Background Introduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment. Objective The aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report writing of future full-scale actual use studies with tobacco products. Methods A small sample (n=100) of healthy adult daily smokers of 7 or more cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at 4 geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including 1 week of baseline smoking and 6 weeks during which participants were provided with oral nicotine pouches for use as desired. Results Online screening procedures with follow-up telephone interviews and on-site enrollment were successfully implemented. Of 100 participants, 97 completed the study, with more than half (59/99, 60%) identifying as dual- or poly-users of cigarettes and other types of tobacco products at baseline. There was more than 90% (91-93/99, 92%-94%) compliance with daily eDiary reporting, and the majority (92/99, 93%) of participants expressed satisfaction with the study processes. Product use data from the eDiary indicated that after an initial period of trial use, pouches per day increased among those continuing to use the products, while per day average cigarette consumption decreased for 82% (79/97) of all study participants. At the end of the week 6, 16% (15/97) of participants had reduced their cigarette consumption by more than half. Conclusions The design of this study, including recruiting, enrollment, eDiary use, and oversight, was successfully implemented through the application of a detailed protocol, a user-friendly eDiary, electronically administered questionnaires, and remote monitoring procedures. High-resolution information was obtained on prospective changes in tobacco product use patterns in the context of availability of a new tobacco product. Future, larger actual use studies will provide important evidence supporting the role that alternatives to combustible cigarettes may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.

Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo (G2 cartridge design) compared to high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo (G1 cartridge design) and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine pharmacokinetics (PK), and physiological endpoints were assessed following a single 10-min ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine PK were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research and provide the scientific evidence to support regulatory decisions demonstrating that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and, therefore, may be a suitable replacement for cigarette smoking for some adult smokers.