E-Cigarette Clinical Trials

[jfjardine02]

This thread continues from one started in Media News, linked below, which changed into a discussion of clinical trials, and is therefore better located here.

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www.e-cigarette-forum.com/forum/media-general-news/239369-penn-state-video-half-right-anyway-5.html

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@Bill....I said "controlled clinical trial" and you cite a study based on 40 people with no control group...i.e. nothing to compare with the results of the 40 that used e-cigs. A controlled clinical smoking cessation trial will ideally recruit a large number of smokers and randomly allocate them to either (a) the intervention of interest..eg e-cigs or (b) some comparison treatment...could be a placebo e-cig, could be an alternative treatment (e.g. nicotine inhaler), but the idea is to have something meaningful to compare with the results of the main intervention group. Unfortunately you cannot meaningully compare the results in one tiny study of 40 people with the results of other studies of different types of smokers (different countries, different levels of dependence and motivation, different behavioral intervention etc etc). Thats why we randomize within the study. Thats how you can be fairly confident that the people in one group are comparable to the people in the other...as they were allocated to each treatment on the basis of chance (like the toss of a coin).

Also dont imply that anyone assumes that people who say they quit smoking by using e-cigs are liars. Nobody assumes that. Its just reality that lots of people saying on the internet that they quit smoking one way or another does not cut it as scientific evidence that the method increases people's chances of quitting. Its a sign that the method might be effective...and worthy of further study, but nothing more.

My understanding is that most of the folks chatting on this site use a username thats not necessarily identical with their everyday name. If Im mistaken about that, then Im honored to have spoken to someone named God Almighty (Im glad to know she exists after all). So you dont have to be a genius to figure out who JFjardine02 from Hershey is, or to use a new thing called Google to find out where he works, what he has published, sources of funding etc. It is simplistic to think that because someone has done work for pharma companies (as well as universities, charities, hospitals, non-profits etc etc) they can therefore no longer use their brain cells for anything else but selling those companies' products. I'm not quite sure how publishing case reports of psychotic episodes while using the patch, or poor results from pharma products in clinical trials, or positive effects on smoking cessation from snus and e-cigs fits in with that idea? JF

 

[rothenbj]

"It is simplistic to think that because someone has done work for pharma companies (as well as universities, charities, hospitals, non-profits etc etc) they can therefore no longer use their brain cells for anything else but selling those companies' products."

So what is the thought process behind TC in discounting anything written or said by anyone that has been paid by the tobacco industry at one time or another? In fact I've seen people that have no association with the tobacco industry accused of being paid shills for BT simply because they don't agree with much of the "science" that has been sold to the public.

 

[jfjardine02]

@rothenbj...good question.

 

[Vocalek]

jfjardine02: I can assure you that the one group that would most welcome someone conducting a large double-blind RCT would be us consumers. Unfortunately, however, those things are expensive.

It's easy enough for companies with the financial assets of a Pfizer or GlaxoSmithKline to fund such studies. However the "e-cigarette industry" is not one huge company or even a group of huge companies. There are numerous relatively small companies manufacturing various brands and models of e-cigarettes in China. There are hundreds of small businesses in the U.S. making modified e-cigarettes by hand, and perhaps thousands of companies in the U.S. adding a variety of flavorings to e-cigarette liquid manufactured in China and reselling it. There are, at most, a handful of U.S. companies that manufacture e-liquid from scratch.

Even if the largest of the Chinese manufacturers could be convinced of the value of funding such a trial, keep in mind that they don't have a staff of scientists familiar with the process of conducting such a trial, simply because they are NOT a pharmaceutical company or medical device manufacturer. So added to the expense of conducting the trial itself would be the expense of hiring physicians, nurses, and other personnel to design and implement the study.

Then, added to that problem we have the problem of "the manufacturer paid for the trial so it must be rigged" viewpoint of tobacco control.

Your suggestions on how to overcome the above problems?

Frankly, it seems to me that population surveys provide sufficient epidemiological evidence to show that e-cigarettes are helping people to move away from inhaling tobacco smoke. Since surveys can be conducted with much less expense, independent researchers are not hampered from conducting these types of studies. Furthermore, independent researchers are much less likely to be attacked as "tobacco industry shills."

I would dearly love to see the CDC add some questions to its annual survey on tobacco use.

Did you quit smoking completely during the past three years?
How long have you been quit?
How many times did you try to quit during the years that you were smoking?
What products or methods did you try that did not work?
What method or product did you use on your successful quit attempt?

 

[jfjardine02]

First step is to identify a good, solid ecig that is widely used and widely regarded as high quality. A clinical trial will almost certainly be based on one brand. Then there is a need to select liquid strength, instructions for use etc. Then need to select comparison product. Leading contenders would be same ecig with zero nic liquid, and nicorette inhalator. Then characterize nicotine delivery and do a small pilot randomized trial with a short term outcome. Little likelihood of a large trial being done prior to that.

 

[rolygate]

Can we start a new thread to discuss these issues, please?

With your agreement I will open a thread titled E-Cigarette Clinical Trials in Electronic Cigarette Research/Medical Research, and move the last two posts across there (and close this thread).

 

[rothenbj]

Can we start a new thread to discuss these issues, please?

With your agreement I will open a thread titled E-Cigarette Clinical Trials in Electronic Cigarette Research/Medical Research, and move the last two posts across there (and close this thread).

Darn Roly, how many freaking tabs do I need to keep open in Chrome dedicated to ECF topics. I think I'm getting ECF addiction.

 

[Ande]

Bill, also based on the blood nicotine data from studies of those types of e-cigs...almost no nicotine delivery.....as compared with Tom Eissenbergs data on experienced users using models with greater battery power...delivering nicotine like a regular cigarette. I'm not saying the $20 gas-station e-cigs are totally useless, but I believe the improved nic delivery of ones used by most experienced users puts them in a different category. The fact is, I've not met many people who switch to gas-station e-cigs (by that I mean e-cigs that are the same size as a cigarette and dont have any enhancements to facilitate hotter, consistent vapor production) and use them daily for 6m or more. I'm sure they exist, as do a few people who persist with zero nic juice, but its clearly not the typical pattern. But lets be clear, we dont know if ANY types of e-cigs are effective for smoking cessation because there hasnt been a single controlled trial published. I happen to believe that such studies should be done, and that they should use the "better" nicotine delivery e-cigs, in order to have a better chance of being effective.

I think one thing that's been neglected is any kind of in between area. The methodology of Eissenberg's original no nicotine study is pretty much laughable. If it proved any thing at all, it's that new users of any product aren't good at using it, and that using one thing (an ecig in this case) as if it were something else (a cigarette) doesn't produce good results. I've proved about as much by trying to use a screwdriver as a hammer.

But in jumping from total novice users on devices they haven't seen before to advanced users with advanced products, we miss the fact that an informed user with a bit of experience actually gets different results than the novice, even with the same product.

I, and many others, stopped smoking while using a very low end cig-lookalike ecigarette.

But I, like most who continue to vape, decided that to maximize enjoyment, I wanted something better. That's how we get onto mods- not because the others "don't work."

Best
Ande

 

[MattZuke]

Me, too. Stopped with NJOY NPRO (RN4081 model, I believe). Now, I have a (*ahem*) big eGo.

Similar tail with me. I started with a Blu, switched to literally 2x $15 KR808s and added a battery. I was on two chargers.

Anyhow I have chatted up Dr. Jonathan Foulds and am attempting to explain the finer details of ohm's law, basically suggesting he translate his data in terms of Watts and Watt Hrs. I mainly wanted to explain gas station e-cigs don't use AAA, but rather something closer to a 3.7V AAAA battery.


[Presuming 3.7V @ 1.5ohms]
(090mAh x 3.7V) x 1000 = .333Whrs / 9watt = 2.22min per battery
(180mAh x 3.7V) x 1000 = .666Whrs / 9watt = 4.44min per battery
(900mAh x 3.7V) x 1000 = 3.330Whrs/ 9watt = 22.22min per battery
(675mAh x 4.8V) x 1000 = 3.24Whrs/ 9watt = 21.6min/battery

 

[Ande]

Driving nails with a screwdriver can work. ;-) Still not the best tool for the job...but if it works, better than leaving them undriven, I guess.

Same with my 510- not an ideal tool, but did the job. And then I got a big eGo.

And THEN...I got an Alpha Ultramax. Sounds pretty egocentric, too.

The overwhelmingly frustrating thing is that there ARE "scientists" researching these things. But most of them know rather less about ecigs than my neighbor. (Doesn't smoke, doesn't vape, doesn't care- but has had a few short conversations in a broken language with me about them.)

And they (the "scientists") never seem to consider that ecig users, of which there are a good number around, might know something about the damn things.

Best,
Ande

 

[jfjardine02]

Ande...not true that scientists "never seem to consider" that ecig users might know something about ecigs. There are a bunch of publications based on surveys, interviews etc with ecig users.

Mattzuke..2 more questions:
1. When an average Joe walks into a gas station, sees an ecig and wonders if it is worth buying, how can he tell? (Does the labelling inform about the voltage of the battery and resistance of the atomizer, and if so, what is the average Joe supposed to understand from that information?
2. Lets assume he believes that a high voltage, low resistance model is likely to produce the best vapor (i.e. consistently able to deliver inhalable nicotine in a manner that will relieve cigarette craving and nicotine withdrawal symptoms)...will he be right?

 

[MattZuke]

1. When an average Joe walks into a gas station, sees an ecig and wonders if it is worth buying, how can he tell? (Does the labelling inform about the voltage of the battery and resistance of the atomizer, and if so, what is the average Joe supposed to understand from that information?

This is a good question. One can logically extend the same question to flashlights. For penlights you have a $2.00 ADC 356WP Disposable Penlight which doesn't list its specifications. But it's a common diagnostic instrument for doctors and mechanics. Hypothetically one could spend more money for a 2xAAAA, 2xAAA, or 2xAA pen light. It's somewhat common knowledge that a bigger battery will last longer, stay brighter longer, or if they want something small they can always swap batteries. If they want more light, get a higher watt bulb, but it'll drain the batteries faster, so you need more batteries or one bigger one.

My first purchase was BluCigs, which are 1/2 the capacity of gas station e-cigs. They "claim" 80-100 puffs, 1 cartridge = 1 pack. Sounds good. But presuming 4.5second drags on a 4watt element on a 90mAh battery, that's only 66.6 drags, and there is no way there is 1ml of liquid in a Blu cartridge. Maybe if their batteries were 110mAh 80 would be reasonable, but without a doubt it's unclear to a new user that an element operating at 60C requires a little longer than burning organic matter at 800C.

I needed another battery, but I opted for a gas station style model, nearly identical to a 1xAAAA pen light with a 4watt bulb. Each unit $15, each with a usb charger, with cartridges 24mg/ml liquid. It was bigger than Blu (306, l88B), and it lasted longer. New cartridges were 24mg/ml, my refill liquid was 18mg/ml. 24mg/ml addressed strong cigarette cravings, 18mg/ml tasted much better. 3 batteries, two chargers and I was golden on a gas station e-cig.

I "believe" number of puffs/e-cig is listed, but I'd imagine regular Joe will just have to buy one one $20, at low/med/high mg/ml, where the FDA in their wisdom dropped nicotine content from real cigarettes. Regular Joe will likely decide 1 battery isn't enough, and buy another one, get annoyed waiting for it to charge, and get yet a 3rd battery. If Joe is smart, he'll Google and find out what's what. Given lightbulbs are sold in terms of watts, and e-cig atomizers are sold in terms of ohms, Joe doesn't really have a point of reference. Without hitting a specialty shop, Joe's choice is limited to 4-5 watt delivery at low, medium, or high concentration.

My 3rd purchase was a $80 T-rex, virtually identical to the Ego. 900mAh, 2.5ohm, 3.2V. Out of the box, identical in wattage to Blu or a gas station model, 4watts. The difference being it lasted all day, representing 5 gas station e-cigs, or 10 Blu Cigs. Given 300 charge cycles on ANY li-ion based battery, given small batteries are $10, a big one being double the price but 5x or 10x the capacity, it represented a lower cost of operation, with the added bonus no one would confuse it to flaming cig.

2. Lets assume he believes that a high voltage, low resistance model is likely to produce the best vapor (i.e. consistently able to deliver inhalable nicotine in a manner that will relieve cigarette craving and nicotine withdrawal symptoms)...will he be right?

2) It's got to be one or the other. Either lower resistance, or higher voltage. Base e-cigarettes operate between 4-5watts, 2.5-3.5ohms at 3.2V-3.7V, about 60C. There is a max limit to operation, around 12watts for single coil, around 12 watts for dual coil. Beyond this Lorann flavoring oils start to change, coils tend to bust, or worst case, you start to smoke your filler material. The Lava Tube from Volcano for example comes stock with a 3ohm atomizer, at 3.2-6V, a range from 4watts-12watts. According to Volcano, it will compensate for lower resistance (higher wattage) elements, thus won't operate a 1.5ohm atomizer at 24watts.

If it was just about the nicotine, NRPs would be an acceptable substitute.

I have every reason to believe a standard 4-5watt model with offerings at 6mg, 12mg, 18mg, and 24mg/ml will address address nicotine dependence given time to adjust to the lack of freebase nicotine and the absence of minor alkaloids.

I have every reason to believe given the choice of 10 small batteries/day, 5 AAAA batteries, or AA battery, the AA wins.

I can say personally given the choice between 18mg/ml at 4 watts (3.5ohm @ 3.7V), and 8mg/ml at 8 watts (1.7ohm @ 3.7V), I'd opt for 8mg at higher wattage. Same would apply if I were to opt for 0mg/ml.

I can say in March 2011, a strong cigarette craving was addressed with 24mg/ml @ 4watts, and the big battery served more to provide security that I could supply 4watts @ 4.5 seconds at any time during the day without risk of a dead battery, and 900mAh @ 3.7V covered this, which happens to be the specification for a 14500 battery.

But given I downgraded my concentration, first to 12mg/ml to 8mg/ml, to compensate for high power (6.8watts and above), I have no doubt watts = higher nicotine delivery for each 4.5 second drag. But the vapor is also more dense, and the vapor temperature is also higher, so the experience is closer to cigarette.

Vapor, Throat Hit, and Flavor (V.T.F.) are the subjective measure of any e-cigarette. Throat Hit is more objective based on temperature (wattage or atomizer length), flavoring, and nicotine. Menthol and Cinnamon have a similar throat hit to nicotine, but taste much better.

 

[DC2]

When an average Joe walks into a gas station, sees an ecig and wonders if it is worth buying, how can he tell?

I'm going to go ahead and say that the average Joe walking into a gas station will not know what is worth buying.
You have to have some level of experience with these devices to have any idea what you want and need.

 

[jfjardine02]

Mattzuke...I think theres a joke out there about how many psychologists does it take to change a lightbulb (A= one, but its got to want to change)...my point is that lots of people (even non psychologists) have no clue about batteries, watts, resistance etc. I am seeking to understand what are the main characteristics of e-cigs that are "good" and I am assuming (though you may disagree) that a critical part of a good ecig (that heavy smokers can comfortably switch to) is that it comes close to a regular cigarette in terms of nicotine absotption. I was thinking that its about the overall power (watts) and the consistency of delivery, and that hotter (more power) is better....hence high voltage low resistance. But it sounds like its not as simple as that (and Ive been on some product websites that also suggest some balancing of volts and ohms
( Technical Stuff : Electronic Cigarettes and E-Liquid - Great Lakes Vapor ). How about this question...many people of on this forum recommend and use an Ego-style ecig. What are the characteristics of this model that make it "good"? I mean, is it simply that it needs recharging less often? Is it the quality of the vapor? Does it deliver more nicotine?...and what it it about its design components that lead to this goodness (ohms, watts, volts etc?). I understand that everyone is a little different, and some prefer different models, but I hear fairly consistent reports that this is a good one, ...better than the ave gas station e-cig...so what makes it better?

 

[MattZuke]

I'm going to go ahead and say that the average Joe walking into a gas station will not know what is worth buying.
You have to have some level of experience with these devices to have any idea what you want and need.

Yea, I was very verbose, but yeah.

The Njoy Pro represents a gas station e-cig (RN4081) See how it works

3 hours to charge

...The NJOY battery will last for approximately 300 to 600 puffs before recharging is required...

On average, each individual cartridge supplies enough nicotine and flavoring to accommodate approximately 300 puffs. When the cartridge no longer produces vapor, you'll know it's time for a replacement. NJOY replacement cartridges are available in two flavors, traditional and menthol, with four nicotine levels to choose (1.8%, 1.2%, .6% and 0.0%)

Battery capacity unclear
atomizer wattage unclear
atomizer size unclear

Based on my experience I know I'd need 5 battery swaps using 4watt atomizers and these 180mAh batteries. But the reason I know this is because I bought a similar unit.

 

[ByStander1]

Not Matt, but chiming in anyway...

You're correct, jfj, it's more complicated and, well, also not...

When it comes to something like comparing a 510 to an eGo, a 510 is a familiar feel to a new "switcher;" whereas an eGo is convenient for duration between charges. "Different strokes" and all that. It's like differences in cars, clothing, or a caffeinated beverage: All of them will get you what you want (locomotion, covering, or alertness bump), but personal tastes and needs still play a role. For some, the repetitive hand-to-mouth is the primary part of their smoking ritual wherein nicotine is a small, or even non-existent, part. With others, nicotine is their overall motivator.

So, for me, it's all of the above: I'm incapable of safely operating a motor vehicle without a 510 in my hand; I need 12 watts to even taste tobacco flavors; and anything over 8 watts sucks the life out of my Irish Cream.

Ever want to have some real fun, try to predict the kind of vaper someone will be based on the kind of smoker they are... HA if you have any luck at this, please pass your secret on to me!!!

 

[MattZuke]

How about this question...many people of on this forum recommend and use an Ego-style ecig.

Virtually all of them.

What are the characteristics of this model that make it "good"?
I mean, is it simply that it needs recharging less often?

1) Cost of operation - a medium sized ego represents 5 gas station e-cig batteries, 10 Blucig batteries, each limited to 300 charge cycles.
2) Duration of operation - 1 charge/day vs 5 charges/day
3) Consistency of operation - A power swing from 4.2v to 3.2V over 8-16 hours, vs the same power swing over 2 hours
4) Reliability - will operate high power atomizers without burning out, will not fail in the case of a leak

Is it the quality of the vapor? Does it deliver more nicotine?

So long as the voltage is the same, a gas station cartomizer will perform the same on an "generic" ego style.
There "might" be a slight performance edge, the cone may retain heat, and this may provide a minor increase in vapor density. But I consume identical amounts of liquid even if I use a gas station e-cig.

Joye Egos are lower voltage than others, 3.2V, but they ship with atomizers that deliver 4 watts. But they deliver 3.2V over 8-16 hours of use. Rivas however would be identical, the same 4.2V->3.2V before empty.

I'm sorry if I have to fall back on technical specs, but really, a daily e-cigarette habit can be boiled town to a simple equation of watts.

That 900mAh habit at 3.7V represents 3.33 watt/hrs. At standard power, 4 watts, this is .8325 hours of solid use, this is 666 4.5 second puffs.

10 Blucigs @ $10 / spare battery
5 180mAh gas station e-cigs @ $10/spare battery
1 medium sized ego style @ $20/spare battery

 

[ByStander1]

its therefore about time this $200m plus global market e-cig industry actually produced a single randomized parrallel group comparative trial that tells us something about the real safety and efficacy of e-cigs

Just gotta note this, because it shows up a lot.

Okay, so there's this monstrous $200,000,000 industry with how many players worldwide? (few hundred? few thousand?)

Compared to another team with $3,000,000,000 sales in the US only annually. And how many players? (about 3)

 

[MattZuke]

Rolygate, its therefore about time this $200m plus global market e-cig industry actually produced a single randomized parrallel group comparative trial that tells us something about the real safety and efficacy of e-cigs. I hope they work, but you have to be honest with people that right now there is an almost complete lack of solid evidence. Surveys of enthusiasts and case reports of individual successes show that something has potential....but ultimately we need solid clinical research studies...lots of them to really prove it. That simply hasnt been done for e-cigs.

Here's the problem, e-cigarette manufacturers have went out of their way to demonstrate the relative safety of their products. Tobacco Control comes back and says they won't listen to any study funded by the e-cigarette industry.

So any larger clinical trial will have to be done with bucks not from the e-cigarette industry, despite the fact that they are more than willing to give their product and money to do so.

Here's where it takes a turn. We have the Master's Settlement, as well as independent settlements such as Florida, with at least 8 Billion a year to address the financial burden on the health care industry. Surely something used by only 2.5 million people, most of whom have replaced smoking, would be in the public interest to study further. But today, tobacco control says it's the industry's responsibly, and they won't accept evidence from the industry.

So the money is there, either industry based or MSA based. We just need a researcher to step up to the plate.

ETA: ByStander is quite correct, it's not a strongly centralized industry. China makes most of the gear from more companies than you can shake a stick at, the juice is produced all over the place.

 

[Ande]

Ande...not true that scientists "never seem to consider" that ecig users might know something about ecigs. There are a bunch of publications based on surveys, interviews etc with ecig users.

Fair enough- I have read some.

But I'm still frustrated by the number of studies which are conducted without considering the actual experience of actual product users, at least in designing the studies. Many studies are flawed in ways that a basic understanding of these devices as they are used would head off.

To answer another question- if your average joe walks into your average gas station, sees an ecig, and wonders if it's worth buying:

It isn't. Virtually all gas station ecigs have a short battery life, long charge time, unsatisfying vapor performance, low reliability, and a short life.

And yet...

It is. In the sense that everyone who vapes gets introduced somehow. Many of us, myself included, picked up the vaping habit, and dropped the smoking one, as soon as we saw the potential of the product. And gas station ecigs are often enough to see the potential of the product. I was vaping my 510, thinking "this is so much better than smoking" but it keeps flooding, burning, running out of juice, breaking...I need something better. So I got something better.

But I wouldn't have spent the money for something better at the start, cause I didn't know why it was better.

Vaping is a journey. Nobody I know is vaping the gear they started with.


Ande