{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12(1)"],"submitter":["Azzopardi D"],"funding":["Imperial Tobacco Canada"],"pubmed_abstract":["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."],"journal":["Scientific reports"],"pagination":["6949"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9050656"],"repository":["biostudies-literature"],"pubmed_title":["A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products."],"pmcid":["PMC9050656"],"pubmed_authors":["Hardie G","Mullard G","Thissen J","Murphy J","Camacho OM","Voisine R","Azzopardi D","Cohen Z","McEwan M","Ebajemito J"],"additional_accession":[]},"is_claimable":false,"name":"A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products.","description":"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.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Apr","modification":"2025-04-25T23:01:14.341Z","creation":"2025-04-06T09:13:59.123Z"},"accession":"S-EPMC9050656","cross_references":{"pubmed":["35484309"],"doi":["10.1038/s41598-022-10544-x"]}}