JMIR Publications

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 (CC), requires premarket authorization by the FDA 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 (AUS) 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+ cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at four geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including one week of baseline smoking and six 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. Ninety-seven of 100 participants completed the study, with approximately half identifying as dual- or poly-users of cigarettes and other types of tobacco products. There was more than 90% compliance with daily eDiary reporting, and the majority 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 81.5% of all study participants. At the end of the Week 6, 16% of participants had reduced their cigarette consumption by more than half.

Conclusions:

The design of this study, including recruiting, enrollment, eDiary utilization, 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 AUS will provide important evidence supporting the role that alternatives to CC may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.