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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Harry Green
+44 (0)23 80793257
harry_green@bat.com


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A study to assess the Breezing Med™ metabolic device following stimulant use
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A study to assess the Breezing Med™ metabolic device following stimulant use

Not Recruiting

Open to: All Genders

Age: Adult

Winchester

Medical Conditions

Metabolic assessment

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

05 Jul 2021 19 Jul 2021

Screening will occur within 28 days of the first testing session. Eligible participants will be asked to attend a total of four testing sessions.
The first testing session is a familiarisation visit. Eligible participants will be shown how to correctly use (and subsequently test) the two study products and also trial the Breezing MedTM device, completing four readings on the device over a 1-hour period. Eligible participants will be provided with the e-cigarette study product (and two associated cartridges) to familiarise themselves with the study product prior to the first study session.
At least 48 hours after the familiarization session, participants will attend the first study session. Before the session, participants will be required to abstain from nicotine, alcohol and caffeine for 12 hours and refrain from high-intensity exercise (24 hours). On the morning of the study sessions, participants should refrain from consuming water within 1 hour of the study session start time. Upon arrival, cigarette abstinence will be confirmed with an exhaled carbon monoxide (eCO) breath test.
Upon completion of the eCO, participants will be seated in a dimly lit room and undertake a 30-minute relaxation period. Two metabolic readings will be taken. Participants will then have a 5-minute product (or no product) use period and use one of the associated study products (e-cigarette use, consume a caffeinated fruit drink, or no product use). Only one study product is to be tested at each session. At specific intervals over the next 1-hour and 10 minute period, participants will have their metabolic readings taken repeatedly.
Participants will repeat three study sessions, each using both study products and observing a no product use session. The order in which the study products are used by each participant will be fully randomised.


Healthy adults, aged 25-35 years, who smoke at least 10 cigarettes per day and are familiar with e-cigarette products.

You can take part if:



You may not be able to take part if:


1. Subjects who self-report to have an acute illness (e.g. upper respiratory tract infection, viral infection, etc) requiring treatment within 4 weeks prior to Screening or on admission2. Subjects who self-report to have any clinically significant abnormalities or underlying health conditions3. Subjects who are self-reported non-inhalers (smokers/vapers who draw smoke/aerosol from the cigarette/e-cigarette into the mouth and throat but who do not inhale)4. Female subjects who are pregnant and breastfeeding or lactating5. Subjects who, prior to enrolment, are planning to quit/alter smoking/vaping within the duration of the study (to follow-up telephone call). All subjects will be informed that they are free to quit smoking/vaping and withdraw from the study at any time.6. Self-reported evidence of metabolic dysfunction7. A self-reported significant history of drug or alcohol abuse [defined as the consumption of more than 14 units for male and female subjects of alcohol a week] within the past 2 years8. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Walnut Unlimited
    St. Swithun's House 1a St. Cross Road
    Winchester
    SO23 9JA

There are no direct benefits to participants. The main risks are the side effects of using nicotine products (such as headache, dizziness, palpitations, and mouth and throat irritation); participants should be familiar with these side effects as a result of being regular users of these products.

Mr Harry Green
+44 (0)23 80793257
harry_green@bat.com



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by British American Tobacco (United Kingdom) and funded by British American Tobacco.



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Read full details for Trial ID: ISRCTN38539210
Last updated 11 July 2022

This page is to help you find out about a research study and if you may be able to take part

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