Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT03581058
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Correlates of Driving and Cannabis
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neural activation on fMRI during driving simulation', 'timeFrame': '30-60 min after cannabis intake vs sober', 'description': 'Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.'}], 'secondaryOutcomes': [{'measure': 'Performance on driving simulator', 'timeFrame': '30-60 min after cannabis intake vs sober', 'description': 'Number of errors while completing driving tasks (e.g. turning, driving straight, speed maintenance, missed stop signs, etc.) under the influence of cannabis and sober.'}, {'measure': 'Performance on cognitive tasks', 'timeFrame': '60-90 min after cannabis intake vs sober', 'description': 'Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.'}, {'measure': 'Blood plasma concentration levels of cannabinoids', 'timeFrame': '10 min and 60 min after cannabis intake', 'description': 'Concentration levels of THC and CBD throughout the session duration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Cannabis', 'Driving'], 'conditions': ['Cannabis Use', 'Driving Impaired']}, 'descriptionModule': {'briefSummary': "Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision.\n\nThe current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers.\n\nThe goals of the study are:\n\n1. identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;\n2. compare participant's performance on cognitive tasks while under the influence of cannabis and sober;\n3. look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;\n4. correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* valid driver's license\n* have normal or corrected-to-normal vision\n* have had prior experience consuming cannabis\n* are currently not and have not been regular users in the past 5 years (regular use is defined as at least 1 time per week for at least 1 month)\n* prescribed medical cannabis\n\nExclusion Criteria:\n\n* not fluent in English\n* do not meet MRI screening criteria\n* use 50 mg/day of morphine equivalents\n* history of neurological, neurodegenerative or psychiatric diseases\n* any serious sensory or motor impairments\n* pregnant women or women trying to get pregnant, or breastfeeding\n* serious lung, liver, kidney, and heart problems, including angina, coronary artery disease, and arrhythmia, and Peripheral Vascular Disease\n* personal or family history of mental disorders or alcohol or drug abuse or dependence"}, 'identificationModule': {'nctId': 'NCT03581058', 'briefTitle': 'Neural Correlates of Driving and Cannabis', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Investigating the Neural Correlates of Driving After Medical Cannabis Exposure', 'orgStudyIdInfo': {'id': '17-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabis - Jean Guy', 'description': 'A participant will be administered 1g of Jean Guy strain of cannabis.', 'interventionNames': ['Drug: Cannabis']}, {'type': 'EXPERIMENTAL', 'label': 'Cannabis - Churchill', 'description': 'A participant will be administered 1g of Churchill strain of cannabis.', 'interventionNames': ['Drug: Cannabis']}, {'type': 'NO_INTERVENTION', 'label': 'Sober', 'description': 'All participants will complete same tasks sober.'}], 'interventions': [{'name': 'Cannabis', 'type': 'DRUG', 'otherNames': ['Marijuana'], 'description': 'Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.', 'armGroupLabels': ['Cannabis - Churchill', 'Cannabis - Jean Guy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Tom Schweizer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}