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
ISRCTN Number
ISRCTN11517760
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
Summary of Research
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.
Summary of Results
The purpose of this study was to investigate the levels of nicotine in the blood following use of three different tobacco products: the Ploom X Advanced heated tobacco device and associated tobacco sticks (two different variants - Evo Gold and Evo Tan) and a conventional combustible cigarette (own brand).The main objectives of this study were 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.
In this study, participants were required to use two variants of Ploom X heated tobacco sticks (EVO sticks using the Ploom X Advanced heated tobacco device) and their own brand of cigarettes, all of which were commercially available products in the UK. The study comprised of three product use periods; each period evaluating one of the products described across three study days. During each product use period, participants were asked to complete two use sessions per day, one session where participants used the product they were 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 used the product as they felt necessary for a period of up to 4 hours. During the single use session on each day, blood samples were taken to measure the levels of nicotine in the blood. In addition, participants were 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.
With respect to the safety objectives of the study, it was determined that all the products evaluated across the study were well tolerated with only 5 events reported and none of these events considered to be related to the products under evaluation (Product A: Ploom X and Tobacco Stick - EVO Gold; Product B: Ploom X and Tobacco Stick - EVO Tan; Product C: Combustible cigarettes (own brand)).
As it relates to the other objectives of the study, the following outcomes were reported:
- Following single use of all products, the levels of nicotine in the blood demonstrated that Product C resulted in the highest levels of nicotine in the blood with the other products demonstrating comparable levels. In addition, the maximum concentration of nicotine in the blood for all products was reached at approximately 7 minutes after use.
- Following use of all products, participants reported that they would use the products again and that their urge to smoke was reduced. Product A was "moderately" to "a lot satisfying" and Product B was "moderately" satisfying. Both products had a calming effect on participants (a little to a lot), relieved cravings (a lot to quite a lot) without causing dizziness or nausea and low scores were observed for taste liking, sensation and enjoyment of using the products. There was no clear pattern for whether the products made participants feel more awake, less irritable, more able to concentrate or reduced feelings of hunger.
- Product C was "quite a lot" to "extremely" satisfying, had a calming effect on participants (quite a lot), relieved cravings (quite a lot to extremely) without causing dizziness or nausea, the taste was liked (quite a lot), participants experienced sensations in their throat and chest (quite a lot) and enjoyed using the product (quite a lot to extremely). The subjective effects for product C scores also tended to be positive for making participants feel more awake, less irritable, more able to concentrate and reducing feelings of hunger.
In summary, the data gathered during the study were considered sufficient to meet the objectives of the study.
REC name
Wales REC 2
REC reference
24/WA/0035
Date of REC Opinion
26 Feb 2024
REC opinion
Favourable Opinion