The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Dennis Thomas¹, Michael Farrell¹, Hayden McRobbie^{1

2}, Piotr Tutka^{1

3}, Dennis Petrie⁴, Robert West⁵, Mohammad Siahpush⁶, Coral Gartner⁷, Natalie Walker⁸, Colin P Mendelsohn⁹, Wayne Hall^{10

11}, Christine Paul¹², Nicholas Zwar^{9

13}, Stuart G Ferguson¹⁴, Veronica C Boland¹, Robyn Richmond⁹, Christopher M Doran¹⁵, Anthony Shakeshaft¹, Richard P Mattick¹, Ryan J Courtney¹

Affiliations

¹ National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.
² Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
³ Department of Experimental and Clinical Pharmacology, Laboratory for Innovative Research in Pharmacology, University of Rzeszów, Rzeszów, Poland.
⁴ Centre for Health Economics, Monash Business School, Monash University, Melbourne, Australia.
⁵ Department of Behavioural Science and Health, University College London, London, UK.
⁶ College of Public Health, University of Nebraska Medical Center, Omaha, United States.
⁷ Faculty of Medicine, School of Public Health, The University of Queensland, Brisbane, Australia.
⁸ National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.
⁹ School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
¹⁰ Faculty of Health and Behavioural Sciences, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.
¹¹ National Addiction Centre, Kings College London, UK.
¹² School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.
¹³ Faculty of Health Sciences and Medicine, Bond University, Queensland, Australia.
¹⁴ School of Medicine, University of Tasmania, Hobart, Australia.
¹⁵ Centre for Indigenous Health Equity Research, Central Queensland University, Brisbane, Australia.

PMID: 30589984
DOI: 10.1111/add.14541

Randomized Controlled Trial

The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Dennis Thomas et al. Addiction. 2019 May.

. 2019 May;114(5):923-933.

doi: 10.1111/add.14541. Epub 2019 Feb 3.

Authors

Affiliations

¹ National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.
² Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
³ Department of Experimental and Clinical Pharmacology, Laboratory for Innovative Research in Pharmacology, University of Rzeszów, Rzeszów, Poland.
⁴ Centre for Health Economics, Monash Business School, Monash University, Melbourne, Australia.
⁵ Department of Behavioural Science and Health, University College London, London, UK.
⁶ College of Public Health, University of Nebraska Medical Center, Omaha, United States.
⁷ Faculty of Medicine, School of Public Health, The University of Queensland, Brisbane, Australia.
⁸ National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.
⁹ School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
¹⁰ Faculty of Health and Behavioural Sciences, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.
¹¹ National Addiction Centre, Kings College London, UK.
¹² School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.
¹³ Faculty of Health Sciences and Medicine, Bond University, Queensland, Australia.
¹⁴ School of Medicine, University of Tasmania, Hobart, Australia.
¹⁵ Centre for Indigenous Health Equity Research, Central Queensland University, Brisbane, Australia.

PMID: 30589984
DOI: 10.1111/add.14541

Abstract

Background and aims: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline.

Design: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment.

Setting: Australian population-based study.

Participants: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services.

Intervention and comparator: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions).

Measurements: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview.

Comments: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.

Keywords: Cost-effectiveness; cytisine; randomized controlled trial; smoking cessation; tobacco; varenicline.

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References

1. Centers for Disease Control and Prevention (CDC). Smoking and Tobacco use. Fast Facts. Atlanta, GA: CDC; 2015.
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1. Cahill K., Stevens S., Perera R., Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev 2013; Issue 5. Art. No.: CD009329. https://doi.org/10.1002/14651858.CD009329.pub2.
1. Anthenelli R. M., Benowitz N. L., West R., St Aubin L., McRae T., Lawrence D. et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016; 387: 2507-2520.
1. West R., Raw M., McNeill A., Stead L., Aveyard P., Bitton J. et al. Health-care interventions to promote and assist tobacco cessation: a review of efficacy, effectiveness and affordability for use in national guideline development. Addiction 2015; 110: 1388-1403.

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The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Affiliations

The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical