Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT06439303
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis and Evaluation of Smoking Treatment With Cytisine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic adherence', 'timeFrame': '3 months', 'description': 'Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effectiveness of the therapy.', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Evaluation of therapeutic adherence in relation to motivation.', 'timeFrame': '3 months', 'description': "Evaluation of adherence to Cytisine therapy in relation to the patient's motivation measured with the Mondor motivational test."}, {'measure': 'Assessment of adherence in relation to the dependency score physics.', 'timeFrame': '3 months', 'description': 'Evaluation of adherence to Cytisine therapy in relation to the addiction score physical measured with the Nicotine dependence questionnaire or Fagerström test.'}, {'measure': 'Safety and Tolerability assessment.', 'timeFrame': '3 months', 'description': 'Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate or Severe Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\> 18 years;\n* patients suffering from moderate or severe tobacco use disorder;\n* prescription of pharmacological therapy with Cytisine;\n* patients returned to the 1st check-up on schedule;\n\nExclusion Criteria:\n\n* Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;\n* Patients undergoing pharmacological or physical treatment for neoplastic pathology;\n* Pregnant or breastfeeding women;\n* Patients for whom specific information for objective assessments is not available;'}, 'identificationModule': {'nctId': 'NCT06439303', 'briefTitle': 'Analysis and Evaluation of Smoking Treatment With Cytisine', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'RS104/IRE/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with moderate or severe tobacco use disorder.', 'description': '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.', 'interventionNames': ['Drug: Cytisine 1,5 mg']}], 'interventions': [{'name': 'Cytisine 1,5 mg', 'type': 'DRUG', 'description': 'Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious', 'armGroupLabels': ['Patients with moderate or severe tobacco use disorder.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Papale, Doctor', 'role': 'CONTACT', 'email': 'maria.papale@ifo.it', 'phone': '0652666903', 'phoneExt': '+39'}], 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Maria Papale, Doctor', 'role': 'CONTACT', 'email': 'maria.papale@ifo.it', 'phone': '0652666903', 'phoneExt': '+39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}