ARE YOU A CIGARETTE SMOKER OR DUAL USER OF E-CIGARETTES AND CIGARETTES?
Inconveience payment of £1,790.
Simbec-Orion Clinical Pharmacology will soon be running a research study to investigate the effects of nicotine on appetite. The overall purpose of this study is to determine how delivery of nicotine via an eCigarette influences appetite (calorie consumption) following a 12-hour period of nicotine abstinence in comparison to a combustible cigarette.
This study will also investigate and compare the level of appetite hormones in the blood prior to and after use of different nicotine strength eLiquids and a commercially available cigarette following a 12-hour period of nicotine abstinence.
Additionally, the study will investigate if nicotine delivery (delivered via an eLiquid and e-cigarette device) can influence mood and cravings through the completion of a variety of questionnaires.
The different eLiquid cartridges will be used with the commercially available eCigarette device (UK trade name Vype EPEN 3.0). All of these products are sold by Nicoventures Trading Limited, a wholly owned subsidiary within the British American Tobacco (Investments) Limited, who are based in, the UK.
In this study, we are looking for volunteers who are current daily users of conventional factory-made cigarettes and/or roll their own cigarettes (minimum of 10 cigarettes per day) and who have done so for at least 3 years. Participants must also be familiar with using eCigarette products ((i.e. have used eCigarettes over a period of more than 1 month within the last 2 years).
The study will comprise of a screening visit, 5 product use periods separated by a minimum of 7 days (each 1 day in duration with 1 overnight stay per product use period) and a post study follow up telephone call (5-7 days after the last product use session). At each product use period, participants will be required to use one of the products in a random order (1 product per product use period with the exception of the first product use session which will require no product use).
For the product use period where you are required to use the commercial combustible cigarette, you will be required to use the cigarette in an ad lib regimen i.e. smoking the cigarette as you like over a 5- minute period. For the product use period where you use the eLiquid products with the eCigarette device, you will be asked to use the product as you like over a period of 5 minutes.
For each product use period, blood samples will be taken at set time points in order to measure the concentration of appetite hormone in the blood, how this changes over time and how this compares between the different strength eLiquids and the conventional cigarette. In addition, we will ask you to complete a number of questionnaires to gather information on your mood and cravings. Each study session will be separated by approximately 7 days.
If you complete this study, you will receive a maximum inconvenience payment of £1790.
A short visit up to 28 days before the first product use period at Simbec-Orion to confirm you are suitable for the study.
PRODUCT USE PERIOD
(DAY -1 to DAY 1)
Arrive at Simbec-Orion on the evening of Day-1. Take part in a study session on the morning of Day 1.
At the first product use period, you will not use any product but this session will provide a baseline of your normal appetite and hormone levels.
At each following product use period, you will use one of the study products, complete questionnaires and have blood samples taken to measure your appetite hormone levels.
You will leave Simbec-Orion on Day 1 of each session and there will be approximately 7 days gap between each product use period.
A phone call from a member of Simbec-Orion staff 5-7 days after your last product use period to check that you are well and not experiencing any side effects.
Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.