Abstract
Background Oral tobacco-derived nicotine (OTDN) products are a rapidly emerging, innovative category of noncombustible tobacco products. These products are tobacco-leaf free and do not contain or generate many of the harmful and potentially harmful constituents (HPHCs) found in combustible cigarettes or smokeless tobacco (ST) products. OTDN products may therefore offer adult tobacco consumers a potentially reduced harm alternative. However, little is known about OTDN product use patterns or their ability to substitute for more harmful tobacco products.Methods We conducted an open-label, 2-phase, actual use study designed to characterize OTDN pouch product (on!® nicotine pouches - NP) use patterns, including impact on other tobacco use behaviors among adult tobacco consumers interested in using NP. Adult current cigarette smokers (AS) and/or adult ST users (ASTU) (n = 1,147 complete) who were not planning to quit were offered free choice of a portfolio of NP (seven flavors at five nicotine levels) to use at-home, ad-libitum, for 6-weeks following an initial 5-day trial. Participants responded to daily electronic surveys that captured the amount, frequency, and topography (e.g., time in mouth, placement in mouth) of NP and other tobacco product use. Results The majority (99 to 100%) of study participants used NP throughout the 6-week period. Participants used ~5-6 pouches/day of a variety of flavors and nicotine levels. At the end of 6 weeks, a modest proportion of AS (27%) and a substantial proportion of ASTU (71%) reported no use of cigarettes or ST respectively, while reporting continued use of NPs. Additionally, 39% of AS and 14% of ASTU reduced daily consumption of cigarettes or ST products, respectively by 50-99%. Conclusions Participants found NPs acceptable with a sizeable proportion completely switching away from or substantially reducing (50-99%) their cigarette or ST consumption by week 6. Availability of a variety of flavors and nicotine levels appeared to facilitate the conversion to NP. These data suggest that, under the conditions of the study, NP can be a potential substitute for cigarettes or ST products and may offer harm reduction potential for adult smokers and smokeless tobacco users not interested in quitting.Trial Registration Note: This study is an observational study with tobacco products currently available in the marketplace for adult tobacco consumers. Since there is no intervention per se and we did not collect any biosamples this is not a “clinical study” and there is no appropriate registry for such behavioral observational studies, we do not believe that this requirement is applicable.