[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cocaine-use-disorder-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cocaine-use-disorder-severe":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Cocaine Use","Cocaine Dependence","Cocaine Use Disorder","Cocaine Use Disorder, Moderate","Cocaine Use Disorder, Severe",[33,34,35,36,37,38,39],"Repetitive transcranial magnetic stimulation","rTMS","TMS","Cognitive behavioral therapy","CBT","Functional magnetic resonance imaging","fMRI","NOT_YET_RECRUITING","2026-04-06",{"date":43,"type":44},"2026-04-07","ACTUAL",{"date":46,"type":21},"2026-05-01",{"date":48,"type":21},"2028-04-28",{"name":50,"class":51},"New York State Psychiatric Institute","OTHER"]