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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

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 ORCID: 0000-0001-7378-3497, Boland, VC, Richmond, R, Doran, CM, Shakeshaft, A, Mattick, RP and 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 , doi: 10.1111/add.14541.

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Abstract

Background and aims: Smoking cessation medications are effective, but often underutilized because of costs and sideeffects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and easternEurope. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, directcomparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and costeffectiveness 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 Quitlinetelephone-based cessation support services. Intervention and comparator Eligible participants will be randomized (1 : 1ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordancewith the manufacturer’s recommended dosing regimen. The medication will be mailed to each participant’s nominatedresidential 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 cytisinecompared 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, itslower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medicationthat could save millions of lives world-wide.

Item Type: Article
Authors/Creators:Thomas, D and Farrell, M and McRobbie, H and Tutka, P and Petrie, D and West, R and Siahpush, M and Gartner, C and Walker, N and Mendelsohn, CP and Hall, W and Paul, C and Zwar, N and Ferguson, SG and Boland, VC and Richmond, R and Doran, CM and Shakeshaft, A and Mattick, RP and Courtney, RJ
Keywords: cost-effectiveness, cytisine, randomized controlled trial, smoking cessation, tobacco, varenicline
Journal or Publication Title: Addiction
Publisher: Carfax Pub. Co.
ISSN: 0965-2140
DOI / ID Number: 10.1111/add.14541
Copyright Information:

© 2018 Society for the Study of Addiction

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