Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT00270803
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2005-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-06', 'studyFirstSubmitDate': '2005-12-25', 'studyFirstSubmitQcDate': '2005-12-25', 'lastUpdatePostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain metabolic activity (FDG)', 'timeFrame': '30-40 minutes'}], 'secondaryOutcomes': [{'measure': 'Reaction time (RTs) and errors in performance', 'timeFrame': '40 minutes'}, {'measure': 'Subjective ratings on visual analog scale', 'timeFrame': '10 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Marijuana, FDG, PET, maze, THC, motor coordination.'], 'conditions': ['Marijuana Dependence']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).', 'detailedDescription': 'This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Marijuana dependence\n* Age 20-65\n* Male and female\n\nExclusion Criteria:\n\n* Pregnant women\n* Dependence on other substances\n* Psychiatric diagnosis apart from marijuana dependence\n* Neurological disorder\n* Young persons'}, 'identificationModule': {'nctId': 'NCT00270803', 'briefTitle': 'The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.', 'orgStudyIdInfo': {'id': 'TASMC-05-EE-03-124-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Low nicotine cigarettes without THC', 'interventionNames': ['Drug: Tetra Hydro Cannabinol (THC)']}], 'interventions': [{'name': 'Tetra Hydro Cannabinol (THC)', 'type': 'DRUG', 'otherNames': ['Marijuana, cannabis'], 'description': 'Oral THC 13mg and 17mg smoked in low nicotine cigarettes', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Department of Nuclear Medicine', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Aviv M Weinstein, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sourasky Medical Center'}, {'name': 'Einat Even-Sapir, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hadassah Medical Organization', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Michal Roll', 'oldOrganization': 'Sourasky Medical Center Tel Aviv'}}}}