Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT06320366
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and all study personnel are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sham vs. real Transcranial Magnetic Stimulation (TMS)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': '5 days', 'description': 'Proportion completing at least 20 TMS session - sham vs. active'}, {'measure': 'Study emergent adverse events', 'timeFrame': '12 weeks', 'description': 'Incidence of study emergent adverse events - sham vs. active'}], 'secondaryOutcomes': [{'measure': 'Weeks of continuous abstinence', 'timeFrame': '12 weeks', 'description': 'Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen.'}, {'measure': 'Days of methamphetamine use', 'timeFrame': '12 weeks', 'description': 'Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview.'}, {'measure': 'Time to first methamphetamine use', 'timeFrame': '12 weeks', 'description': 'Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen'}, {'measure': 'Methamphetamine craving', 'timeFrame': '12 weeks', 'description': 'Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving.'}, {'measure': 'Methamphetamine craving on visual analog scale', 'timeFrame': '12 weeks', 'description': 'Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving.'}, {'measure': 'MRI cue craving', 'timeFrame': 'Pre- and Post- TMS stimulation in week 1', 'description': 'Cue craving data will be collected pre- and post-TMS stimulation in week 1'}, {'measure': 'MRI resting state', 'timeFrame': 'Pre- and Post- TMS stimulation in week 1', 'description': 'Resting state data will be collected pre- and post-TMS stimulation in week 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Methamphetamine Use Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.', 'detailedDescription': 'In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 21-65 years inclusive;\n2. Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;\n3. By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;\n4. Provides a urine drug screen positive for methamphetamine;\n5. Able to provide informed consent;\n6. No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;\n7. Adequate English proficiency for study consent, and completion of the study instruments.\n\nExclusion Criteria:\n\n1. Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;\n2. Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;\n3. Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;\n4. Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;\n5. Presence of a clinically significant abnormality on baseline MRI;\n6. Inability to have an MRI;\n7. Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);\n8. Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);\n9. History of head injury with loss of consciousness for more than 15 minutes;\n10. Diagnosis of dementia;\n11. Prescribed benzodiazepines or anticonvulsants;\n12. Currently enrolled in formal substance use disorder treatment;\n13. Metal implants or non-removable metal objects above the waist;\n14. Lifetime history of prior clinical treatment with TMS;\n15. Serious risk of suicide or homicide;\n16. Unable/unwilling to follow the study procedures;\n17. History of intractable migraine;\n18. Assessed to be at risk for alcohol or opioid withdrawal.'}, 'identificationModule': {'nctId': 'NCT06320366', 'briefTitle': 'Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder', 'orgStudyIdInfo': {'id': '23-1044'}, 'secondaryIdInfos': [{'id': 'K24DA058882', 'link': 'https://reporter.nih.gov/quickSearch/K24DA058882', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham TMS', 'description': 'Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks.', 'interventionNames': ['Device: Sham TMS']}, {'type': 'EXPERIMENTAL', 'label': 'Active TMS', 'description': 'Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks.', 'interventionNames': ['Device: Active TMS']}], 'interventions': [{'name': 'Sham TMS', 'type': 'DEVICE', 'description': 'The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure.', 'armGroupLabels': ['Sham TMS']}, {'name': 'Active TMS', 'type': 'DEVICE', 'description': 'The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.', 'armGroupLabels': ['Active TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph T Sakai, MD', 'role': 'CONTACT', 'email': 'joseph.sakai@cuanschutz.edu', 'phone': '303-724-7402'}, {'name': 'Kristen M Raymond, BA', 'role': 'CONTACT', 'email': 'kristen.raymond@cuanschutz.edu', 'phone': '303-724-3196'}, {'name': 'Joseph T Sakai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Joseph T Sakai, MD', 'role': 'CONTACT', 'email': 'joseph.sakai@cuanschtz.edu', 'phone': '303-724-7402'}, {'name': 'Kristen M Raymond, BA', 'role': 'CONTACT', 'email': 'kristen.raymond@cuanschutz.edu', 'phone': '303-724-3196'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}