Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 9:11 PM
Study NCT ID:
NCT05788068
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Smoking Reduction and Participation', 'timeFrame': '4 weeks', 'description': 'Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.'}], 'primaryOutcomes': [{'measure': 'Biochemically Validated Continuously Abstinence', 'timeFrame': '4 weeks', 'description': 'Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.'}, {'measure': 'Brain Structural Characteristics', 'timeFrame': '4 weeks', 'description': 'Differences of brain structure between successful and unsuccessful smokers after intervention, which will be measured by white matter volume, gray matter volume, cortical thickness, and surface area.'}, {'measure': 'Brain Functional activity', 'timeFrame': '4 weeks', 'description': 'Differences of whole brain function activity between successful and unsuccessful smokers after intervention, which will be measured by ReHo, ALFF, fALFF, and functional connectivity (FC)'}], 'secondaryOutcomes': [{'measure': 'Self-reported 7-day Point Abstinence', 'timeFrame': '4 weeks', 'description': 'Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.'}, {'measure': 'Self-reported Continuous Abstinence', 'timeFrame': '4 weeks', 'description': 'Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking', 'Psychological Interventions', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day\n2. Nicotine dependence (FTCD ≥ 3)\n3. Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .\n4. No other addictions except nicotine\n5. Education level of junior high school or above\n6. Age between 18 to 45 years old\n7. Right-handed\n8. No contraindication of MRI scanning\n9. Willing to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients who are receiving medication\n2. Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.\n3. Brain organic disease, brain injury history, coma history\n4. Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination\n5. Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT05788068', 'briefTitle': 'Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China', 'orgStudyIdInfo': {'id': '20220061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants in the intervention group will receive CBT-based digital smoking cessation intervention. The intervention is a set of smoking cessation methods based on the theoretical study of cognitive behavioral therapy for smoking cessation, and its effectiveness has been confirmed through our large sample of randomized controlled studies. This study plans to intervene smokers for 4 weeks after the start of smoking cessation.', 'interventionNames': ['Behavioral: Cognitive behavior therapy']}], 'interventions': [{'name': 'Cognitive behavior therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '360000', 'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Yanhui Liao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Yanhui Liao', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}