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.

[FTJoe]

Yeah - testing smoking cessation which actually initiates when you start using the e-cig, but they want to stop using nicotine. At least its recognizing the mental (placebo) affect of the act itself. Oh well, someday someone will see if this is a healthier smoking alternative. Unfortunately this study is giving a patch, 16mg strength e-cigs and 0mg. So the 0mg will freak out right away, and the 16mg will probably be okay until they take it away at 8 weeks. Am I reading that right? Seems kind of stupid when even the patch recognizes the benefits of stepping down.

I would consider myself quit after going to 0, because I rarely vape now. But I think the nic addiction was not strong in this one grasshopper, it was more the act of smoking, who knew! I did it by cutting down 2mg a week from 24mg until 0mg, then two weeks later my brain even gave up the ghost of craving when under stress, eating/drinking, etc.

[NeRo9k]

It's definitely a start.

[Christopher]

New Zeland alway seems to be on top of things. This is awesome information. We'll have to keep a close eye on the results.

[FTJoe]

Well...my point was I don't think we may like the results unless they document how the 16mg e-cig users were fine while vaping and liked the results. Calle me a sourpuss, but I think the patch, and both sets of e-cig users are cut off after 8 weeks. So the 16mg users who are probably doing great will freak and the 0mg users will be freaking all the way through it. Unless the addiction is mostly mental, then they will go into withdrawal in a day or two, if they can fight their way out of it, they might be the best group coming out of this.

[actor92191]

That's great news!

I just hope that the e-cigs that are supplied for this experiment are good, because a genuine 510 vs. a bad knockoff brand (some bad RN-4081) could mean the difference between quitting or not!

[snubber]

Sounds promising...hope they don't try to sway the results in any way. Like Actor said..good units may make all the difference in a good report or a bad ending. But at least it's a start in the right direction.

[FTJoe]

Wow. Can someone explain how this is good? I'm not getting it at all. If I read it correctly, they want folks to use e-cigs for 8 weeks then then stop using altogether. Some have 16mg e-cigs, other have 0mg. Smoking cessation is being tested but hey really mean nicotine cessation.