FINALLY! A REAL Clinical Trial on e-cigs!
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Thread: FINALLY! A REAL Clinical Trial on e-cigs!

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    Default FINALLY! A REAL Clinical Trial on e-cigs!

    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.

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    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.


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    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.
    Last edited by bassnut; 06-23-2010 at 06:12 PM.
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    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.
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    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.

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    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.
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    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 TWO important surveys!! CASAA & University of Geneva). Basically, this study is being done by someone who wants to know the real outcome and who has knowledge of e-cigs.

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


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    Quote Originally Posted by kristin View Post
    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.
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    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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    Last edited by v1John; 06-24-2010 at 05:41 AM.

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