Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 6:39 AM
Study NCT ID:
NCT01280968
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2010-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving the Efficacy of Anti-Nicotine Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000536', 'term': 'Aluminum Hydroxide'}, {'id': 'C041524', 'term': 'aluminum sulfate'}, {'id': 'C519280', 'term': 'nicotine Qbeta vaccine'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amukhin@duke.edu', 'phone': 'Telephone: 919-668-5055', 'title': 'Alexey G Mukhin, M.D., Ph.D.', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'The number of participants at risk is different from the number of enrolled participants because not all participants who were randomized to a vaccine or placebo received treatment. Of the 52 participants who were assigned to a treatment group, only 41 received at least one vaccination. Therefore, 41 participants were at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.', 'otherNumAtRisk': 36, 'otherNumAffected': 13, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Changes', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling Cold', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling Hot', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Runny Nose', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness at Injection Site', 'notes': 'At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'OG001', 'title': 'NIC002, Tertile With Highest Antibody Binding Capacity'}, {'id': 'OG002', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}], 'classes': [{'title': 'single cigarette puff', 'categories': [{'measurements': [{'value': '1', 'spread': '5', 'groupId': 'OG000'}, {'value': '-15', 'spread': '7', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'multiple cigarette puffs', 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-9', 'spread': '8', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '9.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'OG001', 'title': 'NIC002, Tertile With Highest Antibody Binding Capacity'}, {'id': 'OG002', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}], 'classes': [{'title': 'single cigarette puff', 'categories': [{'measurements': [{'value': '1', 'spread': '4', 'groupId': 'OG000'}, {'value': '-15', 'spread': '6', 'groupId': 'OG001'}, {'value': '0', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': 'multiple cigarette puffs', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-6', 'spread': '9', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '9.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'OG001', 'title': 'NIC002, Tertile With Highest Antibody Binding Capacity'}, {'id': 'OG002', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}], 'classes': [{'title': 'single cigarette puff', 'categories': [{'measurements': [{'value': '0', 'spread': '11', 'groupId': 'OG000'}, {'value': '15', 'spread': '30', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'multiple cigarette puffs', 'categories': [{'measurements': [{'value': '-2', 'spread': '4', 'groupId': 'OG000'}, {'value': '0', 'spread': '7', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '11.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'OG001', 'title': 'NIC002, Tertile With Highest Antibody Binding Capacity'}, {'id': 'OG002', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '9', 'spread': '30', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at week 1 and week 16', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'FG001', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unable to Follow Experimental Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Commuting Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Anxiety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pre-existing Neurological Condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to Smoke in Supine Position', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NIC002 Vaccine in Aluminum Hydroxide', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.'}, {'id': 'BG001', 'title': 'Placebo Vaccine - Aluminum Hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '56'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '55'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '56'}]}]}], 'paramType': 'MEAN', 'description': 'One participant reported that she was 54 at the screening, but after she was consented, it was discovered that she was actually 56. However, the subject was discontinued after the first study visit because she could not use the smoking delivery device; therefore, she received no vaccinations. Safety Event #14 was submitted to Duke IRB to account for this Protocol Deviation in which the subject was out of the age range.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cigarettes Per Day', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '30'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '30'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'description': 'average number of cigarettes participant smokes each day', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'FULL_RANGE'}, {'title': 'Pack-Years', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '45'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '32'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'description': 'pack-years that each participant has smoked, calculated by multiplying the number of packs of cigarettes participant smokes each day by number of years participant has smoked', 'unitOfMeasure': 'pack-years', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2010-11-16', 'resultsFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-29', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.'}, {'measure': 'Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.'}, {'measure': 'Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs', 'timeFrame': 'measured at week 1 and week 16', 'description': 'There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.'}, {'measure': 'Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff', 'timeFrame': 'measured at week 1 and week 16'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years old\n* Smoked an average of at least 10 cigarettes per day for the past year\n* Have an expired air Carbon Monoxide (CO) reading of at least 15 ppm\n* Express a desire to quit smoking in the next three to four months.\n* Potential subjects must agree to use acceptable contraception during their participation in this study.\n* Potential subjects must agree to avoid the following during their participation in this study:\n* participation in any other nicotine-related modification strategy outside of this protocol\n* use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco\n\n * use of experimental (investigational) drugs or devices;\n * use of illegal drugs;\n * use of psychiatric medications;\n * use of opiate medications;\n * use of systemic steroids or other immunosuppressive agents.\n\nExclusion Criteria:\n\n1. Hypertension (systolic \\>140 mm Hg, diastolic \\>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.\n2. Hypotension with symptoms (systolic \\<90 mm Hg, diastolic \\<60 mm Hg).\n3. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual\'s safety.\n4. Coronary heart disease or other cardiovascular disorder;\n5. Lifetime history of heart attack;\n6. Cardiac rhythm disorder (irregular heart rhythm);\n7. Chest pains (unless history, exam, and Electrocardiogram (ECG) clearly indicate a non-cardiac source);\n8. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);\n9. Liver or kidney disorder (except kidney stones, gallstones);\n10. Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;\n11. Active ulcers in the past 30 days;\n12. Lung disorder (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);\n13. Brain abnormality or other neurological disorder (including but not limited to stroke, brain tumor, and seizure disorder);\n14. Recent, unexplained fainting spells;\n15. Problems giving blood samples;\n16. Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);\n17. Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);\n18. Skin disorder;\n19. Autoimmune disease;\n20. Human immunodeficiency virus (HIV) or HIV risk behavior;\n21. Severe allergies;\n22. Other major medical condition;\n23. Current psychiatric disease including major depressive episode, panic attack, psychosis, bipolar disorder or eating disorder;\n24. Pregnant or nursing mothers;\n25. Use (within the past 30 days) of:\n\n * Illegal drugs (or if the urine drug screen is positive),\n * Experimental (investigational) drugs;\n * Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);\n * Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)\n * Smokeless tobacco (chewing tobacco, snuff), cigars, pipes or e-cigarettes;\n * Nicotine replacement therapy or any other smoking cessation aid.\n26. Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse.\n27. Previous history of negative experiences with "flu" vaccine or any other vaccine.\n28. High chronic exposure to aluminum (occupational or medical);\n29. Pulmonary function test results \\< 60% of predicted value for FEV1 and FVC;\n30. Body Mass Index \\> 38kg/m2;\n31. History of psychosis or bipolar disorder;\n32. Prior exposure to CTY002- NicQ or any other nicotine vaccine.'}, 'identificationModule': {'nctId': 'NCT01280968', 'acronym': 'PETNic002', 'briefTitle': 'Improving the Efficacy of Anti-Nicotine Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving the Efficacy of Anti-Nicotine Immunotherapy', 'orgStudyIdInfo': {'id': 'Pro00019787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIC002 Vaccine in Aluminum hydroxide', 'description': '4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.', 'interventionNames': ['Biological: NIC002 in Aluminum hydroxide (Alum)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Vaccine - Aluminum hydroxide', 'description': '4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.', 'interventionNames': ['Biological: Placebo Vaccine - Aluminum hydroxide']}], 'interventions': [{'name': 'NIC002 in Aluminum hydroxide (Alum)', 'type': 'BIOLOGICAL', 'otherNames': ['CYT002-NicQb (Nicotine-Qbeta)', 'Anti-Nicotine Vaccine'], 'description': 'Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.', 'armGroupLabels': ['NIC002 Vaccine in Aluminum hydroxide']}, {'name': 'Placebo Vaccine - Aluminum hydroxide', 'type': 'BIOLOGICAL', 'description': 'Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.', 'armGroupLabels': ['Placebo Vaccine - Aluminum hydroxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Nicotine & Smoking Cessation Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Alexey G Mukhin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexey Mukhin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Behavioral Science', 'investigatorFullName': 'Alexey Mukhin', 'investigatorAffiliation': 'Duke University'}}}}