[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Payel Roy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100652139","deep-transcranial-magnetic-stimulation-for-tobacco-cessation-in-adults-with-opioid-use-disorder-100652139",false,"NCT07770555","Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use Disorder","A Pilot Trial of Deep Transcranial Magnetic Stimulation (Deep TMS) for Tobacco Cessation in Patients With Opioid Use Disorder (OUD) Receiving Medications for Opioid Use Disorder (MOUD)","Inclusion Criteria:\n\n* Male or female participants, 22-70 years old.\n* Chronic, heavy smoker (\\>10 cigarettes\u002Fday for \\>1 year) with no continuous abstinence period \\>3 months in the past 12 months (self-report), and baseline smoking confirmed by either (a) cotinine-positive urine or (b) clinical documentation of current smoking when cotinine interpretation is not reliable due to nicotine replacement or other nicotine product use reported at baseline.\n* Motivated to quit smoking, defined as a Motivation To Stop Scale (MTSS) score ≥6 at baseline (i.e., endorsing intention to quit within the next 3 months or within the next month).\n* Meet DSM-5 diagnostic criteria for moderate or severe Opioid Use Disorder (OUD), with diagnosis confirmed by the study investigator through clinical interview study assessment.\n* Meet DSM-5 diagnostic criteria for Severe Tobacco Use Disorder, confirmed by the study investigator through clinical interview study assessment.\n* Have received buprenorphine or methadone consistently for the last 3 months (≥80% proportion of days covered or equivalent documentation for clinic-administered dosing, such as opioid treatment program dosing records or medication administration records demonstrating consistent dosing over the same 3-month period).\n* No self-reported illicit fentanyl use in the past 30 days AND evidence of fentanyl-negative urine toxicology, defined as either (a) a documented fentanyl-negative urine drug screen in the medical record within 7 days prior to consent or (b) a fentanyl-negative urine toxicology obtained at baseline screening.\n* Able to communicate fluently in English for accurate administration of assessments and safety monitoring.\n* For participants with the potential to become pregnant: pregnancy status must be confirmed after informed consent and HIPAA authorization and before study treatment. Participants must have either (a) a negative urine pregnancy test obtained by the study team at baseline after informed consent or (b) a documented negative serum or urine hCG result from standard clinical care within 7 days prior to consent, reviewed or abstracted by the study team only after informed consent and HIPAA authorization.\n* At least one prior quit attempt in the past 12 months, defined as intentionally stopping smoking for ≥24 hours (≥1 day) because they were trying to quit, assessed by self-report at baseline screening.\n\nExclusion Criteria:\n\n* History of seizure disorder, epilepsy, stroke, significant head trauma, or other clinically significant neurologic condition or structural brain lesion (e.g., tumor, vascular malformation, intracranial aneurysm\u002Faneurysm repair, meningitis\u002Fencephalitis with neurologic sequelae).\n* Metallic, electronic, magnetically activated, or retained metal implants\u002Fdevices that may contraindicate TMS exposure, including but not limited to pacemaker\u002Fimplantable cardioverter-defibrillator, cochlear or otologic implants, implanted hearing-aid anchors, deep brain stimulator, vagus nerve stimulator, aneurysm clip\u002Fcoil, carotid\u002Fcerebral stent, ocular metallic implant\u002Fstent, cerebrospinal fluid shunt, intracardiac lines\u002Fwires, implanted pump, retained bullet\u002Fpellet\u002Fshrapnel, staples\u002Fsutures or metal hardware in or around the head\u002Fneck, skull\u002Fcervical fixation plates, titanium skull plates, magnetically activated dental implants, or facial tattoos\u002Fpermanent makeup with metallic ink, as determined by the investigator.\n* Unstable or severe medical condition (e.g., uncontrolled cardiac, hepatic, renal, or metabolic disease) that increases risk from study participation, based on medical history review, medical record review, and investigator clinical judgment.\n* Current pregnancy, intention to become pregnant during the study period, or actively breastfeeding. For participants with the potential to become pregnant, a negative pregnancy test is required before initiating study treatment.\n* Active psychotic disorder, bipolar mania, or major depressive episode with psychotic features, as determined by the study investigator.\n* Severe cognitive impairment or neurocognitive disorder that limits the ability to provide informed consent or complete study procedures. Participants unable to complete consent teach-back will be excluded.\n* Acute intoxication or clinically significant opioid withdrawal at baseline screening, defined as a Clinical Opiate Withdrawal Scale (COWS) score ≥12.\n* Current or recent (within the past 30 days) use of any medication known to significantly lower the seizure threshold, including but not limited to bupropion, clozapine, olanzapine, clomipramine, amitriptyline, or tramadol, or other clinically significant use determined by the investigator to further lower seizure threshold.\n* Any lifetime history of electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS).\n* Frequent or severe migraine headaches, defined as ≥8 migraine days per month over the past 30 days, or migraine headaches that, in the investigator's clinical judgment, are expected to interfere with tolerating TMS sessions.\n* Significant hearing loss that, in the investigator's judgment, would prevent safe participation despite use of hearing protection.\n* Participation in another interventional clinical trial within the last 30 days prior to informed consent.\n* First-degree family history of epilepsy or seizure disorder (biological parent, full sibling, or child).\n* History of recurrent syncope or unexplained fainting, including any episode with loss of consciousness or convulsive features, that has not been adequately evaluated\u002Fcleared or would increase risk with TMS in the investigator's judgment.\n* Current prescribed benzodiazepine or anticonvulsant regimen that has not been stable for at least 4 weeks before consent, defined as any new start, discontinuation, dose increase or decrease, route\u002Fformulation change, change in scheduled dosing frequency, or, for as-needed medications, a change in prescribed instructions or clinically meaningful increase in frequency or amount used during the 4 weeks before consent, as determined by the investigator.","ALL","22 Years","70 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot study will evaluate the use of deep transcranial magnetic stimulation (Deep TMS) to help adults with opioid use disorder (OUD) who are receiving medications for opioid use disorder (MOUD) such as buprenorphine or methadone and who continue to smoke cigarettes and want to quit.\n\nDeep TMS is a noninvasive form of brain stimulation that uses magnetic pulses. The BrainsWay Deep TMS System is FDA-cleared for smoking cessation. This study will use the H4 coil smoking-cessation protocol in people with OUD receiving MOUD. Approximately 12 participants will take part and all participants will receive active Deep TMS. There is no sham or placebo group and no random assignment.\n\nParticipants may receive up to 18 Deep TMS sessions over 6 weeks: five sessions per week during the first 3 weeks, followed by one session per week during Weeks 4 through 6. Participants will return for a follow-up visit at Week 10.\n\nThe main purpose of the study is to learn whether this Deep TMS approach is safe, tolerable and feasible for people with OUD receiving MOUD and to estimate how many participants are able to remain smoke-free from Week 6 through Week 10. The study will also look for early changes in tobacco craving, opioid craving, continuation of MOUD, mood and anxiety symptoms, pain, heart rate variability, and participants' experiences with the treatment. The findings will be used to help plan a larger future study.",[27,28],"Opioid Use Disorder","Tobacco Use Disorder",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Deep Transcranial Magnetic Stimulation","Transcranial Magnetic Stimulation","Smoking Cessation","Cigarette Smoking","Neuromodulation","H4 Coil","Insular Cortex","Prefrontal Cortex","Tobacco Craving","Opioid Craving","Tobacco Cue Reactivity","Medications for Opioid Use Disorder","Buprenorphine","Methadone","NOT_YET_RECRUITING","2026-08-12",{"date":47,"type":48},"2026-08-18","ACTUAL",{"date":50,"type":21},"2027-01",{"date":52,"type":21},"2027-12",{"name":54,"class":55},"Payel Roy","OTHER",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"locationsCount":92},"100599079","sparrow-link-neuromodulation-device-for-opioid-withdrawal-management-in-hospitalized-adults-with-opioid-use-disorder-100599079","NCT07079826","Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder","Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)","Inclusion Criteria:\n\nEligible participants must meet at least ONE of the following criteria:\n\n1. Are continuing to experience opioid withdrawal symptoms:\n\n   1. Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications,\n\n      or\n   2. During tapering or detox from full agonist opioids.\n\n   OR\n2. Have chosen to decline methadone or buprenorphine but still require support for withdrawal symptoms and\u002For pain management.\n\nAdditionally, participants must:\n\n* Be 18 years old or older.\n* Have active history of opioid use disorder.\n* Have a COWS score between 5-24 (Mild-moderate opioid withdrawal), indicating residual withdrawal symptoms.\n* Be able to provide informed consent.\n\nExclusion Criteria:\n\n* History of or active seizure disorder.\n* Presence of a cardiac device (e.g., pacemaker, defibrillator).\n* Presence of a neurostimulator (e.g., deep brain stimulator, spinal cord stimulator).\n* Pregnant or lactating individuals.\n* COWS score ≥ 25 (Severe Withdrawal), requiring medical stabilization.\n* Abnormal ear Anatomy, ear Infections, or skin Conditions at Electrode Sites, including congenital malformations, post-surgical changes, significant scarring, open wounds, or hypersensitivity.\n* Active neurological disorders, such as traumatic brain injury, stroke, multiple sclerosis, or other conditions that may interfere with neurostimulation effects or autonomic regulation as assessed at the investigator's discretion.\n* Severe alcohol or benzodiazepine withdrawal that is not adequately controlled with medication, per investigator discretion.\n* Known or documented allergy to hydrocolloid adhesives, as evidenced in the medical record.\n* Evidence of active psychosis, as documented in the medical record or reported by clinical staff.\n* Non-English speakers, whose limited English proficiency precludes informed consent or meaningful participation in study assessments validated only in English.","18 Years",{"count":65,"type":21},50,[24],"This study is evaluating the Sparrow Link, a wearable device that delivers gentle electrical signals to nerves in the outer ear (a technique known as transcutaneous auricular neurostimulation, or tAN). The goal is to assess whether the device is feasible to use, acceptable to patients, and may help reduce opioid withdrawal symptoms in hospitalized adults being treated for opioid use disorder (OUD). Participants will be randomly assigned to receive either the active device or a sham (inactive) version. Neither participants nor their clinical teams will know which version is used. All participants will continue receiving standard hospital care for opioid withdrawal. Researchers will collect information on how long participants use the device, whether they stop using it early, and changes in withdrawal severity. The study will also examine pain, craving, mood, anxiety, heart rate variability, and opioid use during hospitalization.",[69,70],"Opioid Withdrawal","Opioid Use Disorder (OUD)",[72,73,74,75,76,77,78,79,80,81,82,83,84],"transcutaneous auricular neurostimulation","Sparrow Link","tAN","vagus nerve stimulation","trigeminal nerve stimulation","neuromodulation","Clinical Opiate Withdrawal Scale","opioid craving","inpatient addiction care","withdrawal management","Addiction Medicine","anxiety","depression","RECRUITING","2026-05-27",{"date":88,"type":48},"2026-06-01",{"date":86,"type":48},{"date":52,"type":21},{"name":54,"class":55},1,""]