Peer-Reviewed Publications

      Evaluating Use Patterns of a Closed Electronic Nicotine Delivery System Among Adults in the United States Who Smoke Cigarettes Daily: 8-Week Actual Use Study

      Roulet, S.; Kanitscheider, C.; Magnani, P.; Kallischnigg, G.

      Published
      Aug 25, 2025
      DOI
      10.2196/76019
      PMID
      40854156
      Link to publication
      Topic
      Abstract

      Background:
      Adults who smoke cigarettes may reduce their exposure to cigarette smoke by switching completely or partially to an electronic nicotine delivery system (ENDS).

      Objective:
      This study investigated the use of a novel ENDS over 8 weeks, under near real-world conditions, among adults who smoke cigarettes daily and are living in the United States. The objectives were to assess the proportion of participants who switched completely to the novel ENDS and changes in cigarette consumption.

      Methods:
      This actual use study assessed the use of the novel ENDS among exclusive cigarette smokers (n=353) and dual users of cigarettes and ENDS (n=367). Participants were required to be aged 21 to 64 years old, had smoked 100+ cigarettes in their lifetime, smoked cigarettes daily at the time of enrollment, and reported positive intention to try, use, and buy the study product (SP). Participants were recruited from consumer databases. During the baseline period, participants self-reported their daily use of cigarettes and ENDS using an electronic diary. During the observational period, self-reporting also included daily use of SP. The SP was available in 2 variants (tobacco and menthol) at one nicotine concentration (3.5%; 39 mg/mL nicotine). Participants obtained 10 cartridges at the beginning of the observational period and could select either SP variant or both and were allowed to obtain additional SP. SP use patterns and sensory experiences were assessed at the end of the observational period, and cigarette consumption was compared to baseline. SP variant use and its impact on complete switching and cigarette consumption were also assessed.

      Results:
      The average age of enrolled exclusive cigarette smokers and dual users was 47 (SD 10.4) years and 44.3 (SD 9.6) years, respectively, and there were more female than male participants (227/353, 64.3% and 186/367, 50.7%). Participants smoked on average 13.3 (SD 7.3) and 12.1 (SD 7.2) cigarettes per day, and mostly menthol cigarettes (197/353, 55.8% and 201/367, 54.8%). Most participants had no plan to quit cigarette smoking in the next 6 months (261/353, 73.9% and 328/367, 89.4%). At the end of the observational period, 86.2% (304/353) of exclusive cigarette smokers and 92.1% (338/367) of dual users used the SP; 4% (14/353) of exclusive cigarette smokers and 4.1% (15/367) of dual users switched completely to the SP. Furthermore, 25.8% (91/353) of exclusive cigarette smokers and 28.1% (103/367) of dual users substantially reduced their cigarette consumption (50% or more) compared to baseline. Finally, around half of the participants (exclusive cigarette smokers: 166/304, 54.6%; dual users: 167/338, 49.4%) used only the menthol SP variant, which was also more positively evaluated in taste, smell, and aftertaste than the tobacco SP variant.

      Conclusions:
      This study indicates that adults who smoke cigarettes can switch completely to the novel ENDS or substantially reduce their cigarette consumption. These results complement the scientific evidence suggesting that ENDS are an acceptable alternative to cigarettes for adults who smoke in the United States.

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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.