ArticlePilot and feasibility studies2025
Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial.
Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04286295 (Pilot RCT of Cytisine Compared to Combination Nicotine Replacement Therapy to Reduce Cigarette Consumption in Relapsed Smokers), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pilot RCT of Cytisine Compared to Combination Nicotine Replacement Therapy to Reduce Cigarette Consumption in Relapsed Smokers
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCigarette smoking is a leading cause of death and disease, including those related to the cardiovascular system. Cytisine is a plant-based medication, which works in a similar mechanism to varenicline. It is safe, efficacious, and cost-effective for smoking cessation. While there are effective therapies such as nicotine replacement therapy, bupropion, varenicline, and cytisine for smoking cessation, relapse remains common. It is unclear how best to support these individuals. This study aims to assess the feasibility of randomizing patients who relapse to combination NRT or cytisine after admission to a cardiac hospital. STUDY
designRandomized, two-group parallel feasibility trial.
methodsThis trial will recruit relapsed smokers from the University of Ottawa Heart Institute. Participants will be randomized 1:1 to receive cytisine or combination NRT, alongside counseling and follow-up support. Feasibility outcomes include recruitment rates and treatment completion. Secondary outcomes include smoking cessation rates and adverse events. A total of 60 participants will be recruited using stratified randomization by sex to ensure gender balance. Data will be analyzed descriptively, focusing on feasibility and efficacy measures to inform future trials. DISCUSSION: The primary aim of this study is to evaluate the feasibility of recruiting patients who were recently admitted to the hospital and have relapsed to smoking within 180 days post-discharge. This will inform future studies aimed at recruiting patients who have relapsed to understand how best to support them to quit smoking. This study will also compare the acceptability, efficacy, and safety of cytisine compared to combination NRT, as demonstrated in previous studies in other populations. Notably, cytisine's shorter regimen and natural composition broaden its appeal, potentially supporting a wider spectrum of people who smoke. The study's robust design, infrastructure, and expertise enhance its feasibility. Future research avenues, especially among cardiac patients and relapsed individuals, promise further insights, potentially transforming cessation strategies worldwide.
trial registrationRegistered at Clinicaltrials.gov (CT04286295) on 14 March 2022. https://clinicaltrials.gov/study/NCT04286295?locStr=Canada&country=Canada&intr=Cytisine&rank=3 .
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