NCT06885970 The Effect of Cytisine Treatment for Smoking Cessation on Cardiovascular Function in Adult Smokers
| NCT ID | NCT06885970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Athens |
| Condition | Smoking Cessation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2025-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-11-12 with a primary completion date of 2025-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Pharmacological interventions can enhance smoking cessation success and long-term abstinence. Cytisine, a plant derived alkaloid, is a selective partial agonist at alpha-4 beta-2 nicotinic acetylcholine receptors, which are crucial in nicotine dependence. Aim of the Study The primary objective of this observational study is to evaluate the efficacy of cytisine in a standard 25-day dosing regimen among adult smokers and users of alternative nicotine products (e-cigarettes or heated tobacco). The study will assess the impact of cytisine on cardiovascular function, including arterial stiffness, cardiac deformation, and endothelial glycocalyx integrity. The secondary aim is to determine relapse rates post-treatment, treatment side effects, and new cardiovascular events during the treatment period and at six-month follow-up. Materials and Methods: This observational study will recruit smokers visiting the smoking cessation unit at the 2nd Department of Cardiology, Attikon University Hospital, Athens. All participants will receive counseling and treatment from the attending physician. A minimum of 200 participants will be enrolled, categorized into: • At least 50 receiving cytisine in the standard dosing regimen: Days 1-3: 1 tablet every 2 hours (6 tablets daily) Days 4-12: 1 tablet every 2.5 hours (5 tablets daily) Days 13-16: 1 tablet every 3 hours (4 tablets daily) Days 17-20: 1 tablet every 5 hours (3 tablets daily) Days 21-25: 1-2 tablets daily * At least 50 receiving nicotine replacement therapy * At least 50 receiving prolonged cytisine therapy (3 mg, three times daily for 12 weeks) * At least 50 who do not intend to quit smoking (control group) Assessments will be conducted at baseline, one month, and six months post-recruitment. The following measurements will be performed: A. Arterial Stiffness: Pulse wave velocity (cf-PWV) using the Complior device to measure arterial stiffness, Augmentation index and pulse wave velocity using the Arteriograph device via brachial artery cuff. B. Endothelial Glycocalyx Integrity: Perfused boundary region (PBR) assessment of sublingual microvasculature using a Sidestream Dark Field (SDF) camera. C. Cardiac Function: Left ventricular ejection fraction (LVEF), myocardial strain (GLS), and myocardial work assessment via speckle-tracking echocardiography (Echopac 203, GE Horten Norway).The investigators will also calculate myocardial work (MW) using pressure-strain loop analysis. D. Oxidative Stress: Plasma malondialdehyde (MDA) and protein carbonyl (PC) levels measured via spectrophotometry. E. Smoking Cessation Monitoring: Exhaled carbon monoxide (CO) measured using a commercial device (Smokelyzer, Bedfont Scientific Ltd.). This study aims to provide valuable insights into cytisine's effectiveness in smoking cessation and its impact on cardiovascular health.
Eligibility Criteria
Inclusion Criteria: * Smokers willing to participate Exclusion Criteria: * history of coronary artery disease, active malignancy, history of severe liver and renal failure, history of autoimmune disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06885970 currently recruiting?
Yes, NCT06885970 is actively recruiting participants. Contact the research team at ignoik@gmail.com for enrollment information.
Where is the NCT06885970 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06885970 clinical trial?
NCT06885970 is sponsored by University of Athens. The trial plans to enroll 200 participants.