Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:39 AM
Study NCT ID:
NCT00996034
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2009-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Vaccination and Nicotinic Receptor Occupancy
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': 'C557119', 'term': 'NicVAX'}, {'id': 'C426745', 'term': '5-iodo-3-(2-azetidinylmethoxy)pyridine'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'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': 'irina.esterlis@yale.edu', 'phone': '203-932-5711', 'title': 'Irina Esterlis, Ph.D.', 'phoneExt': '3109', 'organization': 'Yale University'}, 'certainAgreement': {'otherDetails': 'The sponsor has 30 days to approve anything that PI would like to publish and/or present', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Smoker', 'description': 'Healthy smokers with nicotine dependence\n\nNicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days\n\n\\[123I\\]5-IA-85380 : up to 10 mCi of \\[123I\\]5-IA-85380, I.V. on each of two SPECT Scan days\n\nNicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean of the Average Nicotine Binding % at Scan 1 and Scan 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Smoker', 'description': 'Healthy smokers with nicotine dependence\n\nNicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days\n\n\\[123I\\]5-IA-85380 : up to 10 mCi of \\[123I\\]5-IA-85380, I.V. on each of two SPECT Scan days\n\nNicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies'}], 'classes': [{'title': 'Scan 1', 'categories': [{'measurements': [{'value': '54.9', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Scan 2', 'categories': [{'measurements': [{'value': '49.1', 'spread': '10.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'This is a comparison of scan 1 and scan 2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.", 'unitOfMeasure': 'percentage of average nicotine binding', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Smoker', 'description': 'Healthy smokers with nicotine dependence\n\nNicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days\n\n\\[123I\\]5-IA-85380 : up to 10 mCi of \\[123I\\]5-IA-85380, I.V. on each of two SPECT Scan days\n\nNicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'withdrawn by PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment in to the study ended in Feb. 2011. Subjects were screened and recruited from the VA West Haven, CT.', 'preAssignmentDetails': 'Several possible subject were not enrolled in to the study because of the exclusion/inclusion criteria, such as allergies to medications, high blood pressure, or SCID II diagnosis'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Smoker', 'description': 'Healthy smokers with nicotine dependence\n\nNicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days\n\n\\[123I\\]5-IA-85380 : up to 10 mCi of \\[123I\\]5-IA-85380, I.V. on each of two SPECT Scan days\n\nNicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.15', 'spread': '8.33', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2009-10-14', 'resultsFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-19', 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of the Average Nicotine Binding % at Scan 1 and Scan 2', 'timeFrame': '3 months', 'description': "nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nicotine, SPECT, vaccine, receptor'], 'conditions': ['Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '23429725', 'type': 'DERIVED', 'citation': "Esterlis I, Hannestad JO, Perkins E, Bois F, D'Souza DC, Tyndale RF, Seibyl JP, Hatsukami DM, Cosgrove KP, O'Malley SS. Effect of a nicotine vaccine on nicotine binding to beta2*-nicotinic acetylcholine receptors in vivo in human tobacco smokers. Am J Psychiatry. 2013 Apr;170(4):399-407. doi: 10.1176/appi.ajp.2012.12060793."}]}, 'descriptionModule': {'briefSummary': 'This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker.\n\nIn this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.', 'detailedDescription': 'The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist \\[123I\\]5-IA-85380 (\\[123I\\]5-IA) and single photon emission computed tomography (SPECT). \\[123I\\]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (\\~6 hours into the \\[123I\\]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second \\[123I\\]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current smoker who smokes at least 10-25 cigarettes a day\n* Good general health\n\nExclusion Criteria:\n\n* Subjects with a pacemaker or other ferromagnetic material in body.\n* Prior exposure to NicVAX or any other nicotine vaccine.\n* Use of systemic steroids or other immunosuppressive agent\n* History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness\n* Cancer or cancer treatment in last 5 years\n* HIV infection\n* Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin), within 30 days prior to administration of NicVAX and for the duration of the study.\n* Inability to fulfill all visits and examination procedures for approximately 20 weeks.'}, 'identificationModule': {'nctId': 'NCT00996034', 'briefTitle': 'Nicotine Vaccination and Nicotinic Receptor Occupancy', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': '123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine', 'orgStudyIdInfo': {'id': '0804003655'}, 'secondaryIdInfos': [{'id': 'R21DA024388', 'link': 'https://reporter.nih.gov/quickSearch/R21DA024388', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Smoker', 'description': 'There is only one arm to the study. All subjects will receive NicVax, \\[123I\\]5-I-A-85380,and Nicotine bitartrate.', 'interventionNames': ['Biological: NicVAX', 'Radiation: [123I]5-IA-85380', 'Drug: Nicotine bitartrate']}], 'interventions': [{'name': 'NicVAX', 'type': 'BIOLOGICAL', 'otherNames': ['Nicotine Conjugate Vaccine'], 'description': '1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies', 'armGroupLabels': ['Healthy Smoker']}, {'name': '[123I]5-IA-85380', 'type': 'RADIATION', 'otherNames': ['5-IA'], 'description': 'up to 10 mCi of \\[123I\\]5-IA-85380, I.V. on each of two SPECT Scan days', 'armGroupLabels': ['Healthy Smoker']}, {'name': 'Nicotine bitartrate', 'type': 'DRUG', 'otherNames': ['IV nicotine'], 'description': '0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days', 'armGroupLabels': ['Healthy Smoker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Veterans Association Connecticut Hospital System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Irina Esterlis, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nabi Biopharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}