Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT07112105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two groups to receive active or sham rTMS.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Relapsed', 'timeFrame': '3 months after last rTMS treatment', 'description': 'Rate of stimulant use relapse compared between active vs. sham rTMS groups'}], 'secondaryOutcomes': [{'measure': 'Reward circuit function and signaling', 'timeFrame': 'Within 1 week before rTMS treatment and within 1 week after rTMS treatment', 'description': 'Before and after treatment, participants will undergo functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra will be measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling will be compared between active vs. sham rTMS groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Magnetic resonance imaging', 'Transcranial magnetic stimulation', 'Intermittent theta burst stimulation', 'Dopamine', 'Reward processing'], 'conditions': ['Stimulant Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe\n* Last use of stimulants \\>2 and \\<8 weeks\n* Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)\n* Stable medical health\n\nExclusion Criteria:\n\n* Pregnant or lactating female\n* History of prior adverse reaction to TMS\n* On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion \\> 400mg/day\n* Seizure disorder or conditions known to substantially increase risk for seizures\n* Implants or medical devices incompatible with TMS\n* Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina\n* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis\n* Other substance use disorder not in remission\n* Chronic or recurring Axis I psychotic disorders\n* For subjects participating in fMRI scans, presence of ferromagnetic material in their body or taking DAergic medications'}, 'identificationModule': {'nctId': 'NCT07112105', 'acronym': 'VA-StARTS', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder', 'orgStudyIdInfo': {'id': 'RRD4-003-24W'}, 'secondaryIdInfos': [{'id': '1-I01-RD-000693-01-A2', 'type': 'OTHER_GRANT', 'domain': 'Department of Veterans Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active rTMS', 'description': 'Receive active rTMS', 'interventionNames': ['Device: Repetitive transcranial magnetic stimulation (rTMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Receive sham rTMS', 'interventionNames': ['Device: Sham rTMS']}], 'interventions': [{'name': 'Repetitive transcranial magnetic stimulation (rTMS)', 'type': 'DEVICE', 'description': 'rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.', 'armGroupLabels': ['Active rTMS']}, {'name': 'Sham rTMS', 'type': 'DEVICE', 'description': 'Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered.', 'armGroupLabels': ['Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1207', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jong H Yoon, MD', 'role': 'CONTACT', 'email': 'jhyoon1@stanford.edu', 'phone': '650-493-5000'}, {'name': 'Jong H. Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Jong H Yoon, MD', 'role': 'CONTACT', 'email': 'jhyoon1@stanford.edu', 'phone': '(650) 493-5000'}], 'overallOfficials': [{'name': 'Jong H. Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}