Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01625767
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2012-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tobacco Approach Avoidance Training for Adolescent Smokers-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'automatic approach tendencies towards smoking-related stimuli', 'timeFrame': 'at end of AAT at Day 1', 'description': 'For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expect that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.'}, {'measure': 'automatic approach tendencies towards smoking-related stimuli', 'timeFrame': 'at end of AAT at Day 8', 'description': 'For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.'}, {'measure': 'automatic approach tendencies towards smoking-related stimuli', 'timeFrame': 'at end of AAT at Day 15', 'description': 'For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.'}, {'measure': 'automatic approach tendencies towards smoking-related stimuli', 'timeFrame': 'at end of AAT at Day 22', 'description': 'For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.'}, {'measure': 'automatic approach tendencies towards smoking-related stimuli', 'timeFrame': 'at end of AAT at Day 29', 'description': 'For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nicotine', 'Smoking', 'Adolescent', 'Tobacco'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://try.yale.edu', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias towards tobacco-related stimuli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 13-18 years\n* Able to read and write in English.\n* Smokers: Smoking 5 or more cigarettes daily for at least 6 months; Baseline urine cotinine levels \\> 500 ng/ml\n* Nonsmokers: Never smokers; Baseline urine cotinine levels \\< 50 ng/ml\n\nExclusion Criteria:\n\n* Current criteria for dependence on another psychoactive substance\n* Current diagnosis of psychosis, major depression or panic disorder\n* Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable\n* Pregnant or lactating girls, based on self report.'}, 'identificationModule': {'nctId': 'NCT01625767', 'acronym': 'AAT-1', 'briefTitle': 'Tobacco Approach Avoidance Training for Adolescent Smokers-1', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1', 'orgStudyIdInfo': {'id': '1103008127-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Approach Avoidance Task experiment', 'description': 'Approach Avoidance Task experiment', 'interventionNames': ['Behavioral: AAT experiment']}], 'interventions': [{'name': 'AAT experiment', 'type': 'BEHAVIORAL', 'description': 'Smokers and nonsmokers complete AAT experiment', 'armGroupLabels': ['Approach Avoidance Task experiment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University, School of Medicine, Dpeartment of Psychiatry', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Suchitra Krishnan-Sarin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'VU University of Amsterdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Suchitra Krishnan-Sarin', 'investigatorAffiliation': 'Yale University'}}}}