Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 2:56 AM
Study NCT ID:
NCT04336293
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2020-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
sTMS for Substance Use-disordered Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-25', 'mcpReleaseN': 12, 'releaseDate': '2024-10-31'}], 'estimatedResultsFirstSubmitDate': '2024-10-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-02', 'size': 286369, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-27T13:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind, sham controlled RCT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)', 'timeFrame': '6 weeks', 'description': 'Quality of Life Enjoyment and Satisfaction Questionnaire\n\nThe Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.'}, {'measure': 'substance specific craving', 'timeFrame': '6 weeks', 'description': 'self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges'}, {'measure': 'Social and Occupational Functioning Assessment Scale (SOFAS)', 'timeFrame': '6 weeks', 'description': 'The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation'], 'conditions': ['Cocaine Addiction', 'Opioid Addiction', 'Alcohol Addiction']}, 'referencesModule': {'references': [{'pmid': '36717148', 'type': 'DERIVED', 'citation': 'Jampel J, Quinn MJ, Catalano JL, Benca-Bachman CB, Brick L, Philip NS, Swift RM, McGeary JE. Synchronised transcranial magnetic stimulation for substance use-disordered Veterans: protocol for the pilot sham-controlled acceptability trial. BMJ Open. 2023 Jan 30;13(1):e066175. doi: 10.1136/bmjopen-2022-066175.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.', 'detailedDescription': 'All non-life-saving human research studies suspended by sponsor in response to COVID19 social distancing policies\n\nThe goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible male and female Veterans\n* between ages 18-70,\n* Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures\n* ongoing medications and psychotherapy will be allowed to continue unchanged during the study\n* for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population\n\nExclusion Criteria:\n\n* pregnancy/lactation,\n* history of moderate or severe traumatic brain injury,\n* current or prior neurologic disorder or lifetime history of\n\n * seizure disorder\n * CNS tumors\n * stroke\n * cerebral aneurysm,\n* unstable medical condition,\n\n * active suicidality as assessed with the Columbia-Suicide Severity Rating Scale\n * primary psychotic disorder.'}, 'identificationModule': {'nctId': 'NCT04336293', 'briefTitle': 'sTMS for Substance Use-disordered Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'sTMS for Substance Use-disordered Veterans', 'orgStudyIdInfo': {'id': 'D3338-P'}, 'secondaryIdInfos': [{'id': 'RX003338', 'type': 'OTHER_GRANT', 'domain': 'VA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active', 'description': 'active sTMS', 'interventionNames': ['Device: sTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham', 'description': 'sham sTMS', 'interventionNames': ['Device: sham sTMS']}], 'interventions': [{'name': 'sTMS', 'type': 'DEVICE', 'description': 'sTMS will be delivered following NeoSync guidelines using the device user\n\nmanual', 'armGroupLabels': ['active']}, {'name': 'sham sTMS', 'type': 'DEVICE', 'description': 'sham sTMS will be delivered following NeoSync guidelines using the device user manual', 'armGroupLabels': ['sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02908-4734', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center, Providence, RI', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'John E McGeary, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VA Medical Center, Providence, RI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}