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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Study protocol

Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial

Authors: Abdul Hameed, Daud Malik

Published in: Trials | Issue 1/2024

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Abstract

Background

Pakistan is one of most vulnerable low- and middle-income countries with 29 million adult active tobacco users. Smoking cessation services are lacking as the tobacco control initiatives have largely failed to address the smoking endemic. Over the last 5 years, Pakistan has witnessed the use of innovative tobacco harm reduction (THR) products such as e-cigarettes and nicotine pouches. However, their use remains limited. THR products are imported legally as consumer goods and are taxable. The lack of sufficient data for THR and its application is a challenge in gauging their effectiveness in assisting smokers quit combustible smoking. Evidence-based studies can help in measuring the effectiveness of e-cigarettes and nicotine pouches as smoking cessation aids.

Method

Keeping in view the study objectives, a sample size of 600 participants will be sufficient to assess the effectiveness of e-cigarettes and nicotine pouches for smoking cessation in Pakistan. Of these, 200 participants each will receive e-cigarettes and nicotine pouches along with basic care counselling, while the remaining 200 participants will only receive basic care counselling for 48 weeks. The association of participants’ characteristics with smoking and health status will be based on the bivariate and multivariate analysis. The simple t-test and variance analysis will assess the differences in intervention indicators between the control and treatment groups. For the inferential analysis, the average treatment impact will be based on the quasi-experimental techniques such as difference in difference (DID) or propensity score matching (PMS).

Discussion

The study will evaluate the participants at the baseline as they decide the quit date. After every 12 weeks, a follow-up survey with the participants will be conducted. Results are anticipated to inform the public, decision-makers, and researchers about the effects of using e-cigarettes and nicotine pouches in the short- and medium-term periods. Critically, the potential of e-cigarettes and other alternative nicotine delivery systems as smoking cessation aid will be assessed.

Trial registration

ClinicalTrials.gov NCT05715164. Registered on February 6, 2023. Protocol version. Protocol version 1.0, 14-12-2022
Trial in progress and not yet recruiting participants. Estimated primary data collection date—April 2024
Appendix
Available only for authorised users
Literature
1.
World Health Organization. WHO global report on trends in prevalence of tobacco use 2000-2025. World Health Organization. 2019.
2.
Been JV, Lugtenberg MJ, Smets E, Van Schayck CP, Kramer BW, Mommers M, et al. Preterm birth and childhood wheezing disorders: a systematic review and meta-analysis. PLoS med. 2014;11(1):e1001596.PubMedPubMedCentralCrossRef
3.
4.
Vos T, Lim SS, Abbafati C, Abbas KM, Abbasi M, Abbasifard M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22.CrossRef
5.
Cevik S. Smoke screen: estimating the tax pass-through to cigarette prices in Pakistan. Rev Develop Econ. 2018;22(3):e1–e15.CrossRef
6.
National Institute of Population Studies (NIPS) [Pakistan] and ICF. Pakistan Demographic and Health Survey 2017-18. In: Islamabad, Pakistan, and Rockville. Maryland, USA: NIPS and ICF; 2019.
7.
Nayab D, Nasir M, Memon JA, Siddique O. The Economic Cost of Tobacco-Induced Diseases in Pakistan. Pakistan Institute of Development Economics. 2021.
8.
Shaheen K, Oyebode O, Masud H. Experiences of young smokers in quitting smoking in twin cities of Pakistan: a phenomenological study. BMC pub health. 2018;18:1–12.CrossRef
9.
Pakistan Bureau of Statistics, Ministry of National Health Services, Regulations and Coordination, World Health Organization. Pakistan Global Adult Tobacco Survey 2014. 2019.
10.
Lee SH, Ahn SH, Cheong YS. Effect of electronic cigarettes on smoking reduction and cessation in Korean male smokers: a randomized controlled study. J Am Board Family Med. 2019;32(4):567–74.CrossRef
11.
Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. Lancet Respirat Med. 2020;8(1):54–64.CrossRef
12.
Myers Smith K, Phillips-Waller A, Pesola F, McRobbie H, Przulj D, Orzol M, et al. E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. Addict. 2022;117(1):224–33.CrossRef
13.
Chiang SC, Abroms LC, Cleary SD, Pant I, Doherty L, Krishnan N. E-cigarettes and smoking cessation: a prospective study of a national sample of pregnant smokers. BMC Pub Health. 2019;19:1–7.CrossRef
14.
Rigotti NA, Chang Y, Tindle HA, Kalkhoran SM, Levy DE, Regan S, et al. Association of e-cigarette use with smoking cessation among smokers who plan to quit after a hospitalization: a prospective study. Ann int med. 2018;168(9):613–20.PubMedCrossRef
15.
Halpern SD, Harhay MO, Saulsgiver K, Brophy C, Troxel AB, Volpp KG. A pragmatic trial of e-cigarettes, incentives, and drugs for smoking cessation. New Engl J Med. 2018;378(24):2302–10.PubMedCrossRef
16.
Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, et al. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PloS one. 2013;8(6):e66317.PubMedPubMedCentralCrossRef
17.
Tseng TY, Ostroff JS, Campo A, Gerard M, Kirchner T, Rotrosen J, et al. A randomized trial comparing the effect of nicotine versus placebo electronic cigarettes on smoking reduction among young adult smokers. Nicot Tobacco Res. 2016;18(10):1937–43.CrossRef
18.
19.
Hameed A, Malik D. Assessing the knowledge, attitude, and practices of cigarette smokers and use of alternative nicotine delivery systems in Pakistan: a cross-sectional study. Adv Pub Health. 2021;2021:1–11.CrossRef
20.
Hameed A, Malik D. Barriers to cigarette smoking cessation in Pakistan: evidence from qualitative analysis. J smoking cessat. 2021;2021
21.
Hameed A, Malik D. Public health practitioners’ knowledge towards nicotine and other cigarette components on various human diseases in Pakistan: a contribution to smoking cessation policies. BioMed Res Int. 2022, 2022;
22.
Rodgman A, Perfetti TA. The chemical components of tobacco and tobacco smoke. Boca Raton FL, USA: CRC press; 2013.
23.
Lam TH, Xu L, Schooling CM, Chan WM, Lee SY, Leung GM. Smoking and mortality in a prospective cohort study of elderly Chinese in Hong Kong. Addiction. 2015;110(3):502–10.PubMedCrossRef
24.
Cui X, Jing X, Wu X, Wang Z, Li Q. Potential effect of smoking on semen quality through DNA damage and the downregulation of Chk1 in sperm. Molecul Med Rep. 2016;14(1):753–61.CrossRef
25.
Tolstrup JS, Hvidtfeldt UA, Flachs EM, Spiegelman D, Heitmann BL, Bälter K, et al. Smoking and risk of coronary heart disease in younger, middle-aged, and older adults. Am j pub health. 2014;104(1):96–102.CrossRef
26.
Gajalakshmi V, Peto R, Kanaka TS, Jha P. Smoking and mortality from tuberculosis and other diseases in India: retrospective study of 43 000 adult male deaths and 35 000 controls. Lancet. 2003;362(9383):507–15.PubMedCrossRef
27.
Doll R, Peto R, Wheatley K, Gray R, Sutherland I. Mortality in relation to smoking: 40 years’ observations on male British doctors. Bmj. 1994;309(6959):901–11.PubMedPubMedCentralCrossRef
28.
Kogel U, Suarez IG, Xiang Y, Dossin E, Guy PA, Mathis C, et al. Biological impact of cigarette smoke compared to an aerosol produced from a prototypic modified risk tobacco product on normal human bronchial epithelial cells. Toxicol Vitro. 2015;29(8):2102–15.CrossRef
29.
Kuehn D, Majeed S, Guedj E, Dulize R, Baumer K, Iskandar A, et al. Impact assessment of repeated exposure of organotypic 3D bronchial and nasal tissue culture models to whole cigarette smoke. J visual exper. 2015;(96)
30.
Rondina RDC, Gorayeb R, Botelho C. Psychological characteristics associated with tobacco smoking behavior. J Brasil de Pneumol. 2007;33:592–601.CrossRef
31.
Jiang H, Li S, Yang J. Work stress and depressive symptoms in fishermen with a smoking habit: a mediator role of nicotine dependence and possible moderator role of expressive suppression and cognitive reappraisal. Front Psychol. 2018;9:386.PubMedPubMedCentralCrossRef
32.
Picciotto MR, Brunzell DH, Caldarone BJ. Effect of nicotine and nicotinic receptors on anxiety and depression. Neurorep. 2002;13(9):1097–106.CrossRef
33.
Boden JM, Fergusson DM, Horwood LJ. Cigarette smoking and depression: tests of causal linkages using a longitudinal birth cohort. British J Psychiatry. 2010;196(6):440–6.CrossRef
34.
Fidler JA, West R. Self-perceived smoking motives and their correlates in a general population sample. Nicot Tobacco Res. 2009;11(10):1182–8.CrossRef
35.
Souza ESTD, Crippa JADS, Pasian SR, Martinez JAB. University of São Paulo Reasons for Smoking Scale: a new tool for the evaluation of smoking motivation. J Brasil de Pneumol. 2010;36:768–78.CrossRef
36.
Iatrou G, Gourgoulianis KI, Kotrotsiou E, Gouva M. Assessment of Greek smokers’ psychological characteristics and empathy while smoking in enclosed public spaces and near nonsmokers. Cureus. 2022;14(3)
37.
Cohen EL, Hoffner C. Gifts of giving: the role of empathy and perceived benefits to others and self in young adults’ decisions to become organ donors. J Health Psychol. 2013;18(1):128–38.PubMedCrossRef
38.
Romero Triñanes E, Domínguez Álvarez B, Castro Isdahl-Troye MA. Predicting smoking among young people: prospective associations from earlier developmental stages; 2017.
39.
Johnson CA, Unger JB, Cruz TB, Baezconde-Garbanati L, Shakib S, Palmer P, et al. Exploring the cultural context of tobacco use: a transdisciplinary framework. Nicot Tobacco Res. 2003;5(Suppl_1):S101–17.
40.
Olando Y, Kuria MW, Mathai M, Huffman MD. Barriers and facilitators to cessation among tobacco users with concomitant mental illness attending group behavioral tobacco cessation: a qualitative study. Tobacco Prevent Cessat. 2020;6
41.
Moran S, Wechsler H, Rigotti NA. Social smoking among US college students. Pediatrics. 2004;114(4):1028–34.PubMedCrossRef
42.
Denscombe M. Peer group pressure, young people and smoking: new developments and policy implications. Drugs: Educ Prevent Policy. 2009;8(1)
43.
Yong HH, Borland R. Functional beliefs about smoking and quitting activity among adult smokers in four countries: findings from the International Tobacco Control Four-Country Survey. Health Psychol. 2008;27(3S):S216.PubMedPubMedCentralCrossRef
44.
Collins D, Lapsley HM. The costs of tobacco, alcohol and illicit drug abuse to Australian society in 2004/05. Canberra: Department of Health and Ageing; 2008. p. 143.
45.
Goodchild M, Nargis N, d'Espaignet ET. Global economic cost of smoking-attributable diseases. Tobacco cont. 2018;27(1):58–64.CrossRef
46.
Ekpu, V. U., & Brown, A. K. (2015). The economic impact of smoking and of reducing smoking prevalence: review of evidence. Tobacco use insights, 8, TUI-S15628.
47.
Glantz SA, Bareham DW. E-cigarettes: use, effects on smoking, risks, and policy implications. Ann rev pub health. 2018;39:215–35.CrossRef
48.
U.S. Department of Health and Human Services. How tobacco smoke causes disease: what it means to you. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2010 [accessed 2017 Apr 20].
49.
Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382(9905):1629–37.PubMedCrossRef
50.
Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. New Engl J Med. 2019;380(7):629–37.PubMedCrossRef
51.
Bonevski B, Manning V, Wynne O, Gartner C, Borland R, Baker AL, et al. QuitNic: a pilot randomized controlled trial comparing nicotine vaping products with nicotine replacement therapy for smoking cessation following residential detoxification. Nicot Tobacco Res. 2021;23(3):462–70.CrossRef
52.
Masiero M, Lucchiari C, Mazzocco K, Veronesi G, Maisonneuve P, Jemos C, et al. E-cigarettes may support smokers with high smoking-related risk awareness to stop smoking in the short run: preliminary results by randomized controlled trial. Nicot Tobacco Res. 2019;21(1):119–26.CrossRef
53.
Martinez U, Simmons VN, Sutton SK, Drobes DJ, Meltzer LR, Brandon KO, et al. Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial. Lancet Pub Health. 2021;6(7):e500–9.CrossRef
54.
Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, et al. The combined effect of very low nicotine content cigarettes, used as an adjunct to usual quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial. Addict. 2012;107(10):1857–67.CrossRef
55.
56.
Hatsukami DK, Benowitz NL, Rennard SI, Oncken C, Hecht SS. Biomarkers to assess the utility of potential reduced exposure tobacco products. Nicot Tobacco Res. 2006;8(2):169–91.CrossRef
Metadata
Title
Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial
Authors
Abdul Hameed
Daud Malik
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07876-y

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