Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT04155632
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pengxi@musc.edu', 'phone': '8437928642', 'title': 'Dr. Xiaolong Peng', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We only investigate a single session of cTBS in participants with CUD. Repeated cTBS sessions may produce long-lasting changes in craving and relapse prevention, which should be explored in future research.'}}, 'adverseEventsModule': {'timeFrame': 'From baseline (Visit 2) through 3 weeks post-TBS (Visit 3), including follow-up calls at 1 day, 1 week, 2 weeks, and 3 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'OG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0026', 'spread': '0.0080', 'groupId': 'OG000'}, {'value': '0.0007', 'spread': '0.0105', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Measured using fMRI during cocaine cue reactivity task. Percent BOLD signal change in OFC from baseline (Visit 2) to post-TBS (Visit 3). Measured using functional MRI during a cocaine cue reactivity task. The outcome reflects the change in raw BOLD signal in the orbitofrontal cortex (OFC) between baseline and post-TBS sessions. Signal change was calculated by comparing activation during cocaine-related image blocks versus neutral image blocks. Values are reported as raw BOLD signal units (not percentages).', 'unitOfMeasure': 'BOLD signal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in POMS Score From Baseline to Post-TBS"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'OG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.53', 'spread': '27.58', 'groupId': 'OG000'}, {'value': '14.63', 'spread': '23.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Total POMS score measured before and after TBS. Higher scores indicate worse mood.', 'unitOfMeasure': 'POMS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Cocaine Craving Rating From Baseline to Post-TBS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'OG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.31', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'FG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Only 32 were randomized and started treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Theta Burst Stimulation', 'description': 'Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'BG001', 'title': 'Sham Theta Burst Stimulation', 'description': 'Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', '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': 'Cocaine Craving Rating', 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '2.04', 'groupId': 'BG000'}, {'value': '4.45', 'spread': '1.98', 'groupId': 'BG001'}, {'value': '4.42', 'spread': '1.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported craving measured using a Numerical Rating Scale (NRS) from 1 to 10, where 1 = no craving and 10 = extreme craving. Higher scores indicate greater craving.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Profile of Mood States (POMS)', 'classes': [{'categories': [{'measurements': [{'value': '23.50', 'spread': '34.86', 'groupId': 'BG000'}, {'value': '18.75', 'spread': '30.95', 'groupId': 'BG001'}, {'value': '21.13', 'spread': '32.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Profile of Mood States (POMS) total score, ranging from 0 to 200. Higher scores indicate greater mood disturbance. Subscales include tension, depression, anger, vigor, fatigue, and confusion', 'unitOfMeasure': 'POMS score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'OFC brain activity', 'classes': [{'categories': [{'measurements': [{'value': '0.0049', 'spread': '0.0096', 'groupId': 'BG000'}, {'value': '-0.0012', 'spread': '0.0102', 'groupId': 'BG001'}, {'value': '0.0018', 'spread': '0.0102', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured using fMRI during cocaine cue reactivity task. Percent signal change in orbitofrontal cortex (OFC) during cocaine vs. neutral image blocks.', 'unitOfMeasure': 'Percent BOLD signal change', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-05', 'size': 297743, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-30T13:35', 'hasProtocol': True}, {'date': '2022-07-25', 'size': 2657316, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-11T16:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2019-11-05', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-03', 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Measured using fMRI during cocaine cue reactivity task. Percent BOLD signal change in OFC from baseline (Visit 2) to post-TBS (Visit 3). Measured using functional MRI during a cocaine cue reactivity task. The outcome reflects the change in raw BOLD signal in the orbitofrontal cortex (OFC) between baseline and post-TBS sessions. Signal change was calculated by comparing activation during cocaine-related image blocks versus neutral image blocks. Values are reported as raw BOLD signal units (not percentages).'}, {'measure': 'Change in POMS Score From Baseline to Post-TBS"', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Total POMS score measured before and after TBS. Higher scores indicate worse mood.'}, {'measure': 'Change in Cocaine Craving Rating From Baseline to Post-TBS', 'timeFrame': 'From baseline to immediately post-TBS', 'description': 'Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cocaine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this project is to examine the effect of combining theta burst stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine-related images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Age 18-65 2. English fluency 4. Meet criteria for cocaine use disorder (CUD), as determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.\n\n5\\. Enrolled in an intensive outpatient treatment program (MUSC Center for Drug and Alcohol Programs Intensive Outpatient Program (CDAP-IOP) or currently engaged in treatment for substance related problems.\n\n6\\. Able to read and understand questionnaires and informed consent 7. Lives within 50 miles of the study site. 8. Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold) 9. Does not have metal objects in the head/neck. 10. Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.\n\n11\\. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.\n\nExclusion Criteria:\n\n1. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases\n2. Any physical or intellectual disability affecting completion of assessments\n3. Any contraindication to MRI\n4. Current or past psychosis\n5. ECT in last 6 months\n6. Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.\n7. Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA \\> 8 will be excluded.\n8. Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)\n9. Has current suicidal ideation or homicidal ideation.\n10. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD\n11. Suffers from chronic migraines\n12. Any physical or intellectual disability affecting completion of assessments"}, 'identificationModule': {'nctId': 'NCT04155632', 'acronym': 'COCA', 'briefTitle': 'Neurocircuit Strategy to Decrease Cocaine Cue Reactivity', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Neurocircuit Strategy to Decrease Cocaine Cue Reactivity', 'orgStudyIdInfo': {'id': '00091981'}, 'secondaryIdInfos': [{'id': '5P50DA046373-04', 'link': 'https://reporter.nih.gov/quickSearch/5P50DA046373-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-acetylcysteine + Theta Burst Stimulation', 'interventionNames': ['Drug: N-acetylcysteine', 'Device: Theta-burst stimulation (TBS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'N-acetylcysteine + Sham Theta Burst Stimulation', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + Theta Burst Stimulation', 'interventionNames': ['Device: Theta-burst stimulation (TBS)']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo + Sham Theta Burst Stimulation'}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'N-acetylcysteine (NAC) is a medication that is used to treat paracetamol (acetaminophen) overdose, and to loosen thick mucus in individuals with cystic fibrosis or chronic obstructive pulmonary disease. It has a long-established safety record in adults and children, with FDA approval since 1963. The side effects most commonly noted in people who take NAC by mouth include diarrhea, nausea, vomiting, and headache. These side effects are usually mild and go away even with continued use of NAC by mouth. There is also a risk of a skin reaction, such as flushing, itching, or rash. A meta-analysis of studies evaluating long-term oral treatment with NAC for prevention of chronic bronchitis found that NAC was well tolerated, with generally mild, most commonly gastrointestinal adverse effects that did not require treatment interruption.', 'armGroupLabels': ['N-acetylcysteine + Sham Theta Burst Stimulation', 'N-acetylcysteine + Theta Burst Stimulation']}, {'name': 'Theta-burst stimulation (TBS)', 'type': 'DEVICE', 'description': 'Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.', 'armGroupLabels': ['N-acetylcysteine + Theta Burst Stimulation', 'Placebo + Theta Burst Stimulation']}]}, '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': 'All Validations Passed Badran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of SC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}