Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Cigarette 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 DESIGN: Randomized, two-group parallel feasibility trial. METHODS: This 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 REGISTRATION: Registered 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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.026 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.012 | 0.007 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.010 |
| Insufficient payload (model declined to judge) | 0.081 | 0.012 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".