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

Area of Science:

• Tobacco Regulatory Science
• Behavioral Economics
• Clinical Trials

Background:

• Flavors in tobacco products are a key regulatory focus.
• Limited understanding exists regarding how flavors influence the appeal of heated tobacco products (HTPs) like IQOS among smokers.

Purpose of the Study:

• To assess the substitution feasibility of menthol-flavored IQOS (IQOS-M) versus regular tobacco-flavored IQOS (IQOS-T) for menthol cigarette smokers.
• To evaluate the impact of flavor on the potential to switch from traditional cigarettes to HTPs.

Main Methods:

• An unblinded, 2-week, parallel-group randomized pilot clinical trial involving 30 adult menthol cigarette smokers.
• Participants were randomized to use IQOS 2.4 with either menthol (IQOS-M) or regular tobacco (IQOS-T) HeatSticks.
• Evaluated substitution using the Experimental Tobacco Marketplace task, puff topography, nicotine levels, and at-home consumption diaries.

Main Results:

• Menthol IQOS (IQOS-M) showed significantly higher cross-price elasticity (0.67) compared to regular IQOS (IQOS-T) (0.14) when both were available.
• Participants reduced cigarette consumption by 80% with IQOS-M versus 37% with IQOS-T.
• No significant differences were observed in puff topography or nicotine delivery between IQOS flavors.

Conclusions:

• Access to menthol-flavored heated tobacco products is crucial for substitution among menthol cigarette smokers but may not ensure complete cessation.
• Tobacco policies restricting menthol HTPs could aid cessation but might deter smokers from switching from cigarettes to HTPs.