Uptake of Nicotine Following a Single Use of HNB 1.2 and a Cigarette
Research type
Research Study
Full title
An Assessment of the Biological Uptake of Nicotine Among Healthy Adult Smokers Following a Single Controlled use of HNB 1.2 and a Combustible Cigarette.
IRAS ID
185541
Contact name
Neil Sherwood
Contact email
Sponsor organisation
JTI International S.A.
Duration of Study in the UK
0 years, 0 months, 27 days
Research summary
Tobacco smoke contains a complex mixture of chemicals that change in nature as smoke ages i.e. the chemistry of tobacco smoke may change as the smoker smokes a given product. There are estimated to be greater than 2000 chemical constituents of tobacco and this number increases significantly as tobacco burns during smoking.
The purpose of the present study is to gain an understanding of the exposure to nicotine, of healthy adult consumers who smoke, following use of the HNB 1.2 device. Inclusion of a conventional reference cigarette within the study will supply context to the clinical PK results.
The HNB 1.2 product has been commercially available in Europe since May 2013. Overall, results obtained to date from chemical analysis, in vitro toxicology and in vivo toxicology testing indicate that the risk profile of HNB 1.2 is considerably reduced as compared to a conventional cigarette.
This conclusion is primarily based on the following experimental findings:• HNB 1.2 vapour predominantly consists of propylene glycol, water, nicotine and flavours
• For all HNB 1.2 products, carbon monoxide levels were found to be below the limit of quantitation or not detectable under both machine smoking regimes examined.The HNB 1.2 is a product that electrically heats ‘pods’ containing tobacco to create a vapour that is inhaled by the consumer. The product consists of a holder that contains the power supply, the heating unit into which the pod is inserted, and a mouthpiece. The consumer activates the product by pressing a switch on the holder. Upon activation, the heating unit heats the pod containing the tobacco and the consumer is able to draw in the resulting vapour through the mouthpiece.
REC name
South East Scotland REC 02
REC reference
15/SS/0133
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion