Archive \ Volume.14 2023 Issue 4

Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC

, , ,


LMICs bear an inexplicably larger share of the burden of tobacco-related death globally due to rising tobacco consumption. Understanding and conducting RCTs in the context of LMICs is mandatory to use THR products as an effective smoking cessation strategy for controlling rising tobacco consumption in these countries. The study is a two-arm, parallel RCT with a 12-week treatment period and a 52-week follow-up period which plans to enroll 258 smokers from general adult population. The participants after meeting eligibility criteria and providing informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counseling (2) Nicotine patches (21mg) with individual counseling. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face-to-face interactions at the trial site as well as follow-up on the telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence.

Downloads: 119
Views: 132

How to cite:
Malik M, Hussain A, Hashmi A, Khan W. Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC. Arch Pharm Pract. 2023;14(4):1-5.
Malik, M., Hussain, A., Hashmi, A., & Khan, W. (2023). Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC. Archives of Pharmacy Practice, 14(4), 1-5.

Download Citation

1.        Kumar N, Janmohamed K, Jiang J, Ainooson J, Billings A, Chen GQ, et al. Tobacco cessation in low-to middle-income countries: A scoping review of randomized controlled trials. Addict Behav. 2021;112:106612.

2.        Sinha DN, Gupta PC, Kumar A, Bhartiya D, Agarwal N, Sharma S, et al. The poorest of poor suffer the greatest burden from smokeless tobacco use: A study from 140 countries. Nicotine Tob Res. 2018;20(12):1529-32.

3.        Sreeramareddy CT, Harper S, Ernstsen L. Educational and wealth inequalities in tobacco use among men and women in 54 low-income and middle-income countries. Tob Control. 2018;27(1):26-34.

4.        Theilmann M, Lemp JM, Winkler V, Manne-Goehler J, Marcus ME, Probst C, et al. Patterns of tobacco use in low and middle income countries by tobacco product and sociodemographic characteristics: nationally representative survey data from 82 countries. BMJ. 2022;378.

5.        Jerzyński T, Stimson GV, Shapiro H, Król G. Estimation of the global number of e-cigarette users in 2020. Harm Reduct J. 2021;18(1):1-0.

6.        Ghebreyesus TA. Progress in beating the tobacco epidemic. Lancet. 2019;394(10198):548-9.

7.        Reitsma MB, Fullman N, Ng M, Salama JS, Abajobir A, Abate KH, et al. Smoking prevalence and attributable disease burden in 195 countries and territories, 1990–2015: a systematic analysis from the Global Burden of Disease Study 2015. Lancet. 2017;389(10082):1885-906.

8.        Ward KD. Tobacco intervention research in low-and middle-income countries: lessons learned and future directions. J Smok Cessat. 2016;11(2):61-4.

9.        Asfar T, Ward KD, Al-Ali R, Maziak W. Building evidence-based tobacco treatment in the Eastern Mediterranean region: lessons learned by the Syrian Center for Tobacco Studies. J Smok Cessat. 2016;11(2):116-23.

10.      Batmanghelidj E, Heydari G. Sanctions, smuggling, and the cigarette: the granting of Iran office of foreign asset control's licenses to big tobacco. Int J Prev Med. 2014;5(2):138.

11.      Ahmadi J, Ashkani H, Ahmadi M, Ahmadi N. Twenty-four week maintenance treatment of cigarette smoking with nicotine gum, clonidine and naltrexone. J Subst Abuse Treat. 2003;24(3):251-5.

12.      Zain Z. Roles of the private sector in tobacco cessation programmes. Addiction. 2002;97(8):960-1.

13.      Rosser A. Contesting tobacco-control policy in Indonesia. Crit Asian Stud. 2015;47(1):69-93.

14.      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 Fam Med. 2019;32(4):567-74.

15.      Zhao SZ, Wu YS, Chau SL, Fong DY, Lam TH, Wang MP. Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. Tob Induc Dis. 2021;19.

16.      Rosner A. Fables or foibles: inherent problems with RCTs. J Manipulative Physiol Ther. 2003;26(7):460-7.

17.      Morrison K. Randomised controlled trials for evidence-based education: some problems in judging'what works'. Eval Res Educ. 2001;15(2):69-83.

18.      Hughes JR. Tobacco control funding versus scientific evidence. Am J Prev Med. 2007;32(5):449-50.

19.      Henningfield JE, Fant RV, Buchhalter AR, Stitzer ML. Pharmacotherapy for Nicotine Dependence 1. CA Cancer J Clin. 2005;55(5):281-99.

20.      George TP. Nicotine and tobacco. InGoldman's Cecil medicine 2012 Jan 1 (pp. 142-146). WB Saunders.

21.      Lovinger RD. Addiction medicine: An introduction for health care professionals. Elsevier Health Sciences; 2019.

22.      Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol, Biomarkers Prev. 2010;19(8):1945-53.

23.      Hébert-Losier A, Filion KB, Windle SB, Eisenberg MJ. A randomized controlled trial evaluating the efficacy of e-cigarette use for smoking cessation in the general population: E3 trial design. CJC Open. 2020;2(3):168-75.

24.      Rafful C, García-Rodríguez O, Wang S, Secades-Villa R, Martínez-Ortega JM, Blanco C. Predictors of quit attempts and successful quit attempts in a nationally representative sample of smokers. Addict Behav. 2013;38(4):1920-3.

25.      Al-Delaimy WK, Myers MG, Leas EC, Strong DR, Hofstetter CR. E-cigarette use in the past and quitting behavior in the future: a population-based study. Am J Public Health. 2015;105(6):1213-9.

26.      Biener L, Hargraves JL. A longitudinal study of electronic cigarette use among a population-based sample of adult smokers: association with smoking cessation and motivation to quit. Nicotine Tob Res. 2015;17(2):127-33.

27.      Adriaens K, Belmans E, Van Gucht D, Baeyens F. Electronic cigarettes in standard smoking cessation treatment by tobacco counselors in Flanders: E-cigarette users show similar if not higher quit rates as those using commonly recommended smoking cessation aids. Harm Reduct J. 2021;18:1-2.

28.      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. Addiction. 2022;117(1):224-33.

29.      Rodgers A, Corbett T, Bramley D, Riddell T, Wills M, Lin RB, et al. Do u smoke after txt? Results of a randomised trial of smoking cessation using mobile phone text messaging. Tob Control. 2005;14(4):255-61.

30.      Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D. Smoking cessation with e-cigarettes in smokers with a documented history of depression and recurring relapses. Int J Clin Med. 2011;2(03):281.

31.      Thornton SL, Oller L, Sawyer T. Fatal intravenous injection of electronic nicotine delivery system refilling solution. J Med Toxicol. 2014;10:202-4.


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.