Sep 22nd 2026
Evolution of Clinical Abuse Liability Study Design for Modern Oral Nicotine Pouches
Clinical abuse liability (AL) studies help evaluate the dependence potential of tobacco and nicotine products, typically using nicotine pharmacokinetics (PK) and subjective responses after controlled product use. Our previous modern oral nicotine pouch studies assessed these endpoints for 240 minutes after a 30minute product use session, with usual brand (UBCC) combustible cigarettes and nicotine replacement therapy (NRT) as high and low AL comparators. Here, we describe an evolved modern oral nicotine pouch AL study design that assesses both acute and extended use and includes UBCC and moist snuff comparators. The proposed design begins with an initial 30minute single-use phase, followed by one-hour assessments of subjective effects and PK. Then participants enter a 7-hour ad libitum phase with permitted additional product use and serial PK sampling. This approach captures nicotine uptake, liking, craving relief, and product effects under acute product use conditions. The ad libitum phase enables characterization of additional product consumption and nicotine exposure under conditions of repeated use. Including UBCC and moist snuff comparators provides AL context across combustible and smokeless tobacco product categories. Overall, the design offers a more comprehensive framework for characterizing modern oral nicotine pouch abuse liability.
