A study examining nicotine delivery in e-cigs and normal cigarettes
Research type
Research Study
Full title
A Randomised Controlled Single-centre Open-label Pharmacokinetic Study to Examine Nicotine Delivery from Different Variants of an E-cigarette and a Conventional Cigarette in Healthy subjects.
IRAS ID
254373
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
British American Tobacco (Investments) Ltd
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
This study is an open-label, randomised pharmacokinetic study to examine the nicotine delivery and levels in the bloodstream of different variations of an e-cigarette and a conventional cigarette.
Cigarette smoking has been identified as a contributing factor to numerous illnesses including lung cancer, chronic obstructive lung disease and heart disease. The health risks associated with cigarette smoking are known to be due to chemicals toxicants in cigarette smoke, which can lead to changes in the body, causing disease. Nicotine is primarily responsible for the addictive properties of cigarette smoking.
This study has been developed by the Sponsor in order to assist the development of an alternative approach to conventional cigarettes, by developing new products which may have the potential to reduce some of the risks of tobacco-related diseases namely “Next Generation Products” (NGP). These are nicotine-delivering devices such as electronic inhalable vapour products (e-cigarettes).
The purpose of this study is to determine the levels of nicotine in the bloodstream when delivered from variations of 2 e-cigarettes containing different concentrations of nicotine and a conventional cigarette when smoked ad libitum or following a fixed 'puff' regime.
This study will be conducted in 24 male and female subjects who are all daily e-cigarette users and active smokers. The study will consist of a screening visit, 8 treatment periods (of 1 day in duration, 12 hour washout between each period) and a follow up phone call.
REC name
Wales REC 2
REC reference
18/WA/0353
Date of REC Opinion
25 Oct 2018
REC opinion
Further Information Favourable Opinion