Wednesday, April 24, 2024
4/24/2024
PROJECT SUMMARY Despite increased morbidity and mortality, 34 million adults in the United States smoke combustible cigarettes. Heat-not-burn (HNB) tobacco products are an emerging nicotine delivery innovation designed to deliver nicotine with less toxins than combustible cigarettes. In 2019, the Food and Drug Administration (FDA) authorized the sale of IQOS, the only HNB tobacco product in the United States. Manufactured by Philip Morris International, IQOS is a rechargeable electronic device that produces a nicotine-containing aerosol by heating a disposable tobacco stick. Since entering the tobacco market in 2014, global sales of IQOS have increased with millions of users across 50 countries. Tobacco scientists and market analysts forecast rapid growth in IQOS sales in the U.S. over the next few years. While awareness and use of IQOS is increasing among cigarette smokers, the lack of data on the impact of IQOS use on cigarette smoking behaviors leaves us unable to answer fundamental questions relevant to public health and regulatory efforts. First, do cigarette smokers switch completely to IQOS or do they dual use these two tobacco products? Phillip Morris International’s claim that IQOS use results in less exposure to harmful chemicals than combustible cigarettes rests on smokers switching completely to IQOS. Second, does IQOS use affect smokers’ intentions to quit smoking cigarettes? Third, how do indices of satisfaction with IQOS use (e.g., craving and withdrawal relief, subjective reward, and relative reinforcing value), as well as IQOS risk perceptions, impact combustible cigarette smoking? The proposed research will fill these gaps in the evidence base by recruiting 100 combustible cigarette smokers to a 21-day protocol using a within-subjects design. Baseline smoking rate will be established during days 1-5. After overnight cigarette smoking abstinence, laboratory visits on days 6 and 7 will assess IQOS-associated craving relief, withdrawal relief, risk perceptions, subjective reward, and the reinforcing value of IQOS relative to combustible cigarettes. Participants will switch from cigarette smoking to IQOS use for the following 14 days (days 8-21). Participants will collect their spent cigarette filters and their used IQOS HeatSticks daily in order to assess consumption of cigarettes per day (cpd) and tobacco sticks per day (spd). The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the IQOS switch phase. Changes in motivation to quit smoking from baseline to study end will be a secondary outcome. As outlined in RFA-OD-19-028, the findings will directly address FDA’s priority to assess the likely impact of heated tobacco products on cigarette smoking behaviors (i.e., switching, use, dual use and smoking cessation-related behaviors) and risk perceptions.
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