Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-08 @ 2:31 AM
Study NCT ID:
NCT02816034
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebellar Alterations in Individuals With a Cannabis Use Disorder
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': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Directional error of hand trajectories towards a target', 'timeFrame': '1 day (a single session)'}], 'secondaryOutcomes': [{'measure': 'Reaction times', 'timeFrame': '1 day (a single session)'}, {'measure': 'Intrinsic Motivational Inventory', 'timeFrame': '1 day (a single session)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Learning', 'Cerebellum'], 'conditions': ['Cannabis']}, 'referencesModule': {'references': [{'pmid': '20697860', 'type': 'BACKGROUND', 'citation': 'Taylor JA, Klemfuss NM, Ivry RB. An explicit strategy prevails when the cerebellum fails to compute movement errors. Cerebellum. 2010 Dec;9(4):580-6. doi: 10.1007/s12311-010-0201-x.'}, {'pmid': '16597717', 'type': 'BACKGROUND', 'citation': 'Mazzoni P, Krakauer JW. An implicit plan overrides an explicit strategy during visuomotor adaptation. J Neurosci. 2006 Apr 5;26(14):3642-5. doi: 10.1523/JNEUROSCI.5317-05.2006.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria.\n* Patients screen positive to cannabis in the urine analysis performed a week prior to assessment.\n* Right-handed patients.\n* Patients provide a signed consent.\n\nExclusion Criteria:\n\n* Patients with another current substance use disorder (with the exception of tobacco).\n* Patients with a visual impairment that has not been corrected.\n* Patients with a cognitive impairment such as mental retardation.\n* Patients with psychotic disorders.'}, 'identificationModule': {'nctId': 'NCT02816034', 'briefTitle': 'Cerebellar Alterations in Individuals With a Cannabis Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Pompeu Fabra'}, 'officialTitle': 'Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm', 'orgStudyIdInfo': {'id': 'CannabinoidsCerebellum'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Explicit', 'description': 'Cannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance', 'interventionNames': ['Behavioral: Visuo-motor rotation', 'Behavioral: Explicit strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Explicit', 'description': 'Healthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance', 'interventionNames': ['Behavioral: Visuo-motor rotation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Implicit', 'description': 'Cannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy', 'interventionNames': ['Behavioral: Visuo-motor rotation', 'Behavioral: Explicit strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Implicit', 'description': 'Healthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy', 'interventionNames': ['Behavioral: Visuo-motor rotation']}], 'interventions': [{'name': 'Visuo-motor rotation', 'type': 'BEHAVIORAL', 'description': 'Participant moves a cursor on a screen by sliding a pen over a digital tablet. Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed. In several block of trials, the mapping of the pen position to the cursor is rotated.', 'armGroupLabels': ['Control Explicit', 'Control Implicit', 'Experimental Explicit', 'Experimental Implicit']}, {'name': 'Explicit strategy', 'type': 'BEHAVIORAL', 'description': 'Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target', 'armGroupLabels': ['Experimental Explicit', 'Experimental Implicit']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Pompeu Fabra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': "Institut d'Investigacions Biomèdiques August Pi i Sunyer", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paul Verschure', 'investigatorAffiliation': 'Universitat Pompeu Fabra'}}}}