Cigarette Smoking Clinical Trial
Official title:
Smoking Topography Study 2018
Verified date | March 2018 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rationale: The World Health Organization Framework Convention on Tobacco Control (WHO FCTC)
aims for a regulatory strategy including the regulation of the contents of tobacco products
(Article 9). Cigarette smoke includes more than 7000 chemicals which are harmful and cause
tobacco-related diseases. In the future, regulation of these harmful cigarette constituents
should be based on more chemical classes, as the WHO suggested. However, in order to
introduce such class-based regulation, a scientific base is needed to define upper limits of
allowed amounts of chemicals (groups) in cigarette smoke emissions and to ensure decreased
harmful health effects due to cigarette smoking. To date, the causality between human
exposure to specific cigarette smoke compounds and the harmful effects is unknown. The first
step in closing the gap in knowledge between cigarette smoke exposure and developing
tobacco-related diseases includes a proper determination of human exposure to cigarette smoke
chemicals. This includes measuring smoking topography and inhalation. Smoking topography is
how the smoker smokes the cigarette (puff volume, duration, flow etc). The goal is to link
smoking behavior to smoke exposure, for 2 different cigarette brands. The participants will
smoke their 'normal' brand Marlboro (experimental day 1) after which they receive the low
TNCO (tar, nicotine and carbon monoxide) Marlboro Prime to smoke at home. A week later the
experimental day (day 2) is repeated with this cigarette. On the last experimental day (day
3), the participants will smoke the Prime cigarette while the ventilation holes of this
low-TNCO cigarette are taped. Afterwards, the personal smoking profiles of the participants,
and thus their individual exposures, will be mimicked in the lab using machine smoking. The
observed smoking topography and inhalation parameters together give information about the
exposure to smoke toxicants. In addition, this study is also designed to measure biomarkers
of exposure in body fluids of smokers, such as nicotine and the most abundant cigarette smoke
chemicals and their metabolites.
Objective: We want to find out whether the individual habitudinal smoking topography of a
smoker smoking his usual brand, and the changes between cigarettes over the day, can be
compared to that of smoking a low-TNCO or high nicotine cigarette (i.e. the Marlboro Prime
and Red Sun). In addition, differences in inhalation patterns are investigated. Next to that,
the exposure will be connected to the nicotine and carbon monoxide levels in blood and/or
urine. Also smoke toxicants (and metabolites) in exhaled air, saliva, urine and blood of
smokers are determined.
Study design: This prospective observational study monitors smokers in their habitudinal
smoking during the day (for 10 hr) while smoking Marlboro, Marlboro Prime and Marlboro Prime
taped cigarette, while during the day bodily fluids are sampled at several time points.
Study population: This population consists of 18 Caucasian, healthy, adult males, aged
between 25-34 years old. Participants should be used to smoke Marlboro (red/regular) for at
least 3 years with a daily average of 13 to 25 cigarettes (about a package every day).
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The participating smokers smoke according to their habitudinal smoking pattern,
and are therefore not increasingly exposed to the harmful health effects of cigarette
smoking. The invasive part of the study is their stay for 3 days (and 1 night when wanted) in
a hotel, and the sampling of blood, saliva, urine and exhaled air.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 28, 2018 |
Est. primary completion date | March 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Male - 25-35 years old (birth year 1982 - 1992) - Caucasian - Smoking Marlboro as usual brand for at least 3 years - Used to smoke between 13 and 25 cigarettes a day (around a package/day) Exclusion Criteria: - Heavy smoker (minimum of 25 cigarettes/day) - Smokes more than 1 brand on a regular base. - Amount of cigarettes per day varies ±10, between days - Daily medication use - Experienced adverse effects due to smoking - Suffering chronic illness |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Burns DM, Dybing E, Gray N, Hecht S, Anderson C, Sanner T, O'Connor R, Djordjevic M, Dresler C, Hainaut P, Jarvis M, Opperhuizen A, Straif K. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tob Control. 2008 Apr;17(2):132-41. doi: 10.1136/tc.2007.024158. — View Citation
Hammond D, Fong GT, Cummings KM, Hyland A. Smoking topography, brand switching, and nicotine delivery: results from an in vivo study. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1370-5. — View Citation
Marian C, O'Connor RJ, Djordjevic MV, Rees VW, Hatsukami DK, Shields PG. Reconciling human smoking behavior and machine smoking patterns: implications for understanding smoking behavior and the impact on laboratory studies. Cancer Epidemiol Biomarkers Pre — View Citation
Wood T, Wewers ME, Groner J, Ahijevych K. Smoke constituent exposure and smoking topography of adolescent daily cigarette smokers. Nicotine Tob Res. 2004 Oct;6(5):853-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Natural smoking behavior: amount | number of cigarettes | 3 days | |
Primary | Puffing parameters: volume | puff volume (ml) | 3 days | |
Primary | Puffing parameter: duration | puff duration(sec) | 3 days | |
Primary | Puffing parameter: amount | puff number | 3 days | |
Primary | Puffing parameter: interval | interpuffinterval(sec) | 3 days | |
Secondary | Biomarkers in blood | Nicotine, cotinine, aldehyde adducts in blood | 13 times in 3 days | |
Secondary | Biomarkers in urine | Nicotine, cotinine, aldehyde adducts in urine | 13 times in 3 days |
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