NCi ECIG Clinical Trials looking for particapants

[Krakkan]

I think it was Sun that hinted at it? Cant remember.

Not to sidetrack the thread, but when I was reading the article at prwatch.org site about the PM/VCU thing, another article caught my eye The Ultimate Irony: Health Care Industry Adopts Big Tobacco's PR Tactics | Center for Media and Democracy In that article it talks about how one way to get people to lobby on their behalf is to get a few people to say bad or false things about the issue in the media, which in turn will cause people to write letters, make calls, etc. And, if you get someone who's a so-called expert to say the negative stuff, it'll spread to other media outlets on it's own, causing more letter writing, etc. And anyway, the paranoid cynic in me cant help but wonder if maybe that's what we've been seeing with the ecig. The negative stuff started appearing more frequently in the press around Feb, right around the same time as the clinical trial thing started. Coincidence? And, by having a small handful of people say how "inhaling PG might be bad and there's no studies on it", when we know from that 1942 Times article that there have been studies on PG, and all the other things we've seen and same bogus crap (like flavors are for kids) repeated over and over, it does make you wonder if we were played and have been unwitting pawns to create awareness and for grassroots lobbying.

It's probably just a coincidence, for we know some good reasons these people would want ecigs shut down (the funding that WHO, tobacco Free Kids, and American Lung Association get from big pharma, for example). And, at this point I dont care if I have been played, so to speak, for I do feel ecigs can save lives. But it's one of those things that makes me go "hmmm. I wonder..."

Wow we could have all been leading the way for them lol. Dude I would be ...... lol I even started the freaking E-cig petition I guess I would look like the biggest lackey of them all. lol But tI think Big Tobacco is forced to pay for those types of programs imagine how much money they would save if those organization were no longer there lol.

 

[Krakkan]

Well Im going to let greater minds than my own discuss this further and hit the hay -- I got up ealry for the first time in forever -- dealing with China's work schedule is hell on us suppliers lol -- Nite All

 

[emsmom]

In reading the study info, it looks like you have to still be smoking analogs? Am I reading this correctly? It looks like they are comparing analog and ecig nicotine levels. Might be kind of hard to find participants here, as most of us have given up on the analogs after finding the ecig I have heard of many here willing to participate in a study, too bad they are including the analogs!

 

[Applejackson]

This is just a guess, but I believe they probably say "'so called' electronic cigarettes" because, although that is the name they are sold under most often, it is not a very accurate description. It contains no tobacco, it does not burn, it doesn't produce smoke. A "personal vaporizer" as people in the community call them, is a much more accurate description, but they are rarely marketed under that name.

 

[Princessdee]

In reading the study info, it looks like you have to still be smoking analogs? Am I reading this correctly? It looks like they are comparing analog and ecig nicotine levels. Might be kind of hard to find participants here, as most of us have given up on the analogs after finding the ecig I have heard of many here willing to participate in a study, too bad they are including the analogs!

"
Exclusion Criteria:
Exclusion criteria include: history of chronic health problems or psychiatric conditions, breastfeeding, or pregnancy (assessed by urinalysis).
Individuals who report current attempts to quit smoking, previous experience with Crown Seven or NJOY. Individuals who report alcohol or marijuana use greater than 20 days within the last 30 days, or recent illicit drug use such as ....... or ....... Women reporting active menopause will be excluded (menopause may cause tobacco/nicotine withdrawal-like symptoms, such as depression, Parry et al., 2001)."

Assumably that really means use of any e-cig, not just those 2 brands.
And OMG! I really really need a vape...no it's just a hot flash.
Gimme a break. I've been smoking analogs almost 40 years. I know the difference between withdrawls and hot flashes.

(The 16mg is promising tho. At least they didn't knock it down to 0.5)

 

[ramblingrose]

For what its worth (probably not much as it related to e-cigs), I've been published in the National Library of Medicine/MedlinePlus under their auspices of the NIH, and have been involved in the analysis of data pooled from studies for several years. My first reaction is that this could be a good thing. Some thoughts...

It's no surprise that PM is involved. They've been experimenting with alternatives for years; it's just smart business to adapt to the current political and social climate. They have funds available for the studies that are needed to keep e-cigs available, and certainly have strong incentive.

The term 'so called' electronic cigarettes doesn't concern me. PVs aren't actually cigarettes, but electronic cigarettes is the common, most recognized name used at this time.

It makes perfect sense that the study requires subjects to smoke - any valid study will have to be able to produce a comparison of the physiological effects. Eliquid, at the full range of nicotine concentrations and ingredients will be subject to clinical trials, as well.

While we're in a tough climate for approval, studies with positive outcomes at least open the door for FDA approval. Even Category A approval (experimental device where absolute risk is not yet ruled out) would be a step in the right direction. Devices are also assigned to a class. PVs would be assigned to Class I or II. If we see a Class I designation, it will be preferable.

My understanding is that the primary purpose of this study is to determine how the nicotine is delivered, and if nicotine delivery from an e-cig will suppress cravings to the extent that a user does not feel he/she needs to smoke a cigarette. That's a mere drop in the bucket in terms of what will be needed for e-cig approval. I hope the bucket starts to fill with positive results.

 

[Krakkan]

For what its worth (probably not much as it related to e-cigs), I've been published in the National Library of Medicine/MedlinePlus under their auspices of the NIH, and have been involved in the analysis of data pooled from studies for several years. My first reaction is that this could be a good thing. Some thoughts...

It's no surprise that PM is involved. They've been experimenting with alternatives for years; it's just smart business to adapt to the current political and social climate. They have funds available for the studies that are needed to keep e-cigs available, and certainly have strong incentive.

The term 'so called' electronic cigarettes doesn't concern me. PVs aren't actually cigarettes, but electronic cigarettes is the common, most recognized name used at this time.

It makes perfect sense that the study requires subjects to smoke - any valid study will have to be able to produce a comparison of the physiological effects. Eliquid, at the full range of nicotine concentrations and ingredients will be subject to clinical trials, as well.

While we're in a tough climate for approval, studies with positive outcomes at least open the door for FDA approval. Even Category A approval (experimental device where absolute risk is not yet ruled out) would be a step in the right direction. Devices are also assigned to a class. PVs would be assigned to Class I or II. If we see a Class I designation, it will be preferable.

My understanding is that the primary purpose of this study is to determine how the nicotine is delivered, and if nicotine delivery from an e-cig will suppress cravings to the extent that a user does not feel he/she needs to smoke a cigarette. That's a mere drop in the bucket in terms of what will be needed for e-cig approval. I hope the bucket starts to fill with positive results.

Yes I do hope this will be one of many such studies

 

[Kate51]

CRAP! I'm too damned old, or I would be VERY happy to participate. That's certainly very discriminatory, don't they know they can't do that?? What the heck, they think I'm gonna keel over?? What?? Shucks, post-menopausal

I see, oops, it's ongoing, right now! When it's finished in September I sure want to know what they came up with. This is great news, this is what we've been waiting for forever!! I really think it will show what we've all been thinking, this is a great smoking alternative, don't see what any problems could be, hopefully their findings will coincide with the Ruyan testing.
I wish them luck!! Who better to conduct the testing. Wondering, are any of the participants on ECF, by chance?? Would love to hear from them.

Excellent Post, Krakkan

 

[SharonLM]

I just sincerely hope the study isn't slanted so that we come out on the wrong end of the deal.

 

[Vapinginmyboots]

This is the news we all been hoping for me thinks! This study at least will show how effective these devices are for most people, and we dont have to be quaking in our boots as to weather our e-cigs are affective. It wont be the last study though, and we are certaintly not out of the woods yet.

 

[Krakkan]

This is the news we all been hoping for me thinks! This study at least will show how effective these devices are for most people, and we dont have to be quaking in our boots as to weather our e-cigs are affective. It wont be the last study though, and we are certaintly not out of the woods yet.

Yeah I do feel this will be good

 

[Tom09]

Leading investigator: T. Eissenberg (Virginia Commonwealth University). So, that’s the study we could read about in previous news articles (April 7 Washington Post, June 2 NY Times).

Will be interesting in as much Eissenberg’s findings may confirm Laugesen/Ruyan-team’s first restults. Recalling this comment from [thread=15034]Eissenberg to Kate:[/thread] "These data, if they are valid and can be replicated, provide little support to the manufacturers' claim that the devices can do what they are marketed to do: deliver a physiologically active nicotine dose to the lung."

 

[Hangtime]

I think this study is great but I already did my own study. I bought e-cig and for some strange reason I havent had a tobacco cig since, hmmm, I didnt buy the e-cig to quit, that just happened by itself. Strangest thing happened too. My wife got her e-cig and didn't want any more 'analogs' either. My conclusion is e-cigs do help you smoke less or quit all together.


This test is very interesting and I cant wait to see the results.

 

[TheKingOfKool]

Why does it say in the description that they are being developed and marketed by the tobacco industry?

Are C7 or NJoy owned by a tobacco company?

if they are claiming its a tobacco product that doesn't fall under FDA jurisdiction then that means they ARE a tobacco company

 

[(So) Jersey Girl]

I'm new here and just found this old thread. Does anyone know if the results of this study have been published yet? Wouldn't it have made more sense if the researchers had used a FDA approved product like the Nicotrol Inhaler instead of an unlit cigarette if they're measuring nicotine delivery to the lungs? I mean, the main reason I see for so much opposition to ecigs is that they don't have FDA approval, so why not compare them to something that does?

 

[kristin]

I haven't seen any updates on this and I'm sure it would be all over the boards if they did publish something.

What they test against is relative to what they are trying to determine. If they are trying to determine if they are as safe as FDA-approved NRTs, then then they would use an NRT as a control. If they are trying to determine if they are "safer" than smoking tobacco cigarettes, then they would, logically, use a cigarette as the control. not sure about using an UNlit cigarette? Where did you see that? It makes no sense, as an unlit cigarette poses no danger to anyone!

EDITED TO ADD: Oh, I see. I looked at the link. They are testing it against an unlit cigarette (as sort of a plaecebo) but they are also testing it against a lit cigarette of the test subject's own brand.

 

[Vocalek]

The researcher is quoted in this story.

E-cigarettes gaining steam in Virginia, but are they safe? - NBC12 - NBC12 News, Weather Sports, Traffic, and Programming Guide for Richmond, VA |


We are getting very mixed messages here. This is part of the description of the study:

Evaluating the effects of these products is crucial to public health, as past industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light" cigarettes) were not evaluated and failed to reduce carbon monoxide (CO), nicotine, and carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking (Stratton et al., 2001).

So it looks as if one goal for harm-reduction products is to reduce the amount of nicotine (although how that reduces the smoking-related diseases isnt clear to me). But in the TV story, it looks as if the researcher's complaint is that the e-cigarette might not deliver enough nicotine.

"If there's not any consistency in what's in the cartridge, then how do we know that there's gonna be any consistency in the effects they produce?" said Dr. Thomas Eissenberg with the VCU Institute for Drug & Alcohol Studies.

I assume that this next paragraph actually refers to Dr. Eissenberg. I have to wonder, after reading the description of his study, why he is bringing up safety, when that was not the topic of the study.

"If this is a safe way of delivering nicotine that keeps people away from cigarettes, then I'm all for it. The question is: Is it safe?" Dr. Thomas said.

There are no results posted on the Clinical Trials page for this study.

 

[(So) Jersey Girl]

Thanks for your replies.

I was curious about this because it seems that the main objection to e-cigs is the lack of FDA approval of them as a drug delivery device, which to me means "smoking cessation." So compare them to what's on the market. I personally did not switch to PV's to quit smoking. And, like Dr. Seigal said on his blog, the question they should be asking is not "Are they safe?" but whether they are safer than tobacco cigarettes.

 

[(So) Jersey Girl]

I guess I should have been a little more patient and waited a couple of days.

 

[Vocalek]

The results are out. Here is a discussion http://www.e-cigarette-forum.com/forum/e-cigarette-news/69409-cnn-com-today.html