PK Study of e-cigarette and combustible cigarette
Research type
Research Study
Full title
A Part-Randomised, Part-Blinded Pharmacokinetic Study of an E-Cigarette Containing Different Solutions and a Combustible Cigarette, in Healthy Subjects
IRAS ID
167016
Contact name
Ian Fearon
Contact email
Sponsor organisation
British American Tobacco
ISRCTN Number
ISRCTN74070762
Duration of Study in the UK
0 years, 0 months, 27 days
Research summary
Smoking is a leading cause of numerous human disorders including lung cancer,
chronic obstructive pulmonary disease and atherosclerotic cardiovascular disease.
The health risks associated with cigarette smoking are correlated with duration of
smoking and degree of daily cigarette consumption, and cessation reduces an individual’s relative risks of tobacco-related disease. Reducing the negative health impacts of tobacco use is a clear public-health priority and has led to a series of regulatory and educational initiatives to persuade people not to smoke. Despite these efforts, smoking rates in adult populations worldwide remain at 15–25%.
Cigarette smoke is a complex and dynamic mixture of more than 5,600 identified
chemical constituents in both its particulate and vapour phases. Some of these
chemicals have been identified as potential contributors to the harmful effects of
cigarette smoke. Nicotine, a chemical also found naturally in tobacco leaf and which
transfers into cigarette smoke, is primarily responsible for the addictive properties of cigarette smoking.
Although many smokers attempt to quit smoking, few succeed without pharmacological supportive treatment. NRT, first introduced in 1978, replaces the nicotine absorbed from cigarettes and is thought to assist patients in stopping smoking by reducing cravings, symptoms of withdrawal and mood changes.E-cigarettes also aim to mimic the experiences of cigarette smoking, both in terms of the cigarette smoking ritual and by delivering nicotine more rapidly into the bloodstream than NRT. Aerosols produced by e-cigarettes do not contain many of the harmful toxicants found in cigarette smoke and those that are present are generally at lower levels than in combustible cigarettes. They are therefore becoming increasingly accepted as offering a safer alternative to smoking. E-cigarettes are widely available commercially, and currently no specific regulatory framework exists for these products. Since e-cigarette manufacturers make no medicinal claims about their products they are not regulated as medicines, despite delivering pharmacologically-active quantities of nicotine.
REC name
HSC REC B
REC reference
14/NI/1118
Date of REC Opinion
21 Nov 2014
REC opinion
Further Information Favourable Opinion