The Effect of Cytisine Treatment for Smoking Cessation on Cardiovascular Function in Adult Smokers

NCT06885970 | Recruiting DMC

• 1 other identifier: Cytisine_Attikon
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Arterial Stiffness; Endothelial Dysfunction

Keywords

arterial stiffness; smoking cessation; myocardial deformation; endothelial glycocalyx

Outcome Measures

Primary Outcomes (3)

• Comparisons of changes in arterial stiffness between treatment groups

  Comparisons of changes in carotid-to-femoral Pulse Wave Velocity between treatment groups

  0, 1, 6 months

• Comparisons of changes in endothelial glycocalyx integrity between treatment groups

  Comparisons of changes in Perfused Boundary Region of sublingual microvessels with diameter range 4-25 μm.

  0,1, 6 months

• Comparisons of changes in myocardial performance between treatment groups

  Changes in Global Longitudinal Strain of the Left Ventricle via echocardiography beween treatment groups

  0,1, 6 months

Secondary Outcomes (2)

• Comparisons of changes in oxidative stress burden between treatment groups

  0,1,6 months

• Comparisons of changes in smoking cessation rates between treatment groups

  0,1,6 months

Study Arms (4)

Standard dose Cytisine Regime

At least 50 participants will receive cytisine at the standard dose regime \[From the 1st to the 3rd day, 1 tablet every 2 hours, 6 tablets; From the 4th to the 12th day, 1 tablet every 2.5 hours, 5 tablets; From the 13th to the 16th day, 1 tablet every 3 hours, 4 tablets; From the 17th to the 20th day, 1 tablet every 5 hours, 3 tablets; From the 21st to the 25th day, 1-2 tablets per day, up to 2 tablets

Drug: Cytisinicline administration

Nicotine Replacement Therapy

At least 50 participants will receive 50 nicotine replacement therapy

Drug: Cytisinicline administration

Prolonged Cytisine Regime

A least 50 participants will receive the prolonged cytisine regime (3mg cytosine 3 times daily for 12 weeks

Drug: Cytisinicline administration

Control Group

At least 50 participants who will not be eager to cease smoking

Drug: Cytisinicline administration

Interventions

Cytisinicline administration DRUG

Participants will receive in the smoki

Also known as: Nicotine Replacement Therapy

Control Group; Nicotine Replacement Therapy; Prolonged Cytisine Regime; Standard dose Cytisine Regime

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are planning to include at least 200 smokers individuals, out of which: at least 50 will receive cytisine at the standard dose regime \[From the 1st to the 3rd day, 1 tablet every 2 hours, 6 tablets; From the 4th to the 12th day, 1 tablet every 2.5 hours, 5 tablets; From the 13th to the 16th day, 1 tablet every 3 hours, 4 tablets; From the 17th to the 20th day, 1 tablet every 5 hours, 3 tablets; From the 21st to the 25th day, 1-2 tablets per day, up to 2 tablets\], at least 50 are on nicotine replacement therapy , at least 50 who will receive the prolonged cytisine regime (3mg cytosine 3 times daily for 12 weeks) and at least 50 that are not eager to quit smoking, as a control group.

You may qualify if:

• Smokers willing to participate

You may not qualify if:

• history of coronary artery disease, active malignancy, history of severe liver and renal failure, history of autoimmune disease.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Attikkon University Hospital

Athens, Haidari, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Ignatios Ikonomidis, MD;PhD

CONTACT

00306944805732; ignoik@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: November 12, 2024
• Primary Completion: July 22, 2025
• Study Completion: August 10, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

GR (1)