A Pilot RCT Exploring Heated Tobacco Product Substitution for Menthol Cigarettes.

Abstract

Flavors are a key regulatory target for tobacco products, but little is known about how flavors influence the appeal of heated tobacco products, such as IQOS, for people who smoke. This study assessed differences in the substitution feasibility of menthol- and regular/tobacco-flavored IQOS for menthol cigarettes. This was an unblinded 2-week, parallel-group randomized pilot clinical trial. Thirty adults who smoked menthol cigarettes in Richmond, VA completed clinical laboratory sessions (Monday and Friday) and reported at-home tobacco consumption. Data were collected from November 2022 to September 2023 and analyzed from October 2023 to February 2024. Participants were randomized to use IQOS 2.4 with fresh menthol (IQOS-M) or regular tobacco (IQOS-T) HeatSticks (1:1) during Week 2 of the study in the clinical laboratory and throughout the second week while they were at home. Laboratory visits involved 10-puff directed use bouts with puff topography, plasma nicotine measurement, subjective effects questionnaires, and the Experimental Tobacco Marketplace task. The primary outcome was the cross-price elasticity of IQOS in the Experimental Tobacco Marketplace at the final clinical laboratory session. Electronic daily diaries measured tobacco consumption at home. In the Experimental Tobacco Marketplace, the average (SD) cross-price elasticity for IQOS was 0.67 (0.09) when IQOS-M and IQOS-T were available concurrently versus 0.14 (0.03) when only IQOS-T was available (p<0.05). At home, participants reduced their typical cigarette consumption by 80% when they had access to IQOS-M versus 37% with IQOS-T (p<0.05). Differences in puff topography and nicotine delivery across IQOS flavors were not significant (p>0.05). Access to menthol-flavored heated tobacco products is an important determinant of potential substitution for people who smoke menthol cigarettes but may not be sufficient to promote complete substitution. Tobacco regulatory policies that restrict access to menthol-flavored heated tobacco products could promote complete tobacco cessation but may reduce attempts to substitute with heated tobacco products among people who smoke menthol cigarettes. This trial was preregistered at www. gov (NCT05499377).