A year-long study to assess the health effects of switching from smoking cigarettes to using Tobacco Heating Products has been launched by British American Tobacco (BAT).
Tobacco Heating Products (THPs), such as BAT's glo, heat tobacco to release an aerosol containing nicotine but do not burn the tobacco, meaning many of the toxicants produced by combustion of tobacco are not present in the THP aerosol.
For the first time, scientists at BAT are conducting a year-long, randomised, multi-center, controlled study to see what impact switching from cigarettes to glo in a real-world setting will have on markers of smoking-related disease development. The study protocol is published today in the Journal of Internal and Emergency Medicine.
Current smokers who do or don't want to quit smoking, and never smokers, will take part in the study. The smokers who don't want to quit will be randomised to either continue smoking cigarettes or switch to using only glo for a year, while smokers who want to quit will receive nicotine replacement therapy and/or nicotine addiction medicine; the never smokers will serve as controls. The subject groups will consist of UK residents aged 23-55, who are in general good health, and groups will be balanced for gender and age range.
During the year, participants will go about their normal lives but will visit the clinic every 30 days for samples of blood, urine and other physiological measurements to be taken, and to complete health-related questionnaires. Subjects' levels of biological markers of the early processes believed to be involved in the development of smoking-related diseases will be measured and compared among the glo users, smokers, quitters and control groups.
It is critical to the utility of the resulting data that participants are completely compliant in not smoking cigarettes if they are in the glo or smoking cessation arms of the study. In order to ensure and measure compliance, participants will use an electronic diary to self-report activity. Also, participants' blood will be tested for signs of exposure to cigarette smoke during visits to the clinic. Furthermore, glo users will visit the clinic every month for new supplies, at which point all empty, part-used, and unused packs of glo consumables will be counted.
"This is BAT's first long-term study to investigate the exposure and potential health effects associated with THP use over a 12-month period and will enable us to observe if any favourable changes are sustained and whether or not they return to levels observed in never smokers," said George Hardie, Head of Clinical Research at BAT.
"This carefully designed study will generate a dataset from which the public health community, regulators and consumers can gain insight into whether or not THPs may provide a viable and less risky alternative to cigarette smoking."
Full results are expected to be published from 2020.