Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Apr 28;12(1):6949.
doi: 10.1038/s41598-022-10544-x.

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

David Azzopardi  1 , James Ebajemito  2 , Michael McEwan  2 , Oscar M Camacho  2 , Jesse Thissen  2 , George Hardie  2 , Richard Voisine  3 , Gavin Mullard  4 , Zvi Cohen  3 , James Murphy  5
Affiliations
Randomized Controlled Trial

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

David Azzopardi et al. Sci Rep. .

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 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.

PubMed Disclaimer

Conflict of interest statement

Imperial Tobacco Canada (ITC) funded this study. ITC is a subsidiary of BAT, a company that manufactures tobacco and nicotine products. All authors are or were employees of BAT, ITC or R.J. Reynolds Tobacco Company, a wholly-owned subsidiary of BAT.

Figures

Figure 1
Figure 1
Study scheme.
Figure 2
Figure 2
Baseline-unadjusted mean plasma nicotine concentrations among adult smokers (N = 32) after single oral product use of three nicotine products under fasting conditions.
Figure 3
Figure 3
Box-and-whiskers plot of plasma nicotine Cmax (a) and AUC0-T (b) among adult smokers after single oral product use of three nicotine products under fasting condition. Arithmetic mean values are shown as solid lines and median values as dashed lines.
See this image and copyright information in PMC

References

    1. US Department of Health and Human Services. The health consequences of smoking–50 years of progress: A report of the Surgeon General. Atlanta: Centers for Disease Control and Prevention. Available from: https://www.hhs.gov/surgeongeneral/reports-and-publications/tobacco/inde... [Accessed 01 February 2021] (2014). - PubMed
    1. Rodgman A, Perfetti TA. The chemical components of tobacco and tobacco smoke. 2. CRC Press; 2013.
    1. Fowles J, Dybing E. Application of toxicological risk assessment principles to the chemical constituents of cigarette smoke. Tob. Control. 2003;12(4):424–430. doi: 10.1136/tc.12.4.424. - DOI - PMC - PubMed
    1. Gottlieb, S. Protecting American families: Comprehensive approach to nicotine and tobacco. Speech by Scott Gottlieb, FDA, White Oak, MD. Available from: https://www.fda.gov/news-events/speeches-fda-officials/protecting-americ... [Accessed 01 February 2021] (2017).
    1. Royal College of Physicians. Nicotine with smoke: Tobacco harm reduction. London: RCP. Available from: https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-toba... [Accessed 01 February 2021] (2016).

Publication types

Associated data