Analysis and Evaluation of Smoking Treatment With Cytisine

Recruiting

• Conditions: Moderate or Severe Tobacco Use Disorder
• Interventions: Drug: Cytisine 1,5 mg

• Registration Number: NCT06439303
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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.

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 Timeline

• Study Start: 2024-03-20
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with moderate or severe tobacco use disorder.	Cytisine 1,5 mg	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.

Primary Outcome Measures

Name	Time	Method
Therapeutic adherence	3 months	Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of the therapy.	3 months	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.
Evaluation of therapeutic adherence in relation to motivation.	3 months	Evaluation of adherence to Cytisine therapy in relation to the patient's motivation measured with the Mondor motivational test.
Safety and Tolerability assessment.	3 months	Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine.
Assessment of adherence in relation to the dependency score physics.	3 months	Evaluation of adherence to Cytisine therapy in relation to the addiction score physical measured with the Nicotine dependence questionnaire or Fagerström test.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy