Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-28 @ 5:26 PM
Study NCT ID:
NCT01411566
Status:
UNKNOWN
Last Update Posted:
2011-08-08
First Post:
2011-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Intervention Psychosis and Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011934', 'term': 'mica'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance use', 'timeFrame': 'one year'}, {'measure': 'Substance use', 'timeFrame': '3 months'}, {'measure': 'Substance use', 'timeFrame': '6 months'}, {'measure': 'Change in drug use motivation', 'timeFrame': '3 months'}, {'measure': 'Change in drug use motivation', 'timeFrame': '6 months'}, {'measure': 'Change in drug use motivation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['KLIPS'], 'conditions': ['Psychosis', 'Substance Abuse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia\n* Addiction\n* Written statement of agreement\n* Majority\n\nExclusion Criteria:\n\n* Acute psychosis\n* Further neuropsychiatric disorder'}, 'identificationModule': {'nctId': 'NCT01411566', 'acronym': 'KLIPS', 'briefTitle': 'Clinical Intervention Psychosis and Addiction', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Evaluation of an Integrative Therapeutic Concept for Schizophrenic Patients With Comorbid Substance Use Disorder', 'orgStudyIdInfo': {'id': 'Koeln-Fortune 104/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Behavioral: Skills trainig for patients with dual diagnosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Behavioral: regular treatment']}], 'interventions': [{'name': 'Skills trainig for patients with dual diagnosis', 'type': 'BEHAVIORAL', 'description': 'Skills trainig for patients with dual diagnosis', 'armGroupLabels': ['Treatment']}, {'name': 'regular treatment', 'type': 'BEHAVIORAL', 'description': 'regular treatment', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51109', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joerg Daumann, PhD', 'role': 'CONTACT', 'email': 'joerg.daumann@uk-koeln.de', 'phone': '+49 221 478', 'phoneExt': '87113'}, {'name': 'Susanne Koenig, Diploma', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'LVR Clinic Cologne - Academic Clinic of the University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Joerg Daumann, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Joerg Daumann, PhD', 'oldOrganization': 'University of Cologne'}}}}