Recently, clinical studies have shown reductions in exposure to tobacco smoke toxicants when smokers of conventional cigarettes switch to a tobacco heating product (THP). Studies on nicotine pharmacokinetics (PK) and subjective effects of potentially reduced-risk products (PRRPs), such as THPs, relative to conventional cigarettes and other nicotine products may help understand the likelihood of switching success and provide data on potential abuse liability.

This study conducted in Verona, Italy (ISRCTN13439529), run in accordance with ICH-GCP, was a randomised, crossover study investigating nicotine PK and subjective effects. Subjects used the glo™ THP with consumables of two different nicotine yields (THP1.0 and THP1.1), a cigarette of subjects’ usual brand, and a licensed nicotine replacement therapy (nicotine inhaler).

32 healthy smokers were recruited with each subject assigned a different product in accordance with pre-defined randomisation sequences over four PK periods following overnight nicotine abstinence. Subjective effects (product liking, urge to smoke a usual-brand cigarette, urge to use the study product, overall intent to use the product again) were also assessed at various timepoints during each PK period.

Based on C_max and AUC_0-240min, systemic nicotine exposure was greater for THPs than for nicotine inhaler, but lower than usual brand cigarette.

For the THPs median T_max (4 min) was closer to that observed for the cigarette (6 min) than for the nicotine inhaler (15 min). Product liking and overall intent-to-use again was greater for the THPs than for the nicotine inhaler, but lower than for cigarettes. Urge to smoke was reduced to the greatest extent when smoking a cigarette, and to the least extent when using the nicotine inhaler.

These findings demonstrate the glo™ THPs had a closer nicotine PK profile to conventional cigarettes than the nicotine inhaler, and that subjective effects of glo™ THPs were more positive than those for the nicotine inhaler.