A study to assess nicotine levels in HTPs and cigarettes
Research type
Research Study
Full title
A Single-centre, Open-label, Randomised, Crossover Study to Assess the Nicotine Pharmacokinetics Following Use of Heated Tobacco Products and Combustible Cigarettes
IRAS ID
339200
Contact name
Donald Nortey
Contact email
Sponsor organisation
JT International SA
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
The purpose of this study is to evaluate the levels of nicotine in the blood following use of three different tobacco products; Ploom X Advanced heated tobacco device and associated tobacco sticks (two different flavours) and a conventional combustible cigarette (own brand).
The main objectives of this study are as follows:
- To measure the levels of nicotine in the blood following single use of the three products.
- To assess different subjective measures i.e., completion of specific questionnaires around product usage such as intent to use, urge to smoke and product satisfaction after a single use and a 4-hour ad libitum use session.
- To assess overall product consumption i.e., number of cigarettes smoked/tobacco sticks used over a 4-hour ad libitum use session.
- To provide general safety information for each of the three products.
The study will enrol up to 24 participants (who are regular users of combustible cigarettes) and the study will comprise three product use periods; each period evaluating one of the products described across three study days.
During each product use period, participants will be asked to complete two use sessions per day, one session where participants will use the product they have been assigned to on that day for a period of 4.5 minutes (10 puffs at 30 second intervals) and a second use session where participants will be required to use the product as they feel necessary for a period of up to 4 hours. During the single use session on each day, blood samples will be taken to measure the levels of nicotine in the blood. In addition, participants will be asked to complete a series of questionnaires in order to assess different measures such as product satisfaction, urge to smoke and the intent to use the products again.
REC name
Wales REC 2
REC reference
24/WA/0035
Date of REC Opinion
26 Feb 2024
REC opinion
Favourable Opinion