Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT03651869
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2018-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nicotine in Tobacco Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595790', 'term': 'Sugp2 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Urge', 'timeFrame': 'Throughout study completion, an average of two weeks.', 'description': 'Smoking urge is measured using questionnaires that ask about a desire to smoke.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking'], 'conditions': ['Smoking, Tobacco', 'Smoking (Tobacco) Addiction']}, 'descriptionModule': {'briefSummary': 'This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 21 years old\n* Daily smoking at least 2 years\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03651869', 'briefTitle': 'Effects of Nicotine in Tobacco Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence', 'orgStudyIdInfo': {'id': '28IR-0063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Condition 1', 'interventionNames': ['Drug: Cigarette 1', 'Drug: Patch 1']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 2', 'interventionNames': ['Drug: Cigarette 2', 'Drug: Patch 1']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 3', 'interventionNames': ['Drug: Cigarette 1', 'Drug: Patch 2']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 4', 'interventionNames': ['Drug: Cigarette 2', 'Drug: Patch 2']}], 'interventions': [{'name': 'Cigarette 1', 'type': 'DRUG', 'description': 'Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)', 'armGroupLabels': ['Condition 1', 'Condition 3']}, {'name': 'Cigarette 2', 'type': 'DRUG', 'description': 'Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)', 'armGroupLabels': ['Condition 2', 'Condition 4']}, {'name': 'Patch 1', 'type': 'DRUG', 'description': 'A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)', 'armGroupLabels': ['Condition 1', 'Condition 2']}, {'name': 'Patch 2', 'type': 'DRUG', 'description': 'A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)', 'armGroupLabels': ['Condition 3', 'Condition 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Adam M Leventhal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Illinois Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Preventive Medicine and Psychology, Director of the Health, Emotion, and Addiction Laboratory', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}