Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction a chart labeled as the "Circadian blood concentrations of nicotine and cotinine during unrestricted smoking" is provided that shows levels of approximately 25ng/ml in the peak hours of noon to midnight.

Near that chart page is this text:
"Although the half-life of nicotine is about 2–3 hours when based on plasma levels, it approximates 11 hours when based on urinary excretion (Benowitz and Jacob, 1994, 1999), so circulating levels tend to accumulate during the day. The afternoon levels of nicotine in the plasma of smokers generally range from 10 to 50 ng/ml, whereas steady-state levels with patches range from 10 to 20 ng/ml and with the nasal spray from 5 to 15 ng/ml (Benowitz and Jacob, 1999)."

 

[rolygate]

Bill G. - .....the two most difficult hurdles of getting smokers to try using snuff is overcoming their fear/disgust of the product (that most Americans have been brainwashed to believe), and learning how to properly use the product (as swallowing tobacco juice isn't very pleasant).

I believe this can also be seen in the demographics of Snus users in Sweden: far less women than men are Snusers, and presumably this is because the ladies are a little more sensitive to these types of issues.

 

[rolygate]

Rothenbj - .....Even after promoting the safest forms of smokeless tobacco to get people to stop smoking, the long term strategy is total elimination of all tobacco/nicotine use.

The thing that makes me laugh is that most of these people are gold-plated hypocrites: presumably they consume coffee, tea, wine, sherry, beer and so on. So basically it's a case of, "You have to give up yours but I'm not giving up mine".

On top of that you need to add that out of all these substances, nicotine is the most 'natural' of all because everyone tests positive for it, due to the fact it is part of the diet. Plus, if you were to try to remove it by avoiding vegetables, you would most likely also remove vitamin B3 (nicotinic acid) as it is co-located and also a nic metabolyte.

I think it unlikely that large-scale trials would find that everyone tests positive for coffee or wine. However, everyone tests positive for nicotine. Also, no long-term clinical trials or other data show that responsible consumption of nicotine is harmful - in fact quite the opposite.

It's amazing how powerful propaganda can be, anyone would think that nicotine is a harmful, alien, toxic chemical. It's far more likely to be found in the body than other similar substances, and there is no evidence it is harmful in moderation - exactly like other similar materials. In terms of harm caused by abuse, the evidence for harm due to nicotine abuse, if existing, would be of the order of 0.00001% of that from substances such as alcohol.

There are probably nutcases out there who believe nicotine poses some kind of threat. It's just a shame they get column inches to promote their loony cause.

 

[Vocalek]

Hmm... I take Niacin (B3) at a dose of 500 mg twice a day. Wonder if that would affect my blood levels? Does B3 metabolize to Cotinine as well?

 

[Penner]

Hi Roly,

In your original post you said "The peak plasma nic levels seen are over 20ng/ml (and after over an hour's vaping) although most users measured less."

Would you be able to provide the range of that, that was measured?

Thanks!

 

[rolygate]

There is one graph in the report, which shows a range of about 6ng to 22ng/ml.

It seems that 10ng/ml is obtained fairly rapidly, then it rises over time.

I believe smokers commonly measure from around 5ng to 50ng, with an average of about 25. There is all sorts of research that could be done in this area, such comparing the levels between smokers and vapers for the same levels of satisfaction; measuring what levels are needed for a range of individuals to induce symptoms of over-consumption; how the use of WTA-inclusive refills affects the measurements; and more.

There can only ever be one first, though, and Vansickel/Eissenberg achieved it.