Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-03-11 @ 11:15 AM
Study NCT ID:
NCT05072795
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2021-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'benitez@musc.edu', 'phone': '843-876-8479', 'title': 'Dr. Andreana Benitez', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Stress Induction', 'description': 'Trier Social Stress Task (TSST): The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Cognitive Ability (GCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent of Intervention', 'description': 'No intervention'}], 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.99', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '1.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The primary outcome is the mean Global Cognitive Ability (GCA) z-score, which is a psychometrically robust, factor analytically-derived, demographically-normed index of global cognitive function. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.', 'unitOfMeasure': 'Standard score (Z-score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypothesis was that women with CUD will have lower GCA scores than men.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stress Induction', 'description': 'Trier Social Stress Task (TSST): The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited between Oct 2021 and May 2023 through community advertisements.\n\nThe first participant was enrolled on 11/19/2021 and the last participant was enrolled on 5/18/2023.', 'preAssignmentDetails': 'There was one participant group (N=47). All participants completed cognitive testing on Day 0 and a stress intervention on Day 8.\n\nCognition was assessed independently of the stress intervention and is the primary outcome. N=47 completed the cognition assessments, which we listed as the non-intervention group. Stress intervention was not a primary outcome and is not reported in results section. N=45 completed the Stress Induction and are listed below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stress Induction', 'description': 'Trier Social Stress Task (TSST): The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.11', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-18', 'size': 221827, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-02T08:06', 'hasProtocol': True}, {'date': '2023-02-01', 'size': 208486, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-07T15:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2021-09-24', 'resultsFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-31', 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Cognitive Ability (GCA)', 'timeFrame': 'Day 0', 'description': 'The primary outcome is the mean Global Cognitive Ability (GCA) z-score, which is a psychometrically robust, factor analytically-derived, demographically-normed index of global cognitive function. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Use']}, 'descriptionModule': {'briefSummary': "The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-80.\n* Women must be \\>1 year post-menopausal.\n* English as a first/primary language.\n* Functional visual and auditory acuity (aided or unaided) to complete tests.\n* Capacity to independently provide informed consent and function at an intellectual level sufficient to allow completion of all instruments.\n* Currently meets DSM-5 criteria for CUD or uses cannabis at least 4 days per week\n* Consent to abstain from alcohol and cannabis use for \\>12 hours prior to Study Visit (Day 0), and TSST (Day 8).\n* Consent to abstain from all drugs other than cannabis or nicotine for the duration of the study.\n\nExclusion Criteria:\n\n* Meet DSM-5 criteria for moderate or severe alcohol or substance use disorder (other than nicotine or cannabis) within the last 12 months.\n* History of major neurocognitive disorder or developmental disorder per DSM-5.\n* A Telephone Interview for Cognitive Status (TICS) score of less than or equal to 22.\n* Significant or unstable medical condition/s that impact cognition as deemed by study investigators, such as active significant cardiac, cerebrovascular, neoplastic, infectious, or metabolic disease, or longstanding and intractable severe mental illness (e.g. schizophrenia spectrum disorder, bipolar disorder).\n* Daily use of medications that adversely impact cognition in aging (i.e. anticholinergics and sedatives).\n* Current suicidal or homicidal ideation/risk.\n* Unable to complete/comply with procedures or pose threat to research staff.\n* Standard MRI contraindications (e.g., implants, claustrophobia).\n* Women who are pregnant, nursing, or of childbearing potential and not practicing and effective means of birth control.'}, 'identificationModule': {'nctId': 'NCT05072795', 'acronym': 'PUMA', 'briefTitle': 'Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults', 'orgStudyIdInfo': {'id': '00111432'}, 'secondaryIdInfos': [{'id': '3U54DA016511-19S1', 'link': 'https://reporter.nih.gov/quickSearch/3U54DA016511-19S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress Induction', 'description': 'Participants completed the Trier Social Stress Test (TSST)', 'interventionNames': ['Behavioral: Trier Social Stress Task (TSST)']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Participants did not complete the Trier Social Stress Test (TSST).'}], 'interventions': [{'name': 'Trier Social Stress Task (TSST)', 'type': 'BEHAVIORAL', 'description': 'The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.', 'armGroupLabels': ['Stress Induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Andreana Benitez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Aimee Aimee McRae-Clark, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andreana Benitez', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}