Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytisine 1,5 mg | Drug | Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic adherence | Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg | 3 months |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Papale, Doctor | Contact | 0652666903 | +39 | maria.papale@ifo.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |