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Open Access Study protocol

A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes

Christopher J Shepperd1*, Nik Newland1, Alison Eldridge1, Don Graff2 and Ingo Meyer3

Author Affiliations

1 British American Tobacco, Group Research and Development, Regents Park Road, Southampton SO15 8TL, UK

2 Celerion, 621 Rose St, Lincoln, NE 68502, USA

3 MPS Hamburg GmbH, Kieler Strasse 99-105, Hamburg 22769, Germany

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BMC Public Health 2013, 13:690  doi:10.1186/1471-2458-13-690

Published: 29 July 2013

Abstract

Background

Despite universal acceptance that smoking is harmful, a substantial number of adults continue to smoke. The development of potential reduced exposure products (more recently termed modified risk tobacco products) has been suggested as a way to reduce the risks of tobacco smoking. This trial is designed to investigate whether changes in toxicant exposure after switching from a commercial to reduced toxicant prototype (RTP) cigarette (7 mg International Organisation for Standardisation (ISO) tar yield) can be assessed by measurement of biomarkers and other factors. The primary objective is to descriptively assess changes in selected biomarkers of exposure (BoE) and biomarkers of biological effect (BoBE) within participants and within and between groups after switching. Secondary objectives are to assess similarly changes in other biomarkers, quality of life, smoking behaviours, physiological measures, mouth-level exposure to toxicants and sensory perception.

Methods/design

This trial will assess current smokers, ex-smokers and never-smokers in a single-centre single-blind, controlled clinical trial with a forced-switching design and in-clinic (residential) and ambulatory (non-residential) periods. Smokers will be aged 23–55 years (minimum legal smoking age plus 5 years) and non-smokers 28–55 years (minimum legal smoking age plus 5 years, plus minimum 5 years since last smoked). Smokers will be allowed to smoke freely at all times. We will assess changes in selected BoE and BoBE and effective dose in urine and blood after switching. Creatinine concentrations in serum, creatinine clearance in urine, cotinine concentration in saliva, diaries and collection of spent cigarette filters will be used to assess compliance with the study protocol. Mouth-level exposure to toxins will be assessed by filter analysis.

Discussion

Data from this study are expected to improve scientific understanding of the effects of RTP cigarettes on BoE and BoBE, and give insights into study design for clinical assessment of potential MRTPs.

Trial registration

The study was registered in the Current Controlled Trials database under the reference ISRCTN81286286.

Keywords:
Biomarker of exposure; Biomarker of biological effect; Tobacco smoke toxicants; Reduced toxicant prototype cigarettes; Potential reduced-exposure product; PREP; Modified risk tobacco product; MRTP; Smoking