Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-03 @ 1:00 AM
Study NCT ID:
NCT01315002
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Effects on Endophenotypes of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.wagner@uni-bonn.de', 'phone': '004922828716377', 'title': 'Prof. Dr. Michael Wagner', 'organization': 'University Hospital Bonn, Department of Psychiatry and Psychotherapy'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 years, 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine First, Then Placebo', 'description': 'Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)\n\nDoses:\n\nnon-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch', 'otherNumAtRisk': 61, 'otherNumAffected': 5, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo First, Then Nicotine', 'description': 'Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)\n\nDoses:\n\nnon-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch', 'otherNumAtRisk': 60, 'otherNumAffected': 5, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Error Percentage in Antisaccade Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Patch', 'description': 'Transdermal nicotine patch\n\nTransdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch\n\nPlacebo patch: Placebo patch'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Three hours after patch application', 'description': 'Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.', 'unitOfMeasure': 'Error Percentage in Antisaccade Task', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine First, Then Placebo', 'description': 'Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)\n\nDoses:\n\nnon-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch'}, {'id': 'FG001', 'title': 'Placebo First, Then Nicotine', 'description': 'Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)\n\nDoses:\n\nnon-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.23', 'spread': '9.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2011-03-14', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-07', 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Error Percentage in Antisaccade Task', 'timeFrame': 'Three hours after patch application', 'description': 'Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nicotine', 'schizophrenia', 'endophenotype'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of nicotine on cognition with the following schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected first-degree relatives of schizophrenia patients and healthy controls receive transdermal nicotine in a double-blind, placebo-controlled, crossover study.', 'detailedDescription': 'Convergent findings suggest that an altered neuronal nicotinic acetylcholine receptor system may contribute to the pathophysiology of schizophrenia. Nicotine consumption through cigarette smoking might represent a form of self-medication in schizophrenia as nicotine reduces cognitive and physiological deficits in schizophrenia. The present study aims to investigate how nicotine affects attentional and executive schizophrenia endophenotypes and how genetic polymorphisms relating to the cholinergic system might play a role in inter-individual differences in the magnitude of nicotine effects.\n\nSchizophrenia patients, first-degree relatives of schizophrenia patients as well as healthy controls will receive transdermal nicotine in a double-blind, placebo-controlled, crossover study and will be assessed with prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task. Subjects will be overnight-abstinent smokers and non-smokers. However, the investigators will particularly test non-smokers in order to eliminate confounding effects of nicotine withdrawal and reinstatement.\n\nMain hypotheses:\n\n* Schizophrenia patients will perform worse than matched controls in all cognitive tests (validating our endophenotypes).\n* Nicotine administration will enhance cognitive performance in overnight-abstinent smokers.\n* Improvement of cognitive performance in smokers with schizophrenia will be stronger than in control smokers.\n* Improvement of cognitive performance in smoking first-degree relatives of schizophrenia patients will be stronger than in control smokers.\n* Nicotine administration will affect cognitive functioning in non-smoking subjects.\n* Nicotine administration will improve cognitive functioning in non-smoking schizophrenia patients.\n* The effects of nicotine in non-smoking subjects are stronger in those subjects who are cognitively more impaired (i.e. performing below the median of the respective group).\n\nThe present research contributes to the issue whether nicotinic cholinergic receptor agonists may have therapeutic value in the treatment of cognition in schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia\n* age 18-55 years old\n* able to provide informed consent\n* treated with antipsychotic medications at a stable dose for at least 6 weeks\n* normal or corrected to normal vision\n* smokers (Fagerström Test for Nicotine Dependence \\> 4)\n* non-smokers (\\< 100 cigarettes/lifetime, not having smoked in the past year)\n\nControls:\n\n* age 18-55 years old\n* able to provide informed consent\n* normal or corrected to normal vision\n* smokers (Fagerström Test for Nicotine Dependence \\> 4)\n* non-smokers (\\< 100 cigarettes/lifetime, not having smoked in the past year)\n\nUnaffected First-Degree Relatives of Schizophrenia Patients:\n\n* same inclusion criteria as controls plus\n* having an adult first-degree relative (sibling, parent, child) with a DSM IV diagnosis of schizophrenia\n\nExclusion Criteria:\n\nPatients:\n\n* substance dependence\n* clinical instability\n* changes in medication in the last 6 weeks\n* anticholinergic medication\n* untreated hypertension\n* cardiovascular disease\n* insulin-dependent diabetes mellitus\n* phaeochromocytoma\n* uncontrolled hyperthyroidism\n* renal or hepatic impairment\n* central nervous system disease\n* pulmonary disease\n* generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)\n* gastric or intestinal ulcer\n* hypersensitivity to nicotine\n* allergy to patches\n* women: pregnancy, lactation\n\nControls:\n\n* substance dependence\n* having a first-, second-, or third-degree relative with a psychotic disorder\n* DSM IV Axis I disorder\n* anticholinergic medication\n* untreated hypertension\n* cardiovascular disease\n* insulin-dependent diabetes mellitus\n* phaeochromocytoma\n* uncontrolled hyperthyroidism\n* renal or hepatic impairment\n* central nervous system disease\n* pulmonary disease\n* generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)\n* gastric or intestinal ulcer\n* hypersensitivity to nicotine\n* allergy to patches\n* women: pregnancy, lactation\n\nUnaffected First-Degree Relatives of Schizophrenia Patients:\n\n* same exclusion criteria as controls'}, 'identificationModule': {'nctId': 'NCT01315002', 'briefTitle': 'Nicotine Effects on Endophenotypes of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Nicotine Effects on Endophenotypes of Schizophrenia', 'orgStudyIdInfo': {'id': 'NICSZ001'}, 'secondaryIdInfos': [{'id': '2008-001362-90', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Patch', 'description': 'Transdermal nicotine patch', 'interventionNames': ['Drug: Transdermal nicotine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo patch', 'description': 'Placebo patch', 'interventionNames': ['Drug: Placebo patch']}], 'interventions': [{'name': 'Transdermal nicotine patch', 'type': 'DRUG', 'otherNames': ['NiQuitin Clear, GlaxoSmithKline Germany'], 'description': '7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)', 'armGroupLabels': ['Nicotine Patch']}, {'name': 'Placebo patch', 'type': 'DRUG', 'otherNames': ['band-aid by Fink and Walter GmbH, Germany'], 'description': 'Placebo patch', 'armGroupLabels': ['Placebo patch']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Wagner, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bonn'}, {'name': 'Wolfgang Maier, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bonn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Nadine Petrovsky', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}