biostudies-literatureUnknown12(1)Azzopardi DImperial Tobacco CanadaNicotine 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 C<sub>max</sub> and AUC<sub>0-T</sub> determined for three 4 mg nicotine products (NP, gum, lozenge) under fasting conditions. The NP, lozenge and gum mean C<sub>max</sub> values were 8.5, 8.3 and 4.4 ng/mL, AUC<sub>0-T</sub> 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 (C<sub>max</sub>), p = 1.0000 (AUC<sub>0-T</sub>)), and superior bioavailability to the gum (p < 0.0001 for C<sub>max</sub> and AUC<sub>0-T</sub>). 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.Scientific reports6949https://www.ebi.ac.uk/biostudies/studies/S-EPMC9050656biostudies-literatureA randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products.PMC9050656Hardie GMullard GThissen JMurphy JCamacho OMVoisine RAzzopardi DCohen ZMcEwan MEbajemito JfalseA 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 C<sub>max</sub> and AUC<sub>0-T</sub> determined for three 4 mg nicotine products (NP, gum, lozenge) under fasting conditions. The NP, lozenge and gum mean C<sub>max</sub> values were 8.5, 8.3 and 4.4 ng/mL, AUC<sub>0-T</sub> 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 (C<sub>max</sub>), p = 1.0000 (AUC<sub>0-T</sub>)), and superior bioavailability to the gum (p < 0.0001 for C<sub>max</sub> and AUC<sub>0-T</sub>). 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/ISRCTN65708311.2022-01-01T00:00:00Z2022 Apr2025-04-25T23:01:14.341Z2025-04-06T09:13:59.123ZS-EPMC90506563548430910.1038/s41598-022-10544-x