Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-23 @ 5:01 PM
Study NCT ID:
NCT03948893
Status:
RECRUITING
Last Update Posted:
2024-08-07
First Post:
2019-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smoking Cessation Behavioral Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-10', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarette Smoking', 'timeFrame': '7 weeks', 'description': 'Biochemical smoking assessment (breath carbon monoxide) at each study visit.'}, {'measure': 'Magnitude of change in fMRI brain response to images', 'timeFrame': '7 weeks', 'description': 'Measure the effects of MORE on fMRI BOLD response to images (change from baseline to end of study) while participants undergo functional magnetic resonance imaging'}, {'measure': 'Magnitude of change in fMRI brain connectivity', 'timeFrame': '7 weeks', 'description': 'Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and up\n* English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks\n* Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks\n* Current nicotine dependent smoker with a minimum smoking history of 2 years\n* Interest in quitting smoking\n\nExclusion Criteria:\n\n* Use of psychotropic (e.g. antiepileptic) medications in the past month\n* Positive urine drug screen\n* Presence of an untreated medical illness\n* Current or past psychosis\n* History of major neurological illness or head injury resulting in loss of consciousness\n* And contraindication to MRI, including claustrophobia\n* Among females, positive urine pregnancy test\n* Inability or unwillingness of subject to give informed consent'}, 'identificationModule': {'nctId': 'NCT03948893', 'briefTitle': 'Smoking Cessation Behavioral Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction', 'orgStudyIdInfo': {'id': '2020602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MORE', 'interventionNames': ['Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)']}], 'interventions': [{'name': 'Mindfulness-Oriented Recovery Enhancement (MORE)', 'type': 'BEHAVIORAL', 'description': 'MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.', 'armGroupLabels': ['MORE']}, {'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.', 'armGroupLabels': ['CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brett Froeliger, PhD', 'role': 'CONTACT', 'email': 'froeligerb@health.missouri.edu', 'phone': '573-882-4785'}, {'name': 'Madhura Athreya, MS', 'role': 'CONTACT', 'email': 'athreyam@health.missouri.edu', 'phone': '5738822799'}], 'facility': 'University of Missouri - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Saladin, PhD', 'role': 'CONTACT', 'email': 'saladinm@musc.edu', 'phone': '843-792-5306'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Madhura Athreya, MS', 'role': 'CONTACT', 'email': 'athreyam@health.missouri.edu', 'phone': '5738822977'}, {'name': 'Brett Froeliger, PhD', 'role': 'CONTACT', 'email': 'froeligerb@health.missouri.edu', 'phone': '5738824785'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of South Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Psychiatry', 'investigatorFullName': 'Brett Froeliger', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}