Healthy volunteer smokers aged 23 to 55 C17034
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We are carrying out a clinical trial with next-generation nicotine products that are being developed as an alternative approach to conventional cigarettes. The information gathered during this clinical trial may support further product development in the future.
In recognition of the time involved in taking part in this study, you will receive £3500 (£1167 compliance bonus and £2333 study payment) on completion of the study provided you comply fully with all the study requirements.
This study will be conducted at our clinical trials unit in London Bridge and will involve healthy male and female smokers.
To see if you are suitable to take part we will speak to you on the phone to explain the study further and ask you some general questions about your status and medical history. If everything is okay you will be invited to screen for this study at our clinical trials unit. Please note we may split the screening over two days to make it easier for you.
If you are suitable after screening you will be invited to take part in the study. On the first day of the study you will be assigned to a group that will either continue to smoke conventional cigarettes or switch to a next generation product, i.e. a tobacco heating device or e-cigarette. This is called Visit 1. After Visit 1 you will be asked to come back to the unit every 30 days and in between you will either continue to smoke conventional cigarettes or the next-generation product that we have provided to you.
In total you will have 14 visits occurring every 30 days.
Screening and admission for the trial will take place in May 2018.
Cohort Arm A-C – Group 2
- Screening period: May 23rd – May 30th 2018 (screening may be split over two days)
- In-house period: May 31st 2018
Who can take part?
To be eligible to take part in this study you must fit the following criteria
- Healthy males or females aged between 23 and 55 (inclusive)
- You must weigh over 50.0 kg (males) and 40.0 kg (females) and have a Body Mass Index (BMI) within the range 17.6-32.0 kg/m² (inclusive)
- You must have smoked filter cigarettes for at least 5 consecutive years prior to your screening visit
- You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse within the last 12 months. (Alcohol abuse is defined as a regular weekly intake of more than 14 units)
- You must be healthy with no underlying medical conditions that may either interfere with participation in the clinical study, and/or put you at any significant risk
- You must not be on any regular medications, including over the counter medications
- You must not be pregnant or breastfeeding
- Female volunteers of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting at least one menstrual cycle before the drug administration and continuing for at least 3 months after the final study drug dose.
- Male subjects must be willing to use appropriate contraception throughout the study and for three months after the last dose of study medication. They must also agree not to donate sperm for three months following the final administration of the study drug.
A full list of acceptable contraceptive methods will be discussed in full by a member of the recruitment team and a study doctor during screening.
Get in touch
Call our team for more information: +44 (0) 20 7042 5800 (opt 1)
We are open weekdays 9am-5pm or email us: firstname.lastname@example.org
Ref: C17034_October 2017_CTS1 (website and email_advert text)
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.Register for this clinical trial