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Randomized Controlled Trial
. 2018 May 4;18(1):596.
doi: 10.1186/s12889-018-5351-7.

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial

Chris Bullen  1   2 , Marjolein Verbiest  3   4 , Susanna Galea-Singer  4   5 , Tomasz Kurdziel  3 , George Laking  6 , David Newcombe  4   7 , Varsha Parag  3 , Natalie Walker  3   4
Affiliations
Randomized Controlled Trial

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial

Chris Bullen et al. BMC Public Health. .

Abstract

Background: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions.

Methods: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups.

Discussion: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates.

Trial registration: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Keywords: Addiction; E-cigarettes; Effectiveness; Electronic cigarettes; Mental illness; Randomised trial; Safety; Smoking cessation; Varenicline.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved on 07/11/2016 by the NZ Southern Health and Disability Ethics Committees (reference 16/STA/153). Two subsequent amendments to the study protocol were approved on 4/09/2017 and 8/12/2017 and ethics approval for all further amendments to the study protocol will be sought, prior to implementation of the changes (information on the trial registry will be updated accordingly). Maintenance of confidentiality and compliance with NZ’s Privacy Act will be emphasised to all study participants. Participation in the study will be entirely voluntary. Both verbal and written consent (Additional file 2) will be obtained from all participants at various times as they move through the study. All data will be entered, stored and backed-up in a secure manner via an internet data management system. If any participants suffer harm from trial participation (which is unlikely), they should be eligible for compensation via their private health or life insurance, or via NZ’s Accident Compensation Corporation (ACC) scheme.

Consent for publication

No identifiable individual participant data (names or other personal identifiers) are contained in this manuscript.

Competing interests

No authors have received financial support from any companies for the submitted work. NW, CB, VP, and MV have received smoking cessation medication and matching placebo from Pfizer, for the conduct of a relapse prevention trial in COPD patients who smoke. CB has previously undertaken research funded by NicoNovum prior to its sale to RJ Reynolds. CB received benefits in kind (accommodation expenses) from a manufacturer of smoking cessation medications. NW has provided consultancy to the manufacturers of smoking cessation medications, received honoraria for speaking at a research meeting and received benefits in kind and travel support from a manufacturer of smoking cessation medications. MV has previously undertaken research supported by an unrestricted grant from Pfizer. All authors, CB, NW, VP and GL were involved in a previous trial investigating the effect of ECs on smoking cessation. All authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work. All authors have no non-financial interests that may be relevant to the submitted work.

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Figures

Fig. 1
Fig. 1
PRECIS-2 wheel showing the pragmatic character of the STATUS Trial
See this image and copyright information in PMC

References

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