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Protocol for a clinical study on reduced toxicant prototype cigarettes published
Date:7/28/2013

selected biomarkers. The protocol for this new study has been approved by an independent ethics committee and is published in BioMed Central Public Health.

The six-month single-centre, single-blinded, controlled switching study with periods of clinical confinement is being conducted in Germany. A total of 260 healthy adult subjects were recruited into the study; 140 smokers, 60 former smokers and 60 never-smokers (ISRCTN81286286). The demographically matched non-smokers serve as a comparison group because some toxicant exposure stems from dietary and environmental sources. The non-smokers also provide reference levels for biomarkers of biological effect.

Smokers are randomly assigned to a control or test group. Both groups smoke a control product for two weeks, at which point baseline measurements of biomarker levels are made. Smokers in the control group then continue to smoke the control product for a further 24 weeks, while smokers in the test group switch to the prototype cigarette. Urine, saliva and blood samples are taken from all smokers at 4, 9, 13 and 24 weeks after the switch. Biomarkers of exposure and biological effect are then measured.

Changes in biomarker levels are analysed at baseline, midpoint and end of the study. Levels within individuals are compared before and after switching, while those between individuals are evaluated by comparing smokers who switched with those who didn't.

Data from this study are expected to improve the scientific understanding of tobacco products. Changes in biomarkers of biological effect may add to the body of evidence of the potential of toxicant reducing technologies in reducing disease risk.

"There are already tobacco and nicotine products available, such as snus and e-cigarettes, that are known to pose substantially lower risk than cigarettes. And we don't know whether it will be possible to scientifically prove that reduced toxicant cigarettes reduce health risks,' said Dr David O'Reill
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Contact: Dr. Marina Murphy
marina_murphy@bat.com
44-077-111-50135
R&D at British American Tobacco
Source:Eurekalert

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