AUTHOR=Torazzi Alessandro , Tedesco Erika , Ceccato Sofia , Santin Laura , Campagnari Simone , Losso Lorenzo , Toldo Silvia , Casari Rebecca , Arzenton Elena , Marini Paola , Chiamulera Cristiano , Lugoboni Fabio 

TITLE=Safety and efficacy of CyTisine for smoking cessation in a hOSPital context (CITOSP): study protocol for a prospective observational study

JOURNAL=Frontiers in Public Health

VOLUME=Volume 12 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1350176

DOI=10.3389/fpubh.2024.1350176

ISSN=2296-2565

ABSTRACT=Tobacco addiction is the primary preventable factor contributing to global mortality and nicotine is one of the substances with the greatest potential for addiction. With a strong affinity for the α4β2 subtype receptor, cytisine (CYT) functions as a partial agonist of the acetylcholine nicotinic cholinergic receptor, counteracting the effects of nicotine without causing any withdrawal symptoms. These features, the limited mild adverse effects and drug-drug interactions made it a cost-effective treatment for smoking cessation. The current protocol describes a prospective observational study on safety and efficacy of CYT administered to inpatient smokers of the Integrated University Hospital of Verona (IUHVR), Veneto (Italy). This is a monocentric, observational, and prospective study on both sex smokers over the age of 18 admitted to the IUHVR who meet criteria for recruitment and have given their consent. Eligible participants will be assigned to the CYT intervention based on West Dosing Schedule and will be followed up for 12 months from treatment initiation. Evaluation of safety, efficacy and compliance will be assessed at 7 and 25 days, with follow-up at 3, 6 and 12 months from the start of treatment (Quit Day). During each visit, any adverse events, and adverse reactions, reported by patients following the intake of CYT will be evaluated. This study will contribute, for the first time, to the knowledge about the use of CYT for smoking cessation in a hospital setting.