Nicotine pharmacokinetics and subjective responses after using nicotine pouches with different nicotine levels compared to combustible cigarettes and moist smokeless tobacco in adult tobacco users.

Introduction:
This article presents the results of a randomized, controlled, clinical study examining the abuse potential of on!® nicotine pouches (NPs) with different nicotine levels compared to combustible cigarettes and moist smokeless tobacco (MST) in adult tobacco users. The study evaluated the nicotine pharmacokinetics (PK) and subjective effects of NPs with five different nicotine levels (1.5, 2, 3.5, 4, and 8 mg) in dual users of cigarettes and MST.

Key Points:

* The study used a randomized, partial single-blind, 7-way crossover design, with each participant using all five nicotine levels and their own brand cigarettes (OBCs) and own brand MST (OBMST) products.
* The nicotine PK profiles were similar among all NPs and OBMST products, and the geometric least squares mean Cmax and AUC (0--180) increased with the increasing nicotine level of the NPs.
* The magnitude of reduction in urges to smoke and craving a cigarette was significantly lower for the 1.5, 2, 3.5, and 4 mg NPs and not statistically different for the 8 mg NP compared to OBCs.
* Participants reported using about five NPs per day during the product trial period, and the average pouch consumption ranged from six pouches (8 mg) to 18 pouches (1.5 mg) during each 4-h ad libitum product use period.
* No serious adverse events were reported, and the most frequently reported event was headache, experienced by eight participants (27%).
* The study suggests that the abuse potential of NPs is not likely to be higher than cigarette or MST, and NPs may be potentially acceptable switching products for AS and adult MST users.

Main Message:
The study's findings indicate that the abuse potential of on!® NPs is not likely to be higher than combustible cigarettes or MST, and NPs may be a potentially acceptable switching product for adult smokers and MST users. The study's results add to the limited scientific knowledge regarding the abuse potential of NP products and provide valuable information for regulatory decision-making.

Liu, J., Rensch, J., Wang, J., Jin, X., Vansickel, A., Edmiston, J., & Sarkar, M. (2022). Nicotine pharmacokinetics and subjective responses after using nicotine pouches with different nicotine levels compared to combustible cigarettes and moist smokeless tobacco in adult tobacco users. Psychopharmacology, 239(9), 2863–2873. https://doi.org/10.1007/s00213-022-06172-y