Smoking Topography Study 2018

NCT03498053 | Completed DMC

• 1 other identifier: NL63420.068.17
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking; Smoking Behavior; Cigarette Smoking Toxicity

Outcome Measures

Primary Outcomes (5)

• Natural smoking behavior: amount

  number of cigarettes

  3 days

• Puffing parameters: volume

  puff volume (ml)

  3 days

• Puffing parameter: duration

  puff duration(sec)

  3 days

• Puffing parameter: amount

  puff number

  3 days

• Puffing parameter: interval

  interpuffinterval(sec)

  3 days

Secondary Outcomes (2)

• Biomarkers in blood

  13 times in 3 days

• Biomarkers in urine

  13 times in 3 days

Study Arms (1)

Cigarette brands smoked by participant

OTHER

The 3 experimental days per participant are exactly the same, except the cigarette brand they smoke. The content of an experimental day is described in the study design.

Behavioral: Marlboro; Behavioral: Marlboro Prime; Behavioral: Marlboro Prime (ventilation holes taped)

Interventions

Marlboro BEHAVIORAL

Participants smoke Marlboro during the first experimental day, ad libitum.

Cigarette brands smoked by participant

Marlboro Prime BEHAVIORAL

Participants smoke Marlboro Prime during the second experimental day, ad libitum.

Cigarette brands smoked by participant

Marlboro Prime (ventilation holes taped) BEHAVIORAL

Participants smoke Marlboro Prime (filter ventilation holes taped) during the third experimental day, ad libitum.

Cigarette brands smoked by participant

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Nicotine metabolism is influenced by the menstrual cycle for females, therefore thy are excluded from the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, 6229ER, Netherlands

Location

Related Publications (4)

• 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. No abstract available.

  PMID: 18375736 BACKGROUND

• 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 Prev. 2009 Dec;18(12):3305-20. doi: 10.1158/1055-9965.EPI-09-1014.

  PMID: 19959678 RESULT

• 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. doi: 10.1080/1462220042000282537.

  PMID: 15700921 RESULT

• 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. doi: 10.1158/1055-9965.EPI-04-0498.

  PMID: 15941943 RESULT

Related Links

• WHO Framework Convention on Tobacco Control. ISBN: 9241591013

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Agnes Boots, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Not-randomized crossover study with a single group

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: April 13, 2018
• Study Start: December 12, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 28, 2018
• Last Updated: April 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)