Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-02 @ 9:33 PM
Study NCT ID:
NCT00952393
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2009-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotinic Receptors and Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071184', 'term': 'Pharmacogenomic Variants'}, {'id': 'C088936', 'term': '3-(2,4-dimethoxybenzylidene)anabaseine'}], 'ancestors': [{'id': 'D011110', 'term': 'Polymorphism, Genetic'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Robert.Freedman@ucdenver.edu', 'phone': '3037244940', 'title': 'Dr. Robert Freedman', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 24 hours.', 'description': 'Subjects were questioned every hour for 8 hours and then 24 later, after administration of drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Pharmacokinetic', 'description': 'This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.\n\nPharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Levels of Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic', 'description': 'This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.\n\nPharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours', 'description': 'This is the plasma level of the drug as determined by high performance liquid chromatography.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is all participants in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pharmacokinetic', 'description': 'This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.\n\nPharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '10', 'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacokinetic', 'description': 'This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.\n\nPharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age in years as determine by asking the subject when their birthdate is.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This is gender or sex as determined by inquiry from the subjects', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'We ask the subjects to report their ethnicity.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'This is the area from which all the subjects come.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This is a collection of volunteers from the health science community who responded to approved advertisements.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2009-08-03', 'resultsFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2009-08-04', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-06', 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Levels of Drug', 'timeFrame': '12 hours', 'description': 'This is the plasma level of the drug as determined by high performance liquid chromatography.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['receptors nicotinic'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.', 'detailedDescription': '3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers: males and females who are incapable of pregnancy\n\nExclusion Criteria:\n\n* Medical illnesses requiring acute treatment\n* History of seizures\n* Substance abuse including nicotine'}, 'identificationModule': {'nctId': 'NCT00952393', 'briefTitle': 'Nicotinic Receptors and Schizophrenia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Nicotinic Receptors and Schizophrenia', 'orgStudyIdInfo': {'id': 'MHBB-005-09S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pharmacokinetic', 'description': 'This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.', 'interventionNames': ['Drug: Pharmacokinetic']}], 'interventions': [{'name': 'Pharmacokinetic', 'type': 'DRUG', 'otherNames': ['GTS-21'], 'description': 'Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined', 'armGroupLabels': ['Pharmacokinetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA Eastern Colorado Health Care System, Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Robert Freedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Eastern Colorado Health Care System, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}