[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,50,69,97,115,138,172,204,237,266,311,338,366,391,418,438,472,497,521,554,595,621,651,685,707],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054217","emotion-regulation-program-for-substance-use-disorders-100054217",false,"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","ALL","19 Years","65 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28],"Substance Use Disorder (SUD)",[30,31,32,33,34,35,36],"Psychosocial intervention","Craving","Group therapy","Acceptance and Commitment Therapy","Emotion regulation","Self-compassion","Motivation to change","NOT_YET_RECRUITING","2026-07-07",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-09",{"date":45,"type":22},"2026-12",{"name":47,"class":48},"The Catholic University of Korea","OTHER",2,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":49},"100053957","craving-management-program-for-substance-use-disorders-100053957","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",{"count":21,"type":22},[25],"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.",[28],[30,31,32,33,62,36,63],"Behavioral activation","Mindfulness",{"date":40,"type":41},{"date":66,"type":22},"2026-08",{"date":45,"type":22},{"name":47,"class":48},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":77,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":49},"100600948","substance-use-in-pregnant-people---optimizing-retention-in-treatment-100600948","NCT07104123","Substance Use in Pregnant People - Optimizing Retention in Treatment","Substance Use in Pregnant People - Optimizing Retention in Treatment by Maximizing Opportunities for Management","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","FEMALE","18 Years",{"count":80,"type":22},40,[25],"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.",[28,84,85,86],"Pregnancy","Postpartum","Contingency Management","RECRUITING","2026-06-17",{"date":90,"type":41},"2026-06-22",{"date":92,"type":41},"2026-02-02",{"date":94,"type":22},"2027-09",{"name":96,"class":48},"Washington University School of Medicine",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":49},"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":21,"type":22},[25],"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.",[28],[30,31,32,33,36],"2026-06-15",{"date":90,"type":41},{"date":90,"type":22},{"date":113,"type":22},"2026-12-31",{"name":47,"class":48},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"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":123,"type":22},39,[25],"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.",[127,28],"Attention Deficit Disorder With Hyperactivity (ADHD)","2026-06-08",{"date":130,"type":41},"2026-06-10",{"date":132,"type":22},"2026-07-01",{"date":134,"type":22},"2028-01-01",{"name":136,"class":48},"University Hospital, Brest",1,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":154,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":137},"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":145,"type":22},50,[25],"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.",[149,150,28,151,152,153],"HEPATITIS C (HCV)","Opioid Use Disorder","Drug Use Disorders","Healthcare Access","Harm Reduction",[155,156,157,158,159,160,161,162,163],"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":128,"type":41},{"date":167,"type":22},"2026-09-01",{"date":169,"type":22},"2027-06-30",{"name":171,"class":48},"University of California, San Francisco",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":179,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"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",true,{"count":181,"type":22},150,[25],"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.",[28,185,186,187],"Alcohol Use Disorder (AUD)","Nicotine Addiction","Healthy Adult Participants",[189,190,191,192,193],"Metabolomics","Gut microbiome","Substance use disorder","nicotine addiction","smoking cessation","2026-05-15",{"date":196,"type":41},"2026-05-18",{"date":198,"type":41},"2025-05-05",{"date":200,"type":22},"2026-10-28",{"name":202,"class":48},"Sigmund Freud PrivatUniversitat",3,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":212,"minAge":78,"maxAge":4,"enrollmentInfo":213,"targetDuration":215,"studyType":216,"phases":4,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":137},"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":214,"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.",[28,219,220,221,222],"Addiction","Anxiety","Emotional Dysregulation","Rumination - Thoughts",[224,225,226,227,228],"Natural Language Processing","Machine Learning","Behavioral Activation","Automatic Thoughts","Residential Rehabilitation","2026-05-14",{"date":231,"type":41},"2026-05-19",{"date":233,"type":41},"2025-05-25",{"date":43,"type":22},{"name":236,"class":48},"Lauro Gutiérrez Castro",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":137},"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":246,"type":22},160,[25],"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.",[250,28],"Severe Mental Illness",[252,253,254,255,256,257],"FACT","Flexible assertive community treatment","Clinical pharmacist","Medication review","Patient counselling","Medication reconciliation","2026-05-13",{"date":231,"type":41},{"date":261,"type":22},"2026-05-01",{"date":263,"type":22},"2031-02",{"name":265,"class":48},"Sykehuset Innlandet HF",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":216,"phases":4,"briefSummary":276,"conditions":277,"keywords":283,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":137},"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* currently enrolled in Ohio START;\n* are unemployed or have family income at or below the federal poverty level,\n* designated as the primary parent in the Ohio START case plan.",{"count":275,"type":22},400,"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",[28,278,279,280,281,282],"Rural Health","Family Resilience","Child Maltreatment","Child Well-beiing","Substance Use Recovery",[191,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,272,299,300,301,302],"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","2026-05-12",{"date":229,"type":41},{"date":306,"type":41},"2026-04-27",{"date":308,"type":22},"2030-08-31",{"name":310,"class":48},"Ohio State University",{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":137},"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":318,"type":22},100,[25],"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.",[28],[323,324,325,326,327,328,329],"sud","CRAFT","addiction","substance use","substance use treatment","family members","support persons","2026-05-11",{"date":229,"type":41},{"date":333,"type":22},"2026-07-15",{"date":335,"type":22},"2027-03-31",{"name":337,"class":48},"Stanford University",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":212,"minAge":78,"maxAge":4,"enrollmentInfo":346,"targetDuration":348,"studyType":216,"phases":4,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":362,"leadSponsor":364,"locationsCount":137},"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":347,"type":22},60,"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.",[28,351],"Treatment Adherence",[353,354,355,31,356,33,357,358],"Therapeutic Communities","Ecological Momentary Assessment (EMA)","Psychological Flexibility","Community Reinforcement","Multilevel Modeling","Dynamic Systems","2026-05-08",{"date":229,"type":41},{"date":194,"type":22},{"date":363,"type":22},"2026-10-02",{"name":365,"class":48},"Under The Tree Therapeutic Community",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":77,"minAge":78,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":137},"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":145,"type":22},[25],"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).",[28,378,379],"Sexual and Reproductive Health","Sexual Risk Behavior",[381],"substance use disorder","2026-05-05",{"date":384,"type":41},"2026-05-06",{"date":386,"type":41},"2025-08-12",{"date":388,"type":22},"2026-12-01",{"name":390,"class":48},"Fairleigh Dickinson University",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"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":400,"type":22},600,[25],"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.",[28],[381,325,405,406,407,408],"recovery","music therapy","mental health","brain health","2026-04-30",{"date":261,"type":41},{"date":412,"type":41},"2025-07-01",{"date":414,"type":22},"2037-06-30",{"name":416,"class":48},"NORCE Norwegian Research Centre AS",11,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":179,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":137},"100622665","contextualization-and-digitalization-of-whos-mental-health-action-gap-intervention-guide-substance-use-disorders-module-100622665","NCT07386574","Contextualization and Digitalization of WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module","Testing a Contextualized and Digitalized WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module in Primary Care Settings of Pakistan: A Feasibility Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary and non-specialized healthcare providers working in the identified health facilities for this study across three targeted cities; willing to give informed consent for participation in this trial.\n\nExclusion Criteria:\n\n* Any primary and non-specialized healthcare provider who is not permanently working in the selected health facilities, has no access to a smart mobile phone and\u002For internet connection; and is uncomfortable using a mobile phone.",{"count":426,"type":22},300,[25],"The aim of study is to:\n\n1. To contextualize, adapt, customize and digitalize WHO's Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG); Substance Use Disorders Module (SUD module) V 2.0 for primary care settings (PCPs) in Pakistan.\n2. To test the feasibility and acceotability of the e-mhGAP-IG (SUD module) training program in a feasibility cluster randomized controlled (cRCT) trial to enable mental health services in primary health care settings in Pakistan.\n\nThe proposed study includes contextualization, adaptation, customization, and a feasibility cRCT of e-mhGAP-IG (SUD module) V 2.0 by constituting a combination of traditional and technological approaches of eHealth (mHealth, blended learning, and telemedicine) enabling mental health services in primary care settings to be well informed and accessible. This intervention will empower 300 Primary Care Physicians (PCPs) based in Primary Care Units (PCUs) from urban settlements and Basic Health Units (BHUs) from rural settlements in three major cities, Karachi, Lahore, and Rawalpindi, Pakistan.",[28],"2026-04-29",{"date":261,"type":41},{"date":433,"type":41},"2025-01-01",{"date":435,"type":22},"2026-06",{"name":437,"class":48},"Pakistan Institute of Living and Learning",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":212,"minAge":78,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":137},"100624809","combining-social-network-strategies-and-routine-substance-use-screening-100624809","NCT07414459","Combining Social Network Strategies and Routine Substance Use Screening","SNSUS","Inclusion Criteria:\n\n* Assigned male sex at birth\n* Has sex with men\n* Speaks English or Spanish\n\nExclusion Criteria:\n\n* Institutionalized individuals\n* Women\n* Non-Hispanic whites",{"count":446,"type":22},500,[25],"This study aims to improve health care for people who may have HIV or substance use disorders by bringing two services to a large community health center in Chicago. First, the clinic will begin offering routine screening for substance use to all patients. Second, the study will offer a social network-based program that helps people identify friends or partners who may need support and link them to care. The goal is to help more people learn their HIV status, reduce HIV levels in the community, and connect people with substance use treatment when needed. The study will also look at how well these services can be added into everyday clinic practice and what is needed to keep them going over time.",[450,28],"HIV",[452,450,381,453,454,455,456,457,458,459,407,460,461,462,463,464,325],"social networks","HIV testing","HIV prevention","harm reduction","social stigma","programs","testing","treatment","community clinic","intervention","color","Chicago","drug abuse",{"date":382,"type":41},{"date":467,"type":22},"2026-07-31",{"date":469,"type":22},"2029-04",{"name":471,"class":48},"University of California, San Diego",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":179,"sex":17,"minAge":480,"maxAge":481,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":137},"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":483,"type":22},92,[25],"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",[487,28,488],"PTSD","Acute Stress Disorder",{"date":490,"type":41},"2026-04-28",{"date":492,"type":41},"2026-03-03",{"date":494,"type":22},"2027-04",{"name":496,"class":48},"Rhode Island Hospital",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":504,"maxAge":19,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":137},"100590906","habits-study-helping-addiction-by-individualized-therapeutic-stimulation-pilot-trial-of-deep-brain-stimulation-guided-by-stereoelectroencephalography-for-treatment-refractory-substance-use-disorders-100590906","NCT06973512","HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders","HABITS","Inclusion Criteria:\n\n* Adult, Age 25-65\n* Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5)\n* Treatment refractory as evidenced by non-response to an adequate trial of ≥2 evidence-based treatment modalities for their substance use disorder in the most recent 3 years of illness, as determined by the study clinical team\n* Able to comply with study visit schedule and timeline\n* Stable housing and reliable transportation\n* Treatment-seeking (\\>7 on a 0-10 readiness ruler and open to the end-of-treatment outcome of abstinence)\n* Capable of understanding and providing informed consent\n\nExclusion Criteria:\n\n* Contraindications to neurosurgical interventions such as major medical co-morbidities, including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant-related infections, immunocompromised state, or malignancy with \\\u003C5 years life expectancy\n* Contraindications for MRI, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces\n* Cardiac pacemaker\u002Fdefibrillator, or other implanted stimulator\n* Presence of epilepsy, stroke, or degenerative disorder of the nervous system\n* Serious problems with literacy, vision, or hearing","25 Years",{"count":506,"type":22},10,[25],"Substance use disorder (SUD) or addiction to drugs\u002Falcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances.\n\nOver 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects.\n\nSEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person.\n\nIn the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care.\n\nSUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.",[219,28],[325,381,511,512,513,514],"deep brain stimulation","stereoelectroencephalography","biomarker","electrophysiology",{"date":430,"type":41},{"date":517,"type":41},"2024-11-01",{"date":134,"type":22},{"name":520,"class":48},"Centre for Addiction and Mental Health",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":553,"locationsCount":4},"100609487","implementation-of-tbi-recover-in-substance-use-treatment-100609487","NCT07215221","Implementation of TBI-RECOVER in Substance Use Treatment","Implementation of the Novel TBI-RECOVER Intervention in Substance Use Treatment: A Hybrid Type 2 Effectiveness-Implementation Pilot 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":530,"type":22},900,[25],"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.",[534,28],"Traumatic Brain Injury",[536,537,538,539,540,541,542,543,544,545,546],"hybrid type 2 effectiveness-implementation","traumatic brain injury","RE-AIM","organizational theory","implementation strategies","implementation mechanisms","substance use disorder treatment","hybrid type 2 trial","cognitive impairment","treatment mechanisms","outpatient substance use treatment","2026-04-15",{"date":549,"type":41},"2026-04-16",{"date":490,"type":22},{"date":552,"type":22},"2030-07-31",{"name":310,"class":48},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":573,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":137},"100576849","pathways-to-perinatal-mental-health-equity-100576849","NCT06790641","Pathways to Perinatal Mental Health Equity","Pathways","Inclusion Criteria for perinatal care setting team members:\n\n* Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention during the study period).\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for peer mentors:\n\n* Have completed PSI training to be a peer mentor\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for perinatal individuals:\n\n* Have received perinatal care at a study partnering perinatal care setting during the study period\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English or Spanish\n\nExclusion Criteria:\n\nAn individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.","70 Years",{"count":563,"type":22},1270,[25],"Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, \"Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?\" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.",[567,568,569,570,571,28,572],"Perinatal Anxiety","Perinatal Depression","Social Determinants of Health (SDOH)","Peer Support","Obstetric Care","Perinatal Depression, Substance Use",[540,574,575,576,577,578,579,580,581,582,583,584,585],"obstetric care","perinatal mental health","perinatal anxiety","perinatal depression","perinatal mood disorders","qualitative study","focus groups","mixed methods","perinatal care","peer mentors","peer support","healthcare-community partnership","2026-04-14",{"date":588,"type":41},"2026-04-20",{"date":590,"type":41},"2025-12-05",{"date":592,"type":22},"2030-10-01",{"name":594,"class":48},"University of Massachusetts, Worcester",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":179,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":610,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":137},"100633604","justice-community-overdose-innovation-network-ii-tcu-hub-100633604","NCT07528846","Justice Community Overdose Innovation Network II TCU Hub","Justice Community Overdose Innovation Network II TCU Hub: TCU Building Resilient Initiatives for Deflection Through Greater Engagement Project (TCU BRIDGE to Deflection Project)","JCOIN II TCU","Staff\n\nInclusion Criteria:\n\n* Directly involved in Deflection services, including:\n* Making referrals (e.g., law enforcement, first responders, community agencies) \\& Providing services to participants (e.g., case managers, peer specialists, coordinators);\n* Aged 18 years or older;\n* Able to complete surveys in English;\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Not affiliated with a participating Deflection agency;\n* No role in Deflection referral or service delivery;\n* Under age 18;\n* Unable or unwilling to provide informed consent\n\nClients\n\nInclusion Criteria:\n\n* Aged 18 years or older;\n* Enrolled in a Deflection program within a participating community;\n* Between 1 and 12 months post-enrollment at time of recruitment;\n* Documented history of substance use disorder (SUD) or risk for SUD;\n* Priority for individuals reporting opioid and\u002For stimulant use within the past year;\n* Able to complete survey and\u002For interview; Willing to provide informed consent\n\nExclusion Criteria:\n\n* Under age 18;\n* Not enrolled in a Deflection program;\n* Insufficient exposure to Deflection (\\\u003C1 month);\n* Unable or unwilling to provide informed consent\n\nCitizens\n\nInclusion Criteria:\n\n* Aged 18 years or older;\n* Resident of a participating community;\n* Represents general community population (including individuals with or without lived experience of SUD\u002FCLS involvement);\n* Able to participate in: Surveys and\u002For Community Listening Sessions;\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Under age 18;\n* Not residing in a participating community;\n* Unable or unwilling to provide informed consent\n\nWorkgroup\n\nInclusion Criteria:\n\n* Aged 18 years or older;\n* Identified as a community or agency leader\u002Fstakeholder involved in Deflection programming;\n* Member of a DAG within a participating community;\n* Represents one of the required stakeholder roles: Law enforcement leadership or staff, Behavioral health leadership or staff Health professional, Community representative (citizen);\n* Able to participate in meetings, surveys, and\u002For focus groups;\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Not part of a DAG in a participating community;\n* Does not hold a role relevant to Deflection leadership or decision-making;\n* Under age 18;\n* Unable or unwilling to provide informed consent",{"count":604,"type":22},1620,[25],"The current study proposes to use a Hybrid Type 3 implementation research strategy to: 1) Significantly enhance our understanding of public health outcomes \\[e.g., overdose incidents and substance-use (SU)-related Emergency Medical Service (EMS) contacts\\] and public safety outcomes (e.g., drug-related arrests) associated with Deflection and Pre-Arrest Diversion initiatives (DPAD, hereafter referred to as Deflection); and 2) Create a lasting contribution to the fields of research focused on SU and the criminal legal system (CLS) by advancing knowledge of effective implementation strategies involving the critical role of community engagement in Deflection. The highly experienced team of Multiple PIs, senior-level collaborators from both Deflection and Community Behavioral Health (CBH), state-level evaluation partners, a national stakeholder advisory group, and CLS and behavioral health partners within each community have teamed up to carry out the proposed project. The study approach uses a hybrid implementation-effectiveness design to examine strategies to improve opioid and stimulant relevant outcomes, and specifically proposes to test the implementation-effectiveness of 2 strategy bundles to promote Deflection models through a CORE community engagement bundle (designed to facilitate community stakeholder engagement) and ENHANCED community engagement bundle (CORE plus a component to systematically involve community advocates) on improving implementation as well as public safety and health outcomes. The proposed randomized control trial includes a total of 20 geographically distinct clinical research performance sites (i.e., 20 communities spanning 5 states; New Mexico, Illinois, Wisconsin, Colorado, and Pennsylvania), with 3-5 communities per state and the inclusion of key CLS and CBH stakeholders within each site. The large scope of the project will maximize potential generalizability of study results and sustainability of implementation strategies.",[28,608,609],"Drug Overdose","Criminal Behavior",[611,612],"deflection","pre-arrest diversion","2026-04-07",{"date":586,"type":41},{"date":616,"type":22},"2026-07",{"date":618,"type":22},"2029-05",{"name":620,"class":48},"Texas Christian University",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":629,"maxAge":561,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":649,"locationsCount":137},"100632971","evaluation-of-the-addpro-vocational-reintegration-program-add-pro-eval-100632971","NCT07520617","Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)","Evaluation of the ADD'Pro Program: A Partnership-Based Approach to Support Vocational Reintegration of Patients Receiving Addiction Care (ADD-PRO-EVAL)","ADD-PRO-EVAL","Inclusion Criteria:\n\n* Adult of working age (18 years or older)\n* Diagnosed substance use disorder receiving medical care\n* Unemployed or on sick leave with a vocational reorientation project\n* Motivated to work in the competitive labour market\n* Living in or wishing to work in the Puy-de-Dôme department (63), France\n* Legally authorised to work\n* Capable of providing written informed consent\n* Affiliated with a French social security scheme\n\nExclusion Criteria:\n\n* Medical care provided under a court-ordered treatment obligation\n* Previously included in the ADD'Pro program\n* Residing outside the Puy-de-Dôme with no plan to work in the department\n* Under legal guardianship (tutelle, curatelle, or sauvegarde de justice)\n* Deprived of liberty","16 Years",{"count":318,"type":22},[25],"The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital.\n\nThe main question it aims to answer is:\n\n\\- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services?\n\nResearchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity.\n\nParticipants will:\n\n* Be randomly assigned to either the ADD'Pro program or standard employment services\n* If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date\n* If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months\n* Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months\n* A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months",[219,634,282,635,636,637,28,638,639,640,641,642],"Addiction Disorders","Return to Work","Recovery","Recovery Outcomes","Employment, Supported","Employment","Substance Related Disorders","Vocational Rehabilitation","Substance Use (Drugs, Alcohol)","2026-04-02",{"date":645,"type":41},"2026-04-09",{"date":647,"type":22},"2026-04",{"date":469,"type":22},{"name":650,"class":48},"University Hospital, Clermont-Ferrand",{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":179,"sex":212,"minAge":78,"maxAge":658,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":669,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":203},"100626311","california-meps-hub-100626311","NCT07433985","California MEPS Hub","California Hub for HIV\u002FSTI\u002FSUD Prevention Research With Reentry Populations","Inclusion Criteria:\n\nRCT Participants\n\n* Assigned male at birth\n* Ages 18 - 59\n* Was released from incarceration in the previous 12 months (incarceration is defined as a stay in jail, prison, or detention centers for over 24 hours)\n* Reports an SUD diagnosis or seeking SUD services at any time in the 24 months prior to enrollment\n* During the 24 months prior to enrollment, either:\n\n  1. Reports intercourse with a person assigned male at birth\n  2. Reports injection drug use\n* Has not received an HIV diagnosis (based on self-report)\n* Possesses a smartphone or plans to obtain one\n* Plans to reside within designated jurisdictions (counties) for the 9 months following enrollment\n\nCBO and agency staff participating in implementation surveys or interviews\n\n* \\>=18 years of age\n* Employed at a study site or otherwise involved with intervention implementation and\u002For maintenance OR works at an agency in the counties where the study is taking place (Los Angeles, Riverside, San Bernardino, and Alameda counties, California).\n* Willing to provide informed consent for participation.\n\nExclusion Criteria:\n\nRCT Participants:\n\n* Does not have a smart phone and is not willing to obtain one\n* Is not able to speak and understand English\n* Has insufficient reading skills to operate a mobile application on a cell phone\n\nCBO participating in implementation interviews\n\n\\- n\u002Fa","59 Years",{"count":660,"type":22},318,[25],"The California Hub for HIV\u002FSUD Prevention Research with Reentry Populations addresses the question: \"Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider range of clients?\"\n\nThe Mobile Enhanced Prevention Support (MEPS) intervention was originally implemented in Los Angeles County and was proven successful in promoting biomedical HIV prevention (PrEP) uptake and preventative screenings in people who used drugs who recently left incarceration. MEPS is an evidence-based intervention for people with substance use disorders (SUD) that incorporates a client-centered planning session, including trained peer mentors, service utilization incentives, and a mobile application (GeoPass).\n\nThe study includes a randomized controlled trial (RCT) across three community partners located in Riverside and Alameda Counties. At least 300 people will be enrolled in these three counties; the first 200 will be randomized to either receive the intervention or usual care, with the final 100 all receiving the intervention. The primary implementation outcome for the study involves using an implementation science framework and assessment tools to examine MEPS's implementation. Key outcomes include how well the implementation strategies used support intervention enrollment and retention, integration with existing services in each partnering community agency, and perceived intervention acceptability, feasibility, appropriateness, and maintenance at 6- and 12-months. The primary effectiveness outcome for the study is an increase in HIV testing, PrEP uptake and adherence, and SUD service utilization at 6 months and 12 months in the MEPS compared to the usual care group. Secondary effectiveness outcomes include frequency of service use for SUDs, hepatitis C virus testing, and linkage to care for those who test positive for HIV or hepatitis C.",[664,665,666,667,668,28],"HIV Prevention","Sexually Transmitted Infections (STI)","Preexposure Prophylaxis (PrEP)","Incarceration","Hepatitis C Virus (HCV)",[670,671,672,673,674,675],"implementation science","contingency management","mobile health technology (mHealth)","community based participatory research","type 3 hybrid implementation effectiveness trial","randomized controlled trial","2026-04-01",{"date":678,"type":41},"2026-04-03",{"date":680,"type":41},"2025-12-01",{"date":682,"type":22},"2029-07-31",{"name":684,"class":48},"University of California, Los Angeles",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":216,"phases":4,"briefSummary":693,"conditions":694,"keywords":695,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":705,"locationsCount":137},"100631621","identifying-substance-use-consequences-100631621","NCT07503067","Identifying Substance Use Consequences","Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials","Inclusion Criteria:\n\n* (1) ability to read and provide informed consent in English, and at least one of the following 2a) currently providing direct care to patients with substance use disorders, 2b) current or past treatment for an substance use disorder, or 2c) self-report of a close friend or family member who currently or previously received treatment for a substance use disorder.\n\nExclusion Criteria:\n\n* 1\\) major psychiatric or medical condition that would interfere with participation (e.g., acute psychosis, severe withdrawal); 2) current intoxication (positive breath alcohol test or behavioral evidence of other substance intoxication).",{"count":145,"type":22},"The goal of this study is to develop a new tool for measuring substance use disorder treatment outcome. We will start by interviewing people and gathering advisory groups to develop the items for this new tool.",[28],[381,696,697],"measurement","patient reported outcomes","2026-03-25",{"date":700,"type":41},"2026-03-31",{"date":702,"type":41},"2026-02-10",{"date":704,"type":22},"2027-07-31",{"name":706,"class":48},"Mclean Hospital",{"id":708,"slug":709,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":712,"acronym":713,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":715,"targetDuration":4,"studyType":23,"phases":717,"briefSummary":718,"conditions":719,"keywords":723,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":729,"lastUpdatePostDateStruct":730,"startDateStruct":732,"completionDateStruct":734,"leadSponsor":735,"locationsCount":137},"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":716,"type":22},124,[25],"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.",[720,721,28,642,722],"Substance Abuse","Substance Addiction","Human Immunodeficiency Virus (HIV)",[724,725,726,727,728],"Substance misuse","HIV risk","Stigma","Psychological distress","Gender affirmation","2026-03-23",{"date":731,"type":41},"2026-03-27",{"date":733,"type":41},"2025-02-10",{"date":704,"type":22},{"name":736,"class":48},"Illinois Institute of Technology"]