Nicotine Replacement Therapy Clinical Trial
Official title:
A Randomised, 4-way Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Cigarette, Nicorette® Inhalator and Cigarette Smoking
The purpose of this study is to assess the amount of nicotine that is absorbed into the blood
stream following the use of a new Electronic Cigarette device called the CN electronic
cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared
to the amount of nicotine delivered from smoking a regular cigarette and from using the
Nicorette® Inhalator.
Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering
nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful
combustion products contained in tobacco smoke.
Electronic cigarettes are readily available in many markets, and may contain significant
quantities of nicotine. However, they are not regulated as medicines, and their manufacturers
can make no medicinal claims about them.
Such products are unregulated, having not been subjected to regulatory review by either the
Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.
It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an
application to the MHRA for the CN Electronic Cigarette, in order to make a high quality,
regulated product available. Males aged 18-65, who smoke and who have no intention of
stopping smoking during the trial are eligible to take part in this study. The study consist
of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on
days 1, 2, 3 and 4 with a post study visit on day 5.
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