NCT03498053

Smoking Topography Study 2018

Completed NA Last updated 13 April 2018

What this trial tests

NA trial testing Marlboro in Cigarette Smoking in 12 participants. Completed in 28 March 2018.

Timeline

12 December 2017

Primary endpoint
21 March 2018

28 March 2018

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	12 December 2017
Primary completion	21 March 2018
Estimated completion	28 March 2018
Sites	1 location across Netherlands

Drugs / interventions tested

• Marlboro
• Marlboro Prime
• Marlboro Prime (ventilation holes taped)

Conditions studied

• Cigarette Smoking — all drugs for Cigarette Smoking →
• Smoking Behavior — all drugs for Smoking Behavior →
• Cigarette Smoking Toxicity — all drugs for Cigarette Smoking Toxicity →

Sponsor

Maastricht University Medical Center

Who can join

Adults 25 to 35, male only, with Cigarette Smoking or Smoking Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Cigarette Type and Smoking Behavior on Urinary Metabolite Levels of Tobacco-Associated Toxicants.
   Hendriks MG, Pauwels CGGM, Conklin DJ, Lorkiewicz P, et al · · 2026 · PMID 41921978 · DOI 10.1021/acs.chemrestox.5c00480