BAT3117011 Tobacco Study
Research type
Research Study
Full title
A randomised, controlled study to evaluate the effects of switching from cigarette smoking to using a Tobacco Heating Product on health effect indicators in healthy subjects
IRAS ID
230414
Contact name
James Ebajemito
Contact email
Sponsor organisation
British American Tobacco (Investments) Ltd
Duration of Study in the UK
1 years, 4 months, 3 days
Research summary
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. Subjects in this study are required to understand the risks associated with smoking. The only known way to reduce the risks of smoking-related diseases is to stop 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 that can be categorised as either electronic inhalable vapour products (e-cigarettes) or tobacco heating products (THPs).
The aim of this study is to collect information about biological and functional changes when the investigational products are given to subjects who change from smoking conventional cigarettes to using a NGP. This study is a randomised, open label study and will compare this information, with that gathered from subjects who continue to smoke conventional cigarettes, subjects who intend to quit smoking, and subjects who have never smoked.
Up to 605 subjects will be enrolled in this study. For all groups, participation in the study will last approximately 1 year and 7 weeks. Subjects will not be required to stay overnight at the clinical research site but will be required to visit the site a total of 15 times including a Screening Visit up to 28 days prior to admission on Day 1, 13 day visits, and a Follow up visit which will take place within 7days of your last visit to the clinical research site at Visit 13.
REC name
Wales REC 2
REC reference
17/WA/0212
Date of REC Opinion
16 Sep 2017
REC opinion
Further Information Favourable Opinion