On December 21, 2013 AEMSA announced that we sponsored a clinical study, performed by Dr. Konstantinos Farsalinos, evaluating Plasma Nicotine Absorption Levels (PNLs) from electronic cigarette use.
http://www.aemsa.org/aemsa-sponsors-clinical-study/
This study measured, in a clinical (hospital) environment with clinical staff and protocols, the amounts of nicotine actually delivered into the blood stream from electronic cigarette use. The study included twenty three participants and over 400 blood samples were taken. Participants arrived after 8 hours of abstinence; the first bold samples were drawn. They then used a ciga-like (cigarette look-a-like type device) for five minutes taking a total of ten puffs – to emulate smoking a single tobacco cigarette; a second blood sample was then taken. The participants were next instructed to use the device at will (as much as they wished) for one hour; blood samples were drawn every fifteen minutes.
This process was repeated on a separate day using an advanced device at a higher (9 watts) power level. Identical protocols, consumption and samples were applied. For all study participants and devices, the exact same 18 mg/ml e-liquid was used. This liquid was thoroughly analyzed by an accredited lab. All results were tabulated, professionally evaluated and analyzed for the study.
On December 19, 2013 AEMSA brought Dr. Farsalinos to the USA to participate in an AEMSA/FDA “Listening Session” and present his study and findings to the FDA personally.
At the time of the original post (link above), the study was pending peer-review and publication. We could not share the specific details of the study beyond what we posted. Dr. Farsalinos also posted, at that time, his own synopsis of his study: http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/146-fda-meeting
The study has now been published and we can now share the full details. We wish to reiterate two points: 1) AEMSA was merely the sponsor (funding source) for this study. We are most proud all AEMSA members, at that time (we have had several new additions since then), participated in this study funding. 2) This was an independent medical/science research study performed by Dr. Farsalinos and clinical teams, under his direct supervision, at the Onassis Cardiac Surgery Center in Athens-Greece.
This study is the first of its kind. Tobacco cigarette nicotine absorption levels were also provided, from other studies, for comparison. The first five-minute use, and related blood samples analyzed, creates a more direct comparison to a single tobacco cigarette. Dr. Farsalinos found that ciga-like use, at 18 mg/ml, might never deliver enough nicotine to raise the detectable Plasma Nicotine levels to that of a single tobacco cigarette. Using the more advanced device, at 9 watts, after 30 minutes of “at will” use delivered more than the ciga-like but still did not deliver enough nicotine to match the PNLs of a single tobacco cigarette.
We believe this may be one of the most important studies, and learned facts about e-cig nicotine delivery, conducted to date. We Thank Dr. Farsalinos and his entire team!
The peer-reviewed and published study, in full detail, can be found here:
http://www.nature.com/srep/2014/140226/srep04133/full/srep04133.html
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