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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial

Authors: Ashleigh Guillaumier, Victoria Manning, Olivia Wynne, Coral Gartner, Ron Borland, Amanda L. Baker, Catherine J. Segan, Eliza Skelton, Lyndell Moore, Ramez Bathish, Dan I. Lubman, Billie Bonevski

Published in: Trials | Issue 1/2018

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Abstract

Background

Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to address smoking in this population are needed. Electronic nicotine devices (ENDs) or electronic cigarettes hold significant potential as both cessation aids and harm reduction support. This study focuses on the potential of ENDs to facilitate smoking cessation and to sustain it in the medium term among people in treatment for AOD use. The aim of this trial is to explore the effectiveness, feasibility and acceptability of ENDs for smoking cessation compared with combination nicotine replacement therapy (NRT) for clients after discharge from a smoke-free AOD residential withdrawal service.

Methods/design

The study is a pragmatic randomised controlled trial. In total, 100 participants will be recruited following admission to a smoke-free residential withdrawal service in Melbourne, Australia. Participants will complete a baseline survey and be randomised to either the END group (n = 50) or the NRT group (n = 50) prior to discharge. Both groups will receive telephone counselling support from quitline. Follow-up measures will be assessed at 6 and 12 weeks following discharge. The primary outcome is continuous abstinence from smoking at 12 weeks post discharge. Secondary outcomes include: 7-day point prevalence from smoking, point prevalence abstinence from all nicotine (including NRT and ENDs), cravings and withdrawal, time to relapse, and treatment adherence (use of NRT, ENDs and quitline).

Discussion

This is the first randomised controlled trial to assess the effectiveness and acceptability of ENDs within a population dependent on AOD, a priority group with very high levels of smoking. The research will test a model of how to incorporate novel smoking cessation support into a period of high treatment receptiveness.

Trial registration

Australian New Zealand Clinical Trial Registry, ACTRN12617000849​392. Registered on 8 June 2017.
Appendix
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Literature
1.
Baker A, Ivers RG, Bowman J, Butler T, Kay-Lambkin FJ, Wye P, Walsh RA, Pulver LJ, Richmond R, Belcher J, et al. Where there's smoke, there's fire: high prevalence of smoking among some sub-populations and recommendations for intervention. Drug Alcohol Rev. 2006;25:85–96.CrossRefPubMed
2.
Guydish J, Passalacqua E, Pagano A, Martinez C, Le T, Chun J, Tajima B, Docto L, Garina D, Delucchi K. An international systematic review of smoking prevalence in addiction treatment. Addiction. 2016;111:220–30.CrossRefPubMed
3.
Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis. 2006;3:A42.PubMedPubMedCentral
4.
Randall D, Degenhardt L, Vajdic CM, Burns L, Hall WD, Law M, Butler T. Increasing cancer mortality among opioid-dependent persons in Australia: a new public health challenge for a disadvantaged population. Aust N Z J Public Health. 2011;35:220–5.CrossRefPubMed
5.
Taylor Hays J, Schroeder DR, Offord KP, Croghan IT, Patten CA, Hurt RD, Jorenby DE, Fiore MC. Response to nicotine dependence treatment in smokers with current and past alcohol problems. Ann Behav Med. 1999;21:244–50.CrossRef
6.
McKelvey K, Thrul J, Ramo D. Impact of quitting smoking and smoking cessation treatment on substance use outcomes: an updated and narrative review. Addict Behav. 2017;65:161–70.CrossRefPubMed
7.
8.
Kelly PJ, Baker AL, Deane FP, Kay-Lambkin FJ, Bonevski B, Tregarthen J. Prevalence of smoking and other health risk factors in people attending residential substance abuse treatment. Drug Alcohol Rev. 2012;31:638–44.CrossRefPubMed
9.
Ferguson J, Bauld L, Chesterman J, Judge K. The English smoking treatment services: one-year outcomes. Addiction. 2005;100(Suppl 2):59–69.CrossRefPubMed
10.
Richter KP, Arnsten JH. A rationale and model for addressing tobacco dependence in substance abuse treatment. Subst Abuse Treat Prev Policy. 2006;1:23.CrossRefPubMedPubMedCentral
11.
12.
Reid MS, Fallon B, Sonne S, Flammino F, Nunes EV, Jiang H, Kourniotis E, Lima J, Brady R, Burgess C, et al. Smoking cessation treatment in community-based substance abuse rehabilitation programs. J Subst Abus Treat. 2008;35:68–77.CrossRef
13.
Shoptaw S, Rotheram-Fuller E, Yang X, Frosch D, Nahom D, Jarvik ME, Rawson RA, Ling W. Smoking cessation in methadone maintenance. Addiction. 2002;97:1317–28.CrossRefPubMed
14.
Stein MD, Weinstock MC, Herman DS, Anderson BJ, Anthony JL, Niaura R. A smoking cessation intervention for the methadone-maintained. Addiction. 2006;101:599–607.CrossRefPubMed
15.
RACGP. Supporting smoking cessation: a guide for health professionals. Melbourne: The Royal Australian College of General Practitioners; 2011.
16.
NSW Ministry of Health. The guide for the management of nicotine dependent inpatients. Gladesville: Better Health Centre; 2002.
17.
Fiore M. Treating tobacco use and dependence: 2008 update: clinical practice guideline. Collingdale: DIANE Publishing; 2008.
18.
Ratschen E, Britton J, McNeill A. The smoking culture in psychiatry: time for change. Br J Psychiatry. 2011;198:6–7.CrossRefPubMed
19.
Wilson AJ, Bonevski B, Dunlop A, Shakeshaft A, Tzelepis F, Walsberger S, Farrell M, Kelly PJ, Guillaumier A. 'The lesser of two evils': a qualitative study of staff and client experiences and beliefs about addressing tobacco in addiction treatment settings. Drug Alcohol Rev. 2016;35:92–101.CrossRefPubMed
20.
Gartner C, Hall W. A licence to vape: is it time to trial of a nicotine licensing scheme to allow Australian adults controlled access to electronic cigarettes devices and refill solutions containing nicotine? Int J Drug Policy. 2015;26:548–53.CrossRefPubMed
21.
Rooke C, Cunningham-Burley S, Amos A. Smokers’ and ex-smokers’ understanding of electronic cigarettes: a qualitative study. Tob Control. 2016;25:e60–6.CrossRefPubMed
22.
St Helen G, Havel C, Dempsey DA, Jacob P 3rd, Benowitz NL. Nicotine delivery, retention and pharmacokinetics from various electronic cigarettes. Addiction. 2016;111:535–44.CrossRefPubMed
23.
McNeill A, Brose LS, Calder R, Hitchman SC, Hajek P, McRobbie H. E-cigarettes: an evidence update. A report commissioned by Public Health England. London: Public Health England; 2015.
24.
Phung A, Luo L, Breik N, Alessi-Severini S. Use of smoking cessation products: a survey of patients in community pharmacies. Can Pharm J/Revue des Pharmaciens du Canada. 2017;150:326–33.CrossRef
25.
Adkison SE, O'Connor RJ, Bansal-Travers M, Hyland A, Borland R, Yong HH, Cummings KM, McNeill A, Thrasher JF, Hammond D, Fong GT. Electronic nicotine delivery systems: international tobacco control four-country survey. Am J Prev Med. 2013;44:207–15.CrossRefPubMedPubMedCentral
26.
Giovenco DP, Delnevo CD. Prevalence of population smoking cessation by electronic cigarette use status in a national sample of recent smokers. Addict Behav. 2018;76:129–34.CrossRefPubMed
27.
Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, Stead LF, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2016;9:CD010216.
28.
Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382:1629–37.CrossRefPubMed
29.
O’Brien B, Knight-West O, Walker N, Parag V, Bullen C. 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;13:5.CrossRefPubMedPubMedCentral
30.
Zhuang YL, Cummins SE, Sun JY, Zhu SH. Long-term e-cigarette use and smoking cessation: a longitudinal study with US population. Tob Control. 2016;25:i90–5.CrossRefPubMedPubMedCentral
31.
Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict. 1989;84:791–9.CrossRefPubMed
32.
Kozlowski LT, Porter CQ, Orleans CT, Pope MA, Heatherton T. Predicting smoking cessation with self-reported measures of nicotine dependence: FTQ, FTND, and HSI. Drug Alcohol Depend. 1994;34:211–6.CrossRefPubMed
33.
West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005;100:299–303.CrossRefPubMed
34.
Taggar JS, Lewis S, Docherty G, Bauld L, McEwen A, Coleman T. Do cravings predict smoking cessation in smokers calling a national quit line: secondary analyses from a randomised trial for the utility of 'urges to smoke' measures. Subst Abuse Treat Prev Policy. 2015;10:15.CrossRefPubMedPubMedCentral
35.
Toll BA, O’Malley SS, McKee SA, Salovey P, Krishnan-Sarin S. Confirmatory factor analysis of the Minnesota nicotine withdrawal scale. Psychol Addict Behav. 2007;21:216–25.CrossRefPubMedPubMedCentral
36.
Patten CA, Martin JE. Measuring tobacco withdrawal: a review of self-report questionnaires. J Subst Abus Treat. 1996;8:93–113.CrossRef
37.
Zhou X, Nonnemaker J, Sherrill B, Gilsenan AW, Coste F, West R. Attempts to quit smoking and relapse: factors associated with success or failure from the ATTEMPT cohort study. Addict Behav. 2009;34:365–73.CrossRefPubMed
38.
Fidler JA, Shahab L, West O, Jarvis MJ, McEwen A, Stapleton JA, Vangeli E, West R. 'The smoking toolkit study': a national study of smoking and smoking cessation in England. BMC Public Health. 2011;11:479.CrossRefPubMedPubMedCentral
39.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory care quality improvement project (ACQUIP). Alcohol use disorders identification test. Arch Intern Med. 1998;158:1789–95.CrossRefPubMed
40.
Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res. 2007;31:1208–17.CrossRefPubMed
41.
Bradley KA, Bush KR, Epler AJ, Dobie DJ, Davis TM, Sporleder JL, Maynard C, Burman ML, Kivlahan DR. Two brief alcohol-screening tests from the alcohol use disorders identification test (AUDIT): validation in a female veterans affairs patient population. Arch Intern Med. 2003;163:821–9.CrossRefPubMed
42.
Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the drug use disorders identification test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11:22–31.CrossRefPubMed
43.
Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003;60:184–9.CrossRefPubMed
44.
Hu SS, Neff L, Agaku IT, Cox S, Day HR, Holder-Hayes E, King BA. Tobacco product use among adults - United States, 2013-2014. MMWR Morb Mortal Wkly Rep. 2016;65:685–91.CrossRefPubMed
45.
Mendelsohn CP, Gartner C. Electronic cigarettes. What should you tell your patients? Med Today. 2015;16:26–32.
46.
Moyses C, Hearn A, Redfern A. Evaluation of a novel nicotine inhaler device: part 2—effect on craving and smoking urges. Nicotine Tob Res. 2015;17:26–33.CrossRefPubMed
47.
Stead LF, Hartmann-Boyce J, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2013;8:Cd002850.
48.
Clare P, Slade T, Courtney RJ, Martire KA, Mattick RP. Use of smoking cessation and quit support services by socioeconomic status over 10 years of the National Drug Strategy Household Survey. Nicotine Tob Res. 2014;16:1647–55.CrossRefPubMed
49.
Miller C, Wakefield M, Roberts L. Uptake and effectiveness of the Australian telephone Quitline service in the context of a mass media campaign. Tob Control. 2003;12:ii53–8.CrossRefPubMedPubMedCentral
50.
Wilson A, Guillaumier A, George J, Denham A, Bonevski B. A systematic narrative review of the effectiveness of behavioural smoking cessation interventions in selected disadvantaged groups (2010-2017). Expert Rev Respir Med. 2017;11:617–30.CrossRefPubMed
51.
SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002;4:149–59.
52.
Cheung KL, de Ruijter D, Hiligsmann M, Elfeddali I, Hoving C, Evers S, de Vries H. Exploring consensus on how to measure smoking cessation. A Delphi study. BMC Public Health. 2017;17:890.CrossRefPubMedPubMedCentral
Metadata
Title
Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
Authors
Ashleigh Guillaumier
Victoria Manning
Olivia Wynne
Coral Gartner
Ron Borland
Amanda L. Baker
Catherine J. Segan
Eliza Skelton
Lyndell Moore
Ramez Bathish
Dan I. Lubman
Billie Bonevski
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2786-1

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