Intellicig will reveal results from major research project tomorrow

[Bill Godshall]

It would be helpful if folks didn't have to register to join a website in order to obtain a copy of the "major study" cited by davidnewns.

BTW major studies are published in peer reviewed scientific journals.

 

[booker]

Yes, an external link wouldn't hurt.

 

[e-pipeman]

Thank you for this - it's very interesting.

I'm glad that someone has taken the time and trouble/expense to look into this. The more information we have in this regard the better imho.

I assume that the redactions relate to commercially sensitive info?

 

[Tom09]

Thanks for providing a glimpse into this interesting report of unpublished proprietary data. Hope your experiments will lead to an actual study, including the necessary experimental details in a formal publication.

How do the Cmax numbers given in the text relate to the tabulated values?
Cmax for cigarette: 5.4 min (in text) vs. 7.8 min (in Table 1)
Cmax for Intellicig(R): 5.1 min (in text) vs. 6 min (in Table 1)

Any explanation for the peculiar shape of plasma nicotine concentrations plotted for the Intellicig sample (in Figure 1)? Indicating the analytical error attached to the blood nicotine data would be of some help.

 

[davidnewns]

Hello Everyone

Sorry for the delay in my reply, I have been travelling, currently sat in Zurich airport waiting for my connecting flight.

The redactions have been made to protect proprietary testing methods and commercially sensitive information, as per my original message we are happy to engage with individuals to answer specific questions, these should be directed at David Lawson davidl@intellicig.com


Some people have started to ask technical questions in relation to this study, truthfully I am not qualified to answer these but if you send them to David Lawson he will do his best. I would much rather you have a complete and accurate answer than me trying to guess.



Intellicig and the principle investigator have chosen not to submit our full report to and scientific journals as suggested by 'Bill Godshall' for various reasons, mainly commercial sensitivity and the fact this is a preliminary trial, and the results have given our science teams many more questions that we now need to answer through additional trials, at the end of the day this is research, no one trial can answer everything, we are all learning. I do however thank Bill Godshall for his suggestion and remark.

As previously stated and noted by other members in this industry we are all responsible for developing our products and we want to participate in this community fully. Our entire team is at the disposal of interested members as long as they can respect some information must remain confidential at least until we achieve our goal of NRT.

In summary I think we have made major progress in understanding how the Intellicig effects the Plasma blood levels, and now we have lots more work to do.

Again if anyone else is interested in undertaking trials of their own product we would be more than happy to conduct these.


I utilised the upload attachment feature of the forum to make the report available to individuals, I was not aware this featured demanded members to logon before downloading. Maybe this is something that should be asked of the forum owners.


Kind Regards

 

[booker]

Our entire team is at the disposal of interested members as long as they can respect some information must remain confidential at least until we achieve our goal of NRT.

Unfortunately this may put whole community under a risk of classifying e-liquid (and PVs) under NRT, requiring to obtain the license and many many vendors which wouldn't affort to get the license for NRT will get vanished.

 

[davidnewns]

Unfortunately this may put whole community under a risk of classifying e-liquid (and PVs) under NRT, requiring to obtain the license and many many vendors which wouldn't affort to get the license for NRT will get vanished.

Hi Booker,

I’m not too sure, most likely as suggested by the industry we have two types of e-cig 1) Medicinal NRT 2) Recreational Product.

 

[booker]

Ah, ok. Hope it will stay this way.

 

[davielawson]

Would it be possible to read what the graphs depict with regard to ng/ml, in the e-cig, and cigarette/patch. Also, what is the testing method used. It says nicotine concentration, but is it metabolised or no...are these not cotinine measurments? Also, what is the mg/ml number for "medium".
It shows correlation but unknown what the readings per graph line designate, except for time intervals.
Will there be an unredacted copy available?
Thanks.

Hi Kate,
Regarding the values for nicotine concentration, as these are commercially sensitive they are unavailable. These values are unique to the Intellicig NDD used in the study. The dose delivered from e-cigs will vary greatly from device to device.

The test method used was to determine the Blood Plasma Nicotine Level. Results were not determined through cotinine level analysis as these would not give useful information such as Cmax and AUC values (Cmax is the highest level of nicotine observed in blood at a time point - maximum concentration reached).

The ECOpure Medium Regular that was tested was 15mg/ml. I can confirm that 11 inhalations of both the cigarette and Intellicig NDD were used as the study dose.

The purpose of the report posted was mainly to compare Cmax values. The downfall of many NRT's currently available is that the Cmax value is too low and too slow to alleviate smoking withdrawal symptoms. Recent scientific review papers have suggested the development of an NRT that delivered a faster dose of nicotine would prove very successful as an NRT (Nature Review Group).

I hope this information is of use to you.

If you require further information please do not hesitate to contact me at davidl@intellicig.com

 

[ckc]

When does the next set of testing start?

Hi Kate,
Regarding the values for nicotine concentration, as these are commercially sensitive they are unavailable. These values are unique to the Intellicig NDD used in the study. The dose delivered from e-cigs will vary greatly from device to device.

The test method used was to determine the Blood Plasma Nicotine Level. Results were not determined through cotinine level analysis as these would not give useful information such as Cmax and AUC values (Cmax is the highest level of nicotine observed in blood at a time point - maximum concentration reached).

The ECOpure Medium Regular that was tested was 15mg/ml. I can confirm that 11 inhalations of both the cigarette and Intellicig NDD were used as the study dose.

The purpose of the report posted was mainly to compare Cmax values. The downfall of many NRT's currently available is that the Cmax value is too low and too slow to alleviate smoking withdrawal symptoms. Recent scientific review papers have suggested the development of an NRT that delivered a faster dose of nicotine would prove very successful as an NRT (Nature Review Group).

I hope this information is of use to you.

If you require further information please do not hesitate to contact me at davidl@intellicig.com

 

[davielawson]

It would be helpful if folks didn't have to register to join a website in order to obtain a copy of the "major study" cited by davidnewns.

BTW major studies are published in peer reviewed scientific journals.

I believe DavidNewns was referring to this study being a "major study" in relative terms. I have not seen any significant study carried out on nicotine levels in electronic cigarettes and so this is of major significance to Intellicig, and indeed all e-cig users.

The information gathered in this study confirms the beliefs of many Intellicig users, that the Intellicig can give them the "kick" that the are used to receiving from smoking tobacco containing cigarettes.

It is the first of many study s to be conducted by Intellicig on electronic cigarettes, and is a giant step for the electronic cigarette industry.

To have a study published in a scientific journal would me a major achievement for any group, and is one worth aiming for!

Intellicig are looking to work with a number of study groups to produce statistical data on electronic cigarettes.

David Lawson

 

[davielawson]

When does the next set of testing start?

Thank you for your reply.

I can not confirm a date at present, however, it is likely to be a matter of weeks rather than months before the next study begins.

Im sure you can appreciate there is a lot of planning and organisation involved in a study of this nature, however we are eager to begin as soon as reasonably possible.

We are still analysing the results of the previous study and assessing what needs further analysis, however planning for the next study is under way.

As previously mentioned by David Newns, if you have any questions regarding e-liquids and e-cigarettes, please feel free to contact us. We are more than happy to assist you with your questions.

David Lawson

 

[davielawson]

Thanks for providing a glimpse into this interesting report of unpublished proprietary data. Hope your experiments will lead to an actual study, including the necessary experimental details in a formal publication.

How do the Cmax numbers given in the text relate to the tabulated values?
Cmax for cigarette: 5.4 min (in text) vs. 7.8 min (in Table 1)
Cmax for Intellicig(R): 5.1 min (in text) vs. 6 min (in Table 1)

Any explanation for the peculiar shape of plasma nicotine concentrations plotted for the Intellicig sample (in Figure 1)? Indicating the analytical error attached to the blood nicotine data would be of some help.

Hi Tom09,

Thank you kindly for your questions regarding the provisional report on our recent study. I have reviewed you questions and can see how the report may not be clear to you. To put simply, the reason for a difference in Cmax in cigarette and Intellicig group is due to the statistical analysis of the data. The first figure given of 7.8 mins is from an average time taken to reach Cmax in both of our groups. The second figure of 5.4 min is the Cmax of the average of results.

To clarify, the first number is the average time taken to reach Cmax. The second figure is the average time taken to reach the average Cmax. For statistical reasons and to clarify in the report I will change the details to omit the average time taken to reach Cmax and change this to use only the average Cmax. It is of greater importance to have the average Cmax than the average time taken to reach Cmax.

I will also change the time units to marry up as there may be some confusion between times, e.g. 5min 30sec = 5.5 min = 0.092hours

The best explanation that I can give for the graph of plasma nicotine concentration is that it follows the trend of a cigarette. A single dose unit is administered, this dose reaches Cmax then is metabolised rapidly initially (half life of nicotine = apx 120min), followed by a slower rate of metabolism as the concentration decreases. It is what we would have expected to see and is standard in trials of nicotine levels in smokers. Similar results were observed in our smoking groups.

Comparison of this with an NRT (patches, gum etc) would show that the NRT reaches Cmax much slower and declines slower. This is partially due to the nicotine being metabolised prior to Cmax being reached and so the rate of decrease is less than that of a faster administered nicotine dose.

With regard to your comment on analytical error on blood nicotine. Much time was taken in formulating the methodology, both scientifically and practically. Also our method of blood plasma nicotine analysis is a fully validated method.

Kind Regards
David Lawson

 

[Vocalek]

One thing that the currently approved NRTs have in common (at least in the U.S.) is that they come with directions on how to wean down and off nicotine. Was that the plan for Intellicig, too?

If the company goal is NOT to cure the "nicotine addiction" then will you be able to get product approval from your government as a medication?

If the end goal is to cure "nicotine addiction", the question would be whether there is any kind of advantage to starting with a higher nicotine replacement level that more closely replicates nicotine levels from smoking.

It is my personal belief that there are people medically dependent on nicotine. For those folks, it doesn't matter how closely you replicate initial dosages and how slowly you reduce dosages. The cognitive and emotional symptoms increase at a rate that corresponds to the reduction in nicotine dosage--getting worse over time as the dosage is reduced. Once the nicotine is all gone, so is their capacity to remember things and to pay attention.

They begin smoking again in self-defense, and feel normal again within a few hours. Each time I resumed smoking after a period of nicotine abstinence, I felt an intense feeling of relief. Like taking a big drink of water when your throat is parched.

People who don't need nicotine for normal brain function seem to be able to throw away their pack of cigarettes and get on with their lives, suffering little more than some cravings.

I have another theory that would need to be tested. That is that those nicotine users who report getting a "kick" from using it are those who actually can take it or leave it without becoming dysfunctional. Those who require nicotine don't experience the "nicotine high" talked about by others.

It might be parallel to the pain medication oxycontin. Some people "abuse" it to get a feeling of intense euphoria. All oxycontin does for people who are in excruciating pain is to provide relief from the pain. There is no euphoria.

It would seem to me that the advantage of more closely replicating the Cmax from smoking is if the product is intended to be used as a permanent replacement for smoking. That close replication would make the product more acceptable as an alternative.

 

[Tom09]

Thanks for your detailed response. It certainly helped to improve my reading of the report. Kind regards,
Tom

 

[Kate51]

Thank you, davielawson, for the info, I think your (1)Aim has been fulfilled, your NDD does deliver nicotine.

 

[StDoodle]

What are the facts? Again and again and again - what are the facts? Shun wishful thinking, ignore divine revelation, forget what 'the stars foretell,' avoid opinion, care not what the neighbors think, never mind the unguessable 'verdict of history' - what are the facts, and to how many decimal places? You pilot always into an unknown future; facts are your only clue. Get the facts!

It's always good to see facts! Thanks for this.

 

[D103]

It's always good to see facts! Thanks for this.

To Heinlein as Lazarus Long I would say: Careful at whose feet you worship! Facts are indeed important, but to place "fact" above all else and to follow the advice of ignoring all of the interesting nuances of life is as misguided as it is utterly nonsensical. "the world is flat...was once a 'fact'; machines cannot be made to fly...was once a 'fact' In the grand scheme of things "facts" are quite transient in nature and only represent what we can objectively "prove" at any given time given the current available "evidence". To herald "facts" as the end-all/be-all is ludicrous and to suggest that the only clue we have in our collective journey is "fact" demonstrates, quite ironically, cluelessness.

 

[rothenbj]

To Heinlein as Lazarus Long I would say: Careful at whose feet you worship! Facts are indeed important, but to place "fact" above all else and to follow the advice of ignoring all of the interesting nuances of life is as misguided as it is utterly nonsensical. "the world is flat...was once a 'fact'; machines cannot be made to fly...was once a 'fact' In the grand scheme of things "facts" are quite transient in nature and only represent what we can objectively "prove" at any given time given the current available "evidence". To herald "facts" as the end-all/be-all is ludicrous and to suggest that the only clue we have in our collective journey is "fact" demonstrates, quite ironically, cluelessness.

So prophetic and wisdom beyond my ears!

 

[StDoodle]

Careful at whose feet you worship!

See, the thing is, I try to avoid "worship" in any sense.