[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514108":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":106,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"New York State Psychiatric Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active (high-frequency) rTMS","ACTIVE_COMPARATOR","Daily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).",[13],"Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham (placebo) rTMS","PLACEBO_COMPARATOR","Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.",[19],"Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active H7-coil repetitive transcranial magnetic stimulation (rTMS)","A magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)","A sham coil is in the same helmet as the active coil. The sham coil mimics the sound, scalp sensations, and facial muscle activation caused by the active coil, but does not create an electrical current in the brain.",[15],[32],{"name":33,"affiliation":5,"role":34},"John Mariani, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Daniel Brooks, MSW","CONTACT","646-774-8181","daniel.brooks@nyspi.columbia.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Amy Mahony, LMHC","212-923-3031","amy.mahony@nyspi.columbia.edu",[46],{"facility":47,"status":26,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"New York State Psychiatric Institute (NYSPI) \u002F Substance Treatment and Research Service (STARS)","New York","10019","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59,62,65],{"name":60,"role":38,"phone":43,"phoneExt":26,"email":61},"Substance Treatment and Research Service (STARS)","stars.info@nyspi.columbia.edu",{"name":63,"role":38,"phone":64,"phoneExt":26,"email":40},"Daniel Brooks, LCSW","6467748181",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"John Mariani MD","Professor of Clinical Psychiatry",[70,73],{"name":71,"class":72},"National Institute on Drug Abuse (NIDA)","NIH",{"name":74,"class":6},"Columbia University","100514108","rtms-and-cognitive-behavioral-therapy-for-cocaine-use-disorder-100514108",false,"NCT05974202","rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder","Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder","Inclusion Criteria:\n\n1. Age 22-65;\n2. Able to give informed consent and comply with study procedures;\n3. Meets DSM-5 criteria for current moderate\u002Fsevere CUD and are treatment-seeking;\n4. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;\n5. Agree to no more than moderate alcohol consumption (\\\u003C15 drinks\u002Fweek for men and \\\u003C8 drinks\u002Fweek for women) and to avoid using amphetamine\u002Fmethamphetamine and non-prescribed benzodiazepines or barbiturates; and\n6. Women of childbearing potential must agree to use a method of contraception with proven efficacy and agree to not become pregnant during the study.\n\nExclusion Criteria:\n\n1. Meets DSM-5 criteria for current moderate\u002Fsevere major depressive episode, OCD, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to substance use;\n2. Hamilton Depression Rating Scale score \\> 17;\n3. Young Mania Rating Scale score \\>10;\n4. Meets DSM-5 criteria for current moderate\u002Fsevere other substance use disorder (aside from tobacco use disorder; physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary);\n5. Heavy weekly alcohol drinking as defined by an average of \\>14 drinks\u002Fweek for men or \\>7 drinks\u002Fweek for women on average during the past 28 days;\n6. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;\n7. More than twice weekly use of non-prescribed medications\u002Fdrugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB\u002FGBL, amphetamines\u002Fmethamphetamine;\n8. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment are unstable, would be disrupted by study procedures, or are likely to require pharmacotherapy or psychotherapy during the study period;\n9. Significant current suicide risk, indicated by either: (1) \"yes\" response on #3, 4, or #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk of suicide or (2) suicidal behavior in the past 3 months (note: non-suicidal self-injurious behavior is not exclusionary);\n10. Females with a positive urine pregnancy test;\n11. Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);\n12. Seizure history including: seizure disorder\u002Fepilepsy, alcohol\u002Fdrug withdrawal seizure, or seizure deemed by the study physician to be related to cocaine intoxication\u002Fwithdrawal (note: febrile seizures are not exclusionary)\n13. Other medical conditions that are relatively contraindicated with TMS (seizure disorders, glaucoma, increased intracranial pressure, severe migraines, stroke, brain lesions, pregnancy or breast-feeding, neurodegenerative disease, meningoencephalitis, intracerebral abscess, parenchymal or leptomeningeal cancers);\n14. Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including bupropion, antipsychotics, lithium, anticholinergics, and tricyclic antidepressants);\n15. Cognitive disorder (MMSE \\\u003C25);\n16. Disqualifying response on the TMS Adult Safety Screen (TASS);\n17. Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant);\n18. Currently taking ototoxic medications (aminoglycosides, cisplatin);\n19. Metal implants or paramagnetic objects in the body that prohibits MR scanning;\n20. Claustrophobia that prohibits MR scanning; or\n21. Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.","ALL","22 Years","65 Years",{"count":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are:\n\n* Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder?\n* What is the brain mechanism of rTMS?\n* Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine?\n\nParticipants will:\n\n* Have two brain MRI scans;\n* Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and;\n* Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder.\n\nResearchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy.\n\nThe former principle investigator, Dr. Derek Blevins, has vacated his position (February 2025), and has transferred the principle investigator role to Dr. John Mariani, the STARS Clinic Director.",[93,94,95,96,97],"Cocaine Use","Cocaine Dependence","Cocaine Use Disorder","Cocaine Use Disorder, Moderate","Cocaine Use Disorder, Severe",[99,100,101,102,103,104,105],"Repetitive transcranial magnetic stimulation","rTMS","TMS","Cognitive behavioral therapy","CBT","Functional magnetic resonance imaging","fMRI","NOT_YET_RECRUITING","2026-04-06",{"date":109,"type":110},"2026-04-07","ACTUAL",{"date":112,"type":87},"2026-05-01",{"date":114,"type":87},"2028-04-28",{"name":5,"class":6},1]