Nicotine pharmacokinetics and subjective response among adult smokers using different flavors of on!® nicotine pouches compared to combustible cigarettes

Rationale on!(R) nicotine pouches (NPs) are oral tobacco-derived nicotine products that are tobacco-leaf free and are available in a variety of flavors and nicotine strengths. Switching completely to NPs from cigarettes may present the potential to reduce harm in adult smokers (AS) unable or unwilling to quit smoking. We characterized the abuse potential of six different flavor variants of NPs compared to cigarettes. Objectives The objective of this study was to evaluate the nicotine pharmacokinetics (PK) and subjective effects of different flavor variants of NPs compared to participants' own brand cigarettes (OBCs) in AS. Methods In this single-blind, randomized, 7-way crossover study, we assessed nicotine PK, subjective measures (using well-established questionnaires), and product use behavior associated with six flavors of 4 mg NPs and OBCs in AS that remained in clinic for the duration of the test period. Results Nicotine C-max values ranged from 9.0 to 11.5 ng/mL for the NPs and 16.3 ng/mL for OBCs. The t(max) ranged from 30.1 to 34.9 min for ONPs and 7.5 min for OBCs. Use of NPs resulted in lower ratings of urge to smoke or craving a cigarette. All the NPs were considered pleasant, but not as much as OBCs. Flavor did not appear to influence the nicotine PK or subjective responses. Conclusions Based on the nicotine PK parameters and subjective responses, we conclude that NPs, regardless of flavor, likely have lower abuse potential than cigarettes. Overall, this study suggests that the NPs may be potentially acceptable switching products for adult smokers.

Automated summary

Based on the nicotine PK parameters and subjective responses, we conclude that NPs, regardless of flavor, likely have lower abuse potential than cigarettes. Overall, this study suggests that the NPs may be potentially acceptable switching products for adult smokers.