[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-use-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-use-disorder":394},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,189,0,25,[9,51,75,103,128,154,182,202,221,257,283,306,332,356,379,410,430,457,482,501,530,550,577,606,624],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100643571","buprenorphine-implementation-at-syringe-service-programs-to-reduce-overdoses-100643571",false,"NCT07631598","Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses","Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial","BISTRO","Inclusion Criteria:\n\n1. ≥ 18 years old;\n2. Meet DSM-5 criteria for moderate or severe OUD;\n3. Interest in receiving buprenorphine treatment;\n4. Speaks English or Spanish;\n5. Currently an SSP client at the time of enrollment;\n6. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;\n2. Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;\n3. Allergy to buprenorphine;\n4. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.",true,"ALL","18 Years",{"count":22,"type":23},512,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.\n\nThe study compares two ways of connecting people to treatment:\n\nReferral to a community treatment provider (usual care before the new program begins).\n\nOnsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.\n\nParticipants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.\n\nThe study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.\n\nThe overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.",[29,30,31],"Opioid Use Disorder","Opioid Use Disorder, Severe","Opioid Use Disorder, Moderate",[33,34,35,36,37],"Buprenorphine","Overdose Prevention","Low-Threshold Treatment","Community-Based Treatment","Medication for Opioid Use Disorder","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2026-08-17",{"date":46,"type":23},"2028-06",{"name":48,"class":49},"Montefiore Medical Center","OTHER",8,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100625257","phase-2-a-study-of-brenipatide-in-participants-with-opioid-use-disorder-100625257","NCT07420283","A Study of Brenipatide in Participants With Opioid Use Disorder","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)","RENEW-Op-1","Inclusion Criteria:\n\n* Have a current mild, moderate or severe opioid use disorder (OUD)\n* Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to administer the study intervention\n  * store and use the provided study intervention as directed\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n* Are intermittently using non-legal, non-prescribed opioids\n* Are taking buprenorphine for treatment on OUD\n\nExclusion Criteria:\n\n* Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco use disorder, mild-to-moderate alcohol or mild-to-moderate cannabis use disorder\n\nNote: any level of caffeine use is allowed\n\n* Are actively suicidal or deemed a significant risk for suicide\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening\n* Had opioid overdose in past 6 months prior to screening\n* Have a lifetime history or current diagnosis of the following:\n\n  * schizophrenia or other psychotic disorder\n  * bipolar disorder\n  * borderline personality disorder\n  * any eating disorder\n* Have type 1 diabetes mellitus, or a history of ketoacidosis, or hyperosmolar state, or coma","75 Years",{"count":61,"type":23},465,[63],"PHASE2","The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.\n\nThe maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.",[29],{"date":41,"type":42},{"date":68,"type":42},"2026-02-13",{"date":70,"type":23},"2028-03",{"name":72,"class":73},"Eli Lilly and Company","INDUSTRY",58,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100643978","phase-1-cannabis-effects-on-opioid-self-administration-100643978","NCT07668635","Cannabis Effects on Opioid Self-Administration","Impact of Cannabis on Opioid Self-Administration","Inclusion Criteria:\n\n* Participants with moderate to severe opioid use disorder who experience opioid withdrawal\n* No allergies or adverse reactions to cannabis or opioids\n* Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks\n\nExclusion Criteria:\n\n* Individuals seeking treatment for opioid use disorder","55 Years",{"count":84,"type":23},30,[86],"PHASE1","The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive\u002Fdesire to take opioids.",[29,89],"Cannabis Use",[91,92],"opioid use","cannabis","NOT_YET_RECRUITING","2026-08-19",{"date":39,"type":42},{"date":97,"type":23},"2026-09-30",{"date":99,"type":23},"2031-07-30",{"name":101,"class":49},"Shanna Babalonis, PhD",1,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":102},"100652943","trtme-improving-outpatient-initiation-of-medication-for-opioid-use-disorder-following-hospitalization-100652943","NCT07780097","TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization","A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial","TRTME","Inclusion Criteria:\n\n1. 18 years of age or older;\n2. A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team\n\nExclusion Criteria:\n\n1. Have a current planned discharge to a nursing facility\n2. be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment\n3. Unable to demonstrate adequate understanding of study procedures during the consent process",{"count":84,"type":23},[26],"The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.",[29,31,30],[116,29,117,118,119],"opioid","MOUD","buprenorphine","methadone","2026-08-18",{"date":41,"type":42},{"date":123,"type":23},"2026-08-12",{"date":125,"type":23},"2027-02-28",{"name":127,"class":49},"T. John Winhusen, PhD",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":19,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":102},"100652779","personalized-addiction-treatment-ehancement-100652779","NCT07778394","Personalized Addiction Treatment eHancement","The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder","Project Path","Inclusion Criteria:\n\n* Age 22+\n* Current Opioid Use Disorder diagnosis\n* Prescribed buprenorphine or methadone\n* Initiated or reinitiated buprenorphine or methadone treatment recently\n* Access to personal smartphone\n\nExclusion Criteria:\n\n* Not fluent in English\n* Limited mental capacity or inability to provided informed consent","22 Years",{"count":138,"type":23},40,[26],"Many patients stop medication-based treatments for Opioid Use Disorder (OUD) prematurely, placing them at increased risk for overdose and death. Providing targeted interventions for OUD, particularly through an accessible, digital health platform, is a potential way to enhance recovery and keep patients engaged in care. The current study seeks to test whether a digital mental health platform, delivered by peer recovery support specialists to individuals prescribed buprenorphine or methadone medication, will improve treatment outcomes for this high risk population.",[29,142,143],"mHealth","Peer Support",[145,146],"Peer Recovery Support","Digital Support",{"date":41,"type":42},{"date":149,"type":42},"2026-08-13",{"date":151,"type":23},"2027-03-31",{"name":153,"class":49},"Rhode Island Hospital",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":24,"phases":165,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":102},"100638947","cerebral-physiology-of-nows-100638947","NCT07610746","Cerebral Physiology of NOWS","Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.","NIRS for NOWS","Inclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n* History of prenatal opioid exposure\n\nControl infants:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n\nMothers of infants with prenatal opioid exposure:\n\n* greater or equal to 19 years of age\n* Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or illicit opioids\n\nMothers of control infants:\n\n* greater than or equal to 19 years of age\n\nExclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n\nControl infants:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n* Any history of prenatal opioid exposure\n\nMothers of infants with prenatal opioid exposure:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n\nMothers of control infants:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n* Tobacco, SSRI or any opioid use during pregnancy","1 Day",{"count":164,"type":23},46,[26],"This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.",[168,169,29,170],"Neonatal Opioid Withdrawal","Neonatal Opioid Withdrawal Syndrome","Intrauterine Exposure",[172,173,174],"neonatal opioid withdrawal syndrome","near infrared spectroscopy","diffuse correlation spectroscopy",{"date":94,"type":42},{"date":177,"type":42},"2026-08-11",{"date":179,"type":23},"2027-08",{"name":181,"class":49},"Indiana University",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":102},"100491750","phase-1-omar-opioid-use-disorder-100491750","NCT05683184","OMAR Opioid Use Disorder","Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder","Inclusion Criteria:\n\n* Able to provide informed consent\n* Male and female 18 years and older\n* DSM-5 diagnosis of opioid use disorder (for OUD group)\n* Physically healthy i.e., no clinically unstable medical conditions\n* Written informed consent and have capacity to consent and comply with study procedures\n\nExclusion Criteria:\n\n* Current neuro-psychiatric illness or severe systemic disease (opioid use disorder is permitted in the OUD group).\n* Presence of ferromagnetic metal in the body or heart pacemaker\n* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits\n* Are claustrophobic",{"count":84,"type":23},[86],"The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.",[193,29],"Healthy Control","2026-08-16",{"date":120,"type":42},{"date":197,"type":42},"2023-03-10",{"date":199,"type":23},"2027-12-15",{"name":201,"class":49},"Yale University",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":217,"leadSponsor":219,"locationsCount":102},"100596362","social-functioning-in-opioid-use-disorder-100596362","NCT07044466","Social Functioning in Opioid Use Disorder","Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others","OUD","Inclusion Criteria:\n\n* Any sex or gender; any race or ethnicity; aged 18 years or older\n* Patient participants must meet DSM-5 diagnostic criteria for current (i.e., past 12 months) OUD (assessed via the Quick Structured Clinical Interview for DSM-5; Quick SCID)\n* Patient participants must be on medication for opioid use disorder (MOUD), as prescribed by their provider, for no more than 12 weeks prior to study initiation\n* Patient participants must be in treatment at a clinic in South Carolina\n* Concurrent substance use disorders (e.g., alcohol, cannabis) for the patient participant are acceptable, provided opioids are the patient participant's primary substance of choice\n* Patient participants must identify a CSO participant who consents to participation in the study as well\n\nExclusion Criteria:\n\n* Moderate-to-severe opioid withdrawal as defined by a score of ≥21 on the Subjective Opioid Withdrawal Scale\n* Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders\n* Current suicidal or homicidal ideation and intent; participants who present a serious suicide risk are likely to require hospitalization during the study and they will be referred clinically\n* CSO participants meeting DSM-5 criteria for opioid use disorder or any other substance use disorder, excepting tobacco use disorder, mild cannabis use disorder, and mild alcohol use disorder\n* Severe interpersonal violence in the past six months between the patient and the CSO, as defined by an adapted version of the Conflict Tactics Scaled Revised (CTS-2)\n* Pregnancy for patient participants\n* Prisoners, institutional individuals, and children will not be recruited for this study.",{"count":211,"type":23},230,[26],"Problems with social functioning are core to opioid use disorder (OUD), though specific, modifiable social functioning targets and how they relate to OUD treatment outcomes are poorly understood. This study will utilize both data from both patients with OUD and their concerned significant other (CSO) to examine associations between specific social functioning metrics and OUD treatment outcomes. Findings from this study will inform future precision-medicine approaches for people with OUD, a population in significant need of enhanced treatment approaches to combat opioid morbidity and mortality.",[29],{"date":44,"type":42},{"date":149,"type":42},{"date":218,"type":23},"2029-08-31",{"name":220,"class":49},"Medical University of South Carolina",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":19,"minAge":136,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100652139","deep-transcranial-magnetic-stimulation-for-tobacco-cessation-in-adults-with-opioid-use-disorder-100652139","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.","70 Years",{"count":230,"type":23},12,[26],"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.",[29,234],"Tobacco Use Disorder",[236,237,238,239,240,241,242,243,244,245,246,247,33,248],"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","Methadone",{"date":120,"type":42},{"date":251,"type":23},"2027-01",{"date":253,"type":23},"2027-12",{"name":255,"class":49},"Payel Roy",2,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":24,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":102},"100609423","producing-outcome-measures-for-otp-quality-improvement-100609423","NCT07214389","PRoducing Outcome Measures for OTP Quality Improvement","Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement","PROMOTE-QI","Only BayMark OTPs are eligible for participation.",{"count":266,"type":23},40194,[26],"This study tests ways to help opioid treatment programs (OTPs) keep patients in care. Staying on methadone or buprenorphine is linked to better outcomes, yet many people leave treatment early. The project will compare two approaches that provide clinics with retention\u002Foutcome quality measures and a quality-improvement (QI) toolkit-either alone or with added facilitation-against usual care.\n\nForty-five BayMark OTPs in multiple states will be randomly assigned to one of three groups: (1) quality measures + QI toolkit; (2) quality measures + QI toolkit + external QI facilitation; or (3) usual care.\n\nThe primary outcome is 90-day retention in treatment, measured from OTP electronic health records and Medicaid claims. Secondary outcomes include emergency department visits, hospitalizations, overdoses, and mortality. Findings will identify practical, scalable strategies to improve patient retention in OTPs.",[29],[271,248,33,272,273,274,275],"Opioid Treatment Programs (OTPs)","Quality Improvement (QI)","Treatment Retention","Addiction Services","Implementation Science",{"date":149,"type":42},{"date":278,"type":42},"2026-01-13",{"date":280,"type":23},"2027-09-01",{"name":282,"class":49},"RTI International",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":102},"100600221","development-of-an-opioid-withdrawal-clinical-outcome-assessment-100600221","NCT07094672","Development of an Opioid Withdrawal Clinical Outcome Assessment","Development of an Opioid Withdrawal Clinical Outcome Assessment Among Persons With Opioid Use Disorder","Inclusion Criteria:\n\n* Past year opioid use disorder, determined by (a) enrollment in current treatment for opioid use disorder and\u002For (b) an opioid-positive saliva test.\n* Fluent in English\n* Has experience with opioid withdrawal at least once in the past 30 days\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to cognitive impairment\n* Being pregnant or breastfeeding\n* History of psychosis or mania as determined by the MINI\n* Exhibiting suicidal behavior in the past 30 days as determined by the C-SSRS\n* Circumstances that could interfere with study participation\n* Previously participated in affiliated Focus Group study",{"count":84,"type":23},"OBSERVATIONAL","Withdrawal management strategies are currently the most utilized and ubiquitous intervention for opioid use disorder in the US, yet existing measures of opioid withdrawal lack Food and Drug Administration (FDA) qualification. This project will develop and validate a clinical outcome assessment (COA) for opioid withdrawal,essential for standardizing withdrawal mitigation strategies and establishing best practices. In line with the FDA's drug development tool qualification guidelines, our methodological process will involve conducting focus groups with persons with lived experience of opioid withdrawal for concept elicitation, refining these concepts through cognitive interviews, and conducting construct and longitudinal validations of the new assessment in laboratory settings and across diverse treatment contexts.",[29],[116,295,296,297],"fentanyl","withdrawal","naloxone",{"date":299,"type":42},"2026-08-14",{"date":301,"type":23},"2026-10-01",{"date":303,"type":23},"2028-09-30",{"name":305,"class":49},"University of Maryland, Baltimore",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":117,"eligibilityCriteria":312,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":102},"100524097","medications-for-opioid-use-disorder-photosensitive-retinal-ganglion-cell-function-sleep-and-circadian-rhythms-implications-for-treatment-100524097","NCT06104280","Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment","Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)","Inclusion Criteria:\n\n1. Adults (18+)\n2. prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control\n3. stable on MOUD (no dose change) for the past month\n4. positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications\n\nExclusion Criteria:\n\n1. eye disease reported by history or noted on exam including disease of the anterior and posterior segment of the eye, cataracts, retinopathy, glaucoma, cataracts, amblyopia, scotoma, color or night blindness, corneal pathologies, macular degeneration, or retinitis pigmentosa;\n2. acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent\n3. self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines\u002Fsedative\u002Fhypnotics in the past month\n4. alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist\n5. positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines\u002Fsedative\u002Fhypnotics\n6. shift workers who work outside normal 7 a.m. to 6 p.m. hours, according to the National Institute of Occupational Safety and Health (NIOSH)\n7. persons diagnosed with narcolepsy","80 Years",{"count":315,"type":23},200,"Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.",[29,318],"Sleep Disturbance",[320,321,322,323],"opioid use disorder","sleep","circadian rhythms","sleep disruption","2026-08-07",{"date":177,"type":42},{"date":327,"type":42},"2025-01-06",{"date":329,"type":23},"2029-01-01",{"name":331,"class":49},"University of Alabama at Birmingham",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":24,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100566130","phase-2-evaluation-of-tirzepatide-as-an-adjunct-to-buprenorphine-for-the-treatment-of-opioid-use-disorder-100566130","NCT06651177","Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder","NIDA CTN-0152: Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder: A Pragmatic, Multi-site, Double-blind, Randomized, Placebo-controlled Trial (TAB)","TAB","Inclusion Criteria:\n\n1. Must be ≥18 years of age;\n2. Must have moderate to severe OUD;\n3. Must, at the time of randomization, be newly initiated on BUP (i.e., within 7 to 80 days) during the current treatment episode, be taking ≥ 8 mg\u002Fday of generic buprenorphine-naloxone film\u002Ftablets (or the equivalent for other buprenorphine products), have documentation of receiving BUP, including dose and the start date of the current treatment episode, from their BUP provider, and, for participants prescribed transmucosal BUP, have at least one UDS positive for buprenorphine\u002Fnorbuprenorphine;\n4. Must be willing to be randomized to tirzepatide or placebo and to comply with study procedures, including weekly visits for 6 months;\n5. Must be able to understand the study, and having understood, provide written informed consent in English;\n6. Must not be breastfeeding; if of child bearing potential, must test negative on the study-administered pregnancy test(s), and if of childbearing potential and engaging \u002Fplanning to engage in sexual intercourse must agree to effective contraception for the duration of the trial through 30 days after the trial; effective contraception is defined as using: a) birth control injection, an intrauterine device, or implant; or b) two birth control methods - for example birth control pills with a barrier method (e.g., condoms, etc.).\n\n   * If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:\n\n     1. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, tubal implants, or tubal ligation), congenital anomaly such as Mullerian agenesis; are\n     2. post-menopausal defined as ≥ 55 years old not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea;\n     3. ≥ 55 years old with a diagnosis of menopause prior to starting hormone replacement therapy; or\n     4. ≥ 40 years old with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone ≥ 40 mIU\u002FmL; participants in this category must test negative on the study-administered pregnancy test(s).\n\nExclusion Criteria:\n\n1. have a history of type 1 or type 2 diabetes mellitus (other than pregnancy-related diabetes);\n2. have a BMI \\\u003C23.0 kg\u002Fm²;\n3. have any of the following cardiovascular conditions within 90 days prior to signing consent: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF);\n4. have a known history of chronic or acute pancreatitis, gallbladder disease, gastroparesis, gastric emptying abnormality, gastroesophageal reflux disease, or other severe gastrointestinal disease;\n5. have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);\n6. have previously taken tirzepatide, have taken any GLP-1 analogue within the 6 months before consent, or have a known history of prior hypersensitivity reaction to any GLP-1 analogue;\n7. have renal impairment defined as an estimated glomerular filtration rate (eGFR) value of \\\u003C 15 mL\u002Fmin\u002F1.73 m2 or requiring dialysis;\n8. have a current, or within the 30 days prior to signing consent, use of, or plan to start during the course of the trial:\n\n   1. medications with glucose lowering properties: GLP-1 analogs, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors;\n   2. systemic steroids including prednisone, hydrocortisone, dexamethasone;\n9. have a history of suicide attempts in the prior year or significant active suicidal ideation as assessed by a qualified study clinician;\n10. have a psychiatric or medical condition that, in the judgment of the site medical clinician (BMC or UMC), would make study participation unsafe or which would make treatment compliance difficult;\n11. have current status as a prisoner OR be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities.",{"count":341,"type":23},310,[63],"The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.",[29,31,30],[346,116,320,118,347],"tirzepatide","GLP-1","2026-08-06",{"date":177,"type":42},{"date":351,"type":42},"2026-01-29",{"date":353,"type":23},"2027-10-31",{"name":127,"class":49},9,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":363,"minAge":4,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100520079","phase-4-assessing-optimal-xrb-initiation-points-in-jail-100520079","NCT06051890","Assessing Optimal XRB Initiation Points in Jail","Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail","Inclusion Criteria:\n\n* Incarcerated men able to provide written informed consent in English.\\*\n* Unsentenced.\n* Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.\n* Minimum anticipated jail stay is 4 days.\n* Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).\n\nExclusion Criteria:\n\n* Sentenced.\n* Allergy, hypersensitivity or medical contraindication to either medication.\n* Chronic pain requiring opioid pain management or other contraindicated medications.","MALE",{"count":365,"type":23},50,[367],"PHASE4","This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.",[29],"2026-08-05",{"date":324,"type":42},{"date":373,"type":42},"2025-06-02",{"date":375,"type":23},"2027-03-01",{"name":377,"class":49},"NYU Langone Health",4,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":24,"phases":388,"briefSummary":389,"conditions":390,"keywords":395,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":102},"100296200","project-i-test-implementing-hiv-testing-in-opioid-treatment-programs-100296200","NCT03135886","Project I Test: Implementing HIV Testing in Opioid Treatment Programs","A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs","Inclusion Criteria:\n\n* Eligible sites must:\n\n  1. See at least 150 unduplicated patients\u002Fyear\u002Fsite\n  2. Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and\u002For HCV tests; b) completed these tests; c) are referred to care\u002Fevaluation (and type of referral) if positive; and d) are linked to care\u002Fevaluation within 30 days of diagnosis\n  3. Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race\u002Fethnicity (in aggregate) and data on HIV\u002FHCV test reimbursement processes and outcomes\n  4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study\n\nExclusion Criteria:\n\n* Sites will be excluded if:\n\n  1. Over 50% of patients served in the prior 6 months were HIV or HCV tested\n  2. They are terminated via PI decision\u002Fdiscretion",{"count":387,"type":23},418,[26],"This study will test two active evidence-based \"practice coaching\" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV\u002FHepatitis C virus (HCV) testing and linkage to care among patients seeking\u002Freceiving substance use disorder treatment.\n\nAims are:\n\nAim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV\u002FHCV intervention on HIV testing.\n\nAim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care.\n\nAim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition.\n\nPrimary Hypothesis:\n\n1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the \"initial impact\" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).\n2. The HIV\u002FHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).",[391,392,393,394],"HIV\u002FAIDS","Hepatitis C","Substance Use Disorders","Opioid-use Disorder",[396,397,398,399,400,401,402],"HIV","HIV Testing","Hepatitis C Virus Testing","Opioid Use Disorder Treatment","Substance Use Disorders Treatment","Hepatitis C Virus","Practice Coaching",{"date":324,"type":42},{"date":405,"type":42},"2017-06-12",{"date":407,"type":23},"2026-08-31",{"name":409,"class":49},"Columbia University",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":416,"minAge":20,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":102},"100511659","predicting-and-preventing-adverse-maternal-and-child-outcomes-of-opioid-use-disorder-in-pregnancy-100511659","NCT05942313","Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy","Inclusion Criteria:\n\n* Pregnant women with OUD and their infant\n* Currently on BUP\u002FMETH for OUD\n* Enrolled in prenatal opioid maintenance program\n* Age \\>18 years\n* Singleton pregnancy\n* Planned delivery at UPMC's Magee Womans Hospital\n* Positive opioid urine screen results\n\nExclusion Criteria:\n\n* Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures\n* HIV or AIDS\n* Known major fetal congenital abnormalities","FEMALE",{"count":418,"type":23},100,"This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.",[29,421],"Pregnancy Related","2026-08-04",{"date":348,"type":42},{"date":425,"type":42},"2023-08-28",{"date":427,"type":23},"2026-12-01",{"name":429,"class":49},"Ilana Hull",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":19,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":102},"100606702","mobile-platform-for-optimizing-wellness-and-engagement-in-recovery-100606702","NCT07178990","Mobile Platform for Optimizing Wellness and Engagement in Recovery","MPOWER","Inclusion Criteria:\n\n* Participants must be enrolled in the Michigan Medicaid program\n* Opioid agonist treatment (OAT): Participants must have initiated OAT with buprenorphine or methadone\n* Participants must have an OAT prescription and Alcohol use disorder (AUD) based on self-report measure during screening\n* Participants must have regular access to a working smartphone and internet connection.\n* Participants must have a reliable mailing address to receive study supplies (e.g., salivary drug tests).\n\nExclusion Criteria:\n\n* Primary Medicare Coverage: Individuals that are dual-eligible for Medicaid and Medicare and aged 65 or older, due to limited availability of Medicaid claims data for this group\n* Individuals that cannot voluntarily provide informed consent themselves for any reason, including legal incompetency\n* Individuals with substantial cognitive impairment that would interfere with study participation\n* Individuals unable to read or understand English\n* Individuals experiencing active suicidality or psychosis.\n* Individuals with a planned admission to residential treatment or incarceration during the study period.","19 Years","63 Years",{"count":365,"type":23},[26],"This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM) treatment among Medicaid beneficiaries. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.",[443,444,29],"Opioid Agonist Treatment","Alcohol Use Disorder",[446,447,448],"Research surveys","App based program","Smartphone","2026-08-03",{"date":348,"type":42},{"date":452,"type":42},"2025-12-08",{"date":454,"type":23},"2027-07-31",{"name":456,"class":49},"University of Michigan",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":24,"phases":466,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":256},"100625320","early-phase-1-pilot-of-mailing-buprenorphine-100625320","NCT07421102","Pilot of Mailing Buprenorphine","A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment","Inclusion Criteria:\n\n* Age ≥ 18\n* English-speaking\n* Diagnosed with OUD and initiated on buprenorphine during hospitalization\n* Discharging to a South Carolina address with a stable mailbox\n* Access to phone or computer\n\nExclusion Criteria:\n\n* Active psychosis or suicidal ideation\n* Severe medical or neurocognitive impairment\n* Pending incarceration",{"count":465,"type":23},20,[467],"EARLY_PHASE1","This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid use disorder (OUD) following medical hospitalization. The intervention aims to improve retention in treatment by overcoming barriers such as transportation and pharmacy access.",[29],[471,472,320,473],"mailing buprenorphine","transitions of care","barriers to buprenorphine","2026-07-29",{"date":476,"type":42},"2026-07-30",{"date":478,"type":42},"2026-04-08",{"date":480,"type":23},"2027-03",{"name":220,"class":49},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":102},"100606499","phase-4-acceptability-and-feasibility-of-extended-release-subcutaneous-buprenorphine-on-a-mobile-pharmacy-clinic-100606499","NCT07176351","Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic","Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic: A Pilot Study","Inclusion Criteria:\n\n* Able to provide written informed consent in English or Spanish\n* Current or history of DSM-5 moderate-to-severe OUD per Rapid Opioid Use Disorder Assessment (ROUDA)\n* Not planning to move out of state or to new location during study enrollment.\n\nExclusion Criteria:\n\n* Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment)\n* Persons who are pregnancy\n* People who show violent or threatening behavior toward staff and\u002For others\n* Allergy, hypersensitivity, or medical contraindication to medication (the BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in persons with latex-sensitivity)",{"count":490,"type":23},60,[367],"This exploratory project will assess the acceptability and feasibility of monthly extended-release subcutaneous buprenorphine (BRIXADI; XR-B) to treat opioid use disorder (OUD) among persons in the community receiving care on a mobile pharmacy clinic (MPC).\n\nParticipants who are interested in initiating monthly or weekly injections of subcutaneous XR-B (BRIXADI) as a treatment for their OUD will be enrolled in a 6-month study assessing the acceptability and feasibility of receiving XR-B on an MPC.",[29],{"date":495,"type":42},"2026-07-31",{"date":497,"type":23},"2026-08",{"date":499,"type":23},"2027-02",{"name":201,"class":49},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":24,"phases":512,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":102},"100597905","phase-1-istep-n-101b-pharmacokinetics-and-safety-study-of-low--and-high-dose-naltrexone-implants-vs-monthly-vivitrol-in-healthy-volunteers-100597905","NCT07064564","iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers","A Randomized, Active-comparator Controlled, Two-Dose-level Study of iSTEP-N in Healthy Adults With Long Term Safety and PK Follow-up","iSTEP-N","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\nHealthy adult male or female volunteers, ages 18 to 55 years.\n\nAble and willing to provide written informed consent prior to any study procedures.\n\nIn good general health as determined by medical history, physical examination, vital signs, ECG, and laboratory tests (chemistry, hematology, and coagulation).\n\nNo clinically significant abnormalities in lab results, as determined by the investigator.\n\nNegative urine drug screen for opioids, cocaine, amphetamines, benzodiazepines, cannabinoids, and other substances of abuse.\n\nNegative breath alcohol test at screening and baseline.\n\nNegative naloxone challenge test, indicating no physiological opioid dependence.\n\nFor females of childbearing potential:\n\nNegative serum pregnancy test at screening and Day 0.\n\nAgreement to use acceptable contraception (including oral hormonal contraception) for the duration of the study.\n\nFor males with female partners of childbearing potential:\n\nAgreement to use effective contraception throughout the study.\n\nNegative infectious disease panel, including HIV, hepatitis B surface antigen, and hepatitis C antibody.\n\nNo evidence of suicidal ideation or behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.\n\nHamilton Depression Rating Scale (HAM-D17) total score of 0 to 10, consistent with no or minimal depressive symptoms.\n\nWilling and able to comply with all study visits, procedures, and restrictions, including pharmacokinetic sampling.\n\nWilling to refrain from donating blood during the study period.\n\nAgree not to use opioid-containing medications for the duration of the study unless medically necessary and approved by the investigator.\n\nExclusion Criteria:\n\nParticipants who meet any of the following conditions will be excluded:\n\nCurrent or recent history (past 12 months) of opioid use disorder, substance use disorder, or alcohol dependence.\n\nPositive urine drug test or breath alcohol test at screening or prior to randomization.\n\nFailure of the naloxone challenge test, indicating possible physical opioid dependence.\n\nUse of any investigational drug or device within 30 days prior to screening.\n\nUse of any opioid-containing medications (prescription or OTC) within 14 days prior to screening.\n\nKnown hypersensitivity or allergy to naltrexone, polycaprolactone (PCL), polylactic acid (PLA), polymeric implants, or any other component of the study drug.\n\nHistory of chronic pain, neurological or psychiatric disorders, or any condition requiring regular use of medications.\n\nActive medical condition or past medical history that, in the opinion of the investigator, could interfere with the study or pose an undue risk, including:\n\nCardiovascular disease\n\nHepatic or renal impairment\n\nGastrointestinal disorders affecting absorption\n\nRespiratory disease\n\nSeizure disorder\n\nAutoimmune or inflammatory disorders\n\nFemales who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n\nBaseline systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg.\n\nHistory of major depressive disorder, bipolar disorder, psychosis, or other severe psychiatric illness.\n\nHAM-D17 score \\>10 at screening or Day 0.\n\nAny suicidal ideation or behavior as defined by the C-SSRS in the past 6 months.\n\nParticipation in another clinical trial with investigational medication or device within the past 30 days.\n\nKnown coagulation disorder or current use of anticoagulants.\n\nInability to comply with study procedures due to geographic, social, or mental limitations.\n\nPresence of any implantable medical device that may interfere with study procedures or assessments.\n\nHistory of keloid formation or abnormal wound healing, which may affect implant insertion site.\n\nHistory of HIV, hepatitis B, or hepatitis C, unless determined to be false positive or clinically insignificant by the investigator.\n\nAny condition that, in the investigator's opinion, would make the subject unsuitable for the study.","65 Years",{"count":511,"type":23},33,[86],"This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids. The implant is placed under the skin of the thigh and is designed to release medication continuously over many months.\n\nThe main purpose of the study is to measure blood levels of naltrexone over time after administration of two different doses of the iSTEP-N implant and to compare those levels with the blood levels achieved by Vivitrol®, an FDA-approved injectable extended-release naltrexone given once every month.\n\nThe study will enroll healthy adult volunteers aged 18 to 65 years. Participants will be randomly assigned to one of three groups:\n\n* Low-dose iSTEP-N implant\n* High-dose iSTEP-N implant\n* Monthly Vivitrol injections\n\nParticipants will be followed closely for approximately 12 months to measure medication levels and monitor safety, side effects, and overall health. The study will help determine whether the iSTEP-N implant can maintain naltrexone levels comparable to or higher than those achieved with monthly injections, especially during periods when protection from relapse is most important.\n\nParticipants who receive an iSTEP-N implant and still have detectable implant material or measurable medication levels at the end of the first year may continue in a long-term follow-up period lasting up to two additional years. During this period, researchers will monitor how long the implant remains detectable and how long medication continues to be released. If the implant remains after two years, participants may choose to have it surgically removed or simply end study participation.\n\nThe study is sponsored by Akyso Therapeutics, LLC, with clinical operations conducted at a dedicated clinical research center and oversight provided by an independent Institutional Review Board. All participants undergo screening examinations to confirm eligibility and are carefully monitored throughout participation.\n\nResults from this study will help determine the appropriate dose of iSTEP-N for future clinical trials and support development of long-acting treatment options for opioid use disorder that may reduce the need for frequent injections.",[29],[516,517,518,519,320,520,521],"naltrexone","biopin","oud","implant","extended-release","vivtrol","2026-07-28",{"date":476,"type":42},{"date":525,"type":42},"2026-07-25",{"date":527,"type":23},"2029-12-31",{"name":529,"class":73},"Akyso Therapeutics, LLC",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":102},"100484525","phase-3-high-dose-buprenorphine-bup-induction-in-the-emergency-department-ed-100484525","NCT05589181","High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)","Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study\n* Treated in the ED during screening hours\n* Meet DSM-5 diagnostic criteria for moderate to severe OUD\n* Clinical Opioid Withdrawal Score (COWS) score ≥ 8\n* Urine toxicology positive for fentanyl\n* Able to speak English or Spanish sufficiently to understand study procedures\n\nExclusion Criteria:\n\n* UDS positive for methadone.\n* Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing\n* Have an unstable medical or psychiatric condition including suicidality requiring hospitalization\n* Require ongoing opioids for pain management\n* Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible\n* Be a prisoner or in custody at the time of the index visit\n* Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.\n* Unable to provide one additional point of contact other than themselves\n* Unwilling to follow study procedures\n* Have prior enrollment in the current study\n* Have a known allergy or hypersensitivity to BUP\n* Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA)\n* Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration\n* Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study",{"count":538,"type":23},140,[540],"PHASE3","This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction.\n\nTrial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.",[29],{"date":476,"type":42},{"date":545,"type":42},"2023-04-06",{"date":547,"type":23},"2026-12-31",{"name":549,"class":49},"Rutgers, The State University of New Jersey",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":416,"minAge":4,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":24,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":256},"100590580","adapting-the-penny-chatbot-for-perinatal-oud-patients-copilot-100590580","NCT06969261","Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT","PENNY-COPILOT","Inclusion Criteria:\n\n* Biological females who are currently pregnant or within 6 weeks postpartum.\n* Able to read, write, and speak English at a 6th grade level.\n* Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.\n* Receiving prenatal care and OUD care at a Penn affiliated hospital.\n\nExclusion Criteria:\n\n-Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).",{"count":465,"type":23},[26],"To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.",[561,29],"Perinatal Opioid Use Disorder",[563,564,565,566,567,568],"Maternal Health","Maternal Substance Use","Perinatal OUD","Chatbot","mHealth Interventions","Loneliness","2026-07-27",{"date":522,"type":42},{"date":572,"type":42},"2026-01-01",{"date":574,"type":23},"2027-05-31",{"name":576,"class":49},"University of Pennsylvania",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":59,"enrollmentInfo":583,"targetDuration":4,"studyType":24,"phases":584,"briefSummary":585,"conditions":586,"keywords":593,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":378},"100558236","phase-2-glp-1r-agonist-treatment-for-opioid-use-disorder-100558236","NCT06548490","GLP-1R Agonist Treatment for Opioid Use Disorder","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Body mass index (BMI) \\> 18.\n* Able and willing to provide informed consent prior to any study-related activities.\n* Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI \\> 3 (\"moderate\" or \"severe\" in the \"Specify If\" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).\n* Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and\u002For at an associated clinic at the time of enrollment.\n* Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.\n* Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.\n* If capable of becoming pregnant and of childbearing age, is not pregnant (confirmed) or breastfeeding at the time of enrollment and agrees to use a medically accepted method of birth control or or to abstain from sexual activity that could result in pregnancy (if applicable) while in the study.\n* Able to read and communicate in English to the level required to accept standard care and complete all study requirements.\n* Able and willing to engage\u002Fadhere to the entirety of the study protocol (19 weeks).\n* Not currently a prisoner.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 75 years.\n* BMI \\\u003C18.\n* Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.\n* Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.\n* History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.\n* Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.\n* Type 1 diabetes or history of diabetic ketoacidosis.\n* Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.\n* Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.\n* Hypoglycemia on intake visit (blood glucose \\\u003C 60 mg\u002FdL).\n* End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin per 1.73 square meters or previous renal transplant.\n* End stage liver disease or previous liver transplant.\n* Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.\n* Current or past diagnosis of gallbladder disease or gallstones.\n* Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke).\n* Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia), and\u002For history or evidence of organic brain disease or dementia that would compromise safety or compliance with the study protocol in the opinion of the site principal investigator (PI) and\u002For physician. As there is no specific scale that determines this, this will include the Site PI\u002Fphysician determining if the potential participant shows consistency in decision making and if they are alert and oriented to time, date, day and location.\n* Significant risk of suicide requiring a different\u002Fhigher level of care, according to the clinical judgment of the study physician or site principal investigator, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and\u002For judgment. A Columbia-Suicide Severity Rating Scale (C-SSRS) indicating a history of suicide attempts within the past year, or active suicidal ideation within the past 1 month, will qualify as significant risk of suicide.\n* Treatment with any investigational drug in the one month preceding the study.\n* Any contraindication to both methadone and BUP.\n* Any contraindication to a GLP-1R agonist.\n* Previous randomization for participation in this trial.\n* Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.\n* Plans for travel outside of the local area over the 19 weeks (1 week of baseline, 12 weeks of medication, 1 week wash-out, and follow-up after a further 28 days) that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study.\n* Currently a prisoner.",{"count":315,"type":23},[63],"The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:\n\n• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?\n\nThe investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.\n\nThe participants will:\n\n* Take semaglutide or a placebo every week for 12 weeks\n* Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires\n* Complete smartphone surveys sent at set times during the study",[29,587,588,589,590,591,592],"Opioid Abuse and Addiction","Narcotic-Related Disorders","Substance-Related Disorders","Chemically-Induced Disorders","Mental Disorder","Opioid",[594,595,596,597,598],"Opiate treatment","Opioid treatment","Glucagon-Like Peptide-1 Agonist","Opioid use disorder","Semaglutide",{"date":522,"type":42},{"date":601,"type":42},"2025-01-13",{"date":603,"type":23},"2027-04",{"name":605,"class":49},"Milton S. Hershey Medical Center",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":59,"enrollmentInfo":613,"targetDuration":4,"studyType":24,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":102},"100478587","phase-2-evaluating-buspirone-to-treat-opioid-withdrawal-100478587","NCT05511909","Evaluating Buspirone to Treat Opioid Withdrawal","Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal","Inclusion Criteria:\n\n* Aged 18-75\n* Opioid positive urine sample\n* Current moderate-severe opioid use disorder with evidence of physical dependence\n* Interested in undergoing opioid detoxification\n\nExclusion Criteria:\n\n* Being pregnant or breastfeeding\n* Enrolled in methadone or buprenorphine maintenance treatment\n* Allergic to study medication or taking medications that are contraindicated with study medication (e.g., CYP3A4 inhibitors or inducers and\u002For monoamine oxidase (MAO) inhibitors)\n* Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in protection of human subjects form).\n* Hypotension and\u002For prolonged QTc interval",{"count":418,"type":23},[63],"The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.",[29,617,245,618],"Opioid Withdrawal","Anxiety",{"date":522,"type":42},{"date":621,"type":42},"2023-03-15",{"date":151,"type":23},{"name":305,"class":49},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":18,"sex":19,"minAge":630,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":24,"phases":633,"briefSummary":634,"conditions":635,"keywords":640,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":664,"leadSponsor":666,"locationsCount":668},"100648636","clinician-practice-companion-to-address-youth-substance-use-100648636","NCT07725289","Clinician Practice Companion to Address Youth Substance Use","Inclusion Criteria:\n\n* Ages 14 to 24 years.\n* Uses drugs or alcohol (past year).\n* Receiving care at a participating study site.\n\nExclusion Criteria:\n\n* Cognitive limitations or intellectual disabilities that prevent provision of informed consent.\n* Any medical or psychiatric condition causing acute distress or requiring emergency evaluation.\n* Current membership on a study Community Advisory Board.","14 Years","24 Years",{"count":490,"type":23},[26],"Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States. Many young people who use substances also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care exist, including harm reduction, overdose prevention (such as naloxone and take-home drug testing strips), and medications for addiction treatment. These approaches remain adult-oriented, however, unevenly implemented in youth-serving settings, and insufficiently centered on the needs and goals of youth and their families.\n\nThis study develops and pilot tests a written \"practice companion\" that helps clinicians and other trusted adults provide developmentally appropriate substance use care to youth ages 14 to 24 in hospital and community settings. The practice companion offers practical, easy-to-use guidance organized by substance and by pattern of use. It addresses cannabis and other substances that youth commonly use and that clinicians frequently seek support with, alongside a strong focus on overdose prevention through its core elements: naloxone, take-home drug testing strips, harm reduction education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how gender, sexuality, housing instability, and other social and structural contexts shape substance use and care.\n\nThe research team will first interview youth who use substances, their families and caregivers, and clinicians to learn how each element of care should be adapted for young people. The team will then produce the practice companion and pilot test it with 60 youth across three sites, in British Columbia, Québec, and Massachusetts. After receiving care guided by the practice companion, youth will complete an interview about whether the care was relevant, useful, appropriate, and acceptable. Families and clinicians will also be interviewed to assess how feasible, sustainable, and faithful to its design the practice companion is in practice.\n\nThroughout the study, the team will work closely with youth and families who have lived experience through a community-based participatory research approach that includes Community Advisory Boards. The work centers equity for Black, Indigenous, and other racialized youth, Two-Spirit and LGBTQ+ youth, and youth experiencing housing instability. Findings will guide a larger future study of the practice companion's effectiveness.",[636,589,637,89,29,638,34,639],"Substance Use","Adolescent Substance Use","Drug Overdose","Co-occurring Mental Health Conditions",[641,642,643,644,645,646,647,648,649,650,651,33,248,652,653,654,655,656,657,658,659,660],"Adolescents","Young adults","Youth","Substance use","Substance use care","Cannabis","Naloxone","Harm reduction","Take-home drug testing strips","Fentanyl","Medications for opioid use disorder (MOUD)","Overdose prevention","Co-occurring mental health","Youth- and family-centred care","Patient-reported outcomes","Health equity","Implementation science","ADAPT-ITT","Community-based participatory research","Toolkit","2026-07-23",{"date":569,"type":42},{"date":251,"type":23},{"date":665,"type":23},"2029-12",{"name":667,"class":49},"Massachusetts General Hospital",5]