FINALLY! A REAL Clinical Trial on e-cigs!

[leaford]

FINALLY! A REAL Clinical Trial on e-cigs!

Auckland University's Clinical Trials Research Unit has announced a six-month clinical trial of the safety and effectiveness of electronic cigarettes for smoking cessation! Currently in set-up phase, the trial has the cute name of END-IT.

END-IT: ELECTRONIC NICOTINE DEVICE INTERVENTION TRIAL

Funded by Health Research Council of New Zealand, the study will be a single-blind randomized control trial. Participants will be recruited from Auckland, NZ, and will receive a standard 8-week course of either a 16mg e-cig, a placebo 0mg e-cig, or nicotine patches, as well as behavioral support. They will be evaluated for continued tobacco abstinence after 6 months, as well as secondary outcomes, and for adverse events.

This study received funding in June 2010 and is currently in set-up phase, with study documents being prepared and ethics and regulatory approval being sought.

I have a few concerns over the study design. For one thing, it is designed to evaluate tobacco abstinence after an 8-week course of e-cigs, so will they count continued e-cig use after the 8 weeks as success or failure? Six months isn't really long enough, for another. And they gave no information on the size of the study.

But, it is a start. A start to the real solid research that we need. Blinded, randomized, placebo controlled, peer-reviewed and published, this will be a GREAT validation for our side when it is complete.

 

[Dkrom68]

Whether it is proper in all ways or not it is being done. Hopefully they will release information as it progresses and look into the chemical compositionof whats being inhaled as well to see the effects we so desperately need to know on a more in depth study. Maybe this will be a snowball effect and start others into doing the same thing.

 

[bassnut]

In the only other trial like this that I know of, the clinicians didn't have a clue about how to use the "mall" model e-cigs they selected so consequentially either did the test subjects.
We've all read about the disappointing experiences new users have before they first come here to ECF. I believe the conclusion of the test was the subjects weren't receiving enough nicotine therefore e-cigs are useless placebo devices.

Here it is. The famous Eissenberg test:
VCU researcher says electronic cigarettes don't deliver the nicotine they promise | Richmond Times-Dispatch

I would hope the clinicians get an e-cig user/specialist on their staff for this test.

 

[jfdpl686]

What real help this study gives to e-cig users?
I mean, it is intended for smoking cessation which is not the base idea of the device. Yeas, it can help to quit but many don’t want to.

Then, some of us, are vaping non-nic liquid… does that count as quit to their eyes?

I think what is really needed is a study proving e-cigs are “safe” or at lest “safer” than its counterpart.

Honestly, I don’t see the point and believe it could damage further the situation if they conclude is not a good solution.

 

[Sylvie]

Its a start.. They need to choose the starting nicotine strength based on rather a smoker smokes light/reg/etc. to really show success or not.. And 8 weeks seems like failure from the start, even the patch is for more than that isn't it??

I know right now that there is no way I would succeed if I was a participant and only given 16mg of nic and only 8 weeks to quit.. not going to be a good result to help support ecigs, I'd also rather see a health study instead but guess something is better than nothing.

 

[JollyRogers]

We need clinical studies done in the US. However, I would volunteer to go to NZ for a few months as a SME to conduct training on E-Cig use, maintenance, and care and ensure they are using products that meet the mark and aren't some cruddy piece of junk that produces no vapor.

 

[CES]

The primary investigator, Chris Bullen MD, and his collaborators have done much of the other decent research related to e-cigs. He's involved with the University of Geneva survey of e-cig users (more info here http://www.e-cigarette-forum.com/forum/casaa/85645-two-important-surveys-casaa-university-geneva.html). Basically, this study is being done by someone who wants to know the real outcome and who has knowledge of e-cigs.

 

[kristin]

As long as they are looking for effectiveness for SMOKING cessation and not for NICOTINE cessation, it's all good.

 

[bassnut]

As long as they are looking for effectiveness for SMOKING cessation and not for NICOTINE cessation, it's all good.

Isn't smoking cessation what they're usually about - patches, gum etc?
3 months or 6 months.... but beyond that they don't really want to know.

 

[v1John]

Why not keep the test more simple and possibly better and larger? Have thousands of serious smokers first, and foremost, undergo a good series of seminars that teach them everything that should be known about analogs, and again with a series about ecigs. An exhaustive final exam is then taken by each pre-experiment participant..



From there, they can then run whatever experiment they want, such as the threaded one here!

In other words, they made no mention of exhausively teaching first every harm from analogs, their contents, and things like that.

1) Those who fail the final exam (pre-experiment) are then absolutely NOT permitted to participate in the experiment.

2) And those who passed and made it to the experiment but switch back to analogs after vaping 0mg to 36mg cartos for the first 6 weeks (let them choose as they see fit and when they see fit for themselves), are then eliminated from the experiment and given treatment for suicidal tendencies... and are then absolutely NOT permitted to participate in the experiment.




...Sounds like a better, more comprehensive, and scientific experminet doesn't it?

...And this brings up another point, the experiment the way they described it, seems too awckward and possibly somewhat unscientific. Who the hell determined that 16mg cartos MUST be used? What happens to those who needed 24 or 36 or 0 and 12 or 16 as needed? One of the greatest things about ecigs is that they're custom made as the user needs, with even 0 nicotine available as freely or occasionaly as we see fit, my God!

And what of those who want grape, or espresso, and menthol in the evening?? I didn't even get to that yet!

The ECA, and the coalition and friends in CASSA should get involved too, if nothing else, just as witnesses to report to us in real time everything we all should know?!

I think Doctor Vapor should be allowed his review of it before this thing starts and potentially runs wild!




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[Kate51]

Sylvie, good point...I was not ok at 16mg to start. It took 24mg just to stay calm enough to keep going with the other withdrawals, i/e hunger, high energy and constant need to vape. (I thought so at the time!)
Still, we do need to know the SAFETY FACTOR, effectiveness will still be subjective, MHO.
Depending on how they detect, quantify, and report the effects of smoking cessation I am a little skeptical as well, as Kristin said, is it smoking cessation or is it nicotine cessation.
Even after a year+ there's no way I want to put the e-cig away, I am using 6-12mg of nicotine now, still not "comfortable" at 6 after more than a couple days. That was not my original plan, as so many seem to be following the same theory...safer, not necessarily quitting nicotine altogether. I would love to be there for some covert observations when they let these people out for the night!!
I wish them luck. It's a very big order to conduct clinicals...how many clinicals have we seen on any other type of addictions. Just curious, as I'm watching Discovery Health "Addiction" at this moment, on alcoholism intervention. Pretty tough stuff. That's what still makes me a little LOT angry how everyone in the world seems to be Hell-bent on Zero Tolerance nicotine use.

 

[leaford]

The primary investigator, Chris Bullen MD, and his collaborators have done much of the other decent research related to e-cigs. He's involved with the University of Geneva survey of e-cig users (more info here http://www.e-cigarette-forum.com/forum/casaa/85645-two-important-surveys-casaa-university-geneva.html). Basically, this study is being done by someone who wants to know the real outcome and who has knowledge of e-cigs.

Good to know.

 

[v1John]

...By someone who wants to know the real outcome, CES?
The real outcome of what, specifically, though?

Also, by someone who has knowledge of ecigs? Big Tobacco and Big Pharma knows ecigs too. Big Tobacco had desgned 'The Heatbar' a long time ago, I understand.

The Big Tobacco Heatbar:

There is no more real outcome than 'outside' of the limited 16mg experiment, is what I'm trying to say. Perhaps they're using 16mg to make it more like gum and patches, but in real life, I think the most success has been by people having the freedom to vary flavors and strengths, and even use zero nicotine, all according to each person's particular level of stress or habit or whatever triggers the need to light up an ecig. It's just too low for many and too high for some, and too strict to limit it at that level for most people. Not that they will O D, because it's unpleasant as you approach too much, they begin to get headaches and nausea. It's best to let vapers decide what strengths they need at which times. ..Oh, and of course, flavor and ecig quality too!

I wouldn't have thought of applying thought to this, except that the problem is what happens afterwards. Then you will have all the people that we spent so much time petitioning and they will focus on everything bad that they can. THey will not mention any of the studie's flaws, though. That seems to be in the pro-vaper's department, and the time seems to be NOW, before the study begins. I am just trying to let y'all know beforehand. True, the complete rules and regulations are not posted, but from the looks of it, it really needs to be looked into. The media probably needs refer to this study as the 'Limited ecig16 Experiment'.



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[CJsKee]

I'm just glad someone, somewhere, is doing something. Of course there are all kinds of problems that we, as commited e-cig users, see...but that these folks probably know little about. I would suggest the researchers use unflavored e-liquid...no disgusting flavors, just mild sweetness. Of course 18-24 mg/ml nic would probably be better, but this research will provide a base that can surely be expanded on at a later date (unless, of course, e-cigs are completely shut down )

 

[Smix]

What real help this study gives to e-cig users?
I mean, it is intended for smoking cessation which is not the base idea of the device. Yeas, it can help to quit but many don’t want to.

Then, some of us, are vaping non-nic liquid… does that count as quit to their eyes?

I think what is really needed is a study proving e-cigs are “safe” or at lest “safer” than its counterpart.

Honestly, I don’t see the point and believe it could damage further the situation if they conclude is not a good solution.

That's because they're wanting to ban smoking outright here so are looking at ways of helping people quit. I don't think they're studying it as an alternative but rather a cessation device.

 

[v1John]

That's because they're wanting to ban smoking outright here so are looking at ways of helping people quit. I don't think they're studying it as an alternative but rather a cessation device.

Alterntaive vs Cessation is really the same thing.
I never smoke when I have a good, lit, ecig in my hand, you see?



Now there are strict rules I must give the researcher--not the other way around. I must be allowed to flow freely from 0 to 24 (to 36,the first 8 weeks for me) and choose the flavor as needed, and I even get to choose the quality of the ecig. (Also, all participants must take the pre-experiment education class that I mentioned, and pass the analog cigarette knowledge test!)





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[CES]

Alterntaive vs Cessation is really the same thing.
I never smoke when I have a good, lit, ecig in my hand, you see?

Now there are strict rules I must give the researcher--not the other way around. I must be allowed to flow freely from 0 to 24 (to 36,the first 8 weeks for me) and choose the flavor as needed, and I even get to choose the quality of the ecig. (Also, all participants must take the pre-experiment education class that I mentioned, and pass the analog cigarette knowledge test.)

I understand your points, and personally i think 16 mgs might be a bit low- BUT, the strict rules that the researchers MUST follow are the ones in place by the InstitutionalReview Board that allows them to do human research. They also have to narrow the early experiments to limit the variables to things that are measurable. And they have to do it in such a way that they are allowed to do the research. Unapproved research won't be publishable in peer reviewed journals.

My point really was that the researchers doing this study don't have the anti-agenda and that they've done decent research in the past. Making sure participants know how to use the e-cigs is important- and they just might get that point. My hypothesis would be that they will see more success with 16mg e-cigs than with 0mg e-cigs or the NRT.

Yes, it's limited, but it's a starting point and has a better chance of being decently designed research than anything that we've seen done by any other group.

 

[kristin]

Isn't smoking cessation what they're usually about - patches, gum etc?
3 months or 6 months.... but beyond that they don't really want to know.

No, the patches and gum, etc. are about NICOTINE cessation, not just smoking cessation. They don't agree that you have "quit smoking" so long as you are still using nicotine. The Big Pharma products are meant to be "weaned off" within 6 months, so you quit using nicotine altogether.

Ecigs are meant to be used as long as the consumer wishes, as a cigarette replacement, so they aren't nicotine cessation products. However, people who use ecigs EXCLUSIVELY have QUIT SMOKING. That's where the confusion is - we say we "quit smoking" and they assume that we quit nicotine, as well. Because we haven't quit nicotine, they claim we haven't quit smoking.

Until they recognize that recreational nicotine has very little risk, absent the smoke, and is an acceptable practice (like drinking coffee for the caffeine) we will continue to have this issue.

 

[v1John]

No, the patches and gum, etc. are about NICOTINE cessation, not just smoking cessation. They don't agree that you have "quit smoking" so long as you are still using nicotine. The Big Pharma products are meant to be "weaned off" within 6 months, so you quit using nicotine altogether.

Ecigs are meant to be used as long as the consumer wishes, as a cigarette replacement, so they aren't nicotine cessation products. However, people who use ecigs EXCLUSIVELY have QUIT SMOKING. That's where the confusion is - we say we "quit smoking" and they assume that we quit nicotine, as well. Because we haven't quit nicotine, they claim we haven't quit smoking.

Until they recognize that recreational nicotine has very little risk, absent the smoke, and is an acceptable practice (like drinking coffee for the caffeine) we will continue to have this issue.

Wow, that's a good explanation. I mean excellent post.

And how would you word the health dilemma? I know that they're healthier than cigarettes for me, but health claims can pluck a nerve every now and them.

With gums and patches, the big pharma thought that they were going to succeed by approaching it from the nicotine end. It's so clear. Nicotine is the addictive thing, they figured, so by using nicotine and reducing the level to zero, they thought they had something good.

The problem is that they failed. I mean actually they made a fortune, but they failed at smoking cessation. They ignored smoking!!! They ignored that smoking is experientially important. That is why ecigs are great, because experientially I am still smoking, but in reality I'm not. I'm quasi-smoking.

I did not want to quit smoking, except it was way tooo dangerous. I wanted to quit the hazard of smoking. I wanted cigarettes to be not as dangerous, and that is also another reason electronic cigarettes are great. Big U.S. tobacco, pharma, and fda, collectively utterly failed to separate the severe hazard from the cigarette however, but by golly, someone had to do it one of these centuries.




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[rolygate]

This trial is a positive move and at least is being carried out by people who are more likely to be neutral. However if the design objective of the trial is to see if ecigarettes can be used to quit smoking tobacco, the result will be a pointless waste of time, and of course wrong, unless:

1. The ecigarettes chosen are those proven to actually deliver (some models aren't very good).
2. They are set up with the help of an expert (some new e-cigarettes don't work well unless correctly prepared).
3. The user must be offered 30mg or 36mg e-liquid otherwise the trial is pointless, I doubt if 16mg would be of any use to most cigarette smokers trying to quit.
4. The user must be offered flavors to taste otherwise the long-term result cannot be optimal.

16mg strength would be useless for me and I'm several months in. I have never met anyone who would find 16mg liquid of any use (at first) though there must be someone somewhere, of course.

In addition, beginners have terrible technique, so they only get a fraction of the nicotine that is available in any case.

As a trial to see if people like them, assuming that a range of flavors are offered if not strengths, I suppose this is a reasonable effort - though I'm not sure I can see the point. As a trial to see if people are prepared to change over to ecigs and/or are prepared to use an ecigarette exclusively, on the current information given, it would be a pointless waste of time and money.

When is someone going to do a real trial? A 'real trial' means smokers must be offered what is out there on the market:

• any nicotine strength they need/want;
• any flavor they want;
• any ecig model they want;
• and if they fail to change successfully to the ecig, then they need to be given a 5 volt device, because standard models don't do it for many.

Regular ecigs don't do the biz for me and I'd be back on the Lucky plains full time without my 5 volt box mod. Why shouldn't anyone else have that choice?

A trial that doesn't offer what is available for smokers to choose if they were managing the process themselves, isn't a realistic trial. It's like testing wine on beer drinkers, and giving them only a Chilean white of this year, and asking them, "That's wine - like it?".



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