Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02542150
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2015-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Acetate and Alcohol on Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearchsupportcenter@ucdenver.edu', 'phone': '3037241111', 'title': 'Jody Tanabe, MD', 'organization': 'University of Colorado Denver | Anschutz'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data collection for an outcome measure related to brain activity during decision making before and after receiving alcohol or acetate was never completed due to feasibility and funding limitations and challenges encountered during the study.'}}, 'adverseEventsModule': {'timeFrame': '1 Day', 'eventGroups': [{'id': 'EG000', 'title': 'Acetate Arm', 'description': 'IV acetate given during magnetic resonance scan\n\nacetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IV Placebo (Acetate Arm)', 'description': 'Placebo given before Acetate.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Alcohol Arm', 'description': 'jello given before magnetic resonance scan\n\nalcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Oral Placebo (Alcohol Arm)', 'description': 'Placebo given before Alcohol.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetate Arm', 'description': 'IV acetate given during magnetic resonance scan\n\nacetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan'}, {'id': 'OG001', 'title': 'IV Placebo (Acetate Arm)', 'description': 'Placebo given before Acetate.'}, {'id': 'OG002', 'title': 'Alcohol Arm', 'description': 'jello shots given before magnetic resonance scan\n\nalcohol: a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.'}, {'id': 'OG003', 'title': 'Oral Placebo (Alcohol Arm)', 'description': 'Placebo given before Alcohol.'}], 'classes': [{'title': 'Right Thalamus', 'categories': [{'measurements': [{'value': '31.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '30.0', 'spread': '9.7', 'groupId': 'OG002'}, {'value': '25.0', 'spread': '7.5', 'groupId': 'OG003'}]}]}, {'title': 'Left Thalamus', 'categories': [{'measurements': [{'value': '32.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '8.9', 'groupId': 'OG002'}, {'value': '24.9', 'spread': '6.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.', 'description': 'cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.', 'unitOfMeasure': 'cc/100 mg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetate Arm', 'description': 'Placebo for 1 hour, then Acetate for 1 hour\n\nIV acetate given during magnetic resonance scan.\n\nacetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan'}, {'id': 'FG001', 'title': 'Alcohol Arm', 'description': 'Placebo for 1 hour, then Alcohol (given as a single dose of jello).\n\njello given before magnetic resonance scan\n\nalcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Completed Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Started Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates: January 2016-March 2017 Target population: Healthy controls Method: Advertisements, flyers, word of mouth'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetate Arm', 'description': 'Placebo for 1 hour, then Acetate for 1 hour.\n\nIV acetate given during magnetic resonance scan\n\nacetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan'}, {'id': 'BG001', 'title': 'Alcohol Arm', 'description': 'Placebo for 1 hour, then alcohol (given as a single dose with jello).\n\njello given before magnetic resonance scan\n\nalcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-22', 'size': 535762, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-02T18:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2015-09-01', 'resultsFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-02', 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling', 'timeFrame': 'fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.', 'description': 'cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Blood Flow', 'Brain Function']}, 'referencesModule': {'references': [{'pmid': '31386214', 'type': 'RESULT', 'citation': 'Tanabe J, Yamamoto DJ, Sutton B, Brown MS, Hoffman PL, Burnham EL, Glueck DH, Tabakoff B. Effects of Alcohol and Acetate on Cerebral Blood Flow: A Pilot Study. Alcohol Clin Exp Res. 2019 Oct;43(10):2070-2078. doi: 10.1111/acer.14173. Epub 2019 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.', 'detailedDescription': 'This study plans to learn more about how alcohol and its metabolite, acetate, affect brain function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria-all:\n\n1. Subjects who are age 21-55,\n2. Subjects who are proficient in English ,\n3. Subjects who understand the nature of the study,\n4. Subjects who have signed an informed consent,\n5. Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),\n\nInclusion Criteria-moderate drinkers:\n\n1. Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).\n2. Subjects who have drunk at least 2 drinks in one hour in the past, and have no history of dependence on drugs or alcohol\n\nInclusions-AUD:\n\n(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)\n\nExclusion Criteria-all:\n\n1. Subjects who have a "facial flushing" response to alcohol,\n2. Subjects who are pregnant or nursing,\n3. Subjects who have major medical problems including diabetes, high blood pressure (\\> 150/90), prior neurological or psychiatric history (schizophrenia, bipolar, or current major depressive disorder), epilepsy (alcohol withdrawal seizures is not an exclusion),\n4. Subjects who have been told they have or been diagnosed with liver or kidney disease,\n5. Subjects who have chronic gastrointestinal disease,\n6. Subjects who are obese (BMI\\>30 kg/m2),\n7. Subjects who take psychoactive medications,\n8. Subjects who have prior head trauma resulting in loss of consciousness \\>15 minutes,\n9. Subjects who have Magnetic Resonance (MR) exclusions which include claustrophobia, intracranial, orbital, or spinal metal implants, pacemakers, cochlear implants, cardiac stents or other non-MR-compatible implants or devices.'}, 'identificationModule': {'nctId': 'NCT02542150', 'briefTitle': 'Effects of Acetate and Alcohol on Brain Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Effects of Acetate and Alcohol on Brain Function', 'orgStudyIdInfo': {'id': '15-0933'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acetate arm', 'description': 'IV acetate given during magnetic resonance scan', 'interventionNames': ['Drug: acetate']}, {'type': 'EXPERIMENTAL', 'label': 'alcohol arm', 'description': 'jello shots given before magnetic resonance scan', 'interventionNames': ['Drug: alcohol']}], 'interventions': [{'name': 'acetate', 'type': 'DRUG', 'otherNames': ['ethanoate'], 'description': 'acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan', 'armGroupLabels': ['acetate arm']}, {'name': 'alcohol', 'type': 'DRUG', 'otherNames': ['ethanol'], 'description': 'a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.', 'armGroupLabels': ['alcohol arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jody L Tanabe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}