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BMC Public Health
Published in: BMC Public Health 1/2014

Open Access 01-12-2014 | Study protocol

Longitudinal study of long-term smoking behaviour by biomarker-supported determination of exposure to smoke

Authors: Anthony Cunningham, Johan Sommarström, Ajit S Sisodiya, Graham Errington, Krishna Prasad

Published in: BMC Public Health | Issue 1/2014

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Abstract

Background

Long-term studies of smokers who switch to lower nicotine yield cigarettes have been identified by the World Health Organization Study Group TobReg and the US Food and Drug Administration as one key area where new knowledge is required to guide science based regulation. The limited number of long-term switching studies have concluded that smokers who switch to lower nicotine yield cigarettes show evidence of partial compensation. Since the European Union tobacco product directive of 2001 introduced tar and nicotine yield ceilings, there has been no long-term observational switching study. To address the limitations of previous studies where smokers were forced switched for relatively short durations, we plan to undertake a long-term study of spontaneous switching which is appropriately powered and includes non-switchers as a control group.

Methods/design

Healthy adult smokers aged 21–64 years will be enrolled into this 5-year non-residential, multicentre study across 10 cities in Germany. They will be assessed at 10 timepoints with 6 month intervals during which inclusion criteria will be reassessed and spent cigarette filter tips, saliva and 24 h urine samples will be collected. These samples will be used to determine average daily cigarette consumption, estimate mouth-level exposure to tar and nicotine and measure selected biomarkers of exposure, respectively. Spontaneous changes in subjects’ preferred cigarette products and any consequent change in tar or nicotine yield will be monitored. Subjects will be required to complete questionnaires on quality of life, smoking behaviours, smoking-related sensory attributes and recent life changes.

Discussion

The planned study is anticipated to contribute to understanding smokers’ behaviours and their consequent exposure to smoke constituents. It will also allow assessment of compensatory changes in their behaviour following spontaneous switching of cigarette product smoked. Data from this study are expected to provide insights into study design and conduct for non-clinical assessment of smokers’ exposure as part of post marketing surveillance programmes.

Trial registration

Current Controlled Trials Database reference ISRCTN95019245.
Appendix
Available only for authorised users
Literature
1.
U.S Department of Health and Human Services: The health consequences of smoking. Cancer. A report of the surgeon general. 1982, Washington: U.S: Government Printing Office
2.
WHO and International Agency for Research on Cancer: IARC monographs on the evaluation of carcinogenic risks to humans, volume 83: tobacco smoke and involuntary smoking. 2004, Lyon: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
3.
U.S Department of Health and Human Services: The health consequences of smoking: cardiovascular disease: a report of the surgeon general. 1983, Rockville, MD: Public Health Service
4.
U.S Department of Health and Human Services: The health consequences of smoking. Chronic obstructive lung disease. A report of the surgeon general. 1984, Washington, DC: US Government Printing Office
5.
Adlkofer F, Scherer G, Biber A, Heller WD, Lee PN, Schievelbein H: Consistency of nicotine intake in smokers of cigarettes with varying nicotine yields. Nicotine, smoking and the low tar programme. Edited by: Wald N, Froggatt P. 1989, Oxford: Oxford University Press, 116-130.
6.
Guyatt AR, Kirkham AJT, Mariner DC, Baldry AG, Cumming G: Long-term effects of switching to cigarettes with lower tar and nicotine yields. Psychopharmacology. 1989, 99: 80-86. 10.1007/BF00634457.CrossRefPubMed
7.
Frost C, Fullerton FM, Stephen AM, Stone R, Nicolaides-Bouman A, Densem J, Wald NJ, Semmence A: The tar reduction study: randomised trial of the effect of cigarette tar yield reduction on compensatory smoking. Thorax. 1995, 50: 1038-1043. 10.1136/thx.50.10.1038.CrossRefPubMedPubMedCentral
8.
Garfinkel L: Changes in the cigarette consumption of smokers in relation to changes in tar/nicotine content of cigarettes smoked. Am J Public Health. 1979, 69: 1274-1276. 10.2105/AJPH.69.12.1274.CrossRefPubMedPubMedCentral
9.
Peach H, Hayward DM, Ellard DR, Morris RW, Shah D: Phlegm production and lung function among cigarette smokers changing tar groups during the 1970s. J Epidemiol Community Health. 1986, 40: 110-116. 10.1136/jech.40.2.110.CrossRefPubMedPubMedCentral
10.
Lynch CJ, Benowitz NL: Spontaneous cigarette brand switching: consequences for nicotine and carbon monoxide exposure. Am J Public Health. 1987, 78: 1191-1194.CrossRef
11.
Heller WD, Scherer G, Gostomzyk JG, Stieber J, Adlkofer F: Cotinine concentration in the serum of smokers within a representative population in Southern Germany measured in 1984/85 and 1987/88 [poster 55]. Effects of nicotine on biological systems symposium. 1990, Hamburg
12.
Muhammad-Kah KS, Mendes P, Rimmer L, Liang Q, Serafin R, Roethig HJ, Sarkar M: Exposure to cigarette smoke constituents in a population of adult cigarette smokers in the U.S. who spontaneously switched to cigarettes with lower or higher machine measured ‘tar’ yield. Beiträge zur Tabakforschung Int. 2011, 24: 166-173.
13.
Benowitz NL: Compensatory smoking of low-yield cigarette. Smoking and tobacco control. Risks associated with smoking cigarettes with low machine-measured yields of tar and nicotine. Edited by: Public Health Services, National Institutes of Health, and National Cancer Institute. 2001, Bethesda, MD: NIH Publication, 39-63.
14.
European Parliament and the Council of the European Union: Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products. Off J Eur Communities. 2001, 194: 26-34.
15.
Yong H-H, Borland R, Thrasher JF, Thompson ME: Stability of cigarette consumption over time among continuing smokers: a latent growth curve analysis. Nicotine Tob Res. 2012, 14: 531-539. 10.1093/ntr/ntr242.CrossRefPubMedPubMedCentral
16.
WHO Study Group on Tobacco Product Regulation: Report on the scientific basis of tobacco product regulation: WHO technical report series 945. 2007, Geneva: World Health Organization
17.
18.
Mariner DC, Ashley M, Shepperd CJ, Mullard G, Dixon M: Mouth level smoke exposure using analysis of filters from smoked cigarettes: a study of eight countries. Regul Toxicol Pharmacol. 2011, 61: S39-S50. 10.1016/j.yrtph.2010.05.006.CrossRefPubMed
19.
World Medical Association: Declaration of Helsinki – ethical principles for medical research involving human subjects. 1996, Ferney-Voltaire: World Medical Association
20.
International Conference on Harmonisation: ICH tripartite guidelines for good clinical practice, adopted by CPMP, issued as CPMP/ICH/135/95. 1996, Geneva: International Conference on Harmonisation
21.
St Charles FK, Ashley M, Shepperd CJ, Clayton P, Errington G: A robust method for estimating human smoked cigarette yields from filter analysis data. Beiträge zur Tabakforschung Int. 2009, 23: 232-243.
22.
Cone EJ, Caplan YH, Moser F, Robert T, Shelby MK, Black DL: Normalization of urinary drug concentrations with specific gravity and creatinine. J Anal Toxicol. 2009, 33: 1-7. 10.1093/jat/33.1.1.CrossRefPubMed
23.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO: The Fagerström test for nicotine dependence: a revision of the Fagerström tolerance questionnaire. Br J Addict. 1991, 86: 1119-1127. 10.1111/j.1360-0443.1991.tb01879.x.CrossRefPubMed
24.
Miller MA, Rahe RH: Life changes scaling for the 1990s. J Psychosom Res. 1997, 43: 279-292. 10.1016/S0022-3999(97)00118-9.CrossRefPubMed
25.
Ware JE, Kosinski M, Bjorner JB, Turner-Boweker DM, Gandek B, Maruish M: User’s manual for the SF-36 v2 health survey. 2007, QualityMetric: Lincoln, RI, 2
26.
Shepperd CJ, Eldridge AC, Mariner DC, McEwan M, Errington G, Dixon M: A study to estimate and correlate cigarette smoke exposure in smokers in Germany as determined by filter analysis and biomarkers of exposure. Reg Tox Pharm. 2009, 55: 97-109. 10.1016/j.yrtph.2009.06.006.CrossRef
27.
Scherer G: Smoking behaviour and compensation: a review of the literature. Psychopharmacology. 1999, 145: 1-20. 10.1007/s002130051027.CrossRefPubMed
28.
Institute of Medicine: Clearing the smoke: assessing the science base for tobacco harm reduction. 2001, Washington, DC: National Academy Press
29.
Hatsukami DK, Giovino GA, Eissenberg T, Clark PI, Lawrence D, Leischow S: Methods to assess potential reduced exposure products. Nicotine Tob Res. 2005, 7: 827-844. 10.1080/14622200500266015.CrossRefPubMed
Metadata
Title
Longitudinal study of long-term smoking behaviour by biomarker-supported determination of exposure to smoke
Authors
Anthony Cunningham
Johan Sommarström
Ajit S Sisodiya
Graham Errington
Krishna Prasad
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2014
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-14-348

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