Vype ePen/ePod cross-sectional biomarker study
Research type
Research Study
Full title
A CROSS-SECTIONAL STUDY TO ASSESS BIOMARKERS OF EXPOSURE AND BIOMARKERS OF POTENTIAL HARM IN SOLUS USERS OF VYPE E-PEN 3 AND E-POD PRODUCTS
IRAS ID
291542
Contact name
Jorg Taubel
Contact email
Sponsor organisation
British American Tobacco (Investments) Ltd
ISRCTN Number
ISRCTN58921739
Duration of Study in the UK
0 years, 3 months, 19 days
Research summary
Cigarette smoking is a leading cause of numerous diseases, including lung cancer, chronic obstructive lung disease and cardiovascular disease. The public health goal of reducing the health burden of cigarette smoking has led to the development of initiatives to reduce smoke toxicant exposure, such as Vype electronic cigarettes, which are considered to contain significantly fewer chemical toxicants compared to cigarette smoke.
We are conducting a study to compare selected biomarkers of exposure and potential harm in subjects who use Vype vapour products (Vype e-Pen3 and or e-Pod), subjects who smoke regular cigarettes, subjects who are ex-smokers and subjects who are never smokers.
Subjects will be “in-house” for a one-night stay for 24 hour urine collection and other investigations.
220 suitable subjects will be enrolled in four arms; Arm A: 100 Vype user; Arm B: 40 smokers; Arm C: 40 ex-smokers; Arm D: 40 never smokers.
No test products will be provided for use during the study. Vype users and smokers will be instructed to bring a supply of their usual Vype device and cartridges or usual brand of cigarettes to the clinic with them. This will be a sufficient amount to cover their typical usage for the period that they are “in-house”. They will be free to use their Vype products or smoke, respectively, in a room dedicated for this purpose, or outside under the supervision of site staff, apart from at times where this would interfere with scheduled assessments.
Adverse event data and any concomitant medication usage will be recorded throughout the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0005
Date of REC Opinion
15 Mar 2021
REC opinion
Further Information Favourable Opinion