Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 12:12 AM
Study NCT ID:
NCT06322303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cannabidiol (CBD) on Vision and Driving
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'To obtain the ODPS, Z-scores were calculated from individual parameters such as the standard deviation of the lateral lane position or the distance travelled into the opposite lane. The z-score is defined as a measure of how many standard deviations an individual value is below or above the group mean. The average Z-score of the individual driving variables is called the ODPS.'}, {'measure': 'Change in motion detection sensitivity after cannabidiol vaporization', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'The subject has to indicate the direction of movement of a pattern of moving dots. The percentage of correct answers is obtained for different degrees of coherence.'}, {'measure': 'Change in contrast sensitivity after cannabidiol vaporization', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'Contrast thresholds are obtained for different spatial frequencies'}, {'measure': 'Change in visual acuity after cannabidiol vaporization', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'Visual acuity is assessed with a commercial test for distance vision.'}, {'measure': 'Change in fixations after cannabidiol vaporization', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'The number of fixations made on different stimuli of interest in a task environment is counted using an eye tracker system.'}], 'secondaryOutcomes': [{'measure': 'Driving simulator: standard deviation of the lateral lane position (SDLP)', 'timeFrame': 'Participants are assessed 20 minutes after vaporization'}, {'measure': 'Distance travelled outside the lane', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': "The SDLP assesses the lane weaving that the subject performs in the lane and indicates whether the vehicle's position is consistent."}, {'measure': 'Mean speed', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': 'Average speed is obtained and analyzed in relation to the speed limits for different sections.'}, {'measure': 'Angular velocity of the steering wheel', 'timeFrame': 'Participants are assessed 20 minutes after vaporization', 'description': "The angular velocity of the steering wheel is a metric that indicates the subject's ability to maintain the vehicle's position."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabis', 'cannabidiol', 'vision', 'driving performance'], 'conditions': ['Cannabis Use']}, 'descriptionModule': {'briefSummary': 'The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being an occasional cannabis and/or cannabidiol user\n* Have a current driving licence\n* Have at least one year's driving experience\n* Drive at least once a week\n* Monocular visual acuity of at least 6/6 (Snellen) with habitual correction for driving\n* Absence of binocular disorders\n\nExclusion criteria:\n\n* Certain past or present medical conditions\n* Current cannabis or alcohol use disorder\n* Use of other drugs\n* Pregnancy or lactation\n* Simulator sickness."}, 'identificationModule': {'nctId': 'NCT06322303', 'briefTitle': 'Effect of Cannabidiol (CBD) on Vision and Driving', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effect of Cannabidiol (CBD) Consumption on Visual Function and Driving Performance', 'orgStudyIdInfo': {'id': 'C-EXP-194-UGR23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (CBD 0%)', 'description': 'Participants are required to vaporize a placebo at 0% CBD concentration', 'interventionNames': ['Other: Placebo (CBD 0%)']}, {'type': 'EXPERIMENTAL', 'label': 'CBD 15%', 'description': 'Participants are required to vaporize CBD at a concentration of 15%.', 'interventionNames': ['Other: CBD 15%']}, {'type': 'EXPERIMENTAL', 'label': 'CBD 30%', 'description': 'Participants are required to vaporize CBD at a concentration of 30%.', 'interventionNames': ['Other: CBD 30%']}], 'interventions': [{'name': 'Placebo (CBD 0%)', 'type': 'OTHER', 'description': 'Participants are required to vaporize placebo at 0% CBD concentration', 'armGroupLabels': ['Placebo (CBD 0%)']}, {'name': 'CBD 15%', 'type': 'OTHER', 'description': 'Participants are required to vaporize CBD at a concentration of 15%.', 'armGroupLabels': ['CBD 15%']}, {'name': 'CBD 30%', 'type': 'OTHER', 'description': 'Participants are required to vaporize CBD at a concentration of 30%.', 'armGroupLabels': ['CBD 30%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'country': 'Spain', 'facility': 'University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sonia Ortiz Peregrina', 'investigatorAffiliation': 'Universidad de Granada'}}}}