[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"substance-use-disorder-sud\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:substance-use-disorder-sud":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,51,82,103,130,150,174,196,244,276,308,338,357,380,405,436,464,483,516,545,577,606,632,659,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652617","phase-2-substance-use-in-pregnancy---optimizing-retention-in-treatment-by-maximizing-opportunities-for-management-100652617",false,"NCT07776457","Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management","Substance Use in Pregnancy- Optimizing Retention in Treatment by Maximizing Opportunities for Management","SUPPORT MOM","Inclusion Criteria:\n\n* Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver\n* Diagnosis of SUD as defined by DSM-5 and\u002For as documented in the clinical record\n* 18 years of age or older\n* Two or more positive domains in first screening for social drivers of health\n* Receiving ongoing care at participating study site\n\nExclusion Criteria:\n\n* Declining follow-up care at participating study site\n* Participated in R61 pilot study for CM\n* Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach\n* Unable to participate in English","FEMALE","18 Years",{"count":21,"type":22},245,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.",[28,29],"Pregnancy","Substance Use Disorder (SUD)",[31,32,33,34,35,36,37],"randomized","pregnancy","prenatal","substance use disorder","contingency management","postpartum","intervention","NOT_YET_RECRUITING","2026-08-17",{"date":41,"type":42},"2026-08-20","ACTUAL",{"date":44,"type":22},"2027-01",{"date":46,"type":22},"2030-02",{"name":48,"class":49},"Washington University School of Medicine","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":50},"100649761","connecting-loved-ones-to-support-and-empowering-recovery-100649761","NCT07740395","Connecting Loved Ones to Support and Empowering Recovery","Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders","Project Closer","Inclusion Criteria for Individuals in Recovery:\n\n* 18+\n* have met criteria for a substance use disorder (with or without concomitant alcohol use disorder) in the past 24 months\n* have taken steps in the past 12 months to quit using drugs, cut down on drug use, or change the way in which they use drugs in order to improve the quality of their lives\n* willing to nominate a loved one to receive KulaMind-Recovery\n* have a loved one who is willing to participate in the study\n* able to understand and speak English and provide written and verbal consent\n\nInclusion Criteria for Loved Ones:\n\n* 18+\n* have a sustained relationship with the individual in recovery and are perceived to be an important person in the individual in recovery's life\n* do not provide professional substance use disorder-related services to the individual in recovery\n* have regular access to a device to engaged with KulaMind-Recovery\n* able to understand and speak English and provide written and verbal informed consent\n* do not endorse current (past month) suicidality",true,"ALL",{"count":62,"type":22},60,[64],"NA","Substance use disorders are highly prevalent. However, recovery from them is possible. The recovery process can benefit greatly from support from loved ones. Loved ones may need guidance in the most helpful ways to support recovery. This study aims to refine and test a web-based intervention, known as KulaMind-Recovery, which offers online skill building and educational modules, one-on-one video sessions and \"on-demand\" text-based support from a coach, and access to a community forum to connect with others with shared experience.",[29,67],"mHealth",[69,70,71,72],"Recovery","Loved Ones","Addiction","Substance Use","RECRUITING",{"date":75,"type":42},"2026-08-19",{"date":77,"type":42},"2026-07-17",{"date":79,"type":22},"2027-04-30",{"name":81,"class":49},"Rhode Island Hospital",{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"100652036","real-time-opioid-study-100652036","NCT07768007","Real-time Opioid Study","Neurofeedback in Individuals With Substance Use Disorders","Inclusion Criteria:\n\n* ≥3 months of methadone treatment for OUD\n* Presence of anhedonia, as assessed via SHAPS\n* Baseline autobiographical memory deficit, as assessed via AMT\n\nExclusion Criteria:\n\n* Failure to pass an MRI screening\n* Women who are pregnant\n* Psychosis, as assessed via Yale PRIME Early Psychosis Screening Test\n* Serious suicidal ideation\n* Serious medical condition\n* Legally blind","50 Years",{"count":91,"type":22},3,[64],"This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting first-in-human data in an OUD population. Investigators will assess tolerability of the intervention and collect preliminary data from 2-3 subjects monitoring changes in anhedonia, non-substance-related autobiographical memory recall, and meaning in life.",[29],"2026-08-11",{"date":39,"type":42},{"date":98,"type":22},"2026-08",{"date":100,"type":22},"2027-02",{"name":102,"class":49},"Yale University",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":50},"100651133","phase-2-the-many-roads-to-trauma-recovery-a-clinical-trial-comparing-empirically-supported-treatments-for-veterans-with-co-morbid-posttraumatic-stress-and-substance-use-disorder-symptoms-100651133","NCT07756723","The Many Roads to Trauma Recovery: A Clinical Trial Comparing Empirically Supported Treatments for Veterans With Co-Morbid Posttraumatic Stress and Substance Use Disorder Symptoms","Inclusion Criteria:\n\n* PTSD diagnosis\n* Enrolled in VA healthcare\n* Attending residential programming at CVAMC\n* Current substance use difficulty based on screening questions\n\nExclusion Criteria:\n\n* Non-English speaking\n* Inability to complete study procedures\n* Lack competency to provide consent\n* Acute intoxication of a substance\n* Active psychotic symptoms at the study visit\n* Suicidal or homicidal ideation with intent and planning\n* Pacemaker or other cardiovascular implants.",{"count":110,"type":22},50,[25,112],"PHASE3","Veterans with co-morbid posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) are at substantial risk of developing hypertension and cardiovascular diseases that often lead to premature death, with some evidence that they may die over 10 years earlier than their counterparts. As such, determining ways to improve their health outcomes is vital. Heart Rate Variability Biofeedback (HRVB) may be one way to restore autonomic balance and teach veterans with PTSD \u002F SUDs how to respond differently to their symptoms. Multiple studies have found that HRVB not only improves autonomic nervous system (ANS) regulation \u002F flexibility among veterans with PTSD, but also reduces PTSD symptoms. Additionally, there is evidence that HRVB reduces cravings and SUD symptoms. Currently it is proposed that the improvement in the PTSD and SUD symptoms are due to a combination of improving ANS regulation and veterans utilizing the HRVB techniques as coping strategies for their symptoms. Yet, none of these studies examined how HRVB versus other active interventions differentially effected symptoms and physiological outcomes. It may be useful to examine HRVB to other active interventions . The current project proposes to alleviate this gap by examining the effects of HRVB to one a active control condition (i.e., Present Centered Psychotherapy; PCT) among 50-residential veterans engaging in PTSD residential programming. Veterans will be recruited from residential programs at the Coatesville VAMC and screened for probable PTSD and an active (i.e., past year) SUD. If eligible, they will attend a brief visit that will include being randomized, engaging in a diagnostic interview, a battery of questionnaires related to PTSD \u002F SUDs, attached to physiology equipment, and then complete 3 tasks (i.e., baseline task, emotion induction, and HRVB or Self-Compassion Break). Upon task completion, all veterans will be screened for risk and begin one of the conditions. Similar research procedures will be conducted after their final session. This study would provide evidence for the real-world effectiveness of HRVB compared to a control condition among one of the highest risk populations treated at the VA, which may provide invaluable insight into active mind-body treatments for veterans with PTSD \u002F SUD.",[115,29],"Posttraumatic Stress Disorder (PTSD)",[117,118,119,120,121],"PTSD","SUD","Veterans","HRV","Biofeedback","2026-08-07",{"date":95,"type":42},{"date":98,"type":22},{"date":126,"type":22},"2030-08",{"name":128,"class":129},"Coatesville VA Medical Center","FED",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":50},"100630398","unified-junction-of-care-integrated-treatments-and-team-coordination-for-adhd-in-prison-settings-with-substance-use-disorder-100630398","NCT07487155","Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Disorder","JUSTICE-TDAH","Inclusion Criteria:\n\n* Adult, under the supervision of the justice system or monitored by a correctional facility\n* Diagnosis of Substance Use Disorder (SUD)\n* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)\n* No objection from the patient\n* Affiliated with a Social Security system\n\nExclusion Criteria:\n\n* Severe or decompensated psychiatric disorders\n* Severe cognitive impairment\n* Lack of understanding of the French language\n* Refusal to participate",{"count":138,"type":22},39,[64],"Substance use disorders (SUD) and attention deficit disorder with or without hyperactivity (ADHD) are frequently co-morbid, particularly among people under court supervision. The coexistence of these disorders increases the social and legal vulnerability of individuals. Better identification of ADHD in vulnerable people with SUD is essential to improving their care. This project aims to provide appropriate support for this at-risk population.",[142,29],"Attention Deficit Disorder With Hyperactivity (ADHD)",{"date":95,"type":42},{"date":145,"type":42},"2026-08-03",{"date":147,"type":22},"2028-01-01",{"name":149,"class":49},"University Hospital, Brest",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":50},"100568242","contingency-management-for-veteran-smokers-undergoing-major-elective-surgery-100568242","NCT06678672","Contingency Management for Veteran Smokers Undergoing Major Elective Surgery","CM_Surgery","Inclusion Criteria:\n\n* English-speaking;\n* Veteran enrolled in healthcare at SFVAHCS;\n* Veteran scheduled for major elective surgery within the next 6 months (including but not limited to: general, spinal, thoracic, vascular, urological, gynecological, orthopedic, gender affirming). Veterans, who are followed at SFVAHCS by Primary Care and are referred to outside institutions for major surgery (e.g., gynecological or gender-affirming surgeries) are also eligible to participate;\n* Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB);\n* Open to receiving smoking cessation interventions.\n\nExclusion Criteria:\n\nEvaluated by investigative team medical record review and clinical assessment: - Psychotic disorders, bipolar disorder, neurocognitive disorder, or other psychiatric or medical conditions judged by the PI to be unstable based on medical record review and\u002For screening results;\n\n* Untreated, current, active problem gambling, assessed by medical record diagnosis and\u002F or Problem Gambling Severity Index (PGSI) score ≥ 8;\n* Enrollment in end of life\u002F palliative care;\n* Surgery with a clinical indication for cancer;\n* Unable to meet time commitment;\n* Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55);\n* A suicide attempt or suicidal ideation with intent in the 30 days before enrollment;\n* Concurrent participation in another tobacco cessation trial.",{"count":158,"type":22},36,[64],"The goal of this study is to design and test the first mobile contingency management (CM) smoking cessation intervention for military Veterans undergoing major elective surgery. Smoking is the leading risk factor for postoperative complications and is associated with longer hospital stays, reoperations, and 30-day mortality. Smoking rates among patients undergoing major elective surgery are high, 22.3-43.0%. It is imperative to identify efficacious, strategically timed smoking cessation interventions for surgery patients.\n\nCM incentivizes smoking cessation through positive reinforcement (rewards) when bioverified abstinence is achieved. To ensure feasibility, CM must be tailored to the clinical context. CM for smoking cessation has never been delivered before and after major surgery, nor has mobile CM bioverification been trialed perioperatively. The investigators will develop and test a tailored mobile smoking cessation CM protocol for Veterans undergoing major elective surgery.",[162,29],"Tobacco Use Disorder",[164,165,166],"Tobacco","Contingency Management","Surgery",{"date":95,"type":42},{"date":169,"type":42},"2025-08-01",{"date":171,"type":22},"2027-07-01",{"name":173,"class":49},"University of California, San Francisco",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":14,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100600948","substance-use-in-pregnancy---optimizing-retention-in-treatment-100600948","NCT07104123","Substance Use in Pregnancy - Optimizing Retention in Treatment","SUPPORT-MOM","Inclusion Criteria:\n\nConfirmed viable intrauterine pregnancy at any gestational age, or within three years postpartum\n\nSUD as defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or clinician documentation\n\nExclusion Criteria:\n\nDecline follow-up care at study site\n\nRequire immediate hospitalization for unstable medical or psychiatric conditions making them clinically unsuitable to participate in a research study",{"count":182,"type":22},40,[64],"Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention.\n\nThis pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors.\n\nFindings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.",[29,28,186,165],"Postpartum","2026-08-06",{"date":189,"type":42},"2026-08-10",{"date":191,"type":42},"2026-02-02",{"date":193,"type":22},"2027-09",{"name":48,"class":49},2,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":214,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":50},"100614348","reducing-parental-substance-use-and-enhancing-family-resilience-among-rural-families-through-ohio-start-100614348","NCT07278427","Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START","Reducing Parental Substance Use, Improving Child Health Outcomes, and Enhancing Family Resilience Among Rural Families Through Ohio START (Sobriety, Treatment, and Reducing Trauma)","Ohio START","Inclusion Criteria:\n\n* age 18 or older\n* who score 3 or higher on the substance use screening tool (UNCOPE)",{"count":205,"type":22},400,[64],"The goal of this observational study is to learn about the roles played by parental activity spaces and social networks in reducing parental substance use and promoting child and family health outcomes in the context of Ohio START (Sobriety, Treatment, and Reducing Trauma) for families in rural areas. This study will investigate if substance use treatment service referrals and family peer mentoring services provided by Ohio START lead to positive changes in parental activity spaces and social networks, and if these positive changes lead to better child and family outcomes. The main questions it aims to answer are:\n\n* Does having behavioral health services (referred by Ohio START workers) close to where parents spend their time help with substance use recovery and child health?\n* Does peer mentor support through Ohio START help parents build stronger social connections and family resilience, and does this lead to better long-term family health?\n* Do these associations differ in rural areas compared to urban areas?\n\nParticipants will:\n\n* Answer survey questions about their substance use, parenting, child health, and family well-being across three waves (Wave 1: when they enroll in the study, Wave 2: 6-month follow-up, and Wave 3: 12-month follow-up)\n* Share information about places they go regularly (such as work, stores, and healthcare visits)\n* Share information about people in their support network",[29,209,210,211,212,213],"Rural Health","Family Resilience","Child Maltreatment","Child Well-beiing","Substance Use Recovery",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,202,231,232,233,234],"Substance use disorder","Child abuse and neglect","Rural health","Child welfare services","Low socioeconomic status","Rurality","Longitudinal study","Prospective study","Family resilience","Social network","Activity spaces","Child maltreatment","Parental substance use","Family peer mentors","Social networks","Rural families","Child well-being","Substance use treatment services","Family health","The START model","2026-07-21",{"date":237,"type":42},"2026-07-22",{"date":239,"type":42},"2026-05-21",{"date":241,"type":22},"2030-08-01",{"name":243,"class":49},"Ohio State University",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":261,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":50},"100583774","the-trans-led-care-study-100583774","NCT06880705","The Trans-Led Care Study","A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women","TLC","Inclusion Criteria:\n\nEligible transgender adults must:\n\n1. be 18 years of age or older;\n2. speak primarily English;\n3. live in the U.S.;\n4. have a gender identity different from their assumed gender, or sex assigned, at birth;\n5. identify as a person of transgender experience;\n6. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.",{"count":253,"type":22},124,[64],"This study is testing a new mutual-help group called \"the TLC program\" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or \"ACT\" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.",[257,258,29,259,260],"Substance Abuse","Substance Addiction","Substance Use (Drugs, Alcohol)","Human Immunodeficiency Virus (HIV)",[262,263,264,265,266],"Substance misuse","HIV risk","Stigma","Psychological distress","Gender affirmation","2026-07-14",{"date":269,"type":42},"2026-07-15",{"date":271,"type":42},"2026-04-14",{"date":273,"type":22},"2027-07-31",{"name":275,"class":49},"Illinois Institute of Technology",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":195},"100645534","preventing-overdose-and-promoting-recovery-through-court-navigation-100645534","NCT07700407","Preventing Overdose and Promoting Recovery Through Court Navigation","Hybrid Type I Trial of a Peer-Led Court Navigation Program to Improve Substance Use Disorder Treatment Receipt and Reduce Overdose and Incarceration Among People Passing Through Courthouses","POPCORN","Inclusion Criteria:\n\n* Aged 18 years or older\n* Current resident of Indiana\n* Able to complete study procedures in English\n* Meets at least one of the following criteria: used heroin, fentanyl, methamphetamine, or cocaine in the past 12 months; is interested in resources or treatment for a substance use disorder; or experienced an opioid-related overdose in the past 12 months\n\nExclusion Criteria:\n\n* Has been sentenced to incarceration in jail or prison for the next 12 months","100 Years",{"count":286,"type":22},600,[64],"This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses. Courthouses are a common point of contact for people with behavioral health needs, but outside of specialty court models, they remain underexplored as a setting for connecting people to substance use disorder treatment and related services. This study will test whether court navigation led by peer recovery specialists can increase receipt of substance use disorder treatment and reduce overdose and incarceration. Peer court navigators will meet with participants in courthouse settings, assess their needs, provide information and referrals, and offer follow-up support for up to 3 months. Peer recovery specialists, who have lived experience with substance use recovery, are increasingly being integrated into criminal legal and community-based settings; however, peer-led court navigation remains an innovative and understudied approach.",[29],[291,292,293,294,295,296,297,298,299],"court navigation","peer recovery coach","substance use disorder treatment","fatal overdose","nonfatal overdose","incarceration","jail booking","prison entry","criminal legal system","2026-07-10",{"date":267,"type":42},{"date":303,"type":22},"2026-10",{"date":305,"type":22},"2030-05",{"name":307,"class":49},"RTI International",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":60,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":336,"locationsCount":195},"100645913","craving-management-program-for-substance-use-disorders-100645913","NCT07698808","Craving Management Program for Substance Use Disorders","A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (Craving Management and Alternative Behavior Enhancement Program) for Substance Use Disorders","Inclusion Criteria:\n\n* Adults aged 19 to 65 years who can understand the study purpose and procedures and provide written informed consent\n* Currently hospitalized (inpatient)\n* Able to communicate and complete questionnaires in Korean\n* Physically able to participate in program activities\n* Has completed detoxification treatment\n* Meets indication thresholds: DAST-10 score \\>= 2, craving reported as present on the VAS-C craving screening (i.e., \"yes\"), and \\>= 2 DSM-5 criteria\n\nExclusion Criteria:\n\n* Cognitive impairment that precludes communication\n* Physical conditions that preclude program participation (e.g., musculoskeletal disorder, severe cardiopulmonary disease)\n* Acute psychotic symptoms or risk of self-harm or harm to others\n* At risk of disrupting group activities such that focus group participation is not feasible\n* Individuals who are inmates or incarcerated at screening are not enrolled; participants who become incarcerated after enrollment are withdrawn","19 Years","65 Years",{"count":318,"type":22},20,[64],"This study examines whether a newly developed eight-session psychosocial treatment program, called the Craving Management and Alternative Behavior Enhancement Program, can be delivered in real-world hospital settings to people receiving inpatient care for substance use disorders in Korea, and whether it shows early signs of benefit. The program combines motivational interviewing, acceptance and commitment therapy, behavioral activation, and group activities, and is delivered twice a week over about four weeks (eight 50-minute sessions). About 20 adults will take part at two psychiatric hospitals.\n\nParticipants complete brief questionnaires and a short interview about their craving, motivation to change, behavioral activation, positive and negative affect, mindfulness, and drug use history before the program, immediately before and after each session, within one week after the program ends, and again at 1 month and 3 months after completion. After the program, some participants also join a small group discussion (focus group interview) to share their experience of the program.\n\nBecause this is a small, single-group preliminary (pilot) study without a comparison group, its primary purpose is to assess feasibility, that is, whether the program and the assessment approach work well enough, and to obtain preliminary effect and variability estimates to inform the design of a future large-scale randomized controlled trial.",[29],[323,324,325,326,327,328,329],"Psychosocial intervention","Craving","Group therapy","Acceptance and Commitment Therapy","Behavioral activation","Motivation to change","Mindfulness","2026-07-07",{"date":332,"type":42},"2026-07-13",{"date":98,"type":22},{"date":335,"type":22},"2026-12",{"name":337,"class":49},"The Catholic University of Korea",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":60,"minAge":315,"maxAge":316,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":356,"locationsCount":195},"100645804","emotion-regulation-program-for-substance-use-disorders-100645804","NCT07698821","Emotion Regulation Program for Substance Use Disorders","A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (Emotion Regulation Program) for Substance Use Disorders","Inclusion Criteria:\n\n* Adults aged 19 to 65 years who can understand the study purpose and procedures and provide written informed consent\n* Currently hospitalized (inpatient)\n* Able to communicate and complete questionnaires in Korean\n* Physically able to participate in program activities\n* Has completed detoxification treatment\n* Meets indication thresholds: DAST-10 score \\>= 2 and \\>= 2 DSM-5 criteria\n\nExclusion Criteria:\n\n* Cognitive impairment that precludes communication\n* Physical conditions that preclude program participation (e.g., musculoskeletal disorder, severe cardiopulmonary disease)\n* Acute psychotic symptoms or risk of self-harm or harm to others\n* At risk of disrupting group activities such that focus group participation is not feasible",{"count":318,"type":22},[64],"This study examines whether a newly developed eight-session psychosocial treatment program, called the Emotion Regulation Program, can be delivered in real-world hospital settings to people receiving inpatient care for substance use disorders in Korea, and whether it shows early signs of benefit. The program combines motivational interviewing, acceptance and commitment therapy, and group activities, and is delivered twice a week over about four weeks (eight 50-minute sessions). About 20 adults will take part at two psychiatric hospitals.\n\nParticipants complete brief questionnaires and a short interview about their craving, motivation to change, difficulties in emotion regulation, self-compassion, depression, and drug use history before the program, immediately before and after each session, within one week after the program ends, and again at 1 month and 3 months after completion. After the program, some participants also join a small group discussion (focus group interview) to share their experience of the program.\n\nBecause this is a small, single-group preliminary (pilot) study without a comparison group, its primary purpose is to assess feasibility, that is, whether the program and the assessment approach work well enough, and to obtain preliminary effect and variability estimates to inform the design of a future large-scale randomized controlled trial.",[29],[323,324,325,326,350,351,328],"Emotion regulation","Self-compassion",{"date":332,"type":42},{"date":354,"type":22},"2026-09",{"date":335,"type":22},{"name":337,"class":49},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":59,"sex":60,"minAge":365,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":50},"100608124","adolescent-stress-and-substance-intervention-subsequent-to-trauma-100608124","NCT07197476","Adolescent Stress and Substance Intervention Subsequent to Trauma","Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes","ASSIST","Inclusion Criteria for Youth:\n\n* Must be 12-17 years\n* Fluent in English or Spanish\n* Able to provide informed assent\n* Have a parent able to provide informed consent\n\nInclusion Criteria for Parents:\n\n* Live with an admitted pediatric trauma patient\n* Fluent in English or Spanish\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prisoner or in police custody\n* Involvement with child protective services\n* Admitted due to suicide attempt or non-suicidal self-injury\n* Any acute condition that would preclude provision of informed consent or assent","12 Years","17 Years",{"count":368,"type":22},92,[64],"The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are:\n\nPHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.\n\nPHASE II\n\n* Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions.\n* Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders.\n\nParticipants in PHASE 1:\n\nParent and child duo:\n\n* Review storyboards for the video interventions\n* Participate in qualitative interviews at hospital admission and 1 month following discharge\n\nPediatric trauma center clinical staff members:\n\n\\- Complete qualitative interviews\n\nParticipants in PHASE II:\n\nParent and child duo:\n\n* Shown their own video interventions\n* Complete assessments at admission and 1-, 2-, 3- months after discharge",[117,29,372],"Acute Stress Disorder",{"date":374,"type":42},"2026-07-09",{"date":376,"type":42},"2026-03-03",{"date":378,"type":22},"2027-04",{"name":81,"class":49},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":50},"100647060","safety-and-feasibility-of-next-generation-dome-helmet-ngdh-for-focused-ultrasound-neuromodulation-in-substance-use-disorder-sud-100647060","NCT07684976","Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)","Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)","Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent (determined by the investigator)\n2. Age between 18 to 70 (inclusive)\n3. Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine\u002Ftobacco use disorder) in the moderate to severe range according to the DSM-5\n4. Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care\n5. On a stable regimen of their psychiatric medications for 30 days before enrolment.\n\nExclusion Criteria:\n\n1. Pregnant or intending to be pregnant during the study\n2. Known active seizure disorder, significant head injury with an imaging verified lesion\n3. Medical illness that is deemed to be unstable or may confound the effects of the intervention\n4. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)\n5. Unable to reliably attend the required screening, treatment, and follow up appointments.\n6. Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.\n7. Scores 18 or below on Montreal Cognitive Assessment (MoCA)\n8. Weighs 250 lbs or more.","70 Years",{"count":318,"type":22},[64],"The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD).\n\nThe main questions it aims to answer are:\n\nCan FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and\u002For anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment?\n\nParticipants will:\n\nComplete baseline clinical assessments, questionnaires, imaging, and safety assessments.\n\nUndergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart.\n\nAttend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.",[29],[393,394,395],"Neuromodulation","Focused Ultrasound (FUS)","treatment-refractory substance use disorder","2026-07-02",{"date":398,"type":42},"2026-07-06",{"date":400,"type":22},"2026-07",{"date":402,"type":22},"2028-07",{"name":404,"class":49},"Sunnybrook Health Sciences Centre",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":50},"100609487","implementation-of-tbi-recover-in-substance-use-treatment-100609487","NCT07215221","Implementation of TBI-RECOVER in Substance Use Treatment","Facilitation as a Strategy for Implementing the Novel TBI-RECOVER Intervention Into Substance Use Treatment: A Mixed Methods Hybrid Type 2 Effectiveness-Implementation Trial","TBI-RECOVER","Patient Inclusion Criteria:\n\n* English-speaking; diagnosed with a substance use disorder; assigned to an outpatient provider for psychotherapy at the treatment clinic participating in the study.\n\nPatient Exclusion Criteria:\n\n* None\n\nProvider Inclusion Criteria:\n\n\\- All providers employed in the outpatient treatment clinic who deliver psychotherapy are eligible (e.g., social workers, counselors, psychologists).",{"count":414,"type":22},900,[64],"The goal of this hybrid type 2 pilot trial is to understand the implementation and effectiveness of the TBI-RECOVER intervention model (e.g., brain injury screening, cognitive and behavioral challenges screening, and neurocognitive accommodations) on patient retention in outpatient substance use disorder treatment. We will evaluate whether an implementation strategy bundle (e.g., training\u002Feducation, champions, audit \\& feedback, facilitation) improves provider use and sustainability of the TBI-RECOVER intervention, and also whether the TBI-RECOVER intervention improves patient symptoms and treatment retention.",[418,29],"Traumatic Brain Injury",[420,421,422,423,424,425,293,426,427,428,429],"hybrid type 2 effectiveness-implementation","traumatic brain injury","RE-AIM","organizational theory","implementation strategies","implementation mechanisms","hybrid type 2 trial","cognitive impairment","treatment mechanisms","outpatient substance use treatment",{"date":330,"type":42},{"date":432,"type":42},"2026-04-28",{"date":434,"type":22},"2030-03-30",{"name":243,"class":49},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":452,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":462,"locationsCount":50},"100646528","the-efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-in-individuals-with-tiletamine-use-disorder-100646528","NCT07689981","The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder","Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Tiletamine Use Disorder: A Randomized Double-Blind Sham-Controlled Trial","taVNS-Tiletami","Inclusion Criteria:\n\n* Age 18-60 years ≥6 years of education\\[7.1\\] DSM-5 diagnosis of substance use disorder related to tiletamine Tiletamine use ≥6 months and ≥1 time\u002Fweek Ability to provide informed consent Willingness to complete follow-up assessments\n\nExclusion Criteria:\n\n* Severe cognitive impairment History of epilepsy, brain injury, neurological disease or serious psychiatric disease Use of cognition-enhancing medications within 6 months Other psychoactive substance abuse within past 5 years (except nicotine) Metal implants in the head or severe skin sensitivity","60 Years",{"count":446,"type":22},30,[64],"Participants diagnosed with tiletamine use disorder will be assigned to active or sham taVNS for 5 days. Clinical outcomes ( e.g., behavioral paradigms measures and clinical scales ) and physiological markers (e.g., EEG and ECG) will be evaluated at baseline, post-treatment, and 3-month follow-ups to determine therapeutic efficacy and mechanisms of action.",[450,29,451],"Tiletamine Use Disorder","Drug Craving",[453,71,454,120,455,393,451,456],"taVNS","Brain-Heart Coupling","EEG","Tiletamine Dependence","2026-07-01",{"date":459,"type":42},"2026-07-08",{"date":457,"type":22},{"date":147,"type":22},{"name":463,"class":49},"Shanghai Mental Health Center",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":60,"minAge":315,"maxAge":316,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":480,"leadSponsor":482,"locationsCount":195},"100641308","first-step-program-for-substance-use-disorders-100641308","NCT07658963","First Step Program for Substance Use Disorders","A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (First Step Program) for Substance Use Disorders","Inclusion Criteria:\n\n* Adults aged 19 to 65 years who can understand the study purpose and procedures and provide written informed consent\n* Currently hospitalized (inpatient)\n* Able to communicate and complete questionnaires in Korean\n* Physically able to participate in program activities\n* Has completed detoxification treatment\n* Meets indication thresholds: DAST-10 score \\>= 2, URICA-DO precontemplation or contemplation stage, and \\>= 2 DSM-5 criteria\n\nExclusion Criteria:\n\n* Cognitive impairment that precludes communication\n* Physical conditions that preclude program participation (e.g., musculoskeletal disorder, severe cardiopulmonary disease)\n* Acute psychotic symptoms or risk of self-harm or harm to others\n* At risk of disrupting group activities such that focus group participation is not feasible\n* Individuals who are inmates or incarcerated at screening are not enrolled; participants who become incarcerated after enrollment are withdrawn",{"count":318,"type":22},[64],"This study examines whether a newly developed four-session psychosocial treatment program, called the First Step Program, can be delivered in real-world hospital settings to people receiving inpatient care for substance use disorders in Korea, and whether it shows early signs of benefit. The program combines motivational interviewing, acceptance and commitment therapy, and group activities, and is delivered twice a week over about two weeks (four 50-minute sessions). About 20 adults will take part at two psychiatric hospitals.\n\nParticipants complete brief questionnaires and a short interview about their motivation to change, craving, engagement in valued living, and social support before the program, immediately before and after each session, within one week after the program ends, and again at 1 month and 3 months after completion. After the program, some participants also join a small group discussion (focus group interview) to share their experience of the program.\n\nBecause this is a small, single-group preliminary (pilot) study without a comparison group, its primary purpose is to assess feasibility, that is, whether the program and the assessment approach work well enough, and to obtain preliminary effect and variability estimates to inform the design of a future large-scale randomized controlled trial.",[29],[323,324,325,326,328],"2026-06-15",{"date":478,"type":42},"2026-06-22",{"date":478,"type":22},{"date":481,"type":22},"2026-12-31",{"name":337,"class":49},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":498,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":50},"100643749","pilot-study-of-an-adapted-partner-navigation-intervention-booster-session-for-sustained-healthcare-engagement-among-people-who-inject-drugs-100643749","NCT07631559","Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs","Inclusion criteria:\n\nFor index participants:\n\n* 18 years of age or older at enrollment\n* History of injecting drug use\n* Completed HCV treatment within the past 3 months\n* Report a primary injecting partner willing to participate\n* Willing and able to provide informed consent\n* English or Spanish speaking\n\nFor primary injecting partners:\n\n* Primary injecting partner of an enrolled index participant:\n* 18 years of age or older at enrollment\n* Willing and able to provide informed consent\n* English or Spanish speaking\n* has context menu\n\nExclusion criteria:\n\nFor both index participants and injecting partners:\n\n* Unable to provide informed consent due to cognitive impairment or acute intoxication at the time of enrollment\n* Previously participated in this study in any capacity",{"count":110,"type":22},[64],"This study builds upon an ongoing NIH-funded randomized controlled trial (R01DA053325) evaluating a Partner Navigation Intervention to increase hepatitis C virus (HCV) treatment initiation among young adult people who inject drugs (PWID) and their injecting partners in San Francisco. The proposed research includes secondary analyses of existing trial data, additional survey measures, qualitative interviews, and a pilot intervention adaptation.\n\nThe study has two primary objectives. First, it examines how racialized discrimination (structural, interpersonal, and internalized) affects HCV treatment initiation and dyadic partner support processes within injecting partnerships. Second, it evaluates whether a brief, adapted \"booster\" partner navigation session delivered at HCV treatment completion can improve engagement in ongoing healthcare.\n\nParticipants include adults (≥18 years) who inject drugs and have been diagnosed with HCV, along with their primary injecting partners. Study activities include longitudinal surveys, qualitative interviews with a subset of participants, and a pilot intervention session with follow-up evaluation.\n\nThis research addresses critical gaps in understanding how social relationships and structural inequities influence healthcare engagement among PWID. Findings will inform culturally responsive adaptations to dyadic interventions and improve continuity of care in a population disproportionately affected by HCV and systemic barriers to healthcare.",[493,494,29,495,496,497],"HEPATITIS C (HCV)","Opioid Use Disorder","Drug Use Disorders","Healthcare Access","Harm Reduction",[499,500,501,502,503,504,505,506,507],"People who inject drugs (PWID)","Partner navigation","Dyadic intervention","Post-treatment healthcare engagement","Behavioral intervention","HCV treatment","Injecting partnerships","Feasibility pilot","Substance use","2026-06-01",{"date":510,"type":42},"2026-06-08",{"date":512,"type":22},"2026-09-01",{"date":514,"type":22},"2027-06-30",{"name":173,"class":49},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":59,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":91},"100577854","metabolome-and-gut-microbiome-changes-during-smoking-cessation-in-long-term-drug-therapy-in-a-therapeutic-community-100577854","NCT06803706","Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community","Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness to quit smoking\n* willingness and ability to consent\n\nInclusion criteria for healthy controls :\n\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness and ability to consent\n\nExclusion Criteria:\n\n* lack of consent, inability to provide informed consent\n* age below 18,\n* acute psychotic symptoms or acute suicidal tendencies\n* cardiovascular disease\n* pregnancy or breastfeeding\n* severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score \\\u003C20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy)\n* probiotic intake within the last 6 months,\n* ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study\n* prior participation in a smoking cessation programme",{"count":524,"type":22},150,[64],"Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.\n\nObjectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.\n\nMethods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.\n\nA cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.",[29,528,529,530],"Alcohol Use Disorder (AUD)","Nicotine Addiction","Healthy Adult Participants",[532,533,215,534,535],"Metabolomics","Gut microbiome","nicotine addiction","smoking cessation","2026-05-15",{"date":538,"type":42},"2026-05-18",{"date":540,"type":42},"2025-05-05",{"date":542,"type":22},"2026-10-28",{"name":544,"class":49},"Sigmund Freud PrivatUniversitat",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":553,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":556,"studyType":557,"phases":4,"briefSummary":558,"conditions":559,"keywords":563,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":50},"100637591","nlp-analysis-of-weekly-narratives-for-dynamic-clinical-assessment-in-sud-100637591","NCT07595614","NLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD","Analysis of Weekly Narratives Using Natural Language Processing in Patients Undergoing Residential Rehabilitation: A Hybrid Approach for the Dynamic Assessment of Clinical Processes","DYNA-NLP","Inclusion Criteria:\n\n1. Clinical diagnosis of severe substance use disorder (polydrug use, including cocaine, methamphetamines, alcohol, and\u002For cannabis), confirmed by the center's admission assessment.\n2. Male sex (all participants in the center's residential program are male).\n3. Age 18 years or older.\n4. Current resident of the participating residential rehabilitation center in Mexico.\n5. Completed at least four weeks of residential treatment at the time of study enrollment.\n6. Able to write coherent weekly narratives in Spanish (no severe cognitive impairment or active psychosis).\n7. Willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of acute psychotic symptoms that interfere with the ability to write or understand the study procedures.\n2. Severe cognitive impairment (e.g., due to traumatic brain injury, intellectual disability) that prevents meaningful narrative production.\n3. Inability to comply with weekly narrative writing (e.g., illiteracy, severe visual impairment).\n4. Planned discharge from the residential program within less than 4 weeks from enrollment.\n5. Enrollment in another interventional clinical trial that could confound the interpretation of outcomes.","MALE",{"count":555,"type":22},35,"20 Weeks","OBSERVATIONAL","This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete validated psychological questionnaires every two weeks, including the Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS).\n\nThe study applies natural language processing (NLP) and machine learning methods to analyze participants' narratives and identify emotional, cognitive, and behavioral patterns associated with clinical change over time. Narrative-derived features are combined with questionnaire scores to generate a dynamic clinical risk representation that may help detect early signs of psychological worsening or improvement during residential treatment.\n\nParticipants continue receiving standard residential care, and the study does not modify treatment decisions or clinical interventions. Up to 35 participants with sufficient longitudinal follow-up data will be included in the primary analysis. Data collection is expected to continue through September 2026.",[29,71,560,561,562],"Anxiety","Emotional Dysregulation","Rumination - Thoughts",[564,565,566,567,568],"Natural Language Processing","Machine Learning","Behavioral Activation","Automatic Thoughts","Residential Rehabilitation","2026-05-14",{"date":571,"type":42},"2026-05-19",{"date":573,"type":42},"2025-05-25",{"date":354,"type":22},{"name":576,"class":49},"Lauro Gutiérrez Castro",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":591,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":50},"100640731","a-study-to-investigate-health-related-quality-of-life-with-a-pharmacist-intervention-compared-to-treatment-as-usual-in-participants-with-severe-mental-illness-and-substance-use-disorder-receiving-treatment-from-fact-teams-100640731","NCT07597863","A Study to Investigate Health Related Quality of Life With a Pharmacist Intervention Compared to Treatment as Usual in Participants With Severe Mental Illness and Substance Use Disorder Receiving Treatment From FACT Teams.","Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams","pharmaFACT","Inclusion Criteria:\n\n* Age over 18 years old\n* Included in and receiving treatment from a participating FACT team\n* Diagnosed with severe mental illness and\u002For substance use disorder\n* Prescribed one or more psychotropic medication\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients not being competent or have the decision-making capacity to consent\n* Planned discharge from the team within the first three months of period 1\n* Patients not able to communicate in Norwegian or English",{"count":586,"type":22},160,[64],"The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.",[590,29],"Severe Mental Illness",[592,593,594,595,596,597],"FACT","Flexible assertive community treatment","Clinical pharmacist","Medication review","Patient counselling","Medication reconciliation","2026-05-13",{"date":571,"type":42},{"date":601,"type":22},"2026-05-01",{"date":603,"type":22},"2031-02",{"name":605,"class":49},"Sykehuset Innlandet HF",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":628,"leadSponsor":630,"locationsCount":50},"100641081","engaging-family-members-during-early-sud-treatment-a-hybrid-trial-100641081","NCT07579299","Engaging Family Members During Early SUD Treatment: A Hybrid Trial","FAMILY MEMBERS:\n\nInclusion Criteria:\n\n* 18 years old or older\n* A parent, child, sibling, spouse\u002Fromantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months\n* Cohabitating with their loved one\n* In frequent contact (in-person or virtual) with their loved one (at least 3x\u002Fweek)\n* Not worried about potential physical harm from their loved one\n* Report no illicit drug use in the past year\n\nPATIENTS:\n\nInclusion Criteria:\n\n* 18 years old or older\n* In frequent contact with a family member (at least 3x\u002Fweek) that they cohabitate with\n* Have initiated substance use treatment in past 3 months\n\nCLINIC PROVIDERS:\n\nInclusion Criteria:\n\n* Counselor\u002FClinician providing care at our partner clinic for SUD\n\nExclusion Criteria (ALL):\n\n* Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)\n* Does not understand English fluently",{"count":613,"type":22},100,[64],"The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.\n\nThis study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.",[29],[618,619,620,621,622,623,624],"sud","CRAFT","addiction","substance use","substance use treatment","family members","support persons","2026-05-11",{"date":569,"type":42},{"date":269,"type":22},{"date":629,"type":22},"2027-03-31",{"name":631,"class":49},"Stanford University",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":553,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":641,"studyType":557,"phases":4,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":655,"leadSponsor":657,"locationsCount":50},"100637664","dynamic-multilevel-processes-of-recovery-in-therapeutic-communities-in-mexico-dico-model-100637664","NCT07588516","Dynamic Multilevel Processes of Recovery in Therapeutic Communities in Mexico (DICO Model)","Comprehensive Behavioral Community Dynamics (DICO): A Prospective Longitudinal Study of Multilevel Community Processes in Therapeutic Communities for Substance Use Treatment in Mexico","DICO","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Currently enrolled in a residential therapeutic community for substance use treatment\n* Minimum stay of at least 7 days prior to baseline assessment\n* Ability to understand and provide informed consent\n* Expected availability for participation during the 8-12 week follow-up period\n\nExclusion Criteria:\n\n* Acute psychotic symptoms or severe psychiatric decompensation that interferes with participation\n* Severe cognitive impairment limiting comprehension of study procedures\n* Current medical instability requiring immediate external intervention\n* Refusal to participate in any component of the study",{"count":62,"type":22},"12 Weeks","This study aims to develop and empirically evaluate the Dinámica Integral Conductual Comunitaria (DICO) model, a multilevel framework that conceptualizes recovery from substance use disorders as a dynamic process emerging from the interaction between individual behavioral variables, social contingencies, and community-level factors within therapeutic communities in Mexico.\n\nA prospective longitudinal design with intensive repeated measures will be implemented over 8 to 12 weeks. Data will be collected using ecological momentary assessment (EMA), psychometric instruments, behavioral records, and semi-structured interviews.\n\nThe study seeks to model recovery trajectories as nonlinear dynamic systems, identifying critical transitions, instability patterns, and contextual moderators associated with treatment adherence and relapse risk.",[29,644],"Treatment Adherence",[646,647,648,324,649,326,650,651],"Therapeutic Communities","Ecological Momentary Assessment (EMA)","Psychological Flexibility","Community Reinforcement","Multilevel Modeling","Dynamic Systems","2026-05-08",{"date":569,"type":42},{"date":536,"type":22},{"date":656,"type":22},"2026-10-02",{"name":658,"class":49},"Under The Tree Therapeutic Community",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":666,"enrollmentInfo":667,"targetDuration":4,"studyType":23,"phases":668,"briefSummary":669,"conditions":670,"keywords":673,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":50},"100584476","worth-paths-intervention-100584476","NCT06889831","WORTH Paths Intervention","Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems","Inclusion Criteria:\n\n* Female sex at birth\n* Aged 18-44 years\n* Past year criminal legal involvement (e.g., incarceration or community supervision)\n* Meets criteria for current substance use disorder (SUD) as defined by DSM-5 and assessed by the Mini-International Neuropsychiatric Interview (MINI)\n* Meets criteria for unmet need for contraception (capable of pregnancy, sexually active, does not want to become pregnant within the next year, but is currently not using contraception)\n* Able to read, write, and speak English\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Currently pregnant or actively trying to conceive\n* Diagnosed infertility (e.g., menopause, tubal ligation, hysterectomy)\n* Unable to provide informed consent due to significant cognitive impairment, mental health condition, or substance intoxication\n* Unable or unwilling to meet study requirements (e.g., attend sessions, complete assessments)","44 Years",{"count":110,"type":22},[64],"Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services.\n\nThis study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use.\n\nParticipants (N=50) will be randomly assigned to one of two groups:\n\nWORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services.\n\nControl Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction.\n\nBoth groups will receive resources for substance use treatment and sexual and reproductive health services.\n\nResearchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use.\n\nPrimary aims:\n\nFeasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination.\n\nAcceptability: Measured by participant ease of use, helpfulness, and satisfaction.\n\nPrimary behavioral outcomes:\n\nSelf-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use.\n\nSecondary behavioral outcome:\n\nLinkage to substance use disorder treatment (measured by appointments made and sessions attended).",[29,671,672],"Sexual and Reproductive Health","Sexual Risk Behavior",[34],"2026-05-05",{"date":676,"type":42},"2026-05-06",{"date":678,"type":42},"2025-08-12",{"date":680,"type":22},"2026-12-01",{"name":682,"class":49},"Fairleigh Dickinson University",{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":23,"phases":692,"briefSummary":693,"conditions":694,"keywords":695,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":708},"100595171","fighting-addictions-improving-lives-comprehensive-drug-rehabilitation-with-music-100595171","NCT07028983","Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music","Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial","FALCO","Inclusion Criteria:\n\n* patients seeking or receiving treatment at the recruitment site for an existing substance use disorder based on ICD-10 criteria\n* ≥18 years old\n* not currently undergoing detoxification (detoxification has been completed or is not currently planned at the time of recruitment)\n* any type of substance use including polysubstance and alcohol use\n\nExclusion Criteria:\n\n* exclusively nicotine dependence\n* psychotic episode in the last 3 months\n* insufficient language skills to participate in treatment without the use of a translator\n* hearing impairment that considerably impairs hearing of music played at a moderate volume (not relevant if hearing is sufficiently compensated by a hearing aid)\n* existing diagnosis of dementia\n* is currently receiving music therapy or has received music therapy (i.e. at planned and reoccurring intervals, not counting single random occurrences) during the past year",{"count":286,"type":22},[64],"FALCO is a parallel pragmatic randomized control trial addressing long-term effects of music therapy (MT) on substance use disorder (SUD).\n\n600 participants will be recruited from multiple European countries (see Locations). They will be randomized into one of the following intervention arms: Active Music Group (AMG), Music Listening Group (MLG) or Treatment as Usual (TAU) as offered locally.",[29],[34,620,696,697,698,699],"recovery","music therapy","mental health","brain health","2026-04-30",{"date":601,"type":42},{"date":703,"type":42},"2025-07-01",{"date":705,"type":22},"2037-06-30",{"name":707,"class":49},"NORCE Norwegian Research Centre AS",11]