A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products.

Nicotine replacement therapies (NRTs) are intended for short-term use to help cigarette smokers to quit. Some smokers find NRTs ineffective or seek a more satisfactory source of nicotine. Tobacco-free oral nicotine pouch (NP) products have emerged as a potential reduced risk product compared with cigarettes and other tobacco products. In a randomised crossover clinical study, thirty-four healthy adult smokers were enrolled and their nicotine Cmax and AUC0-T determined for three 4 mg nicotine products (NP, gum, lozenge) under fasting conditions. The NP, lozenge and gum mean Cmax values were 8.5, 8.3 and 4.4 ng/mL, AUC0-T values were 30.6, 31.5 and 14.3 ng*h/mL, respectively. The NP showed similar nicotine bioavailability to the lozenge (p = 0.6526 (Cmax), p = 1.0000 (AUC0-T)), and superior bioavailability to the gum (p < 0.0001 for Cmax and AUC0-T). Compared with the lozenge, the NP demonstrated greater product satisfaction with a higher number of positive responses to subjective satisfaction questions. All products were judged to be well-tolerated; the incidence of minor adverse events was lower for the NP (18.2%) than the lozenge (33.3%) or gum (18.8%). In summary, NPs may provide smokers with a more satisfying alternative nicotine source as compared to the reference NRTs.Study Registry/Registered Trial No: ISRCTN/ISRCTN65708311.

Smoking intensity before and after introduction of the public place smoking ban in Scotland.

A study was performed to determine whether cigarettes were smoked more intensely outside of public venues in Scotland, compared to indoors, after introduction of the public place smoking (PPS) ban. It was conducted in three waves: before the ban, immediately after and 6 months after introduction. The study included 322 regular smokers of four cigarette brand variants. Filter analysis measurements were used to estimate the human-smoked yields of tar and nicotine from cigarettes smoked predominantly inside (before the ban) or outside (after the ban) public venues. Self-reported cigarette consumption data were also collected. Numbers of cigarettes smoked indoors in public places fell dramatically after the ban. There was a corresponding rise in smoking incidence in outdoor public locations. The ban did not significantly affect the total number of cigarettes smoked by the subjects over the weekends investigated. Human-smoked yields of tar and nicotine decreased slightly after the introduction of the ban and some reductions were significant. Therefore, smoking outdoors at public venues, following the PPS ban, did not increase smoking intensity. Any changes in smoking behaviour that may have occurred had little effect on mainstream smoke exposure or cigarette consumption for those that continued to smoke.

Estimation of nicotine and tar yields from human-smoked cigarettes before and after the implementation of the cigarette ignition propensity regulations in Canada.

In 2005, Human-Smoked (HS) tar and nicotine yields from commercial Canadian cigarettes were determined using a part filter analysis method to obtain estimates representative of human smoking behavior. In 2006, new cigarette designs were introduced to ensure compliance with the Canadian Low Ignition Propensity (LIP) regulations. It was not known how the changes in product design would affect HS yields. To assess the impact of the cigarette design modifications on HS yields, a further group of Canadian smokers was recruited for smoking the modified version of 10 products previously assessed. No differences in estimated HS tar yields were found between products following product modification. The HS nicotine yield was different for one product. In general, HS yields were higher than ISO machine yields while Canadian intense machine yields were more representative of the maximum HS yields. The same product ranking order was obtained for HS yields and the two machine yields but differences between the mean HS yields and ISO yields were smaller as the product ISO yields increased. Higher HS yields were measured when products were smoked by male smokers. The methodology used in this study showed the wide range of HS yields obtained by smokers as well as a good degree of stability in average HS yields just before and after the introduction of LIP regulations.