Discussion
THR
ABUSE
The cornerstone of THR is the principle that the harms associated with cigarette smoking, at both the individual and population levels, can be reduced by providing adult smokers with alternatives to cigarettes which deliver nicotine but with lower levels of the harmful chemicals found in cigarette smokeRegarding subjective effects, use of each of the iD sticks used with the Pulze HTS elicited reductions in the urge to smoke cigarettes, which although approximately 20–30% lower in magnitude than that seen when subjects smoked cigarette were only significantly different to the cigarette for the iD Regular American Blend stick variant. The mean time-course (i.e., onset) of urge reductions was also similar across the study products, and similar to the onset of nicotine delivery the iD Intense American Blend stick variant elicited the most rapid reduction in urge to smoke. The composite positive subjective effects of satisfaction, psychological reward and relief on the PESThere are few subjective effects assessments of HTPs reported in the literature with which to assess our findings against. However, previous studiesThe findings from this study can also be utilised to make an assessment of the relative abuse liability of the Pulze HTS. Abuse liability is a composite measure that can be determined from nicotine pharmacokinetic and subjective effects assessments, which together constitute an assessment of the abuse liability (dependence potential) of a tobacco or nicotine-containing productThe results presented in this paper should be considered within the context of a number of limitations. Firstly, this study assessed nicotine pharmacokinetics in smokers who used different variants of the Pulze HTS, and the findings were used to make assumptions regarding the potential ability of the Pulze HTS to act as a satisfactory alternative to cigarettes and therefore play a role in supporting THR. While we conclude that the pharmacokinetic and subjective effects profiles of the Pulze HTS will support its use as an acceptable alternative to smoking cigarettes, no data are presented concerning its actual ability to help smokers switch. However, data on other HTPs support our conclusions. For example, a recent study found that in adult smokers asked to switch to using the IQOS HTP, smokers initially substituted IQOS for 59% of their average daily cigarette consumption, and this increased to 87% by at the end of the 3-week studyA further limitation is that this study assessed use of the Pulze HTS in a clinical environment using a controlled puffing regimen, at a single point in time, and with only a very brief familiarisation period. Although it has not been reported in the literature for HTPs, for other inhaled nicotine products such as ENDS, increases in CIn conclusion, our pharmacokinetic and subjective effects assessments of three iD stick variants when used with the Pulze HTS demonstrates effective nicotine delivery, generates positive subjective effects including satisfaction, psychological reward, and relief, and reduces urge to smoke. These findings support the conclusion that the Pulze HTS is likely to be an acceptable and satisfying alternative to cigarettes for adult smokers who would otherwise continue to smoke and support transitioning away from cigarettes, and therefore that the Pulze HTS has the potential to make a meaningful contribution to THR. Furthermore, when our findings are used to generate an abuse liability assessment, we conclude that the Pulze HTS has a lower abuse liability than cigarettes. The potential generation by the Pulze HTS of an ‘off-ramp’ away from cigarette smoking, while minimising an ‘on-ramp’ to initiating tobacco/nicotine use, likely serves to enhance its THR potential.