EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study
Pasquale Caponnetto, Davide Campagna, Fabio Cibella, Jaymin B Morjaria, Massimo Caruso, Cristina Russo, Riccardo Polosa, Pasquale Caponnetto, Davide Campagna, Fabio Cibella, Jaymin B Morjaria, Massimo Caruso, Cristina Russo, Riccardo Polosa
Abstract
Background: Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a 'smoking' experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ('Categoria'; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Results: Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants' perception and acceptance of the product under investigation was satisfactory.
Conclusion: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects.
Trial registration: ClinicalTrials.gov NCT01164072 NCT01164072.
Conflict of interest statement
Competing Interests: RP has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has served as a consultant for Pfizer and Arbi Group Srl, the distributor of the Categoria™ e-Cigarette. The other authors have no relevant conflict of interest to declare in relation to this work. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.
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References
- World Health Organization (2008) Report on the global tobacco epidemic.
- The health benefits of smoking cessation (1990) In. Edited by Services UDoHaH; USA, US Department of Health and Human Services, Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.
- World Health Organization (WHO), WHO Framework Convention on Tobacco Control. ISBN: 9241591013.
- Fiore MC, Jaen CR, Baker TB, Bailey WC, Benowitz N, et al. (2008). Treating tobacco use and dependence: 2008 Update. Rockville (MD): U.S. Department of Health and Human Services.
- Casella G, Caponnetto P, Polosa R (2010) Therapeutic advances in the treatment of nicotine addiction: present and future. Ther Adv Chronic Dis 1: 95–106.
- Hon L (2005) A non-smokable electronic spray cigarette (CA 2518174) {Patent notice}. In. Edited by Record CPO, vol. 133.
- Caponnetto P, Campagna D, Papale G, Russo C, Polosa R (2012) The emerging phenomenon of electronic cigarettes. Expert Rev. Respir. Med. 6(1): 63–74.
- Etter JF: Electronic cigarettes (2010) a survey of users. BMC Public Health 10: 231.
- Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D (2011) Smoking cessation with E-cigarettes in smokers with a documented history of depression and recurring relapses. Int. J. Clin. Med 2: 281–284.
- Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D (2011) Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. BMC J. Med. Case Reports 5(1): 585.
- Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, et al. (2011) Effect of an electronic nicotine delivery device (E-cigarette) on smoking cessation and reduction: a prospective pilot study. BMC Public Health 11: 786.
- World Health Organization (2009) study group on tobacco product regulation, report on the scientific basis of tobacco product regulation: third report of a WHO study group. WHO Technical Report Series 955.
- Etter JF, Bullen C, Flouris AD, Laugesen M, Eissenberg T (2011) Electronic nicotine delivery systems: a research agenda. Tob Control 20(3): 243–248.
- Miura K, Kikukawa Y, Nakao T, Tokai H, Izumi Y, et al. (2011) Safety assessment of electronic cigarettes in smokers. Seikatsu Eisei 55(1): 59–64.
- Beck A, Ward C, Mendelson M, Mock J, Erbaugh J (1987) Manual for the Beck Depression Inventory. New York Harcourt Brace Jovanovich.
- Beck AT, Epstein N, Brown G, Steer RA (1988) An inventory for measuring anxiety: Psychometric properties. J Cons Clin Psychol 56: 893–897.
- Fagerstrom KO, Schneider NG (1989) Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med 12(2): 159–182.
- Glover ED, Nilsson F, Westin A. Glover PN, Laflin MT, et al. (2005) Developmental History of the Glover-Nilsson Smoking Behavioral Questionnaire. Am J Health Behav. 29(5): 443–455.
- Jacob P, Wilson M, Benowitz NL (1981) Improved gas chromatographic method for the determination of nicotine and cotinine in biologic fluids. J Chromatogr 222: 61–70.
- Hughes JR (2007) The effects of abstinence from tobacco: Valid symptoms and time course. Nicotine & Tobacco Research 9: 315–27.
- Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, et al. (2000) Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ 321(7257): 329–333.
- Etter JF, Bullen C (2011) Electronic cigarettes: users profile, utilization, satisfaction and perceived efficacy. Addiction 106(11): 2017–2028.
- Siegel MB, Tanwar KL, Wood KS (2011) Electronic cigarettes as smoking cessation tool: Results from an Online Survey. Am J Prev Med 40(4): 472–5.
- Fagerstrom K (2012) Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res 14(1): 75–78.
- Caponnetto P, Cibella F, Mancuso S, Campagna D, Arcidiacono G, et al. (2011) Effect of a nicotine free inhalator as part of a smoking cessation program. Eur Respir J 38(5): 1005–1011.
- Wall MA, Johnson J, Jacob P, Benowitz NL (1988) Cotinine in the Serum, Saliva, and Urine of Nonsmokers, Passive Smokers, and Active Smokers. Am J Public Health 78: 699–701.
- Etter J-F, Bullen C (2011) Saliva cotinine levels in users of electronic cigarettes. Eur Respir J 38: 1219–1236.
- Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L (2012) Nicotine Levels in Electronic Cigarettes. Nicotine Tob Res Apr 22.
- Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, et al. (2009) Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med 169(22): 2148–2155.
- Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, et al. (2006) Smoking cessation with varenicline, a selective alpha4-beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med 166(15): 1561–8.
- Tobacco Advisory Group of the Royal College of Physicians (2007) Harm reduction in nicotine addiction: Helping people who can’t quit. 978-1-86016-319-7.
- Bullen C, McRobbie H, Thornley S, Glover M, Lin R, et al. (2010) Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 19(2): 98–103.
- Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE (2010) A clinical laboratori model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev 19(8): 1945–1953.
- Dawkins L, Turner J, Hasna S, Soar K (2012) The electronic-cigarette: Effects on desire to smoke, withdrawal symptoms and cognition. Addict Behav 37(8): 970–973.
- Aubin HJ, Farley A, Lycett D, Lahmek P, Aveyard P (2012) Weight gain in smokers after quitting cigarettes: meta-analysis. BMJ 345: e4439.
- Fagerstrom KO, Hughes JR, Rasmussen T, Callas PW (2000) Randomised trial investigating effect of a novel nicotine delivery device (Eclipse) and a nicotine oral inhaler on smoking behaviour, nicotine and carbon monoxide exposure, and motivation to quit. Tob Control 9(3): 327–333.
- Cahn Z, Siegel M (2011) Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? J Public Health Policy. Feb 32(1): 16–31.
- Caponnetto P, Keller E, Bruno CM, Polosa R (2013) How to handle relapse in smoking cessation: strategies and recommendations. Intern Emerg Med Feb; 8(1)7–12.
- Carroll KM (1997) Enhancing retention in clinical trials of psychosocial treatments: practical strategies. In: Onken LS, Blaine JD, Boren JJ (Eds). Beyond the Therapeutic Alliance: Keeping the drug dependent individuals in treatment. NIDA Research Monograph Series, Monograph No.165, NIH Pub. No. 97–4142.
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