The two objectives of the study are:(1) to determine te concentrations of nicotine, propylene glycol, glycerol, formaldehyde, acetaldehyde, acrolein, diacetyl, tobacco-specific nitrosamines and metals (V, Cr, Mn, Ni, Cu, Zn, As, Cd, Sn and Pb) in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
schade aan de ademhalingswegen, vermindering van het aantal leukocyten en verhoogd risico op kanker.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ther most important outcomes will be:
(1) The concentration of the following components of exhaled e-cigarette
vapour: nicotine, propylene glycol, glycerol, formaldehyde, acetaldehyde,
acrolein, diacetyl, tobacco-specific nitrosamines and metals (V, Cr, Mn, Ni,
Cu, Zn, As, Cd, Sn and Pb) in exhaled e-cigarette vapour.
(2) The rate at which e-cigarette users release vapour into their environment.
Secondary outcome
not applicable
Background summary
E-cigarette use increases rapidly in the Netherlands. In a recent survey
conducted among Dutch e-cigarette users, a significant fraction of respondends
indicated that limiting the health risks to themselves (57%) and others (25%)
had been motives for using e-cigarettes (instead of regular tobacco cigarettes).
In an earlier study we have made an assesment of the health risks e-cigarettes
pose to users. This revelead that e-cigarette vapour contains several harmful
components in concentrations that can be detrimental to the health of users.
Possible health effects include damage to the respiratory system, a reduction
in lymfocyte count and an increased risk of cancer.
However, very little is currently known regarding the health risks assocaited
with passive exposure to the vapour exhaled by e-cigarette users.
Study objective
The two objectives of the study are:
(1) to determine te concentrations of nicotine, propylene glycol, glycerol,
formaldehyde, acetaldehyde, acrolein, diacetyl, tobacco-specific nitrosamines
and metals (V, Cr, Mn, Ni, Cu, Zn, As, Cd, Sn and Pb) in exhaled e-cigarette
vapour.
(2) to determine the rate at which e-cigarette users release vapour into their
environment.
Study design
1) To determine the composition of exhaled air, subjects will be asked to
inhale a nicotine-containing e-cigarette vapour, and then to exhale into a
setup that allows us to capture the vapour on filters and analyse its
composition at a later time.
2) To determine the amount of vapour exhaled by users in a specified amount of
time, we will ask subjects to use an e-cigarette ad libitum for some time. We
will then measure and record their vaping topology by means of an electronic
flowmeter. We will ask subjects to use their own favourite brand of e-cigarette
and liquid to approximate their normal vaping behaviour as closely as possible,
Intervention
Participants will be asked to take 30 puffs from a popular type of electronic
cigarette filled with a nicotine-containing, tobacco flavoured e-liquid
Study burden and risks
Subjects will be asked to travel to the RIVM in Bilthoven and to take
approximately 40 puffs from e-cigarettes filled with a nicotine-containing
liquid. The number of puffs and the nicotine concentration in this study is
similar to that consumed daily by an average user.
Earlier research, both our own and that of others, has shown that e-cigarettes
are not harmless. Nicotine is harmful and addictive, and the vapour contains
several other compounds that can be detrimental to health. However, the
subjects participating in this study are experienced e-cigarette users that
have been using nicotine-containing e-cigarettes on a daily basis for at least
3 months prior. Therefore, the level of exposure to harmful vapour will be
small compared to the amount they are already exposed to daily outside of the
context of our study.
Our study should provide a good assesment of the health risks associated with
passive exposure to e-cigarette vapour. Current knowledge in this area has
remained very limited to date, while 25% of e-cigarette users indicated in a
recent survey that limiting the health risks to other people in their
environment has been an important motive for them to start using e-cigarettes
(instead of tobacco cigarettes).
The results could prompt users to alter their behaviour and lead governments to
implement new regulations (if necessary), reducing adverse health on a large
scale.
In our opinion, therefore, the additional health risks and inconvenience caused
by our study are justified in light of the potential health benefits on a
population scale.
Rijnstraat 50
Den Haag 2515 XP
NL
Rijnstraat 50
Den Haag 2515 XP
NL
Listed location countries
Age
Inclusion criteria
1. Subjects must be between 18-55 years old.
2. Subjects must he using e-cigarettes daily with an e-liquid containing >6 mg/ml nicotine for 3 months or longer.
Exclusion criteria
1. Subjects may not have experienced adverse effects from using e-cigarettes.
2. Subjects must not be lactating, pregnant, or have plans to get pregnant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL53471.081.15 |