Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: Study protocol for a randomised controlled trial

BMJ Open

Volumn 9, Issue 2, 2019, Pages

  Walker, Natalie ^a   Verbiest, Marjolein ^a,b   Kurdziel, Tomasz ^a   Laking, George ^a   Laugesen, Murray ^c   Parag, Varsha ^a   Bullen, Chris ^a  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b TILBURG UNIVERSITY   (Netherlands)

^c UNIVERSITY OF CANTERBURY   (New Zealand)

Author keywords

cessation; e cigarettes; effectiveness; electronic cigarettes; nicotine patch; randomised controlled trial; safety

Indexed keywords

NICOTINE PATCH;

ADULT; ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; NEW ZEALAND; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; PATIENT SAFETY; PRAGMATIC TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SMOKING CESSATION; SUPERIORITY TRIAL; YOUNG ADULT; ADVERSE EVENT; ELECTRONIC CIGARETTE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME; VAPING;

ELECTRONIC NICOTINE DELIVERY SYSTEMS; HUMANS; NEW ZEALAND; PRAGMATIC CLINICAL TRIALS AS TOPIC; SMOKING CESSATION; TOBACCO USE CESSATION DEVICES; TREATMENT OUTCOME; VAPING;

EID: 85062470830     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2018-023659     Document Type: Article

References (32)

1. Ferguson SG, Shiffman S. The relevance and treatment of cue-induced cravings in tobacco dependence. J Subst Abuse Treat 2009;36:235-43.
2. Przulj D, McRobbie H. The effect of sensorimotor replacement on smoking cessation and craving. Open Addict J 2012;5:41-50.
3. Dawkins L, Turner J, Roberts A, et al. 'Vaping-profiles and preferences: an online survey of electronic cigarette users. Addiction 2013;108:1115-25.
4. Bullen C, McRobbie H, Thornley S, et al. 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 2010;19:98-103.
5. Glasser AM, Collins L, Pearson JL, et al. Overview of electronic nicotine delivery systems: a systematic review. Am J Prev Med 2017;52:e33-e66.
6. Hajek P, Etter JF, Benowitz N, et al. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction 2014;109:1801-10.
7. Goniewicz ML, Hajek P, McRobbie H. Nicotine content of electronic cigarettes, its release in vapour and its consistency across batches: regulatory implications. Addiction 2014;109:500-7.
8. Burstyn I. Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks. BMC Public Health 2014;14:18.
9. Hecht SS, Carmella SG, Kotandeniya D, et al. Evaluation of toxicant and carcinogen metabolites in the urine of e-cigarette users versus cigarette smokers. Nicotine Tob Res 2015;17:704-9.
10. Chen J, Bullen C, Dirks K. A comparative health risk assessment of electronic cigarettes and conventional cigarettes. Int J Environ Res Public Health 2017;14:382.
11. Caponnetto P, Campagna D, Cibella F, 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:e66317.
12. Bullen C, Howe C, Laugesen M, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet 2013;382:1629-37.
13. O-Brien B, Knight-West O, Walker N, et al. E-cigarettes versus NRT for smoking reduction or cessation in people with mental illness: secondary analysis of data from the ASCEND trial. Tob Induc Dis 2015;13.
14. Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2012;11:CD000146.
15. Young D, Wilson N, Borland R, et al. Prevalence, correlates of, and reasons for using roll-your-own tobacco in a high RYO use country: findings from the ITC New Zealand survey. Nicotine Tob Res 2010;12:1089-98.
16. Bullen C, Knight-West O. Issues in regulating e-cigarette clinical research. Clin Res Regul Aff 2015;32:1-5.
17. Hajek P, Goniewicz ML, Phillips A, et al. Nicotine intake from electronic cigarettes on initial use and after 4 weeks of regular use. Nicotine Tob Res 2015;17:175-9.
18. Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med 1989;12:159-82.
19. Heatherton TF, Kozlowski LT, Frecker RC, et al. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict 1991;86:1119-27.
20. West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology 2004;177(1-2):195-9.
21. West R, Hajek P, Stead L, et al. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction 2005;100:299-303.
22. Blondal T, Gudmundsson LJ, Olafsdottir I, et al. Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up. BMJ 1999;318:285-8.
23. Walker N, Howe C, Bullen C, 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. Addiction 2012;107:1857-67.
24. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377-81.
25. Ellenburg S, Fleming T, DeMets D. Data monitoring committees in clinical trials: a practical perspective. Chichester: John Wiley & Sons, 2002.
26. Bates D, Chambers JM, Dalgaard P, et al. The R Project for Statistical Computing Auckland. 1997. http://www.r-project.org (Accessed Mar 2018).
27. Hedeker D, Mermelstein RJ, Demirtas H. Analysis of binary outcomes with missing data: missing = smoking, last observation carried forward, and a little multiple imputation. Addiction 2007;102:1564-73.
28. Ministry of Health. Annual Update of Key Results 2015/16: New Zealand Health Survey. Wellington: Ministry of Health, 2016.
29. Statistics New Zealand. New Zealand Census. Wellington: Statistics New Zealand, 2013.
30. Li J, Bullen C, Newcombe R, et al. The use and acceptability of electronic cigarettes among New Zealand smokers. N Z Med J 2013;126:ISSN 1175 8716.
31. Health Promotion Agency. Data release: Preliminary analysis on 2016 Health & Lifestyle Survey electronic cigarettes questions. Wellington, New Zealand: Health Promotion Agency, 2017.
32. Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015;350:h2147.