Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00699556
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2007-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sherry.mckee@yale.edu', 'phone': '(203) 737-3529', 'title': 'Sherry McKee', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Patch+Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patch+Placebo Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate > 100', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/light headed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyes watering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hands or feet cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Drinks Consumed During an Ad-libitum Drinking Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Patch+Nicotine Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.'}, {'id': 'OG001', 'title': 'Nicotine Patch+Placebo Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '2.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two hour ad-libitum drinking period during laboratory session', 'description': 'Participants are presented with alcohol beverages and allowed to drink at their leisure.', 'unitOfMeasure': 'drinks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Craving for Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Patch+ Nicotine Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.'}, {'id': 'OG001', 'title': 'Nicotine Patch+Placebo Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.75', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '17.03', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first measurement during laboratory session (+60 minutes after beginning of laboratory session)', 'description': 'Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)\n\nThe nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.\n\nOr\n\nWithin subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale.'}, {'id': 'FG001', 'title': 'Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)\n\nThe nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.\n\nOr\n\nWithin subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale.'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\n1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)\n\nThe nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.\n\nOr\n\nWithin subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.\n\n21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch\n\nplacebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2007-12-25', 'resultsFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-12', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Drinks Consumed During an Ad-libitum Drinking Period', 'timeFrame': 'Two hour ad-libitum drinking period during laboratory session', 'description': 'Participants are presented with alcohol beverages and allowed to drink at their leisure.'}], 'secondaryOutcomes': [{'measure': 'Craving for Alcohol', 'timeFrame': 'first measurement during laboratory session (+60 minutes after beginning of laboratory session)', 'description': 'Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcohol', 'nicotine', 'smoking cessation', 'smoking cessation medications'], 'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 21 and over\n* Able to read and write in English\n* Smoker\n* Heavy drinker\n\nExclusion Criteria:\n\n* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine\n* Significant hepatocellular injury\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* Prescription of any psychotropic drug in the 30 days prior to study enrollment\n* Blood donation within the past 8 weeks\n* Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months\n* Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis\n* Specific exclusions for administration of nicotine patch not specified above including history of dermatoses\n* Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray\n* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study'}, 'identificationModule': {'nctId': 'NCT00699556', 'briefTitle': 'Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy', 'orgStudyIdInfo': {'id': 'HIC0508000486'}, 'secondaryIdInfos': [{'id': 'R01AA015596', 'link': 'https://reporter.nih.gov/quickSearch/R01AA015596', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patch+spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.', 'interventionNames': ['Drug: 21mg transdermal nicotine patch (Nicoderm CQ)', 'Drug: 1mg nicotine nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'patch+placebo spray', 'description': 'Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.', 'interventionNames': ['Drug: 21mg transdermal nicotine patch (Nicoderm CQ)', 'Drug: placebo nasal spray']}], 'interventions': [{'name': '21mg transdermal nicotine patch (Nicoderm CQ)', 'type': 'DRUG', 'otherNames': ['Nicoderm CQ'], 'description': '21mg transdermal nicotine patch', 'armGroupLabels': ['patch+placebo spray', 'patch+spray']}, {'name': '1mg nicotine nasal spray', 'type': 'DRUG', 'description': 'two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.', 'armGroupLabels': ['patch+spray']}, {'name': 'placebo nasal spray', 'type': 'DRUG', 'description': 'saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.', 'armGroupLabels': ['patch+placebo spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Mental Health Center & Yale-New Haven Hospital', '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 Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Sherry McKee', 'investigatorAffiliation': 'Yale University'}}}}