A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes

Introduction:
This text provides a summary of a clinical study investigating the pharmacokinetic, pharmacodynamic, and safety profiles of tobacco-free oral nicotine pouches compared to cigarettes. The study aims to evaluate the potential of nicotine pouches as a harm reduction tool for adult smokers.

Key Points:

* The study was a randomized, open-label, cross-over clinical trial involving 24 adult traditional tobacco product users.
* The study compared two nicotine pouch variants (ZoneX #2 and ZoneX #3) with cigarettes in terms of pharmacokinetic, pharmacodynamic, and safety profiles.
* Pharmacokinetic data showed that plasma nicotine levels were lower and time to peak slower for nicotine pouches compared to cigarettes.
* Pharmacodynamic data indicated that nicotine pouches effectively reduced subjects' urge to smoke and presented favorable product liking scores.
* Both nicotine pouches were well tolerated following short-term use, with no serious adverse events reported.
* The study suggests that nicotine pouches may offer an acceptable alternative for adult smokers to achieve satisfactory levels of nicotine delivery while likely having a lower abuse liability and addictive potential compared to continued cigarette smoking.
* The study's findings contribute to the understanding of nicotine pouches' role in tobacco harm reduction strategies.

Main Message:
The study supports the potential of tobacco-free oral nicotine pouches as a reduced-harm alternative to cigarettes for adult smokers. The lower abuse liability and addictive potential, along with satisfactory nicotine delivery and product liking, make nicotine pouches a promising option for harm reduction. However, further research is needed to confirm their position on the relative risk scale and assess their long-term safety and tolerability.

Chapman, F., McDermott, S., Rudd, K., Taverner, V., Stevenson, M., Chaudhary, N., Reichmann, K., Thompson, J., Nahde, T., & O’Connell, G. (2022). A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology, 239(9), 2931–2943. https://doi.org/10.1007/s00213-022-06178-6