Analysis and Evaluation of Smoking Treatment With Cytisine

NCT ID: NCT06439303

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-06-20

Brief Summary

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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

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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.

Conditions

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Moderate or Severe Tobacco Use Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Cytisine 1,5 mg

Intervention Type DRUG

Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious

Interventions

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Cytisine 1,5 mg

Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maria Papale, Doctor

Role: CONTACT

0652666903 ext. +39

Facility Contacts

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Maria Papale, Doctor

Role: primary

0652666903 ext. +39

Other Identifiers

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RS104/IRE/24

Identifier Type: -

Identifier Source: org_study_id

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