Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Aug 2;19(1):415.
doi: 10.1186/s13063-018-2786-1.

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

Ashleigh Guillaumier  1 , Victoria Manning  2   3 , Olivia Wynne  1 , Coral Gartner  4 , Ron Borland  5 , Amanda L Baker  1 , Catherine J Segan  5   6 , Eliza Skelton  1 , Lyndell Moore  1 , Ramez Bathish  2   3 , Dan I Lubman  2   3 , Billie Bonevski  7
Affiliations

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

Ashleigh Guillaumier et al. Trials. .

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, ACTRN12617000849392 . Registered on 8 June 2017.

Keywords: Alcohol and other drugs; Electronic cigarettes; Nicotine replacement therapy; Smoking cessation.

PubMed Disclaimer

Conflict of interest statement

The study was approved by Eastern Health human research ethics committee (E16–2016) and the University of Newcastle human research ethics committee (H-2017-0249). Informed consent will be obtained from all participants.

Not applicable.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, product supply and assessments. DUDIT Drug Use Disorders Identification Test, END electronic nicotine device, GP general practitioner, NRT nicotine replacement therapy
Fig. 2
Fig. 2
Flow chart of participant recruitment and follow-up. AOD alcohol or other drugs, END electronic nicotine device, NRT nicotine replacement therapy, RA research assistant, Wk week
See this image and copyright information in PMC

References

    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. doi: 10.1080/09595230500459552. - DOI - PubMed
    1. 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;111:220–230. doi: 10.1111/add.13099. - DOI - PMC - PubMed
    1. 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. - PMC - PubMed
    1. 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;35:220–225. doi: 10.1111/j.1753-6405.2011.00682.x. - DOI - PubMed
    1. 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;21:244–250. doi: 10.1007/BF02884841. - DOI - PubMed

Publication types

MeSH terms

Grants and funding