RD 683/34970 – Simbec-Orion Skip to content

ARE YOU A CIGARETTE SMOKER OR DUAL USER OF E-CIGARETTES AND CIGARETTES?

If you are healthy and a daily user of cigarettes or a combination of e-cigarette and cigarettes, aged between 25 and 45, then you may be eligible to participate in a research study investigating the effect of nicotine on appetite.

Inconveience payment of £1,790.

study information

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.

study timeline

SCREENING
VISIT

  • 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.

FOLLOW UP
PHONE CALL

  • 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.

APPLY NOW

Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.

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1 Step 1

To enable us to make an assessment of your suitability for a Clinical Trial, we will first need to gather some personal details relating to your health. To ensure your suitability for a Clinical Trial, by ticking the checkbox you agree that the information you have provided is accurate to the best of your ability. Your personal data will be stored on our database which is only accessible by Simbec Research Ltd and our service providers. To aid in your suitability assessment, we will only share with companies that support us delivering our services. Under the current European Data Protection Laws (GDPR), you have a number of rights in relation to your personal data such as the right to access, right to rectification and right to be forgotten where appropriate. Please note: if you have not been contacted within 3 months of applying for a trial, please assume you are ineligible and that your data has been deleted from our system, if you believe you are eligible for another one of our trials, please apply again in 3 months.

For more information regarding our commitment to your privacy, please read our privacy policy.

Agreement

You must be between the age of 25-45 to participate in this trial. 

Your BMI must fall within the range of 18.5 – 29.9 kg/m2 to participate in this trial. 

Your BMI = [ Field17 / ( Field53 * Field53 ) ]

1. Do you regularly use illegal drugs?(i.e. Substances that are used for non-medicinal and leisure purposes. We test as part of the medical.)
2. Have you been diagnosed with Coronavirus/COVID-19?
3. Are you registered with a GP?(must be a UK resident for at least 1 year)
4. Are you taking any prescribed or repeat medication from a GP or a chemist?
5. Do you suffer from or ever had any serious illnesses as diagnosed by your GP or health professional? (e.g. neurological, endocrinal, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic and metabolic disease)?
6. Have you taken part in a clinical trial in the last 90 days or 3 months?
7. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
8. Are you a daily user of both eCigarettes and cigarettes (factory made, not roll your own)?
8.a. Have you smoked for at least 3 years, up to a minimum of 10 cigarettes per day?
8.b. Are you familiar with using e-cigarettes (i.e. have used e-cigarettes over a period of more than 1 month within the last 2 years)?
9. Have you donated Blood in the last 3 months?
10. Do you drink alcohol?
10. a. Do you consume more than 14 units of alcohol per week?
11. Have you had any body piercings or tattoos in the last 6 months?
12. Are you vegan, vegetarian, or have any dietary restrictions that would restrict you from eating standardised meals?
13. Have you received a diagnosis for a restrained eating disorder?
14. (Female only) Are you pregnant or breast-feeding?

Thank you for your time and interest, but unfortunately based on your answer, you would be unable to participate in this trial at this time. But please feel free to fill out a general application form or keep a lookout for other clinical trials we may be recruiting for, as you may be eligible to help in a different trial

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