Impact of Heating Conventional Cigarettes With a Novel Device on Health-Related Biomarkers and Cigarette Use Patterns Among Chinese Adult Smokers Unwilling to Quit: A Pilot Randomized Controlled Trial

Abstract

Abstract Introduction We evaluated the impact of heating conventional cigarettes with a novel heated tobacco product (HTP) device on biomarkers and cigarette use patterns in Chinese adult smokers unwilling to quit smoking. Aims and Methods In this pilot randomized controlled trial, 50 eligible participants were allocated to either control group (smoking conventional cigarettes) or HTP device group (switching to using heated conventional cigarettes by the HTP device). Participants in the HTP device group went through a 2-day run-in period and then used heated conventional cigarettes exclusively for 5 days, followed by flexible use for 14 days. Five biomarkers of exposure (BoEs) were measured at baseline and on day 7. Thirteen biomarkers of biological effect (BoBEs) were measured at baseline and on day 21. Safety, daily cigarette consumption, craving, withdrawal symptoms, and device acceptability, were assessed. Results BoE levels decreased by 26.4 % to 71.4% from baseline in the HTP device group, while BoBE levels did not significantly change in either group. In the HTP group, 56% exclusively used heated conventional cigarettes during the flexible use period, experiencing reduced cravings and withdrawal symptoms, while dual users consumed more cigarettes. Mild to moderate device-related reactions were reported in 36% of users. Satisfaction, taste, and harm reduction belief scores averaged 7.4, 6.6, and 8.7 (out of 10), respectively. Conclusions Switching to heated conventional cigarettes with the HTP device may reduce short-term exposure to smoke toxicants. However, it can lead to increased tobacco use among dual users. Further investigation is needed to confirm these preliminary findings. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn/), ChiCTR2200065055, October 26, 2022. Implications This study is the first to evaluate the impact of heating conventional cigarettes with a novel HTP device on health-related biomarkers and cigarette use patterns among Chinese adult smokers. This novel HTP device can directly heat conventional cigarettes without the necessity for specifically designed tobacco products, avoiding the potential additive risks of traditional HTPs. If the results of this study could be further verified by randomized controlled clinical trials with larger sample sizes, this novel HTP device could serve as a short-term harm reduction alternative for smokers unwilling to quit.