Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01237834
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Responses in Tobacco Chippers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroencephalography', 'timeFrame': 'Changes from baseline during a hard cognitive task', 'description': 'Electroencephalography will be measured during performance on a hard cognitive task.'}], 'secondaryOutcomes': [{'measure': 'Salivary cortisol', 'timeFrame': 'Changes from baseline during performance on a hard cognitive task', 'description': 'Salivary cortisol will be measured at baseline, during a hard cognitive task and 30 minutes after the cognitive task.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking', 'Stress']}, 'descriptionModule': {'briefSummary': 'This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults\n* age 25-55\n\nExclusion Criteria:\n\n* alcohol or drug addiction\n* unstable significant medical problems\n* neurologic disease\n* medications known to affect CNS function or impact physiologic parameters measured in the study\n* significant visual impairment\n* breath carbon monoxide (BCO) level of less than 10 ppm for smokers\n* breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers\n* for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)'}, 'identificationModule': {'nctId': 'NCT01237834', 'briefTitle': 'Physiological Responses in Tobacco Chippers', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)', 'orgStudyIdInfo': {'id': 'IRB6698'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heavy smokers, 15 or more cigarettes/day', 'description': 'Nicotine dependent.'}, {'label': 'Light smokers (chippers)', 'description': 'Less than 2 cigarettes/day, at least 2 days/week. Non nicotine-dependent.'}, {'label': 'Non smokers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Barry Oken', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Laura Carim Todd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Barry S. Oken', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}