A study to evaluate variants in e-cigarettes in healthy volunteers
Research type
Research Study
Full title
A randomised, controlled, open-label, crossover study to assess the nicotine pharmacokinetic profile of different eLiquid formulations delivered by an eCigarette in healthy adult subjects.
IRAS ID
289176
Contact name
Helen Philpott
Contact email
Sponsor organisation
British American Tobacco (Investments) Limited
ISRCTN Number
ISRCTN80837297
Duration of Study in the UK
0 years, 2 months, 13 days
Research summary
This study is an open-label, randomised 8-way crossover study.
The purpose of this study is to measure the levels of nicotine in the bloodstream when delivered from different variations of eLiquids at different nicotine strengths and in comparison with a normal conventional cigarette. The study will also evaluate how the variations in the eLiquid affect the overall user product satisfaction and experience.
This study will investigate 7 different new prototype eLiquids and a normal cigarette. Each of these eLiquids will be different in terms of their nicotine content and the combination/ratio of 3 different acids which are key ingredients in the eLiquids.
The study will consist of a screening visit, 8 product use periods (1 product per period over 8 days) and a follow up telephone call. The study will be conducted in 32 healthy volunteers (male and female) who are daily dual users of eCigarettes and smokers of conventional cigarettes.
At each product use period, participants will be required to use one of the study products. For the 7 prototype eLiquids, participants will have 2 product use sessions per period; one where they use the product in a fixed way i.e. 1 puff every 30 seconds for 10 minutes and another where they will use the product in an ad lib way i.e. taking puffs as they feel necessary for 10 minutes. For the cigarette arm, there will be only one product use session where the product will be used in an ad lib way i.e. as the participant would normally smoke over a 10-minute period.
Blood samples will be taken at set time points before, during and after each product use period to measure the levels of nicotine in the blood and how these levels differ between each product. Questionnaires will also be completed to determine the difference in product satisfaction.
REC name
Wales REC 1
REC reference
20/WA/0264
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion