Smoking Topography Study 2018

Smoking Topography Study 2018 - STS 2018

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44391

Enrollment

Registered

2017-11-02

Start date

2017-12-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gedrag Not applicable

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male - 25-34 years old (birth year 1981 * 1990) - Caucasian - At least 3 years smoking Marlboro as usual brand - Used to smoke between 13 and 25 cigarettes a day (around a package/day)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Monitoring habitual smoking behavior, regarding the moments during the day the cigarettes are smoked, and how they are smoked (smoking topography) differing per cigarette. Output: a table with smoked cigarettes per participant with the associated nicotine and CO(Hb) measurement, and the smoking topography of each cigarette (puff volume, puff duration, puff interval, puff flow).	—

Secondary

Measure	Time frame
Nicotine, cotinine, COHb and leukocyte differentiation in blood per time points per participant. In addition, aldehyde levels will be determined in serum derived from whole blood collected. Also, leukocytes will be isolated from whole blood collected at these time points to assess aldehyde-induced adducts in leukocyte DNA, Nicotine, cotinine, kreatinine and ureum as well as aldehyde metabolites in urine per time points per participant. Smoking-related DNA adducts in saliva and mouth swaps per time points per participant. VOCs and aldehydes in breath per time points per participant (list of compounds in Study Procedures). Metabolic state parameters (ASAT, ALAT, bilirubin, sodium, potassium, urea, TSH, CRP) only measured in baseline samples per participant. These parameters are measured to ensure that the participants have a healthy metabolism and can be used to interpret differences in biomarkers between participants. The values should be in the normal range for their age and gender as used in the Farmaceutisch Kompas .	—

Measure

Time frame

Nicotine, cotinine, COHb and leukocyte differentiation in blood per time points per participant. In addition, aldehyde levels will be determined in serum derived from whole blood collected. Also, leukocytes will be isolated from whole blood collected at these time points to assess aldehyde-induced adducts in leukocyte DNA, Nicotine, cotinine, kreatinine and ureum as well as aldehyde metabolites in urine per time points per participant. Smoking-related DNA adducts in saliva and mouth swaps per time points per participant. VOCs and aldehydes in breath per time points per participant (list of compounds in Study Procedures). Metabolic state parameters (ASAT, ALAT, bilirubin, sodium, potassium, urea, TSH, CRP) only measured in baseline samples per participant. These parameters are measured to ensure that the participants have a healthy metabolism and can be used to interpret differences in biomarkers between participants. The values should be in the *normal* range for their age and gender as used in the Farmaceutisch Kompas .

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Countries

Netherlands

Outcome results