Moderate or Severe Tobacco Use Disorder
Conditions
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.
Interventions
DRUGCytisine 1,5 mg
Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious
Sponsors
Regina Elena Cancer Institute
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic adherence | 3 months | Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Safety and Tolerability assessment. | 3 months | Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine. |
Countries
Italy
Contacts
Primary ContactMaria Papale, Doctor
Outcome results
None listed