[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"substance-use-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:substance-use-disorders":670},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,48,71,102,128,151,171,191,240,262,289,320,345,382,401,432,453,482,504,524,548,570,592,628,650],{"id":10,"slug":4,"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":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053742",false,"NCT07692984","The Effect of Comorbid Alcohol\u002FSubstance Use","The Effect of Comorbid Alcohol\u002FSubstance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria,\n* Being actively followed up at the TRSM for at least 6 months.\n\nExclusion Criteria:\n\n* Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),\n* Individuals with severe cognitive impairment that prevents them from communicating adequately.","ALL","18 Years","65 Years",{"count":20,"type":21},297,"ESTIMATED","OBSERVATIONAL","Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.\n\nAim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.\n\nResearch Questions\n\nWhat are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?\n\nHypotheses\n\nH1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.\n\nH2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.\n\nH3: Social inclusion is lower among patients with substance use compared with the control group.\n\nH4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.\n\nH5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.\n\nH6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.",[25,26,27,28,29,30,31],"Alcohol Abuse","Alcohol Use Disorder","Substance Use Disorders","Severe Mental Disorder","Schizophrenia","Bipolar Disorder","Ostracism",[33,27,28,34],"alcohol use disorder","ostracism","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-06-20",{"date":43,"type":21},"2026-12-30",{"name":45,"class":46},"Abant Izzet Baysal University","OTHER",1,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100610827","NCT07232641","Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic","Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder","IMPACT","Inclusion Criteria:\n\n* Substance use disorder (alcohol and\u002For opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)\n\nExclusion Criteria:\n\n* None",{"count":56,"type":21},185810,"\"Gold-standard\" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide \"whole-patient\" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent.\n\nThis study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.",[27,26,59],"Opioid Use Disorder",[61],"Medications for opioid use disorder (MOUD)","2026-07-01",{"date":64,"type":39},"2026-07-02",{"date":66,"type":39},"2026-06-30",{"date":68,"type":21},"2029-09",{"name":70,"class":46},"Boston University",{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100635627","NCT07555145","Supporting Treatment Access and Recovery in Re-entry (STAR-R)","STAR-R","Inclusion Criteria:\n\n* 18 years or older;\n* Proficient in reading and writing in the English language;\n* Are released from one of the participating jail\u002Fs; and\n* Have a current co-occurring substance use and mental health disorder, which includes both any substance use disorder (including alcohol) and mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and\u002For schizophrenia) as documented by the participating jails.\n\nExclusion Criteria:\n\n* Are acutely suicidal based on the CSSRS; or\n* Are acutely psychotic (as this would require a higher level of care) based on SCID-5-RV.",{"count":78,"type":21},240,"INTERVENTIONAL",[81],"NA","This application is aimed at testing a multicomponent intervention called \"Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.",[84,27,85],"Mental Health","Co-occurring Mental and Substance Use Disorders",[87,88,89,90,91],"MISSION-CJ","co-occurring disorders","peer linkage support","mental health","substance use disorders","NOT_YET_RECRUITING","2026-06-29",{"date":62,"type":39},{"date":96,"type":21},"2026-08-01",{"date":98,"type":21},"2030-08-31",{"name":100,"class":46},"University of Massachusetts, Worcester",2,{"id":103,"slug":4,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":79,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":47},"100622759","NCT07387796","Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation","Clinical and Neurobehavioral Changes With GLP-1 (Glucagon-like Peptide-1) Discontinuation","CLIN-GLP1","Inclusion Criteria:\n\n* Aged 18-70 years.\n* Currently on tirzepatide.\n* Currently receiving care from University of Texas- Southwestern (UTSW) Weight Wellness Clinic.\n* Cognitively capable of understanding and signing informed consent.\n* Be proficient in English.\n\nExclusion Criteria:\n\n* History of major neurological or psychiatric disorders, including substance use disorders that might confound brain imaging results (e.g., stroke, epilepsy, multiple sclerosis, schizophrenia, major depression requiring hospitalization).\n* Diagnosis of Type 2 Diabetes.\n* Current diagnosis of an eating disorder.\n* Use of medications affecting weight other than tirzepatide.\n* Pregnancy or breastfeeding.\n* MR contraindications:\n* Heart pacemaker, heart valve replacement, or aortic clips\n* Metal fragments in the eyes, skin, or elsewhere in the body\n* Brain clips or pieces of metal used in aneurysm surgery or intercranial bypass\n* Venous umbrella\n* Pieces of metal in the body resulting from work as a sheet-metal worker or welder\n* Clips placed in an internal organ\n* Prosthetic devices, such as middle ear, eye, joint, or penile implants\n* Joint replacement\n* Hearing aid that cannot be removed\n* Neurostimulator\n* Insulin pump\n* Shunts or stents\n* Metal mesh or coil implants\n* Metal plate, pin, screws, or wires, or any other metal implants","70 Years",{"count":111,"type":21},40,[81],"The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. Specifically, the study aims to examine how a short pause in tirzepatide affects hunger, mood, sleep, and daily functioning; how stopping and restarting tirzepatide alters brain chemistry and brain responses to food-related images; and how these changes relate to health measures such as quality of life and emotional well-being. There is no comparison group; instead, researchers will assess changes within each participant across three time points: while taking tirzepatide, after stopping it for 3-4 weeks, and after restarting it for 6-8 weeks. Participants will attend three in-person visits lasting approximately 3-4 hours each, during which they will complete interviews, questionnaires, and cognitive tasks; provide a urine sample (pregnancy screening for females); undergo a brain scan using magnetic resonance imaging (MRI) and MR spectroscopy (MRS); and receive a kit to provide a small stool sample. Participants will also complete two brief check-in phone calls between visits and the online BrainHealth Index between sessions, which includes surveys and cognitive tasks. All changes to tirzepatide use will occur under the supervision of a study physician to support participant safety and comfort, and the total study duration is approximately 13 weeks.",[115,27,116,117],"Drug Discontinuation","Eating Behavior Changes","Tirzepatide",[117,115,27,116],"2026-06-24",{"date":121,"type":39},"2026-06-26",{"date":123,"type":21},"2026-06",{"date":125,"type":21},"2029-02",{"name":127,"class":46},"The University of Texas at Dallas",{"id":129,"slug":4,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":79,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100377698","NCT04197921","Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Use Disorders (SUDs)","A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Abuse Disorders (SUDs)","Inclusion Criteria:\n\n1. Males and non-pregnant females, age 18 - 60 years old\n2. Subject meets DSM-5 criteria for OUD and\u002For other SUDs including alcohol (assessed via the SCID-5) of at least two years duration\n3. Subject is currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient\u002Finpatient\u002Fresidential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.\n4. Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen\n5. The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)\n6. Subject is able to communicate sensations during the Exablate Transcranial procedure\n7. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits\n8. Subject is able to make own medical decisions as determined by the clinical team\n9. Subject has signed and received a copy of the approved informed consent form\n\nExclusion Criteria:\n\n1. Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation.\"\n2. Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices\n3. Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)\n4. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)\n5. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n6. Subject with implanted objects in the skull or the brain\n7. Subject diagnosed with advanced kidney disease or on dialysis\n8. Subject with impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2\n9. Subject with known unstable cardiac status or severe hypertension including:\n\n   1. Documented myocardial infarction within six months of enrollment\n   2. Unstable angina on medication\n   3. Unstable or worsening congestive heart failure\n   4. Left ventricular ejection fraction below the lower limit of normal\n   5. History of a hemodynamically unstable cardiac arrhythmia\n   6. Cardiac pacemaker\n   7. Severe hypertension (diastolic BP \\> 100 on medication)\n10. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy\n11. Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure\n12. Abnormal coagulation profile (PLT \\\u003C 100,000\u002Fμl), PT (\\>13.9 sec) or PTT (\\>37.5 sec), and INR \\> 1.2. If values are outside the range of normal limits, any clinically significant value may be excluded as determined by a study investigator.\n13. Subject with cerebrovascular disease as determined by MRI according to the Fazekas criteria. Grades II and III on the Fazekas scale should be excluded\n14. Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5)\n15. Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline\n16. History of suicide attempt\n17. Parental history of completed suicide\n18. Subject meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD)\n19. Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB)\n20. Subject with brain tumors\n21. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area\n22. Any known CNS infection or infection with the Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV). A diagnosis of Hepatitis C (HCV) alone is not exclusionary as long as hepatic function laboratory values are deemed not clinically significant by a study investigator and are ≤ 1.5 times the upper limit of normal.\n23. Subject who has had deep brain stimulation or a prior stereotactic ablation of the NAc, basal ganglia or thalamus\n24. Subject who has been administered botulinum toxins into the arm, neck, or face for 5 months prior to baseline\n25. Subject who is currently participating in another clinical investigation with an active treatment arm\n26. Subject unwilling to abstain from illicit substance use during the course of the study\n27. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator\n28. Subject is non-English speaking\n29. Subject is pregnant or planning to be pregnant",true,"60 Years",{"count":137,"type":21},29,[81],"The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0\u002F2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and\u002For other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.",[141,27],"Opioid-use Disorder",{"date":121,"type":39},{"date":144,"type":39},"2019-11-27",{"date":146,"type":21},"2027-12-31",{"name":148,"class":149},"InSightec","INDUSTRY",4,{"id":152,"slug":4,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":79,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":150},"100610116","NCT07223398","Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)","STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations","Inclusion Criteria:\n\n* able to provide written informed consent in English or Spanish;\n* living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);\n* Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);\n* willing to have HIV testing to determine negative or positive status;\n* persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and\u002For (ii) sharing IDU equipment with HIV positive or unknown status partner; and\u002For (iii) bacterial STI and;\n* Having a history of opioid and\u002For stimulant use in the last 12 months within the community.\n\nExclusion Criteria:\n\n* severe medical or psychiatric disability making participation unsafe;\n* unable to provide consent.\n* persons self-reporting pregnancy",{"count":158,"type":21},400,[81],"This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP\u002FART and substance use\u002Fsubstance use disorder (SU\u002FSUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.",[27],"2026-06-22",{"date":164,"type":39},"2026-06-25",{"date":166,"type":39},"2025-11-24",{"date":168,"type":21},"2028-06",{"name":170,"class":46},"Yale University",{"id":172,"slug":4,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":79,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":101},"100511043","NCT05934305","Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders","Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders","MATTER","Inclusion Criteria:\n\n* HIV+\n* Meet criteria for an illicit (not solely including tobacco, cannabis, or alcohol) SUD\n* Endorse internalized stigma related to HIV, substance use, sexual orientation, or gender-identity\n* Either the participant reports a detectable viral load during past year OR if on oral ART, they report \\\u003C80% adherence in the past month OR if on oral ART, they report missing \\>=7 days of ART in any month in the past year OR for those on long acting injectable (LAI) ART, they report a period of \\>=14 days in the past year between LAI ART injections OR has a detectable HIV viral load (\\>20 copies\u002F mL) in the past year confirmed by medical records or viral load test from blood drawn obtained as part of the baseline visit\n* Provide informed consent in English\n* Verbally communicate and read in English or Spanish\n* Be ≥18 years old\n* Provide evidence or documentation of HIV+ status\n* Release HIV-related health records\n* Have access to a cell phone with text capacity (study will supplement phones and plans as needed consistent with our pilot work).\n\nExclusion Criteria:\n\n\\- HIV-",{"count":179,"type":21},256,[81],"People living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.",[183,27],"Hiv",{"date":185,"type":39},"2026-06-23",{"date":187,"type":39},"2025-03-12",{"date":189,"type":21},"2028-06-30",{"name":70,"class":46},{"id":192,"slug":4,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":198,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":79,"phases":202,"briefSummary":203,"conditions":204,"keywords":230,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":47},"100619125","NCT07340554","Neuroimaging of Adolescent Cannabis Use Treatment","Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment","ACT","Inclusion Criteria:\n\n* 14-17 year old youth\n* Guardian 18 years or older\n* Youth is MRI-eligible: No metal implants, prosthetics, orthodontic devices, transdermal medication patches, piercings and\u002For hair or eyelash extensions that cannot easily be removed, metallic ink tattoos on the neck or face, or claustrophobia, and are not pregnant\n* Youth must endorse having used cannabis at least once per week over the past month OR youth must have been diagnosed with cannabis use disorder within the past three months\n\nExclusion Criteria:\n\n* Youth has a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent\u002Fguardian report\n* Youth or caretaker who is monolingual non-English speaker\n* Youth who is currently experiencing active psychosis symptoms or suicidal\u002Fhomicidal ideation or who has been hospitalized within the past 6 months for psychosis or suicidality\u002Fhomicidality\n* Youth who is currently undergoing contingency management treatment for cannabis use disorder","14 Years","17 Years",{"count":201,"type":21},80,[81],"This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.",[205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,27,226,227,228,229],"Cannabis Use","Cannabis Dependence","Cannabis Use Disorder","Cannabis Abuse","Cannabis Intoxication","Cannabis Smoking","Cannabis Withdrawal","Cannabis-Related Disorder","Cannabis Abuse, in Remission","Cannabis Abuse, Episodic Use","Marijuana","Marijuana Abuse","Marijuana Use","Marijuana Smoking","Marijuana Dependence","Marijuana User","Marijuana-Related Disorder","Marijuana Use Disorder","Addiction","Addiction, Substance","Substance Use","Substance Dependence","Substance Abuse","Substance Related Problem","Substance Abuse Drug Chronic",[231,215,223],"Cannabis","2026-06-18",{"date":162,"type":39},{"date":235,"type":39},"2026-06-15",{"date":237,"type":21},"2030-05-01",{"name":239,"class":46},"Indiana University",{"id":241,"slug":4,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":246,"targetDuration":4,"studyType":79,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":47},"100606638","NCT07178158","Enhancing Addiction Treatment Through Psychoeducation","Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App","Inclusion Criteria:\n\n* current DSM-5 opioid and\u002For stimulant use disorder\n* currently on medication treatment for SUD\n* owning a smartphone with sufficient functionality to download and utilize the NIPA app.\n\nExclusion Criteria:\n\n* current psychosis, mania, or suicidal\u002Fhomicidal ideation\n* non-English speaking",{"count":111,"type":21},[81],"Addiction is a brain disorder characterized by a broad range of both apparent and subtle cognitive impairments in attention, memory, executive functions, and decision-making. These cognitive problems are clinically significant and may contribute to poor treatment outcomes in people with Substance Use Disorders (SUDs), such as a high risk of dropout, low treatment compliance, and shorter periods of abstinence. Studies on cognitive function in SUDs reveal that chronic use of drugs and alcohol can also negatively affect another crucial component of cognition: awareness, or metacognition. Metacognition is defined as an individual's ability to perceive and understand their cognitive functions and use this understanding to regulate them. One of the key consequences of metacognitive impairments is the lack of insight in people with SUDs, which adversely affects treatment outcomes. Substance users with poor metacognition are more reluctant to initiate or continue treatment and are more likely to deny their cognitive problems. Therefore, improving metacognition may remove or reduce motivational barriers to invest time and effort in the recovery process in general, and in the brain recovery process specifically. Despite the importance of neurocognition and metacognition in the recovery process for substance users, there is a dearth of interventions designed to target these functions.",[27],[251,252,253],"tES\u002FTMA: Transcranial electrical stimulation","CT: Cognitive Training","DASES: Drug Abstinence Self-Efficacy Scale","2026-06-08",{"date":256,"type":39},"2026-06-09",{"date":62,"type":21},{"date":259,"type":21},"2027-04-30",{"name":261,"class":46},"Virginia Commonwealth University",{"id":263,"slug":4,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":134,"sex":16,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":79,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":47},"100501963","NCT05816083","Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People","Inclusion Criteria for YMSM are as follows:\n\n* Someone who identifies as a YMSM or identifies as someone with romantic or physical attraction to individuals who identify as men\n* Is aged 15-30 years\n* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)\n* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months\n* Live in the Charleston, SC\u002FTri-county area\n\nInclusion Criteria for adolescents with SUD are as follows:\n\n* Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)\n* Is aged 15-30 years\n* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)\n* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months\n* Live in the Charleston, SC\u002FTri-county area\n\nInclusion Criteria for front line healthcare workers are as follows:\n\n* works directly with adolescents who have experienced ITE and\u002For\n* works directly with adolescents or young adults with SUD and\u002For\n* works directly with YMSM and\u002For\n* works directly with and\u002For adolescent or young adults who are HIV-positive\n\nExclusion Criteria for all participants are as follows:\n\n* exhibits psychotic symptoms;\n* exhibits significant cognitive disability;\n* reports a history of Pervasive Developmental Disorder;\n* has active suicidal or homicidal ideations\n* self-reports high levels of motion sickness","15 Years","30 Years",{"count":270,"type":21},50,[81],"This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)\u002Findividuals who are romantically\u002Fphysically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.",[27,274],"HIV Infections",[91,276,277,278,279,280],"alcohol use","substance use","HIV infections","HIV risk","virtual reality",{"date":282,"type":39},"2026-06-10",{"date":284,"type":39},"2025-02-06",{"date":286,"type":21},"2026-11-30",{"name":288,"class":46},"Medical University of South Carolina",{"id":290,"slug":4,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":79,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":47},"100614566","NCT07281261","tAN for Substance Use Disorder","Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder","Inclusion Criteria:\n\n1. Male or female (evenly recruited) aged 18-64 years old\n2. Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)\n3. Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST\n4. Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \\[PAWSS\\] \\> 4 at admission)\n5. Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \\[CIWA-Ar\\] ≥ 8 at screening)\n6. Positive urine test for alcohol at screening\n7. Be able to provide written informed consent\n8. Female subjects must be non-nursing and not pregnant\n9. Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.\n\nExclusion Criteria:\n\n1. In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN\n2. Current use of tobacco\n3. Is pregnant or nursing\n4. Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)\n5. Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM","64 Years",{"count":297,"type":21},20,[81],"The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.",[26,25,27,301],"Substance Use Disorders Alcohol Use Withdrawal State",[303,26,304,305,306,307,308,309,310],"Alcohol","Substance Use Disorder","Transcutaneous Auricular Neurostimulation","tAN","Neurostimulation","Vagus Nerve Stimulation","Auricular Neurostimulation","Transcutaneous","2026-06-01",{"date":313,"type":39},"2026-06-02",{"date":315,"type":39},"2026-01-28",{"date":317,"type":21},"2026-08-31",{"name":319,"class":149},"Spark Biomedical, Inc.",{"id":321,"slug":4,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":79,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":47},"100604216","NCT07146633","Efficacy of an EMDR App for PTSD and SUD","Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders","Inclusion Criteria:\n\n* Aged 18-years old or older\n* Fluent in English\n* Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score \\>32)\n* Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)\n* Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months\n\nExclusion Criteria:\n\n* Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner\n* Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is \"yes\"",{"count":327,"type":21},24,[81],"The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.",[331,27],"Posttraumatic Stress Disorder (PTSD)",[333,334,335],"EMDR","PTSD","substance dependence","2026-05-20",{"date":338,"type":39},"2026-05-22",{"date":340,"type":39},"2026-01-20",{"date":342,"type":21},"2027-01-30",{"name":344,"class":46},"Centre for Addiction and Mental Health",{"id":346,"slug":4,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":134,"sex":352,"minAge":267,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":79,"phases":356,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":380,"locationsCount":101},"100561090","NCT06585631","The Collaborative Care PrTNER Study","The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project","PrTNER","Inclusion Criteria:\n\nAim 1:\n\n* 15-24 years old;\n* Cisgender male;\n* History of condomless sex;\n* Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,\n* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;\n* Able to read and write in English\n\nAim 2:\n\n* 15-29 years old;\n* Cisgender male;\n* Living with a diagnosis of HIV;\n* CRAFFT score ≥2,\n* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;\n* Able to read and write in English\n\nAim 3\n\n• All randomized study participants will be included in Aim 3.\n\nExclusion Criteria:\n\nAim 2:\n\n* Participants will be excluded if they are:\n* Assigned female sex at birth\n* Identify as transgender\n* Outside the age criteria (\\\u003C15 or \\>29 years old)\n* Cognitively unable to complete study requirements\n* Living outside of the two geographic areas\n* Do not screen positive for SU\n* No prior substance use history\n* No prior condomless sex;\n* Unable to read or write in English,\n* Plan to move in the next 12 months.","MALE","29 Years",{"count":355,"type":21},275,[81],"A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.",[359,27,225,360],"HIV","AIDS",[359,360,362,363,364,276,365,366,367,368,369,370,371,372,373],"Substance use","Substances use disorder","drug use","preexposure prophylaxis","PrEP","peer coaches","community health worker","young men","adolescents","young male","young males","adolescent males","2026-05-15",{"date":376,"type":39},"2026-05-18",{"date":378,"type":39},"2025-01-02",{"date":189,"type":21},{"name":381,"class":46},"Children's Hospital of Philadelphia",{"id":383,"slug":4,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":79,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":47},"100639927","NCT07575373","Feasibility of an Interdisciplinary Intervention to Improve Care Transitions for Hospitalized Patients With Substance Use Disorders","Evaluating the Feasibility of an Interdisciplinary Primary Care-based Intervention to Improve Transitions to Follow-Up Care for Hospitalized Patients With Substance Use Disorders: A Pilot Randomized Controlled Trial","IntACT","Inclusion Criteria:\n\n* Aged 18 years and older\n* Hospitalized at University of Utah Medical Center (UUMC) for any medical reason, and\n* Electronic Health Record (EHR) documented diagnosis of any SUD.\n\nExclusion Criteria:\n\n* Currently incarcerated\n* Tobacco use as only documented substance use disorder",{"count":5,"type":21},[81],"The purpose of this study is to evaluate the feasibility and preliminary effectiveness of a primary care-based Interdisciplinary Addiction Care Transition (IntACT) team that will meet patients with substance use disorders (SUD) during a medical hospitalization and provide intensive care management, peer support, and interim SUD and medical care after discharge while facilitating a transition to long term community-based treatment.",[27],"2026-05-07",{"date":395,"type":39},"2026-05-11",{"date":235,"type":21},{"date":398,"type":21},"2027-09-15",{"name":400,"class":46},"Michael Incze",{"id":402,"slug":4,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":134,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":79,"phases":409,"briefSummary":410,"conditions":411,"keywords":418,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100632905","NCT07519759","Recovery Inspired Support Engagement (RISE) Pilot","(RISE)","Inclusion Criteria:\n\n* Inclusion Criteria for Support Persons:\n\n  * Ages 18+.\n  * Having a loved one who participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by loved one, support person, clinician, or chart review.\n  * Interest in supporting the loved one's recovery from substance use.\n  * At least 4 days per month virtual or in-person contact per month with the loved one.\n  * Access to a computer with internet or mobile phone with video conferencing capabilities.\n  * Ability to provide written informed consent.\n  * Speak and read English.\n* Inclusion Criteria for Loved Ones:\n\n  * Ages 18+.\n  * Participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by self, support person, clinician, or chart review.\n  * At least 4 days per month virtual or in-person contact per month with the support person.\n  * Access to a computer with internet or mobile phone with video conferencing capabilities.\n  * Ability to provide written informed consent.\n  * Speak and read English.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Support Persons:\n\n  * DSM-5 moderate or severe substance use disorder in the past year.\n  * History of domestic violence with the loved one that would interfere with the ability to safely follow through with the intervention plan.\n  * Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.\n  * Prior participation of a support person of the loved one in an ITC-related research study.\n  * Significant prior experience with ITC or CRAFT (e.g., having completed an ITC-related training workshop or course prior to study enrollment)\n* Exclusion Criteria for Loved Ones: N\u002FA",{"count":408,"type":21},18,[81],"The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are:\n\nHow many people complete the program? How satisfied are people with the program?\n\nParticipants will:\n\nComplete weekly telehealth sessions for 12 weeks Complete surveys\u002Finterviews at the beginning, in the middle (\\~week 6), at the end of the program (\\~week 12), and 12-weeks after the end of the program Complete a focus group or interview",[412,413,414,415,416,417,27],"Support Persons","Family Members","Chosen Family","Romantic Partners","Friends","Caregivers",[412,416,27,303,419,420,421,422,423,415,414,413,417],"Substance Use (Drugs, Alcohol)","Social Support","Recovery","Invitation to Change","ITC","2026-04-23",{"date":426,"type":39},"2026-04-28",{"date":62,"type":21},{"date":429,"type":21},"2028-02-28",{"name":431,"class":46},"Mclean Hospital",{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":79,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":47},"100609808","NCT07219394","Peer-Delivered Behavioral Activation in a CCBHC","Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic","Inclusion Criteria:\n\n* Age 18 years old or older\n* Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.\n\nExclusion Criteria:\n\n* Active, under treated psychotic symptoms or mania that would interfere with participation in study procedures\n* Inability to provide informed consent and\u002For complete procedures in English",{"count":439,"type":21},250,[81],"Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and\u002For substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) among individuals receiving services from a community-based treatment setting providing integrated physical and behavioral healthcare.",[443,27],"Major Depressive Disorder","2026-04-15",{"date":446,"type":39},"2026-04-17",{"date":448,"type":21},"2026-05-01",{"date":450,"type":21},"2029-01-15",{"name":452,"class":46},"Wayne State University",{"id":454,"slug":4,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":79,"phases":461,"briefSummary":462,"conditions":463,"keywords":468,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":47},"100633641","NCT07529327","Prevent Language Delays and Disorders Among Children of Caregivers With Substance Use Disorders With Community Groups and Individualized Services","Evidence-based Intervention Enhancements to Reduce Language Delays and Disorders Among Children of Parents With Substance Use Disorders","Inclusion Criteria:\n\n1. Have a:\n\n   1. Self-reported lifetime history of substance use disorder treatment and\u002For\n   2. active substance use in the past year\n2. Be providing care for\u002Fparenting a child at least 10% of the time who is:\n\n   1. between the ages of 12-42 months\n   2. English\u002FSpanish bilingual or monolingual in English or Spanish\n   3. exposed to a third language once a week or less\n   4. not yet combining three or more words regularly\n   5. has less than 150 words in their expressive vocabulary\n3. Be able to provide consent for their target child to participate, or have a legal guardian provide consent for the child to participate\n4. Be able to speak and understand English and\u002For Spanish\n5. Be willing to attend groups once a week for six weeks at a participating site\u002Fgroup time\n6. If assigned additional services, willing to attend Zoom meetings\n7. Be 18 years of age or older\n\nExclusion Criteria:\n\n-Only one caregiver per focal child can participate in the research study. Caregivers whose participating child already has another caregiver enrolled in the research study will not be eligible to participate.",{"count":460,"type":21},244,[81],"The goal of this clinical trial is to test ways to improve early language development among young children of parents with substance use disorder (SUD). Children of parents with SUD are at increased risk for language delays, and early supports may help prevent long-term learning challenges. This study will examine whether adding additional supports to group-based parenting intervention improves child language outcomes compared to the group intervention alone.",[464,27,465,466,467],"Language Delay","Language Disorders in Children","Language Development","Prevention Intervention",[469,470,471,472],"Naturalistic communication intervention","Parenting","Group based intervention","Vocabulary Acquisition","2026-04-14",{"date":475,"type":39},"2026-04-20",{"date":477,"type":39},"2026-03-10",{"date":479,"type":21},"2029-11-30",{"name":481,"class":46},"University of Oregon",{"id":483,"slug":4,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":489,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":79,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":150},"100547900","NCT06413979","Family Support Protocol for Adolescent Internalizing Disorders","Testing the Feasibility of a Family-based Adjunctive Treatment Protocol for Targeting Co-Occurring Internalizing Disorders Among Adolescents With SUD","Fam-AID","Inclusion Criteria:\n\n* Youth is age 13-21.\n* Youth lives with a primary caregiver who can attend treatment sessions.\n* Youth endorses one or more DSM-5-TR symptoms for SUD and meets American Society of Addiction Medicine criteria for outpatient SU treatment.\n* Youth meets DSM-5-TR criteria, or has elevated symptoms and impairment, for any of the following IDs: Current or Recurrent Major Depressive Episode, Pervasive Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder.\n* Youth completes intake and is enrolled as an active case at study site\n\nExclusion Criteria:\n\n* Illness requiring hospitalization\n* Current psychotic symptoms\n* Severe SU problems that require immediate relief (detox or residential placement)\n* Pervasive developmental disorder.","13 Years","21 Years",{"count":492,"type":21},60,[81],"This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively.\n\nA promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD\u002FID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD\u002FID and prevention of youth self-harm. All interventions featured in each module have strong empirical support.\n\nThe Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment.\n\nTo achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD\u002FID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month follow-up.",[496,27],"Internalizing Disorders",{"date":446,"type":39},{"date":499,"type":39},"2025-07-29",{"date":501,"type":21},"2027-03-31",{"name":503,"class":46},"The National Center on Addiction and Substance Abuse at Columbia University",{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":134,"sex":16,"minAge":490,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":79,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":150},"100586994","NCT06922617","STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking","Evaluating a Tobacco Harm Reduction Strategy Among Clients Enrolled in Substance Use Disorder Treatment","STEPS","Inclusion Criteria:\n\n1. 21+ years of age,\n2. smoke at least 5 cigarettes per day daily or near daily for the past 6 months,\n3. be enrolled in outpatient SUD treatment and have an SUD diagnosis (past or current),\n4. must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test,\n5. have had at least one failed smoking quit attempt in their lifetime,\n6. have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and\n7. if female, agrees to use a form of birth control during the study.\n\nExclusion criteria:\n\n1. any significant or unstable medical or psychiatric concern that would affect safety,\n2. current use of pharmacotherapy with smoking cessation efficacy,\n3. pregnant, breastfeeding, or trying to become pregnant,\n4. contraindicated for NRT, and\n5. currently using an ENDS on 20+ days out of the past 30.",{"count":78,"type":21},[81],"The purpose of this study is to investigate whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation will last 6 months and will include five in-person study visits and eleven virtual assessments. Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants must be within 30 days of SUD treatment program admission. This study is being conducted at three outpatient SUD treatment programs across South Carolina. These sites include: 1) the Center for Drug and Alcohol Problems (CDAP) in Charleston, SC, 2) Behavioral Health Services of Pickens County (BHSPC) in Pickens, SC, and 3) Shoreline Behavioral Health Services in Conway, SC. the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.",[515,27],"Tobacco Use","2026-04-02",{"date":518,"type":39},"2026-04-03",{"date":520,"type":39},"2025-10-17",{"date":522,"type":21},"2028-09-01",{"name":288,"class":46},{"id":525,"slug":4,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":531,"targetDuration":4,"studyType":79,"phases":533,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100554258","NCT06496750","Ketamine for Methamphetamine Use Disorder","NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)","KMD","Inclusion criteria\n\nStudy participants must:\n\n1. Be 18 to 65 years old\n2. Be able to sufficiently understand, speak, and read English\n3. Be interested in reducing or stopping methamphetamine use\n4. Meet criteria for methamphetamine use disorder\n5. Use acceptable methods of contraception during participation in the study\n\nExclusion criteria\n\nStudy participants must not:\n\n1. Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent\n2. Be currently in jail, prison, or inpatient overnight facility as required by court of law\n3. Have upcoming surgery planned or scheduled\n4. Be currently pregnant, breastfeeding, or planning on conception, if biologically female\n\nAdditional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.",{"count":532,"type":21},120,[534],"PHASE2","This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD.\n\nThe study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).",[27,225,537],"Methamphetamine Abuse","2026-03-30",{"date":540,"type":39},"2026-04-01",{"date":542,"type":39},"2024-09-11",{"date":544,"type":21},"2026-10-15",{"name":546,"class":46},"University of Texas Southwestern Medical Center",5,{"id":549,"slug":4,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":79,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":47},"100477120","NCT05492825","IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs","Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder","Inclusion Criteria:\n\n1. age ≥18 years old\n2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)\n3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days\n4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)\n5. Willingness to participate in all study components\n6. ability to provide informed consent, assessed using consent teach-back\n\nExclusion Criteria:\n\n1. severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)\n2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality\u002Fhomicidality, psychosis)\n3. cancer pain related to malignancy\n4. yoga practice or PT in the prior 60 days",{"count":555,"type":21},180,[81],"This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.",[27,559,59,560],"Chronic Pain","Back Pain Lower Back Chronic","2026-03-26",{"date":563,"type":39},"2026-03-31",{"date":565,"type":39},"2023-02-27",{"date":567,"type":21},"2026-11-02",{"name":569,"class":46},"Albert Einstein College of Medicine",{"id":571,"slug":4,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":575,"targetDuration":4,"studyType":79,"phases":576,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":101},"100631354","NCT07499583","Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder","Inclusion Criteria:\n\ni) Veterans or first responders ii) 18 -70 years of age iii) Meets criteria for TRD (current major depressive episode without psychotic features by the Mini-International Neuropsychiatric Interview - MINI, with failure to respond to 2 or more evidence-based anti-depressants in the current episode), iv) Meets moderate to severe use criteria for one primary substance (alcohol, cocaine, opioids\u002Fheroin, or cannabis). Moderate to severe co-use of nicotine also acceptable, as well as mild\u002Frecreational use of other substances, v) Able to read English and complete study evaluations and consent vi) In good health as verified by screening examination and medical history vii) able to safely receive MRI\n\nExclusion Criteria:\n\ni) Exclusionary psychiatric conditions include schizophrenia, schizoaffective disorder, bipolar disorder, current post-traumatic stress disorder, or history of medically serious suicide attempt ii) Actively\u002Fimminently suicidal (QIDS-SR question 12 score \\>2, Hamilton - depression scale (HAM-D) question 3 score \\>3, or Montgomery-Åsberg Depression Rating Scale (MADRS) question 10 \\>4) ii) A family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives) iii) Use of selective serotonin reuptake inhibitors (SSRIs) and other medications are acceptable if dose has remained stable for 6 months, and is not contra-indicated with psilocybin, as per the study physician, Dr Conroy iii) Individuals with any prior use of classic psychedelics, including psilocybin iv) Medical conditions that would preclude safe participation in the trial (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, heart failure, history of cerebrovascular accident, severe asthma, hyperthyroidism, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction) v) Sitting blood pressure below 90\u002F50 mmHG or above 165\u002F95 mmHg vi) EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) of \\>450 msec for men and QTc\\>470 msec for women vii) Women who are pregnant or lactating",{"count":270,"type":21},[577,534],"PHASE1","The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD) in veterans and first responders. We seek to answer:\n\n* Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with co-occurring TRD and SUD\n* Whether psilocybin assisted psychotherapy will reduce substance use severity and depression symptoms\n* What neurobiological processes are associated with the effects of psilocybin assisted psychotherapy.\n\nThe researchers will compare the effects of a single dose of psilocybin (either 5mgs or 10mgs or 25mg) alongside psychotherapy on substance use severity and depression symptoms over six weeks in veterans and first responders with TRD and co-occurring SUD.\n\nIn this 14-week study, participants will:\n\n* Visit the clinic for two intake sessions\n* Complete seven psychotherapy sessions. This will include three sessions before psilocybin administration, an 8 to 10 hour dosing session, and three sessions following psilocybin administration\n* Complete short, repeated daily assessments for six weeks, in total, before and after psilocybin administration\n* Complete two brain scans before and after psilocybin administration",[580,27],"Treatment Resistant Depression",[582,583,584,585],"treatment resistant depression","substance abuse disorder","psilocybin assisted psychotherapy","stress","2026-03-24",{"date":538,"type":39},{"date":96,"type":21},{"date":590,"type":21},"2031-02-28",{"name":239,"class":46},{"id":593,"slug":4,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":599,"minAge":17,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":79,"phases":603,"briefSummary":605,"conditions":606,"keywords":611,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":47},"100478851","NCT05515354","Smoking Cessation and Menstrual Cycle Phase","Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial","MC-NRT","Inclusion Criteria:\n\n* Must provide informed consent following the CAMH REDCap e-consent framework and procedures;\n* Stated willingness to comply with all study procedures;\n* Naturally cycling individuals with regular MCs (defined as length ranging 21 to 35 days over past 6 months);\n* Daily smoker of ≥5 cigarettes per day (CPD) over past 6 months;\n* Intention to quit smoking within the next 30 days and willing to make a quit attempt on their assigned TQD;\n* Interested in using, and able to use, nicotine patches and gum or lozenge as a smoking cessation aid;\n* Willing to provide a valid e-mail address to be used for study communications and to complete online questionnaires.\n\nExclusion Criteria:\n\n* Current use of progesterone, estrogen, testosterone, or fertility treatment;\n* Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);\n* Use of hormonal contraceptives in the past 6 months (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring);\n* Pregnancy, or trying to become pregnant in the next 2-3 months;\n* Known hypersensitivity or allergies to any of the components of the nicotine patch;\n* Daily or almost daily use of cannabis in the past 6 months;\n* Daily or almost daily use of tobacco or nicotine products other than cigarettes (e.g., smokeless tobacco, heat-not-burn products, e-cigarettes) in the past 6 months;\n* Polycystic ovary syndrome diagnosis;\n* Unstable psychiatric condition (including substance use disorder) which would compromise study compliance;\n* Life threatening arrhythmias or severe\u002Fworsening angina pectoris;\n* Myocardial infarction or cerebral vascular accident in the past 2 weeks; or\n* Diagnosed with a terminal illness.","FEMALE","40 Years",{"count":602,"type":21},1200,[604],"PHASE4","Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada. Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke. However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men. There is some evidence that hormonal levels and fluctuations throughout the menstrual cycle (MC) may contribute to the greater difficulty women experience when trying to quit smoking. In this study, the start of a quit attempt using nicotine replacement therapy (NRT) will be targeted to specific phases of MC. It was hypothesized that starting a quit attempt during the first half of MC (follicular phase) will result in increased quit success compared to starting during the second half of MC (luteal phase) or the usual practice of not targeting quit start date to MC phase.",[607,608,609,610,27],"Nicotine Dependence","Tobacco Smoking","Smoking Cessation","Nicotine Use Disorder",[612,613,614,615,616,617,618,619],"Menstrual Cycle","Ovarian Hormones","Smoking Cessation Treatment","Nicotine Replacement Therapy","Cancer Prevention","Randomized Controlled Trial","Estrogen","Progesterone","2026-03-17",{"date":622,"type":39},"2026-03-19",{"date":624,"type":39},"2022-11-30",{"date":626,"type":21},"2026-12-31",{"name":344,"class":46},{"id":629,"slug":4,"hasResults":11,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":134,"sex":16,"minAge":17,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":79,"phases":636,"briefSummary":637,"conditions":638,"keywords":641,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":646,"leadSponsor":648,"locationsCount":47},"100609743","NCT07218549","Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use","Inclusion Criteria:\n\n1. English-speaking, 18- to 55-year-old males or females.\n2. Female subjects must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission. In addition, female subjects must meet one of the following conditions:\n\n   * Is a woman of non-childbearing potential defined as no menses for at least 12 months with status confirmed by FSH and estradiol levels at screening or surgically sterile at screening visit OR\n   * Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, from Screening until 9 months after receiving the study medication. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the dose of study intervention.\n3. Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:\n\n   • Not donate fresh unwashed semen\n\n   Plus, either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n   * Use a male condom when engaging in any activity that allows for passage of ejaculate to another person\n4. Physically healthy, as determined by a clinical interview with a physician, laboratory tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, and self-reported medical history.\n5. No current or past diagnosis of severe mental illness, as determined by a clinical interview.\n6. Clinical laboratory test results (CMP, CBC, etc.) must be within the normal reference range or with acceptable deviations that are judged to be not clinically significant by a study physician.\n7. Have a history of self-reported recreational opioid use as defined by at least 10 times in the past year and at least once in the 12 weeks before screening.\n8. Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures.\n9. Agree not to consume any recreational drugs during the study (THC is excluded).\n10. Able to perform study procedures as determined by clinical judgment.\n11. Able to meet eligibility requirements of the Qualification Phase (i.e., drug discrimination) and Naloxone Challenges.\n\nExclusion Criteria:\n\n1. Seeking treatment for a substance or alcohol use disorder as determined by self-report during the intake interview.\n2. Current or past diagnosis of opioid use disorder or other substance use disorder (SUD) within the past year, excluding THC and nicotine-containing products. With regard to marijuana\u002FTHC, an individual must be able to tolerate 48 hours of abstinence from marijuana\u002FTHC products.\n3. History of opioid overdose.\n4. Using medication or supplements that might interact with kratom or oxycodone as determined by self-report during intake interview.\n5. Treatment with any investigational drug during the last 30 days.\n6. Participants on parole or probation.\n7. Currently pregnant or trying to conceive or currently lactating as determined by blood pregnancy testing at screening, urine pregnancy testing at admission, and self-reporting during interview and study visits.\n8. Current or recent history of significant violent or suicidal behavior or suicidal\u002Fhomicidal risk as determined by the C-SSRS.\n9. Sensitivity, allergy, or contraindications\u002Fallergies to kratom, opioids, or similar compounds.\n10. Use prescription or nonprescription drugs and dietary supplements within seven days or five half-lives (whichever is longer) that, in the opinion of the study clinician may interfere with the investigational product.\n11. Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment phases, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at their discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.\n12. Positive alcohol breathalyzer test at each admission in the Qualification and Treatment Phase.\n13. History of sensitivity to heparin or heparin-induced thrombocytopenia.\n14. Has not donated blood or plasma within the last six weeks.\n15. Has a history of increased intracranial pressure or brain tumors.\n16. Has gastrointestinal obstruction, including paralytic ileus.\n17. Has a history of seizure disorders.\n18. Has a chronic obstructive pulmonary disease or cor pulmonale.\n19. Has a history of anemia or any other significant hematologic disorder.\n20. Has a condition or abnormality that, in the opinion of the PI or Study Physician, would compromise the safety of the patient or the quality of the data.\n21. Has a major surgery planned within the next 6 months.","55 Years",{"count":635,"type":21},72,[577],"The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.",[639,27,640],"Opioid Use","Opioid Analgesia",[639,27],"2026-03-11",{"date":644,"type":39},"2026-03-13",{"date":448,"type":21},{"date":647,"type":21},"2029-05-31",{"name":649,"class":46},"Christopher D. Verrico",{"id":651,"slug":4,"hasResults":11,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":11,"sex":16,"minAge":489,"maxAge":199,"enrollmentInfo":657,"targetDuration":4,"studyType":79,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":47},"100476614","NCT05486234","CARS: Cannabis and Alcohol Reduction Study","Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use","CARS","Inclusion Criteria:\n\n* between the ages of 13 and 17\n* be seeking treatment for either cannabis or alcohol use;\n* report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous)\n* have a caregiver willing to participate and provide consent.",{"count":658,"type":21},52,[81],"The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and\u002For cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.",[205,662,225,27],"Alcohol Use, Unspecified","2026-03-05",{"date":665,"type":39},"2026-03-09",{"date":667,"type":39},"2023-01-25",{"date":96,"type":21},{"name":288,"class":46},""]