Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT03085602
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroimaging Studies of Smoking and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in activation in reward processing regions of the brain', 'timeFrame': 'Change from Baseline to Week 4'}], 'secondaryOutcomes': [{'measure': 'Change in activation in cognitive control regions of the brain', 'timeFrame': 'Change from Baseline to Week 4'}, {'measure': 'Change in connectivity between reward and cognitive control regions of the brain', 'timeFrame': 'Change from Baseline to Week 4'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoke \\> 10 cigarettes per day\n* vision is normal or corrected-to-normal\n\nExclusion Criteria:\n\n* serious medical illness unsuitable for the MR scanner based on best clinical judgment\n* any neurologic or psychiatric disorder\n* diabetes\n* known heart disease\n* high blood pressure\n* currently taking psychotropic or cardiovascular medication\n* history of alcohol or other substance dependence or current abuse\n* risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03085602', 'briefTitle': 'Neuroimaging Studies of Smoking and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY00001782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT Treatment', 'description': 'Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact.', 'interventionNames': ['Behavioral: Health education']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - Scans', 'description': 'Participants in this new arm to the study will receive no intervention and will receive three scans.'}], 'interventions': [{'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.', 'armGroupLabels': ['CBT Treatment']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hoglund Brain Imaging Center, University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Laura Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}