Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04721418
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618323', 'term': '1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep studies', 'timeFrame': 'Baseline versus 3 weeks after.', 'description': 'Investigators will explore the association between synaptic density in the mPFC (measured by VT/fP, with 11C-UCB-J PET) and sleep architecture (measured by slow wave \\[N3\\] sleep and total sleep time \\[TST\\], using a sleep study device, e.g., polysomnography \\[PSG\\]), among subjects with CUD, within 1 week of abstinence and 3 weeks later.'}], 'primaryOutcomes': [{'measure': 'Between-group (CUD vs. HC) comparisons in ACC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons in vmPFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons in mOFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC.'}], 'secondaryOutcomes': [{'measure': 'Within subjects (CUD group) comparisons in ACC.', 'timeFrame': 'Baseline versus 3 weeks after.', 'description': 'Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in ACC.'}, {'measure': 'Within subjects (CUD group) comparisons in vmPFC.', 'timeFrame': 'Baseline versus 3 weeks after.', 'description': 'Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in vmPFC.'}, {'measure': 'Within subjects (CUD group) comparisons in mOFC.', 'timeFrame': 'Baseline versus 3 weeks after.', 'description': 'Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in mOFC.'}, {'measure': 'Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of volume of distribution (VT) in ACC.'}, {'measure': 'Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of volume of distribution (VT) in vmPFC.'}, {'measure': 'Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of volume of distribution (VT) in mOFC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of binding potential in ACC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of binding potential (BPND) in ACC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of binding potential in vmPFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of binding potential (BPND) in vmPFC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of binding potential in mOFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of binding potential (BPND) in mOFC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of gray matter volume in ACC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of gray matter volume (GMV) in ACC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of gray matter volume (GMV) in vmPFC.'}, {'measure': 'Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC.', 'timeFrame': 'CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.', 'description': 'Between-group comparisons of gray matter volume (GMV) in mOFC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cocaine Use Disorder', 'Healthy Controls']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.', 'detailedDescription': 'Healthy controls (HC) will be studied as outpatients and undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks. Individuals with Cocaine Use Disorder (CUD) will complete the study as inpatients on our unit and undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks. Participants will complete sleep studies (to evaluate sleep architecture); the first two nights after admission and the last two nights before discharge. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'One group will have current Cocaine Use Disorder, the other group will be Healthy Controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-60 years\n* Physically healthy by medical history, physical, neurological, ECG and laboratory examinations\n* For females, a negative serum pregnancy test\n* For CUD: DSM-5 criteria for Cocaine Use Disorder and positive urine toxicology showing recent use\n* For HC: Negative urine toxicology\n\nExclusion Criteria:\n\n* DSM-5 criteria for other substance use disorders (e.g., alcohol, opiates, sedative hypnotics), except for nicotine\n* A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5)\n* A history of significant and/or uncontrolled medical or neurological illness\n* Current use of psychotropic and/or potentially psychoactive prescription medications\n* Medical contraindications to MRI procedure'}, 'identificationModule': {'nctId': 'NCT04721418', 'briefTitle': 'Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study', 'orgStudyIdInfo': {'id': '2000029552'}, 'secondaryIdInfos': [{'id': '1R01DA052454-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA052454-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cocaine Use Disorder', 'interventionNames': ['Radiation: 11C-UCB-J']}, {'label': 'Healthy Control', 'interventionNames': ['Radiation: 11C-UCB-J']}], 'interventions': [{'name': '11C-UCB-J', 'type': 'RADIATION', 'description': '11C-UCB-J PET scan', 'armGroupLabels': ['Cocaine Use Disorder', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gustavo Angarita, MD', 'role': 'CONTACT'}], 'facility': 'Connecticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Marcella Mignosa, MD', 'role': 'CONTACT', 'email': 'marcella.mignosa@yale.edu', 'phone': '203 974 7557'}], 'overallOfficials': [{'name': 'Gustavo Angarita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}