To determine if adding ammonium to tobacco of cigarettes increases nicotine absorption (amount and speed) in blood of experienced (chronic) smokers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoint is nicotine and cotinine determinations in blood. Secundairy
parameters are nicotine and cotinine determinations in saliva, exposure-related
parameters (carboxyhaemoglobin, NNAL en NNAL-glucuronide, thiocyanate en
acetonitrile) in blood, exposure-related parameters (acetonitrile and nitric
monoxide) in exhaled breath, and bloodpressure and heartfrequency.
Secondary outcome
Secundairy parameters are nicotine and cotinine determinations in saliva,
exposure-related parameters (carboxyhaemoglobin, NNAL en NNAL-glucuronide,
thiocyanate en acetonitrile) in blood, exposure-related parameters
(acetonitrile and nitric monoxide) in exhaled breath, and bloodpressure and
heartfrequency.
Background summary
Several ingredients are added to tobacco during manufacturing of cigarettes to
improve the taste, combustion, or increase the storage life. According to the
tobacco industry ammonium compounds are added for their flavouring properties.
However, recently it has been demonstrated that ammonium compounds might
increase the amount of nicotine absorbed during smoking.
Study objective
To determine if adding ammonium to tobacco of cigarettes increases nicotine
absorption (amount and speed) in blood of experienced (chronic) smokers.
Study design
Experienced smokers smoke two cigarettes from two different brands, that are
commercially available on the Dutch market. Both brands contain the same
amounts of tar and nicotine, but differ in ammonium-content. The study will be
performed according to the cross-over design, in other words, a person smokes
cigarette A in the morning and, after a wash-out period, cigarette B in the
afternoon. Testcigarettes will be smoked via a tube, so volumes will be the
same per puff. In addition, studypersons need to smoke according to a regime:
every 60 sec an inhalation of 55 ml in 2 sec, then a 2 sec breath-hold, after
which smoke can be exhaled. From each cigarette, 6 puffs will be taken, after
which the cigarette will be extinguished. Before, during and after smoking the
test-cigarette, blood (2 times 12 ml and 6 times 3 ml) will be drawn via a
venous catheter (in total 84 ml), and saliva will be collected with a cotton
swab. Study persons are also connected to a real-time bloodpressure and
heartfrequency monitor.
Intervention
Smoking of a cigarette with a high ammonium-content and a cigarette with a low
ammonium-content.
Study burden and risks
Volunteers need to visit the Slotervaarthospital once. Smoking the night before
until the study is not allowed. The study comprises 2 times one-and-half hour
investigation. Between the investigations is a 4 hour break, wherein smoking is
not allowed.
Louwesweg 6
1066 EC Amsterdam
Nederland
Louwesweg 6
1066 EC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
18-50 years of age; Good health; Smoking more than 20 cigarettes or fine-cut tobacco (roll-yor-own) per day; Inhale during smoking.
Exclusion criteria
Use of medicines, except oral contraconceptives or replacement hormones; Use of nicotin-containing products; Pregnancy or lactation; History of psychiatric problems/conditions; History of cardiac and pulmonary conditions.
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 | NL14930.048.06 |