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, Michael Farrell, Hayden McRobbie, Piotr Tutka, Dennis Petrie, Robert West, Mohammad Siahpush, Coral Gartner, Natalie Walker, Colin P. Mendelsohn, Wayne Hall, Christine Paul, Nicholas Zwar, Stuart G. Ferguson, Veronica C. Boland, Robyn Richmond, Christopher M. Doran, Anthony Shakeshaft, Richard P. Mattick, Ryan J. Courtney

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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.

Original languageEnglish
Pages (from-to)923-933
Number of pages11
JournalAddiction
Volume114
Issue number5
Early online date27 Dec 2018
DOIs
Publication statusPublished - May 2019

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Smoking Cessation
Cost-Benefit Analysis
Safety
Population
Random Allocation
Telephone
Smoking
Costs and Cost Analysis
Eastern Europe
Carbon Monoxide
Nicotine
Tobacco Products
Tablets
Capsules
cytisine
Varenicline
Non-Randomized Controlled Trials
Outcome Assessment (Health Care)
Interviews

Cite this

Thomas, Dennis ; Farrell, Michael ; McRobbie, Hayden ; Tutka, Piotr ; Petrie, Dennis ; West, Robert ; Siahpush, Mohammad ; Gartner, Coral ; Walker, Natalie ; Mendelsohn, Colin P. ; Hall, Wayne ; Paul, Christine ; Zwar, Nicholas ; Ferguson, Stuart G. ; Boland, Veronica C. ; Richmond, Robyn ; Doran, Christopher M. ; Shakeshaft, Anthony ; Mattick, Richard P. ; Courtney, Ryan J. / 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. In: Addiction. 2019 ; Vol. 114, No. 5. pp. 923-933.
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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.",
author = "Dennis Thomas and Michael Farrell and Hayden McRobbie and Piotr Tutka and Dennis Petrie and Robert West and Mohammad Siahpush and Coral Gartner and Natalie Walker and Mendelsohn, {Colin P.} and Wayne Hall and Christine Paul and Nicholas Zwar and Ferguson, {Stuart G.} and Boland, {Veronica C.} and Robyn Richmond and Doran, {Christopher M.} and Anthony Shakeshaft and Mattick, {Richard P.} and Courtney, {Ryan J.}",
year = "2019",
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Thomas, D, Farrell, M, McRobbie, H, Tutka, P, Petrie, D, West, R, Siahpush, M, Gartner, C, Walker, N, Mendelsohn, CP, Hall, W, Paul, C, Zwar, N, Ferguson, SG, Boland, VC, Richmond, R, Doran, CM, Shakeshaft, A, Mattick, RP & Courtney, RJ 2019, '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' Addiction, vol. 114, no. 5, pp. 923-933. https://doi.org/10.1111/add.14541

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. / Thomas, Dennis; Farrell, Michael; McRobbie, Hayden; Tutka, Piotr; Petrie, Dennis; West, Robert; Siahpush, Mohammad; Gartner, Coral; Walker, Natalie; Mendelsohn, Colin P.; Hall, Wayne; Paul, Christine; Zwar, Nicholas; Ferguson, Stuart G.; Boland, Veronica C.; Richmond, Robyn; Doran, Christopher M.; Shakeshaft, Anthony; Mattick, Richard P.; Courtney, Ryan J.

In: Addiction, Vol. 114, No. 5, 05.2019, p. 923-933.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Farrell, Michael

AU - McRobbie, Hayden

AU - Tutka, Piotr

AU - Petrie, Dennis

AU - West, Robert

AU - Siahpush, Mohammad

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AU - Walker, Natalie

AU - Mendelsohn, Colin P.

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AU - Paul, Christine

AU - Zwar, Nicholas

AU - Ferguson, Stuart G.

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AB - 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.

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