[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550092":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"open label BUP","EXPERIMENTAL",null,[13],"Drug: Buprenorphine Patch",{"label":15,"type":16,"description":11,"interventionNames":17},"Real vs Placebo BUP","ACTIVE_COMPARATOR",[13,18],"Drug: Placebo",{"label":20,"type":16,"description":11,"interventionNames":21},"Real vs Sham TMS",[22,23],"Device: Transcranial Magnetic Stimulation (TMS)","Device: Sham Transcranial Magnetic Stimulation (TMS)",[25,30,34,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Buprenorphine Patch","Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert\u002Frecommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (\\\u003C30 MEQ = 5mcg\u002Fhr patch, 30-80 MEQ =10-15mcg\u002Fhour patch; \\>80 MEQ = 20mcg\u002Fhour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated",[15,9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Placebo","double-blinded randomization to placebo or transdermal buprenorphine",[15],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"DEVICE","Transcranial Magnetic Stimulation (TMS)","double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS",[20],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Sham Transcranial Magnetic Stimulation (TMS)","double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS",[20],[44],{"name":45,"affiliation":5,"role":46},"Kelly Barth","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":11,"email":51},"CONTACT","843-792-0686","stephen@musc.edu",{"name":53,"role":49,"phone":11,"phoneExt":11,"email":54},"Rafael Mendoza","mendozra@musc.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Charleston","South Carolina","29407","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-79.93275,32.77632,{"lat":67,"lon":66},[70,71,72],{"name":45,"role":49,"phone":11,"phoneExt":11,"email":51},{"name":53,"role":49,"phone":11,"phoneExt":11,"email":54},{"name":45,"role":46,"phone":11,"phoneExt":11,"email":11},{"type":46,"investigatorFullName":45,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor-Faculty",[76],{"name":77,"class":78},"National Institute on Drug Abuse (NIDA)","NIH","100550092","phase-1-action-trial-of-adding-buprenorphine-cbt-and-tms-to-improve-outcomes-of-long-term-opioid-therapy-for-chronic-pain-100550092",false,"NCT06442566","ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain","Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)","ACTION","Inclusion criteria:\n\nAge \\>\u002F= 18 years\n\nEnglish-speaking\n\nOn LTOT, defined as taking daily prescription opioid therapy for 90 days or more\n\nPast week average morphine equivalent dose (MED) \\>\u002F= 20mg\n\nWilling and able to complete written informed consent\n\nWilling and able to use a mobile\u002Fcell phone\n\nHave at least one additional risk for opioid toxicity or overdose from the following list:\n\nOpioid Toxicity or Overdose Risks:\n\n1. Taking benzodiazepines with opioids\n2. Substance Use Disorder diagnosis \\[non-tobacco; Opioid Risk Tool\\]\n\n2\\) Having ever experienced an overdose 4) Current major medical problem \\[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\\]a,b 5) Response to BPI Item 8 \\\u003C30%, suggesting less than moderately clinically meaningful response to pain treatmentc 6) Co-morbid psychiatric diagnosis \\[Opioid Risk Tool\\] 7) Signs of opioid misuse \\[any score \\>0 on the following COMM Items: 3,4,5,9,10,11,14,15,16\\] 8)Opioid Risk Tool \\>3 or Current Opioid Misuse Measure ≥ 9 9) Struggling with any of the following side effects from opioids \\[self-report\\]\n\n1. Dizziness and\u002For falls\n2. Difficult-to-manage stomach pain, nausea, constipation or GI issues\n3. Fatigue or low energy\n4. Sleepiness or sedation\n5. Trouble with memory or thinking clearly \\[COMM Item 1\\>0\\]\n6. Other troublesome side effect \\[open answer\\]\n\nExclusion criteria:\n\nKnown allergy to buprenorphine\n\nActive moderate or severe substance use disorder with the exception of those listed below:\n\n1. . Those with nicotine use disorder.\n2. . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis.\n\nCognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention\n\nReceiving methadone or buprenorphine treatment for OUD or pain\n\nTaking naltrexone\n\nPregnancy\n\nCurrently incarcerated\n\nTaking medications that prolong QTc interval, as determined by study investigators\n\nPersonal\u002Fimmediate family history of Long QT Syndrome.\n\nSignificant or unstable condition\u002Fs or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure \\>180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), major psychiatric disorder (e.g. active bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal\u002Fhomicidal intent within the past month, or any suicide attempts within the past year or current active suicidal ideation, as determined by medical clinician), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury).\n\nEnrolled in a clinical trial or has received an investigational medication or device in the last 30 days.\n\nTMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking contraindicated medications, no identifiable motor threshold, as determined by study investigators).",true,"ALL","18 Years",{"count":91,"type":92},240,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE1","PHASE2","This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) \"accelerated\" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.",[99,100],"Opioid Withdrawal","Chronic Pain",[102],"opioids, long-term opioid use, chronic pain, TMS","2025-11-03",{"date":105,"type":106},"2025-11-05","ACTUAL",{"date":108,"type":106},"2024-08-12",{"date":110,"type":92},"2029-03-31",{"name":5,"class":6},1]