Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-04 @ 10:53 PM
Study NCT ID:
NCT03295903
Status:
UNKNOWN
Last Update Posted:
2019-10-23
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabinoid Supplementation on Vascular and Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating cannabidiol and nitric oxide markers', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured by venous blood sampling'}, {'measure': 'Vascular function', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Duplex ultrasound system'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Height in cm'}, {'measure': 'Weight', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Weight in kg'}, {'measure': 'Body mass index', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Body mass in kilograms divided by height in meters squared'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured by automated sphygmomanometer'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured by automated sphygmomanometer'}, {'measure': 'Heart rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured by 3-lead electrocardiogram'}, {'measure': 'Respiration', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured by spirometry'}, {'measure': 'Medical History Questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assesses inclusion/exclusion criteria and prior history of medical conditions.'}, {'measure': 'Gastrointestinal Distress Questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured using a 10 cm visual analogue scale'}, {'measure': 'Anxiety Questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assessed with a visual analog scale'}, {'measure': 'Cognitive performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Computerized battery of neuropsychological tests'}, {'measure': 'Exercise performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Step-wise exercise test on cycle ergometer'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular function', 'Cannabidiol supplementation'], 'conditions': ['Diet Modification']}, 'referencesModule': {'references': [{'pmid': '31512143', 'type': 'DERIVED', 'citation': 'Patrician A, Versic-Bratincevic M, Mijacika T, Banic I, Marendic M, Sutlovic D, Dujic Z, Ainslie PN. Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study. Adv Ther. 2019 Nov;36(11):3196-3210. doi: 10.1007/s12325-019-01074-6. Epub 2019 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available evidence suggests that there are marked therapeutic CBD effects for diverse disease processes including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this study, in both younger and older healthy humans, is to improve our understanding of how CBD might control and regulate blood vessel health as well as cognitive and exercise performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoking\n* non-obese\n* between the ages of 18-30 \\& 60-75 years\n* have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.\n\nExclusion Criteria:\n\n* are obese\n* are taking prescription drugs or over-the-counter supplements that influence cardiovascular or nitric oxide metabolism\n* have a history of smoking\n* have history of cardiovascular, respiratory (including asthma) or neurological disease\n* have known intolerance to ginseng or ginkgo herbals\n* have kidney, gastrointestinal or liver disease\n* have epilepsy\n* have diabetes\n* are pregnant or breast feeding\n* do not speak English as first language\n* a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung and Vascular Health\n* medical or recreational use of cannabis\n* clinically diagnosed anxiety or depression\n* history of opioid use\n* unwilling or unable to execute the informed consent documentation'}, 'identificationModule': {'nctId': 'NCT03295903', 'briefTitle': 'Cannabinoid Supplementation on Vascular and Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.', 'orgStudyIdInfo': {'id': 'H17-01957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sugar pill that will have no effect.', 'interventionNames': ['Dietary Supplement: Cannabidiol supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol and herbal capsules (1 dose)', 'description': 'Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.', 'interventionNames': ['Dietary Supplement: Cannabidiol supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol (1 dose)', 'description': 'Only cannabidiol supplement.', 'interventionNames': ['Dietary Supplement: Cannabidiol supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol and herbal capsules (2 dose)', 'description': 'Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.', 'interventionNames': ['Dietary Supplement: Cannabidiol supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol only (2 dose)', 'description': 'Only cannabidiol supplement.', 'interventionNames': ['Dietary Supplement: Cannabidiol supplement']}], 'interventions': [{'name': 'Cannabidiol supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be administered in a double-blinded, randomized and cross-over design', 'armGroupLabels': ['Cannabidiol (1 dose)', 'Cannabidiol and herbal capsules (1 dose)', 'Cannabidiol and herbal capsules (2 dose)', 'Cannabidiol only (2 dose)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V 1V7', 'city': 'Kelowna', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual values will be reported in figures if applicable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lexaria Bioscience Corp.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Ainslie', 'investigatorAffiliation': 'University of British Columbia'}}}}