Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study

Abstract

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.

Tobacco-Free Nicotine Pouches and Their Potential Contribution to Tobacco Harm Reduction: A Scoping Review

“…Data from a prospective observational study conducted among 100 healthy US adults aged 21 years old or older were described by Campbell et al [94]. Participants were daily menthol and/or non-menthol cigarette smokers of at least seven cigarettes per day (CPD) who had no intention of quitting tobacco use over the eight-week study period.…”

Effect of Flavored on! Nicotine Pouch Products on Smoking Behaviors: Protocol for a Sequential, Multiple Assignment, Randomized Controlled Trial

“…Among the few studies assessing the longitudinal use of NPs among AS, initial evidence suggests AS may switch to these smoke-free products or use them to help reduce cigarette consumption. To date, we are aware of only two published studies of switching behavior or smoking reduction over time among AS provided with NPs [13,18]. Campbell et al (2022) provided participants with free choice among NPs in two flavors-mint or citrus-in a single nicotine level (4 mg) to use ad libitum for six weeks [18].…”

“…To date, we are aware of only two published studies of switching behavior or smoking reduction over time among AS provided with NPs [13,18]. Campbell et al (2022) provided participants with free choice among NPs in two flavors-mint or citrus-in a single nicotine level (4 mg) to use ad libitum for six weeks [18]. At the end of the study, the majority of participants reduced cigarette consumption (82%, 79 out of 97), with 16% (i.e., 15 of 97) reducing by ≥50% and 3.1% (3 out of 97) self-reporting stopping smoking.…”

Effect of Fruit and Mint Flavored Rogue Oral Nicotine Product Use on Smoking Reduction and Quitting in a 6-Month Prospective Cohort of Adults who Smoke Cigarettes

“…The research that is available on ONP and switching behaviors are based on cross-sectional surveys [31], secondary analyses of results from small-sample pharmacological studies [32], and short-term (4-or 6week), site-based actual use studies [33][34][35][36]. Results from one study on ad libitum use of nicotine pouches found that using more avor varieties over 6 weeks was associated with increased cigarette reduction [36].…”