Analysis and Evaluation of Smoking Treatment With Cytisine

Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study

The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study.

Study Overview

• Status: Recruiting
• Conditions: Moderate or Severe Tobacco Use Disorder
• Intervention / Treatment: Drug: Cytisine 1,5 mg

Detailed Description

The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls.

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Maria Papale, Doctor; Phone Number: +39 0652666903; Email: maria.papale@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Maria Papale, Doctor; Phone Number: +39 0652666903; Email: maria.papale@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.

Description

Inclusion Criteria:

• patients aged > 18 years;
• patients suffering from moderate or severe tobacco use disorder;
• prescription of pharmacological therapy with Cytisine;
• patients returned to the 1st check-up on schedule;

Exclusion Criteria:

• Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;
• Patients undergoing pharmacological or physical treatment for neoplastic pathology;
• Pregnant or breastfeeding women;
• Patients for whom specific information for objective assessments is not available;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with moderate or severe tobacco use disorder.; Patients hospitalized at the IRE anti-smoking center, National Cancer Institute "Regina Elena", suffering from moderate or severe tobacco use disorder, who are prescribed pharmacological therapy with Cytisine 1.5 mg.	Drug: Cytisine 1,5 mg; Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic adherence	Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the effectiveness of the therapy.	Evaluation of the effectiveness of the therapy with the achievement of smoking cessation subsequent checks occurred after clinical evaluation and measurement of the monoxide value exhaled carbon.	3 months
Evaluation of therapeutic adherence in relation to motivation.	Evaluation of adherence to Cytisine therapy in relation to the patient's motivation measured with the Mondor motivational test.	3 months
Assessment of adherence in relation to the dependency score physics.	Evaluation of adherence to Cytisine therapy in relation to the addiction score physical measured with the Nicotine dependence questionnaire or Fagerström test.	3 months
Safety and Tolerability assessment.	Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine.	3 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: RS104/IRE/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No