Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT05641766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This proof-of-concept study will use a double-blind, randomized, cross-over (within-subject), placebo-controlled, counterbalanced study design in which participants will receive 0 (placebo) or 0.03 mg/kg intravenous THC over 20 minutes while undergoing simultaneous MEG/EEG data collection.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in brain dynamics during the Sternberg Working Memory Task', 'timeFrame': 'Baseline and starting at +15 minutes after start of IV THC or placebo administration', 'description': 'Changes in brain dynamics will be characterized during the Sternberg Working Memory Task where participants are presented with a list of items to memorize, followed by a memory maintenance period during which the subject must maintain the list of items in memory.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and starting at +15 minutes after start of IV THC or placebo administration', 'description': 'To confirm the acute effects of THC, feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high","anxious","calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line from 0=not at all to 100=extremely.'}, {'measure': 'Clinician Administered Dissociative Symptoms Scale (CADSS)', 'timeFrame': 'Baseline and starting at +15 minutes after start of IV THC or placebo administration', 'description': 'To confirm the acute effects of cannabis, perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-report items and 8 clinician-rated items scored 0=not at all to 4=extremely. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MEG', 'EEG', 'THC', 'Placebo', 'Working Memory', 'Neural Noise', 'Cognitive Process'], 'conditions': ['THC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.', 'detailedDescription': "The goal of this study is to use multimodal MEG/EEG to gain novel insight into the acute effects of THC on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cannabis use at least once in the past 12 months\n* No cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day\n* Good physical and mental health\n\nExclusion Criteria:\n\n* Cannabis naïve individuals\n* Lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per PI discretion.\n* Positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion\n* Major current or recent stressors\n* Positive urine drug test\n* Contraindication for Magnetic Resonance Imaging\n* Treatment with psychotropic medication as per discretion of the PI\n* IQ less than 80\n* Weight exceeding 166kg\n* Diagnosis of major psychotic or manic disorder in first-degree relatives.'}, 'identificationModule': {'nctId': 'NCT05641766', 'acronym': 'THC-MEG', 'briefTitle': 'Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks', 'orgStudyIdInfo': {'id': '2000033383'}, 'secondaryIdInfos': [{'id': '1R03DA054453-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R03DA054453-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THC', 'description': 'Participants will receive THC into a rapidly flowing IV infusion.', 'interventionNames': ['Drug: THC']}, {'type': 'OTHER', 'label': 'Placebo', 'description': 'Participants will receive an equivalent amount (about 1-2 ml) of placebo (sterile 190 proof USP ethanol). The placebo does not produce any measurable blood alcohol levels or subjective/behavioral effects.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'THC', 'type': 'DRUG', 'description': 'Participants will receive THC into a rapidly flowing IV infusion.', 'armGroupLabels': ['THC']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive an equivalent amount (about 1-2 ml) of placebo (sterile 190 proof USP ethanol). The placebo does not produce any measurable blood alcohol levels or subjective/behavioral effects.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Jose Cortes-Briones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Connecticut Healthcare System, Yale School of Medicine', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'centralContacts': [{'name': 'Jose Cortes-Briones, PhD', 'role': 'CONTACT', 'email': 'jose.briones@yale.edu', 'phone': '203-903-5711', 'phoneExt': '5539'}], 'overallOfficials': [{'name': 'Jose Cortes-Briones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Jose Cortes', 'investigatorAffiliation': 'Yale University'}}}}