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METHODS article

Front. Public Health
Sec. Substance Use Disorders and Behavioral Addictions
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1350176

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

Provisionally accepted
Alessandro Torazzi Alessandro Torazzi 1,2*Erika Tedesco Erika Tedesco 2Sofia Ceccato Sofia Ceccato 1Laura Santin Laura Santin 3Simone Campagnari Simone Campagnari 3Lorenzo Losso Lorenzo Losso 3Silvia Toldo Silvia Toldo 1Rebecca Casari Rebecca Casari 3Elena Arzenton Elena Arzenton 1Paola Marini Paola Marini 2Cristiano Chiamulera Cristiano Chiamulera 1Fabio Lugoboni Fabio Lugoboni 3
  • 1 Department of Diagnostics and Public Health, University of Verona, Verona, Veneto, Italy
  • 2 Department of Pharmacy, Integrated University Hospital of Verona, Verona, Veneto, Italy
  • 3 Department of Internal Medicine, Integrated University Hospital Verona, Verona, Veneto, Italy

The final, formatted version of the article will be published soon.

    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.

    Keywords: cytisine, Smoking Cessation, Tobacco Addiction, Hospital setting, Safety, protocol, cost-effective

    Received: 05 Dec 2023; Accepted: 09 Sep 2024.

    Copyright: © 2024 Torazzi, Tedesco, Ceccato, Santin, Campagnari, Losso, Toldo, Casari, Arzenton, Marini, Chiamulera and Lugoboni. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Alessandro Torazzi, Department of Diagnostics and Public Health, University of Verona, Verona, 37134, Veneto, Italy

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.