Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-04-11 @ 6:32 PM
Study NCT ID:
NCT05937893
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BHB levels in the brain', 'timeFrame': 'Approximately 90 minutes after Baseline Assessment', 'description': 'β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.'}], 'secondaryOutcomes': [{'measure': 'Change in GABA levels in the brain', 'timeFrame': 'Approximately 90 minutes after Baseline Assessment', 'description': 'GABA levels will be assessed in the brain via MRSI to determine if they are elevated in key brain regions relative to the baseline scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BHB', 'AUD'], 'conditions': ['BHB Transport', 'Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain.', 'detailedDescription': 'The primary objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain. Furthermore, BHB levels in identified brain regions will be compared against measures of craving.\n\nThe secondary objective of this study is to investigate if GABA levels will be elevated in key brain regions relative to the baseline scan in AC subjects due to preferential BHB metabolism. The goal is to acquire preliminary data to apply for an R01 or equivalent grant submission to pursue this metabolic therapy in greater detail using the state-of-the-art MRSI platform at Yale University to study alcohol use disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For AUD patients: individuals assessed to be with mild to - medium severity according to the DSM-5 criteria.\n* For non-dependent heavy at-risk drinkers: must be Individuals who consume more than 14 drinks per week for men or more than 8 drinks per week for women, for at least the last 2 months.\n* For healthy controls: must be light drinkers not dependent on alcohol, who consume fewer than 2 drinks per week for at least the last 6 months.\n* English speaking\n* Can read and understand a study the consent form\n\nExclusion Criteria:\n\n* Non-English speaking\n* Unable to read and understand the consent form\n* History of alcohol withdrawal in the last 12 months. This will reduce chances of a volunteer having withdrawal symptoms in the middle of the experiment.\n* Participants with a history of psychiatric conditions (that include PTSD, schizophrenia, and bipolar disorders), or a history of neurological conditions\n* Women who test positive on a pregnancy test collected on either the screening visit or day of the study.\n* Healthy subjects identified with substance use with the exception of tobacco and alcohol will be excluded.\n* AC subjects identified with substance use, with the exception of tobacco, alcohol, and mild cannabis use disorder (based on the DSM-5 criteria during the medical history) in the last 6 months, will be excluded.\n* Persons unable to refrain from alcohol use for 48 hours and undergo a 10-hour fast prior to the study'}, 'identificationModule': {'nctId': 'NCT05937893', 'briefTitle': 'Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)', 'orgStudyIdInfo': {'id': '2000035050'}, 'secondaryIdInfos': [{'id': '000', 'type': 'OTHER', 'domain': 'yctg'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Alcohol consumer (AC) participants', 'description': 'Adult volunteers who are alcohol consumers drawn from both an outpatient population and recruited heavy drinkers from the community.', 'interventionNames': ['Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans']}, {'type': 'OTHER', 'label': 'Healthy participants', 'description': 'Healthy adult volunteers who are not dependent on alcohol.', 'interventionNames': ['Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans']}], 'interventions': [{'name': 'Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans', 'type': 'OTHER', 'description': 'Following baseline scans, the participant will orally consume the keto-ester, for subsequent scans which will include repeated BHB MRSI acquisitions to dynamically measure BHB labeling in the brain, followed by a final GABA MRSI acquisition.', 'armGroupLabels': ['Alcohol consumer (AC) participants', 'Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Anlyan Center (TAC)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Chathura Kumaragamage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/', 'timeFrame': 'Following study completion and final funder reporting obligations.', 'ipdSharing': 'YES', 'description': 'De-identified data from this study be submitted to the NIMH data archive (NDA) at the NIH.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}