Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 7:49 AM
Study NCT ID:
NCT00773357
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2008-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modeling Stress-precipitated Smoking Behavior for Medication Development
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016316', 'term': 'Guanfacine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sherry.mckee@yale.edu', 'phone': '2037373529', 'title': 'Sherry McKee', 'organization': 'Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Titration period of 21 days', 'eventGroups': [{'id': 'EG000', 'title': 'Guanfacine', 'description': 'guanfacine 3mg/day\n\nguanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 35, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo control\n\nplacebo: placebo', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 12, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impotence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Latency to Initiate Ad-lib Smoking Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Guanfacine', 'description': 'guanfacine 3mg/day\n\nguanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo control\n\nplacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '31.55', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '30.31', 'spread': '5.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '50 minutes', 'description': 'latency to initiate smoking (in minutes) during a 50-minute period.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Guanfacine', 'description': 'guanfacine 3mg/day\n\nguanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo control\n\nplacebo: placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Guanfacine', 'description': 'guanfacine 3mg/day\n\nguanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo control\n\nplacebo: placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.36', 'spread': '10.05', 'groupId': 'BG000'}, {'value': '36.92', 'spread': '11.73', 'groupId': 'BG001'}, {'value': '36.14', 'spread': '10.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cigarettes per day', 'classes': [{'categories': [{'measurements': [{'value': '15.44', 'spread': '7.58', 'groupId': 'BG000'}, {'value': '15.12', 'spread': '8.11', 'groupId': 'BG001'}, {'value': '15.28', 'spread': '7.845', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-31', 'size': 111132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-07T14:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2008-10-14', 'resultsFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-07', 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency to Initiate Ad-lib Smoking Session', 'timeFrame': '50 minutes', 'description': 'latency to initiate smoking (in minutes) during a 50-minute period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking lapse behavior', 'guanfacine'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ages 18-60\n* able to read and write in English\n* smokers\n\nExclusion Criteria:\n\n* any significant current medical conditions that would contraindicate smoking\n* current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence\n* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines\n* women who are pregnant or nursing\n* suicidal, homicidal or evidence of severe mental illness\n* participants prescribed any psychotropic drug in the 30 days prior to study enrollment\n* blood donation within the past 6 weeks\n* participants who have engaged in a quit attempt in the past 3 months\n* specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \\>450 msec for men and QTc\\>470 msec for women; known intolerance for guanfacine"}, 'identificationModule': {'nctId': 'NCT00773357', 'briefTitle': 'Modeling Stress-precipitated Smoking Behavior for Medication Development', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Modeling Stress-precipitated Smoking Behavior for Medication Development', 'orgStudyIdInfo': {'id': '0808004163'}, 'secondaryIdInfos': [{'id': 'RL1DA024857', 'link': 'https://reporter.nih.gov/quickSearch/RL1DA024857', 'type': 'NIH'}, {'id': 'P50DA033945', 'link': 'https://reporter.nih.gov/quickSearch/P50DA033945', 'type': 'NIH'}, {'id': 'P01AA027473', 'link': 'https://reporter.nih.gov/quickSearch/P01AA027473', 'type': 'NIH'}, {'id': 'U54AA027989', 'link': 'https://reporter.nih.gov/quickSearch/U54AA027989', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guanfacine', 'description': 'guanfacine 3mg/day', 'interventionNames': ['Drug: guanfacine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo control', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'guanfacine', 'type': 'DRUG', 'otherNames': ['Tenex'], 'description': '3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.', 'armGroupLabels': ['Guanfacine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Center for Clinical Investigation, Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Sherry A McKee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': "Office of Research on Women's Health (ORWH)", 'class': 'NIH'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Sherry McKee', 'investigatorAffiliation': 'Yale University'}}}}