Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT01853020
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabinoids and Cerebellar-Motor Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2015-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebellum Dependent Associative Learning (% CRs)', 'timeFrame': 'Measured +15 minutes after infusion', 'description': '% conditioned responses (CRs) will be measured'}, {'measure': 'Cerebellum Dependent Associative Learning (CR Latency)', 'timeFrame': 'Measured +15 minutes after infusion', 'description': 'conditioned response (CR) Latency will be measured'}, {'measure': 'Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)', 'timeFrame': 'Measured +45 minutes after infusion', 'description': 'Total time taken to complete the grooved pegboard tasks will be the dependent measure.'}, {'measure': 'CANTAB Motor Screening Test (Reaction Time)', 'timeFrame': 'Measured +45 minutes after infusion', 'description': 'Using a touch screen, reaction time to touch a target will be the dependent measures.'}, {'measure': 'CANTAB Motor Screening Test (Accuracy)', 'timeFrame': 'Measured +45 minutes after infusion', 'description': 'Using a touch screen, accuracy to touch a target will be the dependent measures.'}, {'measure': 'Paced Finger Tapping (Correct Responses)', 'timeFrame': 'Measured +45 minutes after infusion', 'description': 'Using a button on a computer keyboard, correct responses will be measured.'}, {'measure': 'Paced Finger Tapping (Reaction Time)', 'timeFrame': 'Measured +45 minutes after infusion', 'description': 'Using a button on a computer keyboard, reaction time and tapping variability will be measured.'}], 'secondaryOutcomes': [{'measure': 'THC intoxication, as measured by the Visual Analog Scale (Total Score)', 'timeFrame': 'Baseline; +45, +100, +240 minutes after infusion', 'description': '0 being none; 100 being completely'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cannabinoids', 'Eyeblink Conditioning', 'EBC'], 'conditions': ['Cannabis', 'Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.', 'detailedDescription': 'The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have used cannabis at least once in their lifetime\n* No cannabis use in the past month\n* Men and women aged 21 to 35 years (extremes included) on the day of the first dosing\n\nExclusion Criteria:\n\n* Hearing deficits\n* Psychiatric or mental disorders\n* Hearing Deficits'}, 'identificationModule': {'nctId': 'NCT01853020', 'briefTitle': 'Cannabinoids and Cerebellar-Motor Functioning', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cannabinoids and Cerebellar-Motor Functioning', 'orgStudyIdInfo': {'id': '1211011055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'THC', 'description': 'Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.\n\nLow dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.\n\nMedium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.', 'interventionNames': ['Drug: THC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'THC', 'type': 'DRUG', 'description': 'Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.\n\nLow Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.\n\nMedium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.', 'armGroupLabels': ['THC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}