Dennis Thomas1, Michael Farrell1, Hayden McRobbie1,2, Piotr Tutka1,3, Dennis Petrie4, Robert West5, Mohammad Siahpush6, Coral Gartner7, Natalie Walker8, Colin P Mendelsohn9, Wayne Hall10,11, Christine Paul12, Nicholas Zwar9,13, Stuart G Ferguson14, Veronica C Boland1, Robyn Richmond9, Christopher M Doran15, Anthony Shakeshaft1, Richard P Mattick1, Ryan J Courtney1. 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.
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.
RCT Entities:
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.
Authors: Hilary A Tindle; Matthew S Freiberg; Natalia Gnatienko; Elena Blokhina; Debbie M Cheng; Tatiana Yaroslavtseva; Sally Bendiks; Michael Winter; Evgeny Krupitsky; Jeffrey H Samet Journal: Contemp Clin Trials Commun Date: 2020-07-16
Authors: Ryan J Courtney; Hayden McRobbie; Piotr Tutka; Natasha A Weaver; Dennis Petrie; Colin P Mendelsohn; Anthony Shakeshaft; Saki Talukder; Christel Macdonald; Dennis Thomas; Benjamin C H Kwan; Natalie Walker; Coral Gartner; Richard P Mattick; Christine Paul; Stuart G Ferguson; Nicholas A Zwar; Robyn L Richmond; Christopher M Doran; Veronica C Boland; Wayne Hall; Robert West; Michael Farrell Journal: JAMA Date: 2021-07-06 Impact factor: 56.272