Motivating Smokers at Outdoor Public Smoking Hotspots to Have Quit Attempt With Nicotine Replacement Therapy Sampling

NCT02491086 | Completed

• 1 other identifier: 201409176211
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background About half of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. 37.9% of daily smokers attempted to quit but failed. Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal symptoms during early stage of tobacco abstinence and increase quit rate. However, the prevalence of using NRT in Hong Kong is lower than most of the developed countries. The proposed project aims to test if providing free NRT sampling to smokers can increase quit attempt and hence quit successfully. Methods Nurses and university undergraduate students will be trained, and will invite smokers at outdoor public places to participate in the randomized controlled trial, which randomized eligible smokers to intervention or control group. The intervention group will be provided with 1-week free NRT sampling and medication counselling, whereas the control group will only be advised to purchase NRT on their own. The primary outcome is the proportion of any self-reported quit attempt (no smoking for at least 24 hours) in the past month at 1- and 3-month telephone follow-up. Discussions The findings will inform the feasibility and effectiveness of delivering free NRT sampling to increase quit attempt and abstinence. It will yield more information on smokers' adherence to the NRT sampling, side effect and safety issue of the usage. Moreover, it will guide a future larger trial to test the effect from the NRT sampling and translation to practice.

Conditions

Smoking Cessation

Keywords

intervention, nicotine replacement sampling, smoking cessation, smoking hotspots

Outcome Measures

Primary Outcomes (1)

• Self-reported quit attempt

  No smoking for at least 24 hours in the past month

  1 month

Secondary Outcomes (3)

• Self-reported 7-day prevalence of tobacco abstinence

  1 month

• Proportion of participants using NRT in the past month

  1 month

• Biochemically validated quit rate, measurement of exhaled carbon monoxide

  1 month

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive a free pack of one-week NRT. The nurse will help the subject to decide which NRT product (patch, gum and lozenge) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption, followed by the delivery of the sampling, instructions of using the NRT sampling, an education card about NRT and a 12-page smoking cessation booklet (Figure 1). Based on the experience in the previous trials, the choice of NRT (either patch, lozenge or gum) will be made according to subject's preference, and the counsellors will provide medication counselling \[25-27\]. If the subject is willing to continue the counselling at recruitment, the ambassador will further introduce the NRT's side effects, adherence and effectiveness (Table 1). Otherwise, the ambassador will contact the subject for providing these details and enquiring the usage through telephone within 2 days.

Drug: Nicotine replacement therapy (NRT) sampling; Behavioral: Smoking cessation counseling

Control

ACTIVE COMPARATOR

The control group subjects will only be advised by the ambassador to purchase the NRT on their own, but will not be given the sampling. The same education card and the 12-page smoking cessation booklet will be provided.

Behavioral: Smoking cessation counseling

Interventions

Nicotine replacement therapy (NRT) sampling DRUG

1-week free NRT

Intervention

Smoking cessation counseling BEHAVIORAL

Smoking cessation counseling

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above;
• Smoke 10 cigarettes or more per day in the past week;
• Able to read and speak Chinese;
• Have not used NRT for the past 3 months

You may not qualify if:

• Have severe angina and serious cardiac arrhythmias;
• Have suffered from acute myocardial event in the past 4 weeks;
• Pregnant and breastfeeding

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 00, Hong Kong

Location

Related Publications (33)

• McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, Pow M, Lam TH, Hedley AJ. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006 Apr;15(2):125-30. doi: 10.1136/tc.2005.013292.

  PMID: 16565461 BACKGROUND

• Koplan JP, An WK, Lam RM. Hong Kong: a model of successful tobacco control in China. Lancet. 2010 Apr 17;375(9723):1330-1. doi: 10.1016/S0140-6736(10)60398-4. Epub 2010 Mar 25. No abstract available.

  PMID: 20347129 BACKGROUND

• Census & Statistics Department (Hong Kong SAR government): Thematic Household Survey, Report No. 53: Pattern of Smoking. In. Hong Kong: Census & Statistics Department; 2013

  BACKGROUND

• Hong Kong Council on Smoking and Health: June 2013, COSH Report No. 16 - Quit to Win 2010 and smoking cessation. In. Hong Kong: Hong Kong Council on Smoking Health; 2013.

  BACKGROUND

• 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 Jan;108(1):193-202. doi: 10.1111/j.1360-0443.2012.04009.x. Epub 2012 Aug 14.

  PMID: 22891869 BACKGROUND

• Lancaster T, Stead L, Silagy C, Sowden A. Effectiveness of interventions to help people stop smoking: findings from the Cochrane Library. BMJ. 2000 Aug 5;321(7257):355-8. doi: 10.1136/bmj.321.7257.355. No abstract available.

  PMID: 10926597 BACKGROUND

• 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 Making. 2002 Sep-Oct;22(5 Suppl):S26-37. doi: 10.1177/027298902237708.

  PMID: 12369228 BACKGROUND

• Borland R, Li L, Driezen P, Wilson N, Hammond D, Thompson ME, Fong GT, Mons U, Willemsen MC, McNeill A, Thrasher JF, Cummings KM. Cessation assistance reported by smokers in 15 countries participating in the International Tobacco Control (ITC) policy evaluation surveys. Addiction. 2012 Jan;107(1):197-205. doi: 10.1111/j.1360-0443.2011.03636.x.

  PMID: 21883605 BACKGROUND

• 2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.

  PMID: 18807274 BACKGROUND

• National Institue for Clinical Excellence: Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. In. NHS, London: National Institue for Clinical Excellence; 2002.

  BACKGROUND

• Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

  PMID: 10170434 BACKGROUND

• West R, Sohal T. "Catastrophic" pathways to smoking cessation: findings from national survey. BMJ. 2006 Feb 25;332(7539):458-60. doi: 10.1136/bmj.38723.573866.AE. Epub 2006 Jan 27.

  PMID: 16443610 BACKGROUND

• Jimenez-Muro A, Nerin I, Samper P, Marqueta A, Beamonte A, Gargallo P, Oros D, Rodriguez G. A proactive smoking cessation intervention in postpartum women. Midwifery. 2013 Mar;29(3):240-5. doi: 10.1016/j.midw.2012.01.003. Epub 2012 Feb 22.

  PMID: 22361008 BACKGROUND

• 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 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492.

  PMID: 22123796 BACKGROUND

• 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 Jul;16(7):992-9. doi: 10.1093/ntr/ntu025. Epub 2014 Mar 7.

  PMID: 24610399 BACKGROUND

• Larabie LC. To what extent do smokers plan quit attempts? Tob Control. 2005 Dec;14(6):425-8. doi: 10.1136/tc.2005.013615.

  PMID: 16319368 BACKGROUND

• Ferguson SG, Shiffman S, Gitchell JG, Sembower MA, West R. Unplanned quit attempts--results from a U.S. sample of smokers and ex-smokers. Nicotine Tob Res. 2009 Jul;11(7):827-32. doi: 10.1093/ntr/ntp072. Epub 2009 Jun 9.

  PMID: 19509277 BACKGROUND

• Murray RL, Lewis SA, Coleman T, Britton J, McNeill A. Unplanned attempts to quit smoking: missed opportunities for health promotion? Addiction. 2009 Nov;104(11):1901-9. doi: 10.1111/j.1360-0443.2009.02647.x. Epub 2009 Aug 4.

  PMID: 19681806 BACKGROUND

• 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 Aug;103(8):1371-8. doi: 10.1111/j.1360-0443.2008.02268.x.

  PMID: 18855827 BACKGROUND

• 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 Jul;36(7):713-6. doi: 10.1016/j.addbeh.2011.02.002. Epub 2011 Feb 13.

  PMID: 21371825 BACKGROUND

• 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 Aug;10(8):1405-13. doi: 10.1080/14622200802239280.

  PMID: 18686189 BACKGROUND

• Lindson-Hawley N, Aveyard P, Hughes JR. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008033. doi: 10.1002/14651858.CD008033.pub3.

  PMID: 23152252 BACKGROUND

• Asfar T, Ebbert JO, Klesges RC, Relyea GE. Do smoking reduction interventions promote cessation in smokers not ready to quit? Addict Behav. 2011 Jul;36(7):764-8. doi: 10.1016/j.addbeh.2011.02.003. Epub 2011 Feb 12.

  PMID: 21420791 BACKGROUND

• A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report. The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives. JAMA. 2000 Jun 28;283(24):3244-54.

  PMID: 10866874 BACKGROUND

• Medline Plus: Nicotine Replacement Therapy. In: Nicotine Replacement Therapy: MedlinePlus Medical Encyclopedia U.S.: U.S. National Library of Medicine, National Insititutes of Health; 2009.

  BACKGROUND

• World Health Organization: Adherence to long-term therapies: Evidence for action. In. Geneva: World Health Organization; 2003.

  BACKGROUND

• Abdullah AS, Hedley AJ, Chan SS, Lam TH. A randomized controlled trial of two different lengths of nicotine replacement therapy for smoking cessation. Biomed Res Int. 2013;2013:961751. doi: 10.1155/2013/961751. Epub 2013 Sep 9.

  PMID: 24089693 BACKGROUND

• Chan SS, Leung DY, Abdullah AS, Wong VT, Hedley AJ, Lam TH. A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking. Addiction. 2011 Jun;106(6):1155-63. doi: 10.1111/j.1360-0443.2011.03363.x. Epub 2011 Mar 7.

  PMID: 21226883 BACKGROUND

• Lam TH, Abdullah AS, Chan SS, Hedley AJ; Hong Kong Council on Smoking and Health Smoking Cessation Health Centre (SCHC) Steering Group. Adherence to nicotine replacement therapy versus quitting smoking among Chinese smokers: a preliminary investigation. Psychopharmacology (Berl). 2005 Feb;177(4):400-8. doi: 10.1007/s00213-004-1971-y. Epub 2004 Jul 29.

  PMID: 15289997 BACKGROUND

• Cooke F, Bullen C, Whittaker R, McRobbie H, Chen MH, Walker N. Diagnostic accuracy of NicAlert cotinine test strips in saliva for verifying smoking status. Nicotine Tob Res. 2008 Apr;10(4):607-12. doi: 10.1080/14622200801978680.

  PMID: 18418783 BACKGROUND

• Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. Addiction. 2005 Feb;100(2):159-67. doi: 10.1111/j.1360-0443.2004.00957.x.

  PMID: 15679745 BACKGROUND

• 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 Oct;19 Suppl 2(Suppl 2):i18-23. doi: 10.1136/tc.2009.029710.

  PMID: 20935195 BACKGROUND

• Cheung YT, Leung JP, Cheung CK, Li WH, Wang MP, Lam TH. 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. Trials. 2016 Jul 26;17(1):355. doi: 10.1186/s13063-016-1485-z.

  PMID: 27456342 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Yee Tak Derek Cheung, Cheung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral Fellow

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)