An exploratory, randomised, crossover study to investigate the effect of a nicotine containing electronic cigarette on appetite in healthy adult smokers, after a period of smoking abstinence: study protocol
DOI:
https://doi.org/10.18203/2349-3259.ijct20222692Keywords:
Nicotine, E-cigarette, Appetite, Smoking cessation, Tobacco harm-reductionAbstract
Background: Many individuals continue to smoke despite the known harmful effects of cigarette smoking. Tobacco harm reduction (THR) is a public health strategy that seeks to reduce or prevent projected harm caused by cigarette smoke via encouraging smokers, who would otherwise continue to smoke, to switch to products with reduced risk profiles (such as e‑cigarettes). Research shows smoking can influence numerous physiological and psychological functions such as appetite, cognitive function and emotion. For some smokers, the loss of such effects upon cessation has been cited as an incentive to resume smoking. The effect of e‑cigarettes (and other non-combustible alternatives to cigarette smoking) on the above-described physiological and psychological functions has not been widely researched. Such information may be important for more thoroughly evaluating 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 use of a nicotine containing e-cigarette can influence appetite to the same extent as a combustible cigarette following a period of nicotine abstinence in current smokers. Up to 40 current smokers will be recruited into the study. Enrolment started in February 2021 and the results from the study are expected in 2022.
Conclusions: The data from this study will be a valuable addition to the growing body of literature about the potential of e-cigarettes as a satisfactory and viable long-term alternative to cigarettes for existing smokers.
Trial Registration: This study is registered with the ISRCTN registry, number ISRCTN72435551.
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References
WHO report on the global tobacco epidemic, 2021. Available at: https://www.who.int/publications/i/ item/9789240032095. Accessed on 15 February 2022.
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. Regul Toxicol Pharmacol. 2017; 90:342-57.
Belushkin M, Tafin Djoko D, Esposito M, Korneliou A, Jeannet C, Lazzerini M, et al. Selected Harmful and Potentially Harmful Constituents 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.
Nicotine without smoke: Tobacco harm reduction. Available at: ttps://www.fda.gov/tobacco-products/health-effects-tobacco-use/nicotine-why-tobacco-products-are-addictive. Accessed on 15 February 2022.
McNeil A, Brose L, Calder R, Hitchman S, Hajek P and McRobbie H. E-cigarettes: an evidence update. A report commissioned by Public Health England. Public Health England. 2015;111:14-5.
McNeill A, Brose L, Calder R, Simonavicius E, Robson D. Vaping in England: An evidence update including vaping for smoking cessation, February 2021. Public Health England. 2021: 1-247.
Action on Smoking and Health. Available at: https://ash.org.uk/wp-content/uploads/2019/10/ SmokingStatistics.pdf. Accessed on 15 February 2022.
Audrain-McGovern J, Benowitz NL. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011;90:164-8.
Heishman SJ, Kleykamp BA, Singleton EG. Meta-analysis of the acute effects of nicotine and smoking on human performance. Psychopharmacology. 2010;210:453-69.
Schwartz A and Bellissimo N. Nicotine and energy balance: A review examining the effect of nicotine on hormonal appetite regulation and energy expenditure. Appetite. 2021;164:105260.
Aubin HJ, Farley A, Lycett D, Lahmek P and Aveyard P. Weight gain in smokers after quitting cigarettes: meta-analysis. BMJ. 2012;345:e4439.
Ashare RL, Falcone M, Lerman C. Cognitive function during nicotine withdrawal: Implications for nicotine dependence treatment. Neuropharmacology. 2014;76: 581-91.
Borrelli 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. Addictive Behav. 1998;23:609-22.
Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007;9: 315-27.
Green HJ, O'Shea OK, Philpott HL and Newland N. 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. Int J Clin Trials. 2022;9:23-9.
Bennett LJ, Totosy de Zepetnek JO, Brett NR, Poirier K, Guo Q, Rousseau D, et al. Effect of commercially available sugar-sweetened beverages on subjective appetite and short-term food intake in girls. Nutrients. 2018;10:23-8.
Branton A, Akhavan T, Gladanac B, Pollard D, Welch J, Rossiter M, et al. Pre-meal video game playing and a glucose preload suppress food intake in normal weight boys. Appetite. 2014;83:256-62.
Yannakoulia M, Anastasiou CA, Zachari K, Sidiropoulou M, Katsaounou P and Tenta R. Acute effect of smoking and smoking abstinence on energy intake and appetite-related hormones blood concentrations. Physiol Behav. 2018;184:78-82.
Ebajemito JK, McEwan M, Gale N, Camacho OM, Hardie G and Proctor CJ. A randomised controlled single-centre open-label pharmacokinetic study to examine various approaches of nicotine delivery using electronic cigarettes. Sci Rep. 2020;10:19980.
Perkins KA, Sexton JE, DiMarco A and Fonte C. Acute effects of tobacco smoking on hunger and eating in male and female smokers. Appetite. 1994;22:149-58.
Pisinger C, Jorgensen T. Weight concerns and smoking in a general population: the Inter99 study. Prev Med. 2007;44:283-9.
Jackson SE, Brown J, Aveyard P, Dobbie F, Uny I, West R, et al. Vaping for weight control: A cross-sectional population study in England. Addict Behav. 2019;95:211-9.
Guirguis AB, Ray SM, Zingone MM, Airee A, Franks AS and Keenum AJ. Smoking cessation: barriers to success and readiness to change. Tenn Med. 2010;103:45-9.
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