Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00279604
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2006-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INCA - Intervention and Neuropsychology in Cannabis Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2006-01-18', 'studyFirstSubmitQcDate': '2006-01-18', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannabis consumption,'}, {'measure': 'motivational change'}], 'secondaryOutcomes': [{'measure': 'ASSIST-Score'}]}, 'conditionsModule': {'conditions': ['Marijuana Abuse']}, 'descriptionModule': {'briefSummary': "INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research goals. One is to study efficacy of a short intervention the 'Problem Profile Intervention', which utilizes individual feedback from a 'substance problem check-up'. Subjects will randomly receive the 'Problem Profile Intervention' or the WHO Brief Intervention, a brief intervention, which has been shown to be efficacious. Currently efficiency studies are under way. The WHO Brief Intervention has been translated into German by our group. In contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of them will randomly receive either the Problem Profile Intervention or the WHO Brief Intervention (active control). A total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). Intervention outcome will be assessed three months, six month and 12 months after the intervention. We hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The second aim of the study is to study mechanism of substance abuse. Initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004; Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: Decision-making capability, or risk-taking behaviour, respectively (e.g. Ernst and Paulus, 2005)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASSIST-Score for cannabis consume ≥ 4 ≤ 26\n* german mother tongue (or comparable level)\n\nExclusion Criteria:\n\n* major current psychiatric disorder (e.g. psychosis)\n* addiction to other illegal drugs or alcohol\n* recent or current intravenous drug use\n* CNS-affecting medication\n* current psychotherapy, other treatment for substance use disorder\n\nexclusion criteria for fMRI-part:\n\n* left-handedness\n* medication (birth control pill, thyroid gland hormones possible)\n* internistic illnesses (hypertension, diabetes, diseases of lungs)\n* metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos)\n* history of serious trauma\n* claustrophobia\n* gestation'}, 'identificationModule': {'nctId': 'NCT00279604', 'briefTitle': 'INCA - Intervention and Neuropsychology in Cannabis Abuse', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)', 'orgStudyIdInfo': {'id': '01EB0432'}}, 'armsInterventionsModule': {'interventions': [{'name': "'Problem Profile Intervention' vs. WHO-Brief Intervention", 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53105', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian G Schütz, MD MPH', 'role': 'CONTACT', 'email': 'christian.schütz@ukb.uni-bonn.de', 'phone': '+49 228 2879664'}, {'name': 'Christian G Schütz, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Friedrich-Wilhelms-University, Department of Psychiatry', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Norbert Scherbaum, MD', 'role': 'CONTACT', 'email': 'norbert.scherbaum@uni-essen.de', 'phone': '+49 201 7227 180'}, {'name': 'Norbert Scherbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Essen, Department of Psychiatry and Psychotherapy', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Christian G Schuetz, MD MPH', 'role': 'CONTACT', 'email': 'christian.schütz@ukb.uni-bonn.de', 'phone': '+49 228 287 9664'}], 'overallOfficials': [{'name': 'Christian G Schuetz, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bonn, Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}]}}}