An exploratory, randomised, crossover study to investigate the effect of nicotine on cognitive function in healthy adult smokers who use an electronic cigarette, after a period of smoking abstinence: study protocol
DOI:
https://doi.org/10.18203/2349-3259.ijct20221114Keywords:
Nicotine, E-cigarette, Cognitive function, Smoking cessation, Tobacco harm-reductionAbstract
Background: Despite the known harmful effects of cigarette smoking, many individuals continue to smoke. Published scientific evidence suggests that smoking can influence various physiological and psychological functions (including effects on cognitive function, body weight and emotion). For some smokers, the loss of such effects have been cited as barriers to cigarette smoking cessation and the deficits in such effects may contribute to resumption of smoking post quitting. Whilst not positioned as cigarette cessation devices, the effect of e-cigarettes (and other potentially reduced risk alternatives to cigarette smoking) on such functions has not been widely researched. Such information would provide support for the proposition that smokers seeking alternatives may find e-cigarettes a satisfactory substitute for conventional cigarettes.
Methods: This randomised, partially blinded, crossover study will test the hypothesis that acute nicotine delivery via an e-cigarette can influence cognitive parameters including sustained attention, episodic memory, working memory and executive function to the same extent as a combustible cigarette after a period of nicotine abstinence in current smokers. To determine participants’ cognitive ability, the study will utilise the Cambridge Neuropsychological Test Automated Battery (CANTAB) Connect Profile Software (CANTAB® www.cantab.com). Up to 40 current smokers will be recruited into the study.
Conclusions: The data from this trial will be a valuable addition to the growing body of literature assessing the impact of RRPs for existing smokers.
Trial registration: This study is registered with the ISRCTN registry, number ISRCTN35376793.
References
WHO. WHO report on the global tobacco epidemic, 2021. Available at https://www.who.int/publications /i/item/9789240032095. Accessed on 02 October 2021.
World Population Review. Smoking rates by country, 2021. Available at: worldpopulationreview. com. Accessed on 10 December 2021.
Murphy J, Gaca M, Lowe F, Minet E, Breheny D, Prasad K, et al. Assessing modified risk tobacco and nicotine products: Description of the scientific framework and assessment of a closed modular electronic cigarette. Regulatory Toxicol Pharmacol. 2017;90:342-57.
Belushkin M, Djoko D, Esposito M, Korneliou A, Jeannet C, Lazzerini M, et al. Selected Harmful and Potentially Harmful Constituent Levels in Commercial E-Cigarettes. Chem Res Toxicol. 2020;33:657-68.
Margham J, McAdam K, Forster M, Liu C, Wright C, Mariner D, et al. Chemical composition of aerosol from an E-Cigarette: a quantitative comparison with cigarette smoke. Chem Res Toxicol. 2016;29:1662-78.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems. Public Health Consequences of E-Cigarettes. Eaton DL, Kwan LY, Stratton K, eds. Washington, DC: National Academies Press (US); 2018.
McNeil A, Brose L, Calder S, Hajek P, McRobbie H. E-cigarettes: an advance update. A report commissioned by Public Health England. Am J Public Health. 2015;109(11):e26-7.
McNeill A, Brose L, Calder R, Erikas S, Robson D. Vaping in England: an evidence update including vaping for smoking cessation, 2021. Available at: Vaping in England: an evidence update including vaping for smoking cessation. Accessed on 10 December 2021.
Royal College of Physicians. Nicotine without smoke: tobacco harm reduction, 2016. Available at: https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction. Accessed on 10 December 2021.
McGovern J, Benowitz N. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011;90:164-8.
Schwartz A, Bellissimo N. Nicotine and energy balance: A review examining the effect of nicotine on hormonal appetite regulation and energy expenditure. Appetite. 2021;164:105260.
Heishman S, Kleykamp B, Singleton E. Meta-analysis of the acute effect of nicotine and smoking on human performance. Psychopharmacol. 2011;210:453-69.
Benowitz N. Nicotine addiction. N Engl J Med. 2021;362:2295-303.
Borelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998;23:609-22.
Jeffrey R, Hennrikus D, Lando H, Murray D, Liu J. Reconciling conflicting findings regarding postcessation weight concerns and success in smoking cessation. Health Psychol. 2000;19:242-6.
Ashare R, Falcone M, Lerman C. Cognitive Function During Nicotine Withdrawal: Implications for Nicotine Dependence Treatment. Neuropharmacol. 2014;76:581-91.
Hughes J. Effects of abstinence from tobacco: Valid symptoms and time course. Nic Tob Res. 2007;9:315-27.
Theobald W, Smith S, Fiore M. Insights: Smoking in Wisconsin University of Wisconsin Medical School: UW center for Tobacco Research and Intervention. 2002.
Guirguis A, Ray S, Zingone M, Airee A, Franks A, Keenum A. Smoking cessation: barriers to success and readiness to change. Tenn Med. 2010;103:45-9.
Barnett J, Blackwell A, Sahakian B, Robbins T. The paired associates learning (PAL) test: 30 years of CANTAB translational neuroscience from laboratory to bedside in dementia research. Curr Top Behav Neurosci. 2016;28:449-74.
Kaser M, Deakin J, Michael A, Zapata C, Bansal R, Ryan D et al. Modafinil improves episodic memory and working memory cognition in patients with remitted depression: A double-blind, randomised, placebo-controlled study. Biological Psychiatry. 2017;2:115-22.
AhnAllen C, Bidwell L, Tidey J. Cognitive effects of very low nicotine content cigarettes, with and without nicotine replacement, in smokers with schizophrenia and controls. Nicotine Tobacco Res. 2014;17:510-14.
Ebajemito J, McEwan M, Gale N, Camacho O, Hardie G, Proctor C. A randomised controlled single-centre open-label pharmacokinetic study to examine various approaches of nicotine delivery using electronic cigarettes. Sci Rep. 2020;10:19980.
Wesnes K, Warburton D. The effects of cigarettes of varying yield on rapid information processing performance. Psychopharmacol. 1984;82:338-42.
Edwards J, Wesnes K, Warburton D, Gale A. Evidence of more rapid stimulus evaluation following cigarette smoking. Addict Behav. 1985;10:113-26.