Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-07 @ 2:29 PM
Study NCT ID:
NCT03104257
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2016-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neural Correlates of Cannabis Use
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'When specimens and information are stored, researchers are careful to try to protect your identity from discovery by others. Samples and information will receive a unique code. Other researchers will only receive coded samples and information, and will not be able to link the code to subjects. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CB1R availability using [11-C]OMAR PET imaging', 'timeFrame': 'Change in CB1R availability from baseline to 48 hours and 28 days', 'description': 'Change in CB1R availability (e.g. volume distribution).'}], 'secondaryOutcomes': [{'measure': 'Changes in Cognition during withdrawal using a computerized battery', 'timeFrame': 'Change in CB1R availability from baseline to 48 hours and 28 days', 'description': 'Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.'}, {'measure': 'Changes in brain rhythms measured by Electroencephalography', 'timeFrame': 'Change in CB1R availability from baseline to 48 hours and 28 days', 'description': 'Changes in electroencephalographic (EEG) brain rhythms related to information processing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Healthy Control, Cannabis, Dependence'], 'conditions': ['Cannabis Dependence', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.', 'detailedDescription': 'The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using \\[11-C\\]OMAR PET imaging and electroencephalography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Cannabis Dependent Subjects\n\n* Current cannabis consumption\n* Willing to abstain from cannabis use for four weeks\n\nInclusion Criteria for Healthy Controls\n\n* No current cannabis consumption\n\nExclusion Criteria:\n\n* MRI metal exclusions and claustrophobia\n* Education completed is less than 12 years'}, 'identificationModule': {'nctId': 'NCT03104257', 'acronym': 'Multimodal', 'briefTitle': 'The Neural Correlates of Cannabis Use', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'The Neural Correlates of Cannabis Use', 'orgStudyIdInfo': {'id': '1308012514'}, 'secondaryIdInfos': [{'id': '1R01DA040698-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA040698-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cannabis Dependent Subjects', 'description': 'Subjects who are frequent cannabis users', 'interventionNames': ['Drug: [11-C]OMAR']}, {'label': 'Healthy Controls', 'description': 'Subjects with no current cannabis use', 'interventionNames': ['Drug: [11-C]OMAR']}], 'interventions': [{'name': '[11-C]OMAR', 'type': 'DRUG', 'description': 'The radiotracer, \\[11-C\\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.', 'armGroupLabels': ['Cannabis Dependent Subjects', 'Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Conneticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Mohini Ranganathan, MD', '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': 'Associate Professor', 'investigatorFullName': 'Mohini Ranganathan', 'investigatorAffiliation': 'Yale University'}}}}