Summary
Introduction:
This text reports the results of a study on the abuse liability (aL) of Vuse Solo G2 electronic nicotine delivery system (ENDS) compared to combustible cigarettes and nicotine gum. The study was conducted using an open-label, randomized crossover confinement aL design and assessed subjective measures, nicotine pharmacokinetics (PK), and physiological endpoints following a single 10-min ad libitum product use session.
Key Points:
* The study found that product liking, intent to use again, suppression of urge to smoke were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum.
* No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use.
* The abuse liability (aL) of a tobacco product is defined as the likelihood that individuals will engage in persistent or problematic use and experience undesirable consequences as a result of use.
* aL assessments are important to the FDa in determining if a new product is appropriate for the protection of public health.
* Nicotine's reinforcing effects are linked to the PK profile, and other attributes of tobacco product use contribute to the early experiences of craving relief.
* There is no single assessment that determines the relative aL of a tobacco product, and conclusions are made by integrating the results of multiple types of assessments.
* The FDa CTP considers aL evaluations integral to their determination of whether a new tobacco product is appropriate for the protection of the public health and thus eligible for marketing authorization.
* The study design was based on FDa guidance regarding assessments of human abuse potential of drugs and the application of these methods to tobacco products.
Main Message:
The main message of this text is that the abuse liability of Vuse Solo G2 is lower than that of combustible cigarettes but higher than that of nicotine gum. These findings support the potential of Vuse Solo G2 as a suitable replacement for cigarette smoking for some adult smokers. The study provides the scientific evidence to support regulatory decisions regarding the abuse liability of ENDS and the potential for harm reduction in tobacco product use.
Citation
Campbell C, Jin T, Round EK, Schmidt E, Nelson P, Baxter S. Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum. Scientific reports. 2022;12(1):22080. doi:10.1038/s41598-022-26417-2