Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00218218
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2005-09-16', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking behavior (measured by automated topography)', 'timeFrame': 'after 5 hrs abstinence'}], 'secondaryOutcomes': [{'measure': 'Adverse events (measured by self-report throughout the study)', 'timeFrame': 'ongoing'}, {'measure': 'Nicotine withdrawal severity', 'timeFrame': 'after 5 hrs abstinence'}, {'measure': 'Smoking urge', 'timeFrame': 'after 5 hrs withdrawal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nicotine Dependence', 'Tobacco Dependence'], 'conditions': ['Schizophrenia and Disorders With Psychotic Features', 'Tobacco Use Disorder', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.', 'detailedDescription': 'Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokes between 20 and 50 cigarettes per day\n* Diagnosis of schizophrenia or schizoaffective disorder\n\nExclusion Criteria:\n\n* If enrolled in the control group, must not be diagnosed with a psychiatric disorder\n* Currently dependent on alcohol or any drug (other than nicotine)\n* Currently trying to quit smoking\n* Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin\n* History of liver disease\n* History of heart attacks or chest pain\n* Allergic to adhesives\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00218218', 'briefTitle': 'Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)', 'orgStudyIdInfo': {'id': 'NIDA-14002-1'}, 'secondaryIdInfos': [{'id': 'R01-14002-1'}, {'id': 'DPMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Transdermal nicotine, 42 mg', 'interventionNames': ['Drug: Transdermal Nicotine Patch']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Transdermal nicotine, 21 mg', 'interventionNames': ['Drug: 21 mg transdermal nicotine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'placebo patch', 'interventionNames': ['Drug: placebo patch']}], 'interventions': [{'name': 'Transdermal Nicotine Patch', 'type': 'DRUG', 'otherNames': ['nicotine patch'], 'description': '42 mg transdermal nicotine', 'armGroupLabels': ['1']}, {'name': '21 mg transdermal nicotine', 'type': 'DRUG', 'otherNames': ['nicotine patch'], 'armGroupLabels': ['2']}, {'name': 'placebo patch', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Jennifer W. Tidey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Jennifer W. Tidey', 'oldOrganization': 'Brown University'}}}}