Skip to main content
Top
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial

Authors: Yee Tak Derek Cheung, Jessica Pui Kei Leung, Chelsia Ka Ching Cheung, William Ho Cheung Li, Man Ping Wang, Tai Hing Lam

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

About half of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. More than one-third (37.9 %) of daily smokers have attempted to quit but failed. Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to increase abstinence by reducing withdrawal symptoms during the early stage of smoking abstinence. However, the prevalence of NRT use in Hong Kong is lower than in most developed countries. The proposed study aims to assess the effectiveness of providing free NRT samples to smokers on increasing quit attempts and the quit rate.

Methods

Trained university undergraduate students as ambassadors will invite smokers at outdoor public smoking hotspots to participate in the randomized controlled trial, in which eligible smokers will be randomized to receive a 1-week free NRT sample and medication counselling (intervention) or advice to purchase NRT on their own (control). The primary outcome is self-reported quit attempts (no smoking for at least 24 hours) in the past 30 days at 1-month and 3-month telephone follow-up.

Discussion

The findings will inform the effectiveness of delivering free NRT samples at outdoor public smoking hotspots to increase quit attempts and abstinence. The study will also provide information on smokers’ adherence to the NRT sample, side effects and safety issues related to the usage. This will improve the design of a large trial to test the effect of the NRT sample.

Trial registration

ClinicalTrials.gov NCT02491086. Registered on 7 July 2015.
Appendix
Available only for authorised users
Literature
1.
go back to reference McGhee S, Ho L, Lapsley H, Chau J, Cheung W, Ho S, Pow M, Lam T, Hedley A. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006;15:125–30. McGhee S, Ho L, Lapsley H, Chau J, Cheung W, Ho S, Pow M, Lam T, Hedley A. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006;15:125–30.
2.
go back to reference Koplan JP, An WK, Lam RMK. Hong Kong: a model of successful tobacco control in China. Lancet. 2010;375(9723):1330–1.CrossRefPubMed Koplan JP, An WK, Lam RMK. Hong Kong: a model of successful tobacco control in China. Lancet. 2010;375(9723):1330–1.CrossRefPubMed
3.
go back to reference Census & Statistics Department (Hong Kong SAR Government). Thematic Household Survey, Report No. 53: Pattern of Smoking. Hong Kong: Census & Statistics Department; 2013. Census & Statistics Department (Hong Kong SAR Government). Thematic Household Survey, Report No. 53: Pattern of Smoking. Hong Kong: Census & Statistics Department; 2013.
4.
go back to reference Ashley M, Saunders P, Mullard G, Prasad K, Mariner D, Williamson J, Richter A. Smoking intensity before and after introduction of the public place smoking ban in Scotland. Regul Toxicol Pharmacol. 2011;61(3, Suppl):S60–5. Ashley M, Saunders P, Mullard G, Prasad K, Mariner D, Williamson J, Richter A. Smoking intensity before and after introduction of the public place smoking ban in Scotland. Regul Toxicol Pharmacol. 2011;61(3, Suppl):S60–5.
5.
go back to reference Kennedy RD, Behm I, Craig L, Thompson ME, Fong GT, Guignard R, Beck F. Outdoor smoking behaviour and support for outdoor smoking restrictions before and after France’s national smoking ban. Eur J Public Health. 2012;22 Suppl 1:29–34. Kennedy RD, Behm I, Craig L, Thompson ME, Fong GT, Guignard R, Beck F. Outdoor smoking behaviour and support for outdoor smoking restrictions before and after France’s national smoking ban. Eur J Public Health. 2012;22 Suppl 1:29–34.
6.
go back to reference Chan SSC, Wong DCN, Cheung YTD, Leung DYP, Lau L, Lai V, Lam T-H. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015;30(4):609–21. Chan SSC, Wong DCN, Cheung YTD, Leung DYP, Lau L, Lai V, Lam T-H. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015;30(4):609–21.
7.
go back to reference Kasza KA, Hyland AJ, Borland R, McNeill AD, Bansal-Travers M, Fix BV, Hammond D, Fong GT, Cummings KM. Effectiveness of stop-smoking medications: findings from the International Tobacco Control (ITC) Four Country Survey. Addiction. 2013;108(1):193–202.CrossRefPubMed Kasza KA, Hyland AJ, Borland R, McNeill AD, Bansal-Travers M, Fix BV, Hammond D, Fong GT, Cummings KM. Effectiveness of stop-smoking medications: findings from the International Tobacco Control (ITC) Four Country Survey. Addiction. 2013;108(1):193–202.CrossRefPubMed
8.
go back to reference Lancaster T, Stead L, Silagy C, Sowden A. Effectiveness of interventions to help people stop smoking: findings from the Cochrane Library. BMJ. 2000;321(7257):355–8.CrossRefPubMedPubMedCentral Lancaster T, Stead L, Silagy C, Sowden A. Effectiveness of interventions to help people stop smoking: findings from the Cochrane Library. BMJ. 2000;321(7257):355–8.CrossRefPubMedPubMedCentral
9.
go back to reference Song F, Raftery J, Aveyard P, Hyde C, Barton P, Woolacott N. Cost-effectiveness of pharmacological interventions for smoking cessation: a literature review and a decision analytic analysis. Med Decis Mak. 2002;22(5 Suppl):S26–37.CrossRef Song F, Raftery J, Aveyard P, Hyde C, Barton P, Woolacott N. Cost-effectiveness of pharmacological interventions for smoking cessation: a literature review and a decision analytic analysis. Med Decis Mak. 2002;22(5 Suppl):S26–37.CrossRef
10.
go back to reference Borland R, Li L, Driezen P, Wilson N, Hammond D, Thompson ME, Fong GT, Mons U, Willemsen MC, McNeill A. Cessation assistance reported by smokers in 15 countries participating in the International Tobacco Control (ITC) policy evaluation surveys. Addiction. 2012;107(1):197–205. Borland R, Li L, Driezen P, Wilson N, Hammond D, Thompson ME, Fong GT, Mons U, Willemsen MC, McNeill A. Cessation assistance reported by smokers in 15 countries participating in the International Tobacco Control (ITC) policy evaluation surveys. Addiction. 2012;107(1):197–205.
11.
go back to reference Abdullah AS, Hedley AJ, Chan SSC, Lam T-H. A randomized controlled trial of two different lengths of nicotine replacement therapy for smoking cessation. BioMed Res Int. 2013;2013:9. Abdullah AS, Hedley AJ, Chan SSC, Lam T-H. A randomized controlled trial of two different lengths of nicotine replacement therapy for smoking cessation. BioMed Res Int. 2013;2013:9.
12.
go back to reference Barnoya J, Jin L, Hudmon KS, Schootman M. Nicotine replacement therapy, tobacco products, and electronic cigarettes in pharmacies in St. Louis, Missouri. J Am Pharm Assoc. 2015;55(4):405–12.CrossRef Barnoya J, Jin L, Hudmon KS, Schootman M. Nicotine replacement therapy, tobacco products, and electronic cigarettes in pharmacies in St. Louis, Missouri. J Am Pharm Assoc. 2015;55(4):405–12.CrossRef
13.
go back to reference Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, Dorfman SF, Froelicher ES, Goldstein MG, Healton CG, et al. Treating tobacco use and dependence: 2008 update. Rockville: Department of Health and Human Services; 2008. Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, Dorfman SF, Froelicher ES, Goldstein MG, Healton CG, et al. Treating tobacco use and dependence: 2008 update. Rockville: Department of Health and Human Services; 2008.
14.
go back to reference National Institue for Clinical Excellence. Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. London: NHS National Institue for Clinical Excellence; 2002. National Institue for Clinical Excellence. Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. London: NHS National Institue for Clinical Excellence; 2002.
15.
go back to reference Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12(1):38–48.CrossRefPubMed Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12(1):38–48.CrossRefPubMed
17.
go back to reference Jiménez-Muro A, Nerín I, Samper P, Marqueta A, Beamonte A, Gargallo P, Oros D, Rodríguez G. A proactive smoking cessation intervention in postpartum women. Midwifery. 2013;29(3):240–5. Jiménez-Muro A, Nerín I, Samper P, Marqueta A, Beamonte A, Gargallo P, Oros D, Rodríguez G. A proactive smoking cessation intervention in postpartum women. Midwifery. 2013;29(3):240–5.
18.
go back to reference Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011;171(21):1901–7.CrossRefPubMedPubMedCentral Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011;171(21):1901–7.CrossRefPubMedPubMedCentral
19.
go back to reference Jardin BF, Cropsey KL, Wahlquist AE, Gray KM, Silvestri GA, Cummings KM, Carpenter MJ. Evaluating the effect of access to free medication to quit smoking: a clinical trial testing the role of motivation. Nicotine Tob Res. 2014;16:992-999. Jardin BF, Cropsey KL, Wahlquist AE, Gray KM, Silvestri GA, Cummings KM, Carpenter MJ. Evaluating the effect of access to free medication to quit smoking: a clinical trial testing the role of motivation. Nicotine Tob Res. 2014;16:992-999.
21.
go back to reference Ferguson SG, Shiffman S, Gitchell JG, Sembower MA, West R. Unplanned quit attempts—results from a US sample of smokers and ex-smokers. Nicotine Tob Res. 2009;11:827-832. Ferguson SG, Shiffman S, Gitchell JG, Sembower MA, West R. Unplanned quit attempts—results from a US sample of smokers and ex-smokers. Nicotine Tob Res. 2009;11:827-832.
22.
go back to reference Murray RL, Lewis SA, Coleman T, Britton J, McNeill A. Unplanned attempts to quit smoking: missed opportunities for health promotion? Addiction. 2009;104(11):1901–9.CrossRefPubMed Murray RL, Lewis SA, Coleman T, Britton J, McNeill A. Unplanned attempts to quit smoking: missed opportunities for health promotion? Addiction. 2009;104(11):1901–9.CrossRefPubMed
23.
go back to reference Shiffman S, Ferguson SG, Rohay J, Gitchell JG. Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: relationship with use and compliance. Addiction. 2008;103(8):1371–8.CrossRefPubMed Shiffman S, Ferguson SG, Rohay J, Gitchell JG. Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: relationship with use and compliance. Addiction. 2008;103(8):1371–8.CrossRefPubMed
24.
go back to reference Ferguson SG, Gitchell JG, Shiffman S, Sembower MA, Rohay JM, Allen J. Providing accurate safety information may increase a smoker’s willingness to use nicotine replacement therapy as part of a quit attempt. Addict Behav. 2011;36(7):713–6.CrossRefPubMed Ferguson SG, Gitchell JG, Shiffman S, Sembower MA, Rohay JM, Allen J. Providing accurate safety information may increase a smoker’s willingness to use nicotine replacement therapy as part of a quit attempt. Addict Behav. 2011;36(7):713–6.CrossRefPubMed
25.
go back to reference Vogt F, Hall S, Marteau TM. Understanding why smokers do not want to use nicotine dependence medications to stop smoking: qualitative and quantitative studies. Nicotine Tob Res. 2008;10(8):1405–13.CrossRefPubMed Vogt F, Hall S, Marteau TM. Understanding why smokers do not want to use nicotine dependence medications to stop smoking: qualitative and quantitative studies. Nicotine Tob Res. 2008;10(8):1405–13.CrossRefPubMed
26.
go back to reference Lindson-Hawley N, Aveyard P, Hughes JR. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database Syst Rev. 2012;2012:11. Lindson-Hawley N, Aveyard P, Hughes JR. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database Syst Rev. 2012;2012:11.
27.
go back to reference Asfar T, Ebbert JO, Klesges RC, Relyea GE. Do smoking reduction interventions promote cessation in smokers not ready to quit? Addict Behav. 2011;36(7):764–8.CrossRefPubMedPubMedCentral Asfar T, Ebbert JO, Klesges RC, Relyea GE. Do smoking reduction interventions promote cessation in smokers not ready to quit? Addict Behav. 2011;36(7):764–8.CrossRefPubMedPubMedCentral
28.
go back to reference The Tobacco Use and Dependence Clinical Practice Guideline Panel (Staff and Consortium Representatives). A clinical practice guideline for treating tobacco use and dependence. A US public health service report. JAMA. 2000;283:3244–54.CrossRef The Tobacco Use and Dependence Clinical Practice Guideline Panel (Staff and Consortium Representatives). A clinical practice guideline for treating tobacco use and dependence. A US public health service report. JAMA. 2000;283:3244–54.CrossRef
29.
go back to reference Medline Plus. Nicotine replacement therapy. In: Nicotine Replacement Therapy: MedlinePlus Medical Encyclopedia. Bethesda, Maryland: US National Library of Medicine, National Insititutes of Health; 2009. Medline Plus. Nicotine replacement therapy. In: Nicotine Replacement Therapy: MedlinePlus Medical Encyclopedia. Bethesda, Maryland: US National Library of Medicine, National Insititutes of Health; 2009.
30.
go back to reference World Health Organization. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003. World Health Organization. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003.
31.
go back to reference Chan SSC, Leung DYP, Abdullah ASM, Wong VT, Hedley AJ, Lam T-H. A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking. Addiction. 2011;106(6):1155–63.CrossRefPubMed Chan SSC, Leung DYP, Abdullah ASM, Wong VT, Hedley AJ, Lam T-H. A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking. Addiction. 2011;106(6):1155–63.CrossRefPubMed
32.
go back to reference Lam T-H, Abdullah ASM, Chan SSC, Hedley AJ, Hong Kong Council on Smoking, Health Smoking Cessation Health Centre Steering Group. Adherence to nicotine replacement therapy versus quitting smoking among Chinese smokers: a preliminary investigation. Psychopharmacology. 2005;177(4):400–8.CrossRefPubMed Lam T-H, Abdullah ASM, Chan SSC, Hedley AJ, Hong Kong Council on Smoking, Health Smoking Cessation Health Centre Steering Group. Adherence to nicotine replacement therapy versus quitting smoking among Chinese smokers: a preliminary investigation. Psychopharmacology. 2005;177(4):400–8.CrossRefPubMed
33.
go back to reference Cooke F, Bullen C, Whittaker R, McRobbie H, Chen M-H, Walker N. Diagnostic accuracy of nicalert cotinine test strips in saliva for verifying smoking status. Nicotine Tob Res. 2008;10(4):607–12.CrossRefPubMed Cooke F, Bullen C, Whittaker R, McRobbie H, Chen M-H, Walker N. Diagnostic accuracy of nicalert cotinine test strips in saliva for verifying smoking status. Nicotine Tob Res. 2008;10(4):607–12.CrossRefPubMed
34.
go back to reference Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. Addiction. 2005;100(2):159–67.CrossRefPubMed Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. Addiction. 2005;100(2):159–67.CrossRefPubMed
35.
go back to reference Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20(2):187–91. discussion 191–3.CrossRefPubMed Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20(2):187–91. discussion 191–3.CrossRefPubMed
36.
go back to reference Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
37.
go back to reference Hong Kong Council on Smoking and Health. June 2013, COSH Report No. 16—‘Quit to Win 2010’ and smoking cessation. Hong Kong: Hong Kong Council on Smoking Health; 2014. Hong Kong Council on Smoking and Health. June 2013, COSH Report No. 16—‘Quit to Win 2010’ and smoking cessation. Hong Kong: Hong Kong Council on Smoking Health; 2014.
38.
go back to reference Fu SS, van Ryn M, Sherman SE, et al. Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med. 2014;174(5):671–7.CrossRefPubMed Fu SS, van Ryn M, Sherman SE, et al. Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med. 2014;174(5):671–7.CrossRefPubMed
39.
go back to reference Tzelepis F, Paul CL, Wiggers J, Walsh RA, Knight J, Duncan SL, Lecathelinais C, Girgis A, Daly J. A randomised controlled trial of proactive telephone counselling on cold-called smokers’ cessation rates. Tob Control. 2011;20(1):40–6. Tzelepis F, Paul CL, Wiggers J, Walsh RA, Knight J, Duncan SL, Lecathelinais C, Girgis A, Daly J. A randomised controlled trial of proactive telephone counselling on cold-called smokers’ cessation rates. Tob Control. 2011;20(1):40–6.
40.
go back to reference Yang J, Hammond D, Driezen P, Fong GT, Jiang Y. Health knowledge and perception of risks among Chinese smokers and non-smokers: findings from the Wave 1 ITC China Survey. Tob Control. 2010;19 Suppl 2:i18–23.CrossRefPubMed Yang J, Hammond D, Driezen P, Fong GT, Jiang Y. Health knowledge and perception of risks among Chinese smokers and non-smokers: findings from the Wave 1 ITC China Survey. Tob Control. 2010;19 Suppl 2:i18–23.CrossRefPubMed
Metadata
Title
Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial
Authors
Yee Tak Derek Cheung
Jessica Pui Kei Leung
Chelsia Ka Ching Cheung
William Ho Cheung Li
Man Ping Wang
Tai Hing Lam
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1485-z

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue