Study 36234

If you are healthy and a daily user of combustible cigarettes (average of 10 cigarettes per day over the past 12 months), aged between 19 and 65, then you may be eligible to participate in a research study investigating commercially available heated tobacco products (HTPs) and a combustible cigarette.

*Terms & Conditions apply.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running an exploratory research study to evaluate the levels of nicotine in the blood following use of three different types of tobacco product; the 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 nicotine 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 will be required to use two different flavours of heated tobacco sticks (using the Ploom X Advanced heated tobacco device) and their own cigarettes which they usually smoke on a daily basis, all of which are commercially available products in the UK and/or EU

The study will comprise of 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. The purpose of the data generated in this study is to provide further information about these types of heated tobacco products (HTPs) to add to the growing body of data being generated for these types of products.

The study will comprise of a screening visit, three product use periods over one in-house stay (requiring 4 overnight stays at the clinical unit from Day -1 to Day 4) and a post study follow up telephone call (approximately 4-7 days after discharge from the clinical unit on Day 4). You should ensure that you are able to commit to completing all visits before agreeing to participate in this study. If you complete this study, you will receive a maximum inconvenience payment of £1675.

The product use periods will occur on Day 1, Day 2 and Day 3 respectively. Each day will comprise of two product use sessions; one single use session in the morning and one multiple ad libitum use session in the afternoon where you will use one of the three products on each day.

If you complete this part of the study, you will receive a maximum inconvenience payment of £1675.

Study Payment: £1675 Apply. Be amazing

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