A study to investigate new e-cigarette devices in healthy volunteers
Research type
Research Study
Full title
A Pilot Study to Investigate Nicotine Delivery Using Investigational Nicotine Delivery Products
IRAS ID
272898
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Nerudia Ltd
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is an open-label, randomised pilot study. The purpose of this study is to examine the nicotine delivery and determine the levels of nicotine in the bloodstream when delivered from a range of different types of newly developed/adaptive design nicotine delivery products i.e. e-cigarette devices, e-liquids and liquidpods and to determine the overall user satisfaction of each of the products.
The study overall will be split into up to 12 groups (known as sub-studies); each investigating different combinations of the products. Some of the groups will compare the newly developed products with products which are already available on the market for use.
Cigarette smoking has been identified as a contributing factor to numerous illnesses including lung cancer and heart disease. The health risks associated with cigarette smoking are known to be due to chemical 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. These are nicotine-delivering devices such as electronic inhalable vapour products (e-cigarettes).
This study will be conducted in a maximum of 72 participants (up to 10 participants within each group). Subjects may be male or female subjects who are all daily e-cigarette users.
The initial study group (Group 1) will consist of a screening visit, 6 product use periods (of 1 day in duration per period, 12 hour washout between each period) and a follow up phone call.
Within subsequent groups, there will be variations in types of product used along with the number of product use periods and associated assessment schedule.
REC name
Wales REC 2
REC reference
19/WA/0316
Date of REC Opinion
13 Dec 2019
REC opinion
Further Information Favourable Opinion