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

Area of Science:

• Tobacco regulatory science
• Behavioral science
• Public health

Background:

• Premarket authorization by the US Food and Drug Administration (FDA) is required for new tobacco products.
• Understanding consumer behavior impact is crucial for regulatory review.
• Efficient recruitment and data capture are needed for real-world studies.

Purpose of the Study:

• To develop and test a protocol for an actual use study of a new tobacco product.
• To gather learnings for future full-scale tobacco product studies.
• To assess the usability of oral nicotine pouches as a smoking reduction tool.

Main Methods:

• A 8-week prospective observational study with 100 adult daily smokers.
• Recruitment across 4 US sites with online screening and telephone interviews.
• Smartphone-based electronic diary (eDiary) for daily tobacco product use tracking.

Main Results:

• High participant compliance (>90%) with eDiary reporting and study completion (97%).
• Oral nicotine pouch use increased over time, while daily cigarette consumption decreased for 82% of participants.
• 16% of participants reduced cigarette consumption by over half within 6 weeks.

Conclusions:

• The study protocol, including eDiary use and remote monitoring, was successfully implemented.
• High-resolution data on tobacco product use changes were obtained.
• Future studies can inform the role of novel tobacco products in smoking reduction and public health.