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

British American Tobacco has published the protocol for a clinical study designed to determine whether using reduced-toxicant prototype cigarettes that reduce smokers' exposure to smoke toxicants impacts biological effect (ISRCTN81286286).

The study protocol refers to the 'recipe' used to conduct a study, describes what will be done during the study, how this will be done and why it is being done.

This study follows a previous study by researchers at British American Tobacco that showed that it is possible to reduce smokers' exposure to certain smoke toxicants by switching them to novel prototype cigarettes with lower amounts of some toxicants in the smoke (doi:10.1016/j.yrtph.2013.02.007). This was a short-term study, lasting six weeks. Now a second clinical study will assess whether this reduced exposure is maintained over the longer term, and also whether longer term exposure reduction results in detectable changes in biological effect.

The prototype cigarettes used in both studies contained technologies designed to reduce key toxicants in smoke. A resin that removes aldehydes and a nano-porous carbon that traps volatile smoke compounds were added to the filter. An enzyme-treatment was used on the tobacco to remove proteins and polyphenols that become toxicants when burned, and inert calcium carbonate and glycerol were added to dilute the smoke.

BAT combined these technologies into three different prototype cigarettes and showed in a clinical study that there was a reduction in exposure to certain toxicants in smokers who switched to the prototype cigarettes for six weeks.

However, that study was not long enough to explore the potential for a reduction in risk of smoking-related diseases or adverse biological effects. Now a longer-term (six months) study will determine whether use of prototype cigarettes leads to both continued reductions in exposure to toxicants and beneficial changes in the body, as shown by assessment of
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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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