[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcoholism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcoholism":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,44,57,92,116,151,177,205,234,272,294,318,344,374,403,433,458,487,510,540,572,600,625,653,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053883","smart-r-substance-monitoring-and-active-relapse-tracking-repository-100053883",false,"NCT06676059","SMART-r: Substance Monitoring and Active Relapse Tracking Repository","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in the repository, an individual must meet all of the following criteria:\n\n* Must understand and be willing to complete an online informed consent process.\n* Be an adult aged 18 or older.\n* Self-report alcohol or other drug use within the past 30 days.\n* Have a smartphone as their primary mobile phone.\n\n  --For the AWARE app data monitoring procedure, there may be times during this study period where, due to technical or OS limitations, the app is only available to users of certain devices (e.g., Android, iOS). If there is such a limitation, this information will be evaluated during screening. For example, if the AWARE app is not available for iOS, then the screening form may exclude iPhone users for that time period where the limitation exists, if the only procedures offered are daily diary surveys and AWARE data monitoring.\n* Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, open-ended survey questions with the TTR Chatbot, uploading historical conversational AI data, and\u002For follow-up surveys.\n* Understand and write in English.\n\n  --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.\n* Live in the United States.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this repository:\n\n1\\. Any impairment severe enough to preclude informed consent or valid self-report.","ALL","18 Years","120 Years",{"count":20,"type":21},10000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAbout 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program. For those who start treatment, about 70% return to substance use within weeks or months after starting treatment. To discover why patients drop out of treatment and return to substance use - and what can be done about it - researchers need to learn more about people who use drugs and alcohol.\n\nObjective:\n\nTo create a data repository by gathering survey and smartphone data from adults who use drugs and alcohol in order to conduct future research.\n\nEligibility:\n\nAdults who have used drugs or alcohol in the past and have a Android smartphone. The researchers will recruit targeted demographics at different times throughout the duration of the study period.\n\nDesign:\n\nData will be collected for up to 6 months. All research activities will be online.\n\nParticipants will download a smartphone app called TTRU-Curtis AWARE and keep it active on their phone. The app will run in the background and collect participant data, including: screen unlocks, duration of time the screen is on; apps used; words typed (except passwords); duration and time of phone calls; estimated location (exact location is not collected); and movement, such as how many steps are taken in a day. All personally identifying information is automatically removed before the data is stored (including phone numbers, names, or locations described in messages).\n\nEach day, participants will receive a text with a link to a survey. They will answer questions about their mood, behavior, and substance use from the day before. This survey should take less than 5 minutes to complete.\n\nEvery 30 days, participants will complete a longer survey. They will answer questions about their personal relationships, risky behaviors, mood, substance use, and feelings. They can skip any questions they do not feel comfortable answering. These surveys should take about 30 minutes to complete.\n\nParticipants may opt to allow researchers to access their social media posts.",[25,26],"Alcoholism","Substance-Related Disorders",[28,29,30],"Alcohol","Substance use","digital phenotyping","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-07-16",{"date":39,"type":21},"2044-12-31",{"name":41,"class":42},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":45,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":48,"keywords":49,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":56,"locationsCount":43},"100568042","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in the repository, an individual must meet all of the following criteria:\n\n* Must understand and be willing to complete an online informed consent process.\n* Be an adult aged 18 or older.\n* Self-report alcohol or other drug use within the past 30 days.\n* Have a smartphone as their primary mobile phone.\n* Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, uploading historical conversational AI data, and\u002For follow-up surveys.\n* Understand and write in English.\n\n  --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.\n* Live in the United States.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this repository:\n\n1\\. Any impairment severe enough to preclude informed consent or valid self-report.",{"count":20,"type":21},[25,26],[28,29,30],"2026-07-01",{"date":52,"type":35},"2026-07-02",{"date":54,"type":21},"2026-07-07",{"date":39,"type":21},{"name":41,"class":42},{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100217453","behavioral-and-functional-task-development-implementation-and-testing-100217453","NCT02108054","Behavioral and Functional Task Development, Implementation, and Testing","* INCLUSION CRITERIA:\n* between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies\\*.\n\nEXCLUSION CRITERIA:\n\n* Are not cleared on a neuromotor examination\n* Are currently receiving psychotropic medication\n* Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the\n\npast 30 days CIWA score \\> 8).\n\n-MRI Exclusion Criteria:\n\n* Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;\n* Are pregnant, as determined by a negative pregnancy test\n* Left handed\n* Claustrophobia.\n\n  * To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.",true,"65 Years",{"count":66,"type":21},400,"INTERVENTIONAL",[69],"NA","Background:\n\n\\- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.\n\nObjective:\n\n\\- To develop tasks that investigate a person s behavior that can be used in later studies.\n\nEligibility:\n\n* Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old.\n* Healthy right-handed volunteers 18-65 years old.\n\nDesign:\n\n* Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.\n* Participants will have between one and three visits.\n* Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.\n* Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.\n* The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.",[72,73,25,74,75],"Alcohol Dependence","Alcohol Drinking","Alcohol Use Disorder","Addiction",[77,25,78,79,80,81,82],"fMRI","Phenotype","Imaging","EEG","Psychophysiology","Near Infrared","2026-06-27",{"date":85,"type":35},"2026-06-30",{"date":87,"type":35},"2014-05-28",{"date":89,"type":21},"2026-12-31",{"name":91,"class":42},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":43},"100217454","characterization-imaging-instruments-in-alcoholics-and-non-alcoholics-100217454","NCT02108080","Characterization Imaging Instruments in Alcoholics and Non-Alcoholics","Characterization Imaging Instruments for Addiction Neuroimaging Assessments","* INCLUSION CRITERIA:\n\nAll adult participants must be:\n\n* Age 18 years or older,\n* Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any\n\nNIAAA study (including 14-AA-0181).\n\nEXCLUSION CRITERIA:\n\nAs this is a natural history protocol, there are no exclusionary criteria for this study.\n\nParticipants should have been tested negative prior to the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be re-scheduled or withdrawn from the study.\n\nUpon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.\n\n-Exclusion criteria for MR scan\\*\n\n* Positive BrAC#,\n* Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, and opiates for outpatients. Positive UDT for benzodiazepines is not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes.\n* Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,\n* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments),\n* Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,\n* Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,\n* Women: are pregnant#,\n* Are left-handed.\n* Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score \\> 8.\n\n  * Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.\n\n    * Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion.",{"count":100,"type":21},1000,"Background:\n\n\\- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA.\n\nObjective:\n\n\\- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.\n\nEligibility:\n\n\\- Adults age 18 and older.\n\nDesign:\n\n* Participants will visit the NIH Clinical Center once during the study.\n* Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview.\n* Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder.\n* Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner.\n* MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.",[72,73,103,25,104],"Alcohol-Related Disorders","Brain Mapping",[28,106,107,78,79,108],"Biomarkers","Adults","Natural History","2026-06-23",{"date":111,"type":35},"2026-06-24",{"date":113,"type":35},"2014-07-10",{"date":89,"type":21},{"name":91,"class":42},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":67,"phases":126,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100609614","safety-and-effectiveness-of-the-brainsway-deep-transcranial-magnetic-stimulation-deep-tms-for-treatment-of-alcohol-use-disorder-aud-100609614","NCT07216872","Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)","A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)","Inclusion Criteria:\n\n1. Male or female subjects, 18-86 years old.\n2. Subjects diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (\\> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).\n3. Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening (average \\>=8 HDD\u002Fmonth), based on TLFB).\n4. Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.\n5. Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.\n6. Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.\n\nExclusion Criteria:\n\n1. Subjects diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).\n2. Subjects with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.\n3. Subjects who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin, naltrexone, topiramate and varenicline.\n4. Subjects with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine headaches, etc.).\n5. Subjects experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein subjects with a value of \\>7 will not be permitted to receive TMS on that day to mitigate any potential risk of a seizure. Treatments may be rescheduled and CIWA-AR and alcohol breath tests may be reassessed, although if more than the allowed treatment sessions are missed, the subject will be withdrawn from the study.\n6. Subjects with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).\n7. Individuals with a first-degree relative family history of seizure.\n8. Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.\n9. Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (outside the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work).\n10. Subjects with cardiac pacemakers or active implantable electrodes\u002Fneurostimulators within 30 cm of the treatment coil.\n11. Subjects with a significant neurological disorder or insult including, but not limited to:\n\n    * Any condition likely to be associated with increased intracranial pressure\n    * Space occupying brain lesion\n    * History of cerebrovascular accident\n    * Transient ischemic attack within two years\n    * Cerebral aneurysm\n    * Dementia\n    * Mini Mental State Exam score of less than or equal to 24\n    * Parkinson's disease\n    * Huntington's chorea\n    * Multiple sclerosis\n12. Subjects suffering from significant hearing loss.\n13. Previous treatment with TMS within one year.\n14. Participation in another clinical investigation in which a device or drug has been used within 4 weeks of screening.\n15. If participating in psychotherapy, subject is not in stable treatment for at least 3 months prior to entry into the study or anticipates a change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.\n16. Known or suspected pregnancy or lactation or planning to become pregnant.\n17. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.","86 Years",{"count":125,"type":21},186,[69],"The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases:\n\n1. Pre-study Screening and Baseline Phase\n2. Acute Treatment Phase and\n3. Maintenance Treatment and Follow up Phase\n\nSubjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration.\n\nEligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks.\n\nThe Maintenance Treatment \\& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit.\n\nAt each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered.\n\nThe study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2-4, based on the Time Line Follow Back (TLFB) reporting. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving.\n\nSafety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.",[74,25,129,72,130,131],"Alcohol Abuse","Alcohol Abuse\u002FDependence","Alcohol Addiction",[133,134,135,136,137,138,139,140],"alcohol use disorder","alcoholism","alcohol abuse","alcohol dependence","alcohol addiction","DTMS","rfTMS","Brainsway","2026-06-18",{"date":143,"type":35},"2026-06-22",{"date":145,"type":35},"2025-11-07",{"date":147,"type":21},"2027-12-01",{"name":140,"class":149},"INDUSTRY",9,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":67,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":174,"locationsCount":43},"100443464","crp-and-sa-for-inpatient-veterans-100443464","NCT05054738","CRP and S&A for Inpatient Veterans","Impact of Combined Recovery Program and Home Telehealth Among Veterans With Substance Use Disorders in the VA Inpatient Setting","CRP and S&A","Inclusion Criteria:\n\n* Meeting DSM-V criteria for current SUD diagnosis of alcohol and\u002For illicit drug use disorder\n* Use of substances in past 30 days prior to date of index inpatient admission\n* Able to comprehend English\n* Able to provide informed consent\n* Functioning at an intellectual level sufficient to allow accurate completion of all assessments\n* Willing to commit to 6 group inpatient therapy sessions, telehealth S\\&A, as well as baseline, and 1-and 3-month follow-up assessments\n\nExclusion Criteria:\n\n* Auditory or visual impairment that would interfere with study procedures\n* Inability to speak or understand English\n* Acutely psychotic patients",{"count":160,"type":21},195,[69],"The purpose of this study is to evaluate how well three types of treatments work to improve the outcomes for people with substance use problems. Veterans admitted to the Charleston VA Psychiatric inpatient unit may be invited to participate. The three types of treatments that will be evaluated are:\n\n1. Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit.\n2. A Home Telehealth program, called Stable and Able (S\\&A), provided just prior to discharge and provides additional support for up to 3 months\n3. Treatment-as-usual (TAU), which is the treatment currently provided on the unit, consisting of various mental health topics and sessions designed to help with recovery.\n\nParticipation begins on the inpatient unit, beginning with CRP and\u002For TAU, and may continue with S\\&A post discharge. Participants will be followed up at 1 and 3- months post treatment.",[25,164,165],"Substance-related Disorders","Dual Diagnosis",[25,167,165],"Substance-related disorders","2026-04-27",{"date":170,"type":35},"2026-05-04",{"date":172,"type":35},"2022-09-06",{"date":89,"type":21},{"name":175,"class":176},"VA Office of Research and Development","FED",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":67,"phases":187,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":43},"100218563","phase-2-ketamine-alcohol-in-treatment-resistant-depression-100218563","NCT02122562","Ketamine Alcohol (in Treatment-Resistant Depression)","Functional Neuroimaging of the Enhanced Antidepressant Efficacy of Ketamine in a Biologically-Enriched Subgroup","INCLUSION CRITERIA:\n\n1. 18 to 55 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the consent quiz.\n3. Diagnostic and Statistical Manual-4th Edition-Text Revision (DSM-IV-TR)) diagnosis of major depressive disorder (MDD), single-episode (296.30) or recurrent (296.20) without psychotic features based on clinical assessment and confirmed by a Structured Clinical Interview for the DSM-IV- Patient Version (SCID-P). Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.\n4. Past failure of greater than or equal to one standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF).\n5. MADRS score greater than or equal to 20 at baseline and the day of ketamine infusion.\n\nEXCLUSION CRITERIA:\n\n1. Inadequate knowledge of family mental and substance use history, e.g. adoption.\n2. Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS).\n3. Current\u002Factive DSM-IV-TR substance use disorder (except for caffeine or nicotine dependence).\n4. Pregnant or nursing women or women of childbearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper\u002Fhypothyroidism or active cancer.\n6. Presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n7. Clinically significant abnormal laboratory tests.\n8. Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for \\> 5 minutes or requiring hospitalization.\n9. Treatment with psychiatric medications, e.g. selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, benzodiazepines and antipsychotics, at least two weeks of study phase II.\n10. Treatment with fluoxetine within 5 weeks of study phase II.\n11. Treatment with device-based treatment for depression, e.g. electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), within 4 weeks of study phase II.\n12. Lifetime history of deep brain stimulation.\n13. Treatment with any disallowed concomitant medications.\n14. Positive HIV test\n15. Presence of ferromagnetic implants, e.g, heart pacemaker or aneurysm clip, or other contraindications to magnetic resonance imaging (MRI), e.g. claustrophobia or hearing loss.\n16. Clinically-significant anatomical brain abnormalities detected on routine brain MRI.\n17. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of greater than or equal to 4.\n18. A current NIMH employee\u002Fstaff or their immediate family member (N.B. former exclusion criteria likely to be no longer relevant at the University of Iowa Health Care).\n19. Currently engaged in an evidence-based structured psychotherapy for mood and\u002For anxiety disorders, e.g. cognitive-behavioral therapy (CBT) or interpersonal psychotherapy (IPT).\n\nAdditionally, the investigators may exclude or terminate any patient for clinical reasons.","55 Years",{"count":186,"type":21},60,[188],"PHASE2","A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of the strongest identified predictors of an improved antidepressant response to ketamine. Like ketamine, alcohol is a functional NMDA receptor antagonist. FHP is associated with differential response to ketamine, e.g. blunted psychotomimetic side effects. One of the primary mechanistic hypotheses for ketamine's antidepressant action is the acute intrasynaptic release of glutamate from major output neurons, e.g. cortical pyramidal cells. Preliminary clinical studies have demonstrated this acute glutamate \"surge\" in response to subanesthetic dose ketamine. Based on these findings, the investigators hypothesize that ketamine's enhanced antidepressant efficacy in FHP TRD subjects is, at least in part, attributable to increased glutamate release relative to TRD subjects without a family history of alcohol use disorder (Family History Negative, FHN). To test this hypothesis, the investigators have designed a now two-site, open-label study of 18-55-year-old medically and neurologically healthy, currently moderately-to-severely depressed TRD patients. In total, the investigators plan to recruit 25 FHP and 25 FHN TRD subjects. All subjects must not have a current substance use disorder (except nicotine or caffeine). The experimental portion consists of two phases. The preliminary first phase is a medication taper (if needed) and psychotropic medication-free period. The experimental second phase comprises one subanesthetic dose (0.5mg\u002Fkg x 40 minute) ketamine infusion. The ketamine infusion will occur during 7T-magnetic resonance imaging (MRI), both resting-state functional MRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) to detect glutamate in the ventromedial prefrontal cortex\u002Fventral anterior cingulate cortex (vmPFC\u002FvACC). The primary outcome measure is group mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from pre-ketamine infusion (baseline) to one-week post-infusion, where the investigators observed ketamine's greatest antidepressant effect in FHP TRD. Additional outcome measures are vmPFC\u002FvACC glutamate change in response to ketamine based on family history status. In summary, this study will provide key mechanistic information on ketamine's improved antidepressant efficacy in a biologically-enriched subgroup. This will contribute to the systematic development of more efficacious, personalized treatments for major depression in an effort to reduce its enormous public health burden.",[191,192,25],"Magnetic Resonance Imaging","Major Depression",[194,192,195],"Ketamine","NMDA Antagonist",{"date":197,"type":35},"2026-05-01",{"date":199,"type":4},"2014-04-23",{"date":201,"type":21},"2028-09",{"name":203,"class":204},"Mark Niciu","OTHER",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":67,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":43},"100484806","a-study-of-the-effect-of-a-nurse-navigator-program-on-high-risk-patients-100484806","NCT05592847","A Study of the Effect of a Nurse Navigator Program on High Risk Patients","The Effect of a Nurse Navigator Program on Readmission Rates for Patients With Elevated BMI, COPD, CHF, Dialysis Use, and H\u002Fo Alcohol Abuse","Inclusion Criteria:\n\n\\- Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI.\n\nExclusion Criteria:\n\n\\- Decrease cognitive capacity to consent to the study.",{"count":213,"type":21},300,[69],"The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.",[217,218,219,220,221,222,223,25],"Patient Readmission","Arthroplasty, Replacement, Knee","Arthroplasty, Replacement, Hip","Heart Failure","Pulmonary Disease, Chronic Obstructive","Renal Insufficiency","Body Mass Index","NOT_YET_RECRUITING","2026-03-17",{"date":227,"type":35},"2026-03-19",{"date":229,"type":21},"2027-01",{"date":231,"type":21},"2027-06",{"name":233,"class":204},"Mayo Clinic",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":67,"phases":245,"briefSummary":246,"conditions":247,"keywords":252,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100588260","phase-2-effects-of-tirzepatide-on-alcohol-intake-in-patients-diagnosed-with-schizophrenia-and-alcohol-use-disorder-100588260","NCT06939088","Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder","Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder","DUALPSYCHIATRY","Inclusion Criteria:\n\n* Informed Consent: The patient must provide both oral and written informed consent.\n* Diagnosis:\n\n  * Diagnosed with alcohol dependence according to the International Classification of Diseases, 10th Edition (ICD-10), and alcohol use disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n  * Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5\n* AUDIT Score: Alcohol Use Disorder Identification Test (AUDIT) score greater than 15.\n* Body Mass Index (BMI): BMI of 23 kg\u002Fm² or higher.\n* Age Range: Between 18 and 70 years old (inclusive).\n* Heavy Alcohol Consumption: Defined as 4 or more heavy drinking days within a consecutive 21-day period during the 28 days preceding the baseline evaluation. The 21-day period will be selected based on the largest total alcohol consumption and the greatest number of heavy drinking days within the 28-day timeframe. This will be assessed using the Timeline Followback (TLFB) method. Heavy drinking days are defined as days with an alcohol intake of 4 or more units (48 g of alcohol) for women and 5 or more units (60 g of alcohol) for men.\n\nExclusion Criteria:\n\n* Intellectual Disability: individuals with a diagnosis of intellectual disability.\n* Acute Psychosis: Acute exacerbation of psychosis, as indicated by a score of 6 or 7 on the Clinical Global Impression-Severity (CGI-S) scale.\n* Coercive Measures: Current use of coercive measures, which includes individuals sentenced to treatment ('dom til behandling').\n* Suicidal Behaviour: Evidence of current severe suicidal behaviour, as assessed by the investigator during clinical evaluation.\n* History of Severe Alcohol Withdrawal: History of delirium tremens or alcohol withdrawal seizures.\n* Severe Withdrawal Symptoms: Clinical Institute Withdrawal Assessment of Alcohol Scale, revised (CIWA-Ar) score greater than 9 at baseline examination.\n* Severe Neurological Conditions: Presence of severe neurological diseases, including severe traumatic brain injury.\n* Diabetes: Type 1 or 2 diabetes\n* Pregnant or Potentially Pregnant Women: WOCBP who are pregnant, breastfeeding, intend to become pregnant within the next 6 months (including 16 weeks of treatment plus two months after discontinuation of semaglutide), or are not using a highly effective contraceptive method throughout the study period. Highly effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level greater than 3 U\u002FL at inclusion will also be excluded.\n* Liver Function: Impaired hepatic function, defined as liver transaminases greater than three times the upper limit of normal.\n* Renal Function: Impaired renal function, indicated by an estimated glomerular filtration rate (eGFR) below 50 mL\u002Fmin and\u002For plasma creatinine above 150 μmol\u002FL.\n* Pancreatic Function: History of acute or chronic pancreatitis or amylase levels more than twice the upper limit of normal.\n* Thyroid Conditions: Previous medullary thyroid carcinoma (MTC) or a family history of MTC and\u002For Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).\n* Cardiac Issues: Decompensated heart failure (NYHA class III or IV), unstable angina pectoris, or myocardial infarction within the past 12 months.\n* Uncontrolled Hypertension: Systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg.\n* Alcohol Use Disorder Medication: Use of medications for alcohol use disorder (e.g., disulfiram, naltrexone, acamprosate, nalmefene) within the 28 days prior to inclusion as recorded in the Timeline Followback (TLFB) schedule.\n* Investigational Drugs: Receipt of any investigational drug within the past three months.\n* Weight-Lowering Medications: Use of other weight-lowering pharmacotherapy in the past three months.\n* Allergic Reactions: Hypersensitivity to the active substance or any of the excipients.\n* Language Barriers: Inability to speak and\u002For understand Danish.\n* Other Conditions: Any other condition that, in the investigator\\'s opinion, may interfere with participation in the trial.\n\nFor the subgroup of participants undergoing brain scans:\n\n* MRI Contraindications: any contraindications for MRI (e.g., magnetic implants, pacemaker, claustrophobia).\n* Benzodiazepine Use: Intermittent use of benzodiazepines within 12 days prior to the scanning session is not allowed. However, regular use of a stable dose of benzodiazepines is permitted.","70 Years",{"count":244,"type":21},108,[188],"Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide\u002FGLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied.\n\nThe key anticipated outcomes include:\n\n* decreased alcohol consumption and\n* reduced alcohol cue-induced brain activity in the GIP\u002FGLP-1-treated patient group compared with the placebo group. To the best of the investigators knowledge, this has never been examined before.",[74,130,72,25,248,249,250,251],"Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[253,254,77,255,256,257,258,259,260,133,261],"GLP-1","Glucagon-like peptide 1","GIP","Glucose-dependent Insulinotropic Polypeptide","Tirzepatide","Mounjaro(R)","schizophrenia","alcohol","dual diagnosis","2026-02-05",{"date":264,"type":35},"2026-02-10",{"date":266,"type":35},"2025-05-05",{"date":268,"type":21},"2028-12-31",{"name":270,"class":204},"Anders Fink-Jensen, MD, DMSci",2,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":242,"enrollmentInfo":280,"targetDuration":4,"studyType":67,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":271},"100581039","phase-2-a-trial-to-investigate-the-effects-of-cannabidiol-plus-naltrexone-on-alcohol-craving-in-patients-with-alcohol-dependence-100581039","NCT06845124","A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence","ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence","ICONICplus","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Patients meeting the diagnosis of an alcohol dependence according to the ICD-10\n* Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent (must be available before enrollment in the study)\n* Consent to random assignment\n* For women with childbearing potential (WOCBP) and males with partners with CBP, use of a highly effective birth control method until one month after last IMP administration (see Appendix 1) and negative pregnancy test\n\nExclusion Criteria:\n\n* Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations\n* Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, prothipendyl, pipamperone, promethazine and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and\u002For doxepine in low doses \\[max. 75mg daily\\]), Opioid-containing Cough\u002Fcold agents, Systemical Steroids, Other anti-craving (e.g. Acamprosate) or aversive medication (e.g. disulfiram), THC- or CBD-containing medication, Antiretroviral medication (e.g., Efavirenz), Xanthines (e.g., Theophylline), General anesthetics (e.g., propofol), Hypericum perforatum, Antibiotics (e.g., Rifampin, Clarithromycin, Erythromycin)\n* Positive drug screening (amphetamines\u002Fecstasy, opiates, cocaine, barbiturates)\n* Pregnancy, lactation or breastfeeding\n* Current severe somatic comorbidities: severe liver cirrhosis \\[CHILD B or C\\] or epilepsy determined by medical history\n* Patients with elevated transaminase levels (AST or ALT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above twice the ULN value\n* History of hypersensitivity to the investigational medicinal product CBD and\u002For Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product CBD and\u002For Naltrexone\n* Participation in other clinical trials or observation period of competing clinical trials, respectively.\n* Acute suicidal tendency or acute endangerment of self and others",{"count":281,"type":21},150,[188],"Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.",[131,25],"2026-01-30",{"date":287,"type":35},"2026-02-03",{"date":289,"type":35},"2025-07-22",{"date":291,"type":21},"2028-09-30",{"name":293,"class":204},"Central Institute of Mental Health, Mannheim",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":301,"targetDuration":4,"studyType":67,"phases":302,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":43},"100441415","phase-4-naltrexone-in-aud-reward-drinkers-100441415","NCT05028062","Naltrexone in AUD Reward Drinkers","Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation","Inclusion Criteria:\n\n* Age 18-65 years old\n* Willing to provide signed, informed consent and commit to completing the study procedures\n* Able to read at an 8th grade or higher level\n* Current DSM-5 diagnosis of AUD\n* Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent\n* Expresses a desire to reduce or stop drinking and a willingness to receive two injections of study medication over 8 weeks of treatment.\n* Either a reward drinker \\[i.e., an individual with a score of 19 or greater on the reward subscale and less than or equal to 18 on the relief subscale of the Inventory of Drinking Situations (IDS)\\] or a relief drinker (i.e., an individual with a score of 21 or greater on the relief subscale and less than or equal to 18 on the reward subscale of the IDS).\n* Has a stable address in the local area; not planning to move; has documents for an ID check\n* Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth control and have a negative urine pregnancy test prior to the initiation of the study procedures. Examples of medically acceptable methods for this protocol include oral contraceptive pills, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm\u002Fspermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence).\n\nExclusion Criteria:\n\n* Planned surgery within the timeframe of the study\n* A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, diabetes, liver disease, kidney disease, or cardiomyopathy as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or direct bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).\n* Chronic or episodic painful conditions that could require opioid medications for pain control\n* History of seizure disorder (excluding childhood febrile seizures)\n* History of allergy or other serious adverse event due to treatment with XR-NTX\n* Current psychotic disorder (bipolar, schizophrenia, major depression with suicidal ideation, or psychotic features) identified by clinical examination or the structured interview that could interfere with study participation or make it hazardous for the subject.\n* Current DSM-5 diagnosis of any drug use disorder other than alcohol, nicotine, or cannabis or a urine drug screen that is positive for benzodiazepines, opioids, amphetamines, cocaine or barbiturates.\n* Current treatment with a psychotropic, anticonvulsant, opioid, anticoagulant or AUD treatment medication (i.e., naltrexone, acamprosate, disulfiram, topiramate, gabapentin, varenicline, or baclofen)\n* Receipt of any experimental medication within the past 30 days\n* In need of medical detoxification from alcohol\n* Subjects cannot have been mandated by court for alcohol or drug abuse treatment or have pending legal proceedings that could result in incarceration within 6 months of enrollment.\n* Homicidal or other behavioral disturbance that requires immediate clinical attention\n* Judged by the principal investigator or his designee to be an unsuitable candidate for study participation",{"count":186,"type":21},[303],"PHASE4","This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection.\n\nStudy subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.",[74,25],[307,308,28],"XR-NTX","Naltrexone","2026-01-16",{"date":311,"type":35},"2026-01-20",{"date":313,"type":35},"2022-03-07",{"date":315,"type":21},"2028-07",{"name":317,"class":204},"University of Pennsylvania",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":67,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":43},"100255457","suicidal-behavior-in-patients-diagnosed-with-bipolar-disorder-100255457","NCT02604277","Suicidal Behavior in Patients Diagnosed With Bipolar Disorder","Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors","Inclusion Criteria:\n\n* English speaking\n* Diagnosis of Bipolar Disorder (BD)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Cognitive impairments\n* Acutely psychotic\n* Medically unstable\n* History of schizophrenia spectrum disorder\n* History of mood incongruent psychotic symptoms\n* History of primary substance disorder\n* History of primary organic disease and\u002For dementia","64 Years",{"count":327,"type":21},130,[69],"The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.",[331,25,332],"Depression","Drug Abuse",[334],"Psychology","2026-01-05",{"date":337,"type":35},"2026-01-07",{"date":339,"type":35},"2016-01",{"date":341,"type":21},"2026-12",{"name":343,"class":204},"Emory University",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":353,"conditions":354,"keywords":360,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":43},"100616445","cohort-study-on-medical-students-mental-health-100616445","NCT07305701","Cohort Study on Medical Students' Mental Health","Mental Health of Medical Students in Orleans: a Cohort Study of a New Faculty","OSMOSE","Inclusion Criteria:\n\n* Students who have been enrolled in first year of health studies at the University of Orléans\n* Aged 18 or over\n\nExclusion Criteria:\n\n* Does not speak French\n* Person under legal guardianship\n* Person deprived of liberty\n* Person under guardianship or trusteeship",{"count":20,"type":21},"The main objective of this study is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter the medical program (students not accepted into the second year of medical school).\n\nMajor Depressive Disorder (MDD) will be assessed using a validated tool: the Composite International Diagnostic Interview Short-Form (CIDI-SF).\n\nThis a prospective, longitudinal, cohort study. The plan is to inform each new cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study.\n\nA link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a web page where the questionnaire can be completed. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year for the duration of the study or until the student completes their studies.\n\nDuration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.",[355,356,357,25,358,359],"Major Depressive Disorder","Generalized Anxiety Disorder","Suicidal Ideation","Marijuana Abuse","Loneliness",[361,362,363,364],"Students","Medical students","depression","epidemiology","2025-12-26",{"date":367,"type":35},"2025-12-31",{"date":369,"type":35},"2025-10-22",{"date":371,"type":21},"2047-10-31",{"name":373,"class":204},"Centre Hospitalier Régional d'Orléans",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":382,"targetDuration":4,"studyType":67,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":43},"100590632","phase-2-ketamine-and-neurofeedback-as-combined-therapeutic-interventions-to-target-glutamatergic-neurotransmission-in-alcohol-use-disorder-100590632","NCT06969937","Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder","Phase II, Randomised, Placebo-controlled, Double Blind, Parallel Group, Single Centre Study Investigating Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder","Nektar","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* In- and outpatients aged 18 to 65 years of all sexes.\n* DSM-IV diagnosis of alcohol use disorder (mild - severe).\n* Motivation to reduce or stop alcohol use\n* Normal level of language comprehension (German or Swiss-German)\n* Good physical health with no unstable medical conditions\n* Participants of childbearing potential must use an effective and established method of contraception for the entire study duration\n* Comply with the study protocol as explained by investigator\n\nExclusion Criteria:\n\n* History of DSM-IV severe drug dependence other than alcohol (except for caffeine or nicotine) and any opiod use disorder within two months prior to enrolment.\n* Hallucinogen and ketamine use 3 months prior to study participation (including regular microdosing).\n* Alcohol withdrawal symptoms at any of the treatment visits (V2 and V3) (CIWA-Ar Scale \\>9).\n* Current or lifetime psychotic disorders\n* History of severe substance-induced psychosis\n* Current or lifetime bipolar I or II disorders\n* Current suicidality\n* Previous suicide attempts during the last 2 years\n* High risk of adverse emotional and behavioral reactions\n* Unmedicated or unstable hypertension\n* Severe illness (e. g. myocardial ischemia or arrythmias, severe pulmonary secretions, glaucoma, congestive heart failure or angina, significant renal or hepatic impairment)\n* Acute infection (e. g. pulmonary or upper respiratory tract infection)\n* Insufficient treated or uncorrected hyperthyroidism\n* Severe central nervous system related traumas or disorders (e. g. stroke, cerebral trauma with loss of consciousness over more than 24h, epilepsy)\n* During the study, new use or dose changes of already existing concomitant medication without prior informing the investigators.\n* Taking medications that are known to modualte uridine diphosphate glucuronosyltransferase-enzyme\n* Medication directly affecting glutamate signaling (e. g. anticonvulsant medication)\n* Inhibitors of UGT1A9 and 1A10 should be discontinued at least five half-lives prior to the administration of ketamine.\n* Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors should be discontinued at least 5 half-lives prior to the dose of ketamine.\n* Pregnancy or lactation\n* Women of childbearing potential with no use of medically accepted contraceptive (e. g. condoms, contraceptive diaphragm, birth control pill, hormone injection, intrauterine device)\n* BMI \\\u003C 17 or \\> 35\n* Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine\n* Contradictions to magnetic resonance imaging\n* Concurrent participation in other clinical study",{"count":383,"type":21},75,[188],"The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training on the treatment of individuals with alcohol use disorder (AUD). The main questions the investigators aim to answer are:\n\n* Can the investigators observe a positive, significant therapeutic effect by comparing changes in alcohol use via i) mean alcohol use per day, ii) heavy drinking days one month after the last treatment intervention?\n* Are changes in glutamatergic neurotransmission in the nucleus accumbens related to cue-induced cravings in individuals with AUD?\n* Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens?\n\nParticipants will be given ketamine or placebo and real-time fMRI neurofeedback (rt-fMRI NFT) or sham rt-fMRI NFT.\n\nThe investigators will compare three intervention groups to investigate the effects of the stand-alone effects as well as potential synergies between the combination of pharmacological and non-pharmacological intervention.",[130,387,25],"Alcohol Use Disorder (AUD)",[74,25,72,194,389,390,391,392,393,394],"Glutamate","Placebo-controlled","Neurofeedback Training","Realtime fMRI","Therapeutic effects","Mechanistic effects","2025-11-27",{"date":397,"type":35},"2025-12-05",{"date":399,"type":35},"2025-06-01",{"date":341,"type":21},{"name":402,"class":204},"Dr. med. Marcus Herdener",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":67,"phases":412,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":43},"100554029","alcohol-misuse-treatment-to-patients-newly-diagnosed-with-alcohol-related-liver-disease-a-randomized-controlled-trial-100554029","NCT06493773","Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Inclusion criteria\n\n* Age \\> 18 years\n* Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.\n* A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.\n* Excessive alcohol consumption defined as \\>7 units\u002Fweek for women and \\>14 units\u002Fweek for men within the previous year.\n* The patient is able to understand the purpose of the study and give informed oral and written consent to participate.\n\nExclusion criteria\n\n* Not enough proficiency in Danish to participate in interviews and questionnaires.\n* Pregnancy\n* Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.",{"count":411,"type":21},221,[69],"To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.",[415,74,416,25,417],"Liver Diseases, Alcoholic","Treatment Adherence","Liver Disease; Alcohol-Related",[419,420,421,422,423],"Alcoholic liver disease","Alcohol use disorder","Alcohol treatment","randomized clinical trial","hepatology clinic","2025-11-14",{"date":426,"type":35},"2025-11-18",{"date":428,"type":21},"2025-11-15",{"date":430,"type":21},"2029-04-01",{"name":432,"class":204},"Zealand University Hospital",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":63,"sex":16,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":67,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":271},"100602593","alcohol-and-the-social-brain-an-alcohol-administration-hyperscanning-study-employing-a-within-subject-design-100602593","NCT07125534","Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design","Inclusion Criteria:\n\n* Between the ages of 21 and 30\n* Regularly consumes alcohol\n\nExclusion Criteria:\n\n* History of adverse reaction to the amount of beverage employed in the study\n* Have a history of major problems associated with alcohol\n* Take medications that could adversely interact with alcohol\n* Have medical conditions that contraindicate alcohol administration\n* Individuals with a history of skull fractures or who indicate discomfort with EEG procedures used\n* Female participant is pregnant or trying to become pregnant","21 Years","30 Years",{"count":442,"type":21},200,[69],"The study investigates the effects of alcohol consumption on social and individual behaviors using a within-subject design. Participants, aged 21-30, will attend two laboratory sessions approximately one week apart, participating as part of a dyad (pair). During one session, they will consume an alcoholic beverage, while in the other, they will receive a control beverage, with the order of conditions randomized. This design facilitates direct within-participant comparisons of behaviors and neural activity in intoxicated versus sober states.\n\nTo achieve these aims, the study employs EEG technology to explore intra-brain and inter-brain dynamics during social interactions. Additionally, validated self-report questionnaires will capture data on mood, social bonding, and other psychological variables. The findings are expected to enhance understanding of alcohol's role in social reward processes and contribute to developing evidence-based prevention and intervention strategies for alcohol use disorder.",[73,387,446,447,25,448],"Alcohol Intoxication","Alcohol; Harmful Use","Binge Drinking","2025-08-22",{"date":451,"type":35},"2025-08-29",{"date":453,"type":35},"2025-08-09",{"date":455,"type":21},"2028-05",{"name":457,"class":204},"University of Illinois at Urbana-Champaign",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":16,"minAge":464,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":67,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":43},"100548033","developing-functional-connectivity-guided-tms-for-alcohol-use-disorder-100548033","NCT06415721","Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder","Inclusion Criteria:\n\n* Between age 25 and 75.\n* Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).\n* Able to attend scheduled clinic visits\n* Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.\n* If on a medication regimen, that regimen will be stable for the duration of the study;\n* Fluency in English.\n\nExclusion Criteria:\n\n* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device\u002Fobjected in the head and body within 30 cm of the treatment coil.\n* General medical condition, disease or neurological disorder that interferes with the assessments or participation.\n* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.\n* Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.\n* Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.\n* Severe impediment to vision, hearing and\u002For hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).\n* Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold\n* unstable chronic illness.\n* Current or lifetime history of bipolar disorder or psychosis.\n* Participation in another concurrent intervention based clinical trial.","25 Years","75 Years",{"count":467,"type":21},40,[69],"Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.",[74,129,25,471,472],"Drinking Behavior","Drinking Problem",[474,475,476,477],"Transcranial Magnetic Stimulation","Veterans","Neuroimaging","Relapse","2025-08-07",{"date":480,"type":35},"2025-08-13",{"date":482,"type":21},"2025-08-25",{"date":484,"type":21},"2026-01-01",{"name":486,"class":176},"VA Palo Alto Health Care System",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":67,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":43},"100421890","effectiveness-of-high-frequency-rtms-in-reducing-alcohol-consumption-in-non-abstinent-patients-with-an-alcohol-use-disorder-100421890","NCT04773691","Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder","Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study","ALCOSTIM","Inclusion Criteria:\n\n* a person who has given his or her free, written and informed consent\n* adult patient\n* patient with mild to severe alcohol use disorder according to DSM-5 criteria\n* voluntary patient to reduce alcohol consumption\n* patient who has already made at least one attempt at alcohol withdrawal (failure or relapse), or at reducing consumption\n\nExclusion Criteria:\n\n* person who is not affiliated to or not a beneficiary of national health insurance\n* person subject to a legal protection measure (curatorship, guardianship)\n* person subject to a legal safeguard measure\n* pregnant, parturient or breastfeeding women\n* adult unable to express consent\n* patient of childbearing age with a positive pregnancy test at inclusion\n* patient with an exhaled alcohol level \\> 0 milligrams\u002Flitre inclusive\n* patient with heavy alcohol consumption \\\u003C 6 days in the 4 weeks prior to inclusion (European Medicine Agency, 2010; one day with alcohol consumption of 60g or more for men and 40g for women)\n* patient with an average alcohol consumption below the WHO average risk level in the 4 weeks prior to inclusion (WHO, 2000, less than or equal to 40g\u002Fday for men and 40g for women)\n* patient being abstinent more than 5 days before inclusion\n* patient with a CIWA (Clinical Institute Withdrawal Evaluation: assessment of the severity of alcohol withdrawal) score greater than or equal to 10 at inclusion\n* Patient with concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefen (\\\u003C 1 month)\n* Patient with a history or presence of pre-delirium tremens or delirium tremens\n* Patient with a substance use disorder (DSM-5 criteria) with psychoactive substances other than tobacco and alcohol.\n* Patient with acute psychiatric disorders requiring hospitalization and\u002For immediate adjustment of psychotropic medication\n* Patient with severe depression, defined by a score of 24 or more on the Hamilton Depression Scale (HAM-D).\n* Patient who has had a recent change (\\\u003C 1 month) in the prescription of psychotropic treatment\n* Patient with severe and\u002For chronic psychiatric disorders, including schizophrenia, paranoia and bipolar disorders type I and II\n* Patient with severe heart, kidney, liver or lung failure or other condition that the doctor believes could compromise the patient's participation in the study.\n* Patient with a contraindication to the practice of rTMS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material.\n* Patient simultaneously participating in another therapeutic trial\n* Patient employed by the investigator or trial site\n* Patient who, according to the investigator, is unable to complete a consumption diary and follow up visits for 6 months\n* Patient refusing to sign the \"safety contract \"\\* specific to the study",{"count":496,"type":21},144,[69],"The fight against alcoholism is a public health priority. Around 15 million Europeans and 10 million North Americans are alcohol dependent. Worldwide, 1 death out of 25 is thought to be attributed to alcohol. In France, the latest published data on alcohol-related mortality indicates that there were 49,000 alcohol-related deaths in 2009. Alcohol is thought to be the leading cause of hospitalisation for French people, and its social cost is estimated at 37.4 billion euros.\n\nHowever, few patients with an alcohol use disorder are treated: less than 8% in Europe and less than 10.5% in the USA receive appropriate treatment for their alcohol problem. This low rate of treatment is mainly due to the fact that these patients are not ready to stop drinking. They are therefore not attracted by the goal of abstinence that is required by most current therapies and drug treatments. The arrival of new treatments aimed at reducing consumption (rather than abstinence) should make treatment more attractive. To date, nalmefen is the only treatment marketed for this indication. Baclofen should be marketed in 2020, but with restrictive prescription criteria.\n\nIn this new strategy to reduce consumption, brain stimulation could play a predominant role as an alternative or complementary therapy. Indeed, functional brain imaging techniques have made it possible to visualise the cortical regions involved in craving, in particular the dorsolateral prefrontal cortex (DLPFC). Craving, i.e. the irrepressible desire to consume, is often at the origin of consumption and relapse. Stimulation of the dorsolateral prefrontal cortex with non-invasive cerebral stimulation techniques, such as repeated transcranial magnetic stimulation (rTMS), has provided encouraging results for the reduction of cravings in all addictive behaviours (alcohol, tobacco, cocaine, food). Furthermore, stimulation of the DLPFC seems to modulate decision-making processes: it may thus reduce impulsivity and strengthen inhibitory control, leading to a reduction in substance use.\n\nThe hypothesis to be tested is that repeated transcranial magnetic stimulation allows a reduction in alcohol consumption in patients with an alcohol use disorder.",[25,500],"rTMS Stimulation","2025-04-15",{"date":503,"type":35},"2025-04-17",{"date":505,"type":35},"2021-03-01",{"date":507,"type":21},"2027-08",{"name":509,"class":204},"Centre Hospitalier Universitaire Dijon",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":517,"targetDuration":4,"studyType":67,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":43},"100586544","comparing-combined-behavioral-intervention-and-ericksonian-hypnotherapy-for-alcohol-addiction-100586544","NCT06916754","Comparing Combined Behavioral Intervention and Ericksonian Hypnotherapy for Alcohol Addiction","Comparing the Efficacy of Combined Behavioral Intervention and Ericksonian Hypnotherapy in the Treatment of Alcohol Addiction: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and 65 years\n* Meets DSM-5 diagnostic criteria for Alcohol Use Disorder (mild to severe)\n* Medically and psychiatrically stable as determined by a clinician\n* Willing and able to participate in weekly sessions over a 12-week period\n* Provides informed consent\n\nExclusion Criteria:\n\n* Current diagnosis of a severe psychiatric disorder (e.g., psychotic disorder, bipolar I disorder)\n* Significant cognitive impairment that would interfere with treatment participation\n* Participation in another structured addiction treatment during the study period\n* Current use of psychotropic medications that may influence outcome measures (as assessed by the clinical team)\n* Unstable medical condition requiring immediate intervention\n* Pregnancy or planning to become pregnant during the study period",{"count":518,"type":21},90,[69],"This clinical study is being conducted to compare the effectiveness of two psychological treatments for alcohol addiction: Combined Behavioral Intervention (CBI) and Ericksonian Hypnotherapy (EH). The purpose of the study is to determine whether Ericksonian Hypnotherapy, a more personalized and indirect therapeutic method, is equal to or more effective than the gold-standard approach, Combined Behavioral Intervention, in helping individuals reduce their alcohol consumption and improve psychological well-being.\n\nAlcohol addiction is a serious condition that affects mental, emotional, and physical health. Many treatment options exist, but not all individuals respond in the same way. This study aims to evaluate two different types of therapy in a structured way, to better understand which works best, for whom, and under what circumstances.\n\nThe study will include 90 adult participants diagnosed with Alcohol Use Disorder (AUD). Participants will be randomly assigned to one of three groups: (1) a group receiving weekly sessions of Combined Behavioral Intervention, (2) a group receiving weekly sessions of Ericksonian Hypnotherapy, or (3) a control group receiving general educational materials about alcohol addiction. Treatment will last for 12 weeks, and all participants will be followed up three months after the last session to assess long-term effects.\n\nThroughout the study, researchers will measure changes in alcohol consumption, alcohol craving, mental health symptoms (such as depression and anxiety), quality of life, and motivation to change. The findings of this study may help improve the way alcohol addiction is treated by offering evidence on alternative approaches such as hypnotherapy.",[103,25,164],[523,524,525,526,527,528,529,530],"Ericksonian Hypnosis","Hypnotherapy","Cognitive Behavioral Therapy","Motivational Interviewing","Relapse Prevention","Craving","Substance Craving","Psychotherapy","2025-04-13",{"date":533,"type":35},"2025-04-16",{"date":535,"type":35},"2025-03-01",{"date":537,"type":21},"2026-02-01",{"name":539,"class":204},"Beykoz University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":43},"100569996","assessing-habitual-goal-directed-and-pavlovian-influences-in-alcohol-use-disorder-100569996","NCT06701500","Assessing Habitual, Goal-Directed, and Pavlovian Influences in Alcohol Use Disorder","SFB TRR 265: Losing and Regaining Control Over Drug Intake Project B03: Role of Pavlovian Mechanisms for Control Over Substance Use Project B09: Maladaptive Context Inference As Key Mechanism Underlying Impaired Control","ReCoDe","Inclusion Criteria:\n\n* 18-65 years of age\n* AUD subjects only: meet 4 or more criteria for DSM-5 alcohol use disorder\n* Sufficient motor skills and visual acuity to use PC\n* Ability to consent to the study and complete the questionnaires\n* Sufficient German skills\n\nExclusion Criteria:\n\n* Lifetime diagnosis of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder\n* Current diagnosis of severe major depression according to DSM-5, or presence of suicidal intention\n* Pregnancy\n* Severe withdrawal symptoms\n* Acute drug intoxication at the appointments",{"count":549,"type":21},180,"The first aim of this study is to establish the role of maladaptive reliance on habits for impaired control in addiction, employing a novel task - the Action-Sequence-Task (AST), which assesses interference between habitual and goal-directed control. The AST, along with the developed computational model, will be employed to test whether participants with Alcohol Use Disorder (AUD) and control participants differ with respect to task performance and estimated model parameters. The investigators hypothesize stronger habitual behavior (increased habitual tendency) and an increased susceptibility to conflict between habitual and goal-directed control, measured as increased interference, are associated with AUD.\n\nThe second aim of the study is to understand whether Pavlovian-to-Instrumental Transfer (PIT) reflects more of a controlled, goal-directed process, or a more automatic, habitual process. The investigators will use the single-lever PIT task as it is an efficient tool for testing the interaction between Pavlovian cues and instrumental behavior, especially when they are in conflict. In these trials, top-down control must be allocated to successfully overcome the conflict, which may share some common underlying mechanisms with the arbitration between goal-directed and habitual behavior during conflict, as assessed by the novel AST. The third aim of the study is to investigate whether severely dependent AUD patients would show a stronger PIT effect compared to a control group, consistent with the investigators' previous findings.",[387,25,552],"Substance Use Disorders",[554,555,556,557,558,559,560,561,562],"Substance use disorder (SUD)","Alcohol use disorder (AUD)","Outcome-specific Pavlovian to instrumental transfer","Humans","Surveys and Questionnaires","Reward","Cues","Habit formation","Goal-directed behavior","2024-11-19",{"date":565,"type":35},"2024-11-22",{"date":567,"type":35},"2024-03-02",{"date":569,"type":21},"2027-06-30",{"name":571,"class":204},"Technische Universität Dresden",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":546,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":580,"conditions":581,"keywords":586,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":43},"100569995","role-of-pavlovian-mechanisms-for-control-over-substance-use-100569995","NCT06701487","Role of Pavlovian Mechanisms for Control Over Substance Use","SFB TRR 265: Losing and Regaining Control Over Drug Intake Work Package 1 of Project B03: General and Specific Pavlovian-to-Instrumental Transfer Effects in a Range of Substance Use Disorders","Inclusion Criteria:\n\n* Men and women between 18-65 years of age,\n* AUD, and\u002For SUD subjects only: meet 4 or more criteria for DSM-5 alcohol-related and\u002For substance-related (cannabis, amphetamine, methamphetamine or cocaine disorder (not requiring withdrawal as assessed by an independent psychiatrist),\n* Currently using alcohol without a desire for abstinence\n* Ability to consent to the study and complete the questionnaires.\n* Sufficient language(German) and motor skills for using PC\n* existing health insurance\n\nExclusion Criteria:\n\n* Lifetime diagnosis of DSM-5 bipolar disorder or schizophrenia or schizophrenia spectrum disorder (if induced by drugs, it should happen more than a month ago)\n* Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention\n* High risk (≤ 26) ASSIST scores in other substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, tobacco\n* History of traumatic brain injury or severe neurological disease (such as Dementia, Parkinson's disease, multiple sclerosis, Epilepsy, Meningitis, Stroke)\n* Pregnancy or breastfeeding,\n* Ingestion of medications known to interact with the dopamine system in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test); A detailed list of permitted medication can be added upon request\n* MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples)\n* Color vision deficiency\n* sensorineural hearing loss of 30 dB or greater,\n* Tinnitus and\n* Acute alcohol, substance (cannabis, or methamphetamine, amphetamine, cocaine) intoxication at assessement day verified by breath alcohol tests and drug intoxication verified by rapid urine test.",{"count":442,"type":21},"During the first funding period (1st FP), the investigators developed a novel full Pavlovian-to-instrumental transfer (PIT) task that allows assessing both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, the investigators want to compare specific and general PIT effects in patients with moderate to severe substance use disorders (alcohol, cannabis, methamphetamine, amphetamine and cocaine) to healthy controls on the behavioral and neural level (fMRI).",[387,25,552,582,583,584,585],"Cannabis Use Disorder","Methamphetamine-dependence","Amphetamine Use Disorder","Cocaine Use Disorder",[587,588,589,584,585,387,590,591,592,593,594,476,557,558,559,560],"Substance Use Disorder (SUD)","Cannabise Use Disorder","Methamphetamine Use Disorder","Pavlovian-to-Instrumental Transfer (PIT)","General Pavlovian-to-Instrumental Transfer","Outcome-specific Pavlovian-to-Instrumental Transfer","Amygdala","Ventral Striatum",{"date":565,"type":35},{"date":597,"type":35},"2024-08-05",{"date":569,"type":21},{"name":571,"class":204},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":546,"eligibilityCriteria":606,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":607,"targetDuration":4,"studyType":67,"phases":609,"briefSummary":610,"conditions":611,"keywords":614,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":43},"100535832","effect-of-social-isolation-on-the-role-of-pavlovian-mechanisms-for-control-over-alcohol-use-100535832","NCT06256952","Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use","SFB TRR 265: Losing and Regaining Control Over Drug Intake B03: Role of Pavlovian Mechanisms for Control Over Substance Use WP2: Effects of Social Isolation on PIT in AUD","Inclusion Criteria:\n\n* Males and females between 18-65 years of age,\n* AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),\n* Currently using alcohol without a desire for abstinence,\n* Ability to consent to the study and complete the questionnaires.\n* Sufficient language skills: German\n* Availability between 3pm-6pm on 2 consecutive days,\n* existing health insurance\n\nExclusion Criteria:\n\n* Lifetime diagnosis according to DMS-5 for a: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, cannabis, and\u002For methamphetamine\n* Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,\n* History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)\n* Pregnancy or breastfeeding,\n* Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),\n* Color vision deficiency",{"count":608,"type":21},100,[69],"During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study:\n\nInvestigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.",[74,25,612,613,552],"Stress Reaction","Ostracism",[554,555,615,616,557,558,559,560],"General and outcome-specific Pavlovian to instrumental transfer","Social exclusion","2024-08-27",{"date":619,"type":35},"2024-08-28",{"date":621,"type":21},"2024-10-01",{"date":569,"type":21},{"name":624,"class":204},"Charite University, Berlin, Germany",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":546,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":16,"minAge":631,"maxAge":64,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":633,"conditions":634,"keywords":637,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":271},"100515497","cue-effects-in-human-addiction-pavlovian-to-instrumental-transfer-100515497","NCT05992272","Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer","Inclusion Criteria:\n\n* males and females between 16-65 years of age\n* AUD subjects only: meet a minimum of 2 criteria for DSM-5 alcohol-related disorder (AUD) (not requiring withdrawal as assessed by an independent psychiatrist) and AUDIT \\> 4\n* Smokers: Daily smokers only: smoke 7 days\u002Fweek during the last three months\n* Non-daily smokers only: smoke at least once but less than 7 days\u002Fweek during the last three months\n* Ability to consent to the study and complete the questionnaires\n* Sufficient language skills: German\n* Availability between 3pm-6pm on 2 consecutive days (Experiment 1, acute stress question)\n* Females only: luteal phase (Experiment 1, acute stress question)\n\nExclusion Criteria:\n\n* Lifetime diagnosis according to DMS-5 for: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, or cannabis\n* Currently meeting DSM-5 diagnostic criteria for a depressive episode, suicidal ideation\n* Past traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)\n* Pregnancy or breastfeeding\n* Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test)\n* MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples)\n* Color vision deficiency\n* Sensorineural hearing loss of 30 dB or greater,\n* Tinnitus\n* Presence of claustrophobia\n* Acute alcohol intoxication at MRI appointments verified by breath alcohol testing or drug intoxication verified by rapid urine testing\n* For women only: not peri- or postmenopausal, not taking contraceptives (Experiment 1, acute stress question)","16 Years",{"count":213,"type":21},"Individuals with substance use disorders (SUD) have to cope with drug-related cues and contexts, which can affect instrumental drug seeking as shown with Pavlovian to instrumental transfer (PIT) paradigms in animals and humans. The investigators aimed to investigate the impact of acute and chronic stress on Pavlovian-to-instrumental transfer (PIT), how PIT it is associated with cognitive control abilities and whether such effects predict losing vs. regaining control in subjects with AUD. Moreover, the investigators aimed to develop a novel full transfer task that assesses both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects.",[387,25,552,635,612,636],"Smoking, Tobacco","Stress",[638,639,640,641,642,593,643,594,476,557,558,559,644,560],"substance use disorder (SUD), cognitive control\u002Finterference","alcohol use disorder (AUD)","Smokers","general and outcome-specific Pavlovian to instrumental transfer","chronic and acute stress","Stroop Test","Fractals","2024-08-20",{"date":647,"type":35},"2024-08-21",{"date":649,"type":35},"2020-11-24",{"date":651,"type":21},"2024-12-31",{"name":624,"class":204},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":16,"minAge":661,"maxAge":64,"enrollmentInfo":662,"targetDuration":4,"studyType":67,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":43},"100515766","phase-2-psilocybin-assisted-psychotherapy-for-alcohol-use-disorder-100515766","NCT05995769","Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder","Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial","PAP-AUD","Inclusion Criteria:\n\n* Meets DSM-5 AUD criteria of at least moderate severity\n* Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days\n* Desire to decrease alcohol consumption\n* Limited lifetime hallucinogen use\n\nExclusion Criteria:\n\n* Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months\n* Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis\n* Active suicidal ideation or serious attempt within past 3 years\n* Currently pregnant, nursing, or trying to become pregnant\n* Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test","22 Years",{"count":663,"type":21},128,[188],"The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).",[74,25],"2024-05-06",{"date":669,"type":35},"2024-05-07",{"date":671,"type":35},"2024-03-20",{"date":673,"type":21},"2027-10-01",{"name":675,"class":204},"University of Calgary",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":63,"sex":684,"minAge":17,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":67,"phases":687,"briefSummary":688,"conditions":689,"keywords":700,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":43},"100543557","the-man-van-project-100543557","NCT06357416","The Man Van Project","The Man Van Project: An Evaluation of the Effectiveness of a Mobile Outreach Screening Clinic Model for Earlier Detection of Prostate Cancer and Other Male Cancers","MV","Patients are eligible to be included in the research study if they are eligible to access the Man Van mobile outreach clinic, which is a novel clinical service delivered by The Royal Marsden Hospital NHS Foundation Trust. The inclusion and exclusion criteria have been designed to be as broad as possible, in order to include data from as many patients using the Man Van clinical service as possible.\n\nAs the primary purpose of the Man Van mobile outreach clinic is to screen for prostate, testicular, penile and other cancers that affect men, only men are eligible to be reviewed in the mobile outreach clinic hence only males will be recruited into this study.\n\nInclusion criteria for the Main Study\n\n1. Participating in the linked Man Van mobile outreach clinic\n2. Age ≥45 years\n3. Male\n\n   (The initial pilot study had a age criteria of ≥18 years, but this was amended).\n\n   MV-POCT\n\n   Inclusion Criteria: Any patient having a PSA and\u002For an HbA1c test as part of a Man Van work up, or via the our rapid diagnostics clinic.\n\n   MV-QualQ\n\n   Inclusion Criteria: Any patient attending the Man Van for an assessment.\n\n   MV-Eco\n\n   Inclusion Criteria: Any patient attending the Man Van for an assessment.\n\n   MV-PRS\n\n   Inclusion Criteria: Any patient attending the Man Van for an assessment and able to provide saliva samples.\n\n   MV-DNA\n\n   Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide blood\u002Fsaliva samples.\n\n   MV MV-UctDNA\n\n   Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide urine samples.\n\n   MV-SSI\n\n   Inclusion criteria:\n   * Aged \\> 18 and over (on date of invitation to participate)\n   * Works for healthcare organisation, other stakeholder or professional or potential man van patient who was not seen or relative of a Man Van patient\u002Fpotential patient\n\n   Exclusion criteria:\n   * Man van patient who has attended appointment\n\n   MV-TPP\n\n   Inclusion criteria:\n\n   Healthcare Professionals\n   * Aged \\> 18 and over (on date of invitation to participate)\n   * Speaks English\n   * Works within the UK\n   * Profession: GPs, Practice Staff (Nurses, Physician Assistants and Associates\n   * Healthcare assistants)\n   * Experienced in adopting new tests and guidelines into practice.\n   * Experienced in detecting, managing, and referring symptoms and asymptomatic patients with symptoms of prostate, pancreatic, GI cancer and\u002For are at an increased risk of developing these cancers.\n\n   Patients\n   * Aged \\> 18 and over (on date of invitation to participate)\n   * Speaks English\n   * Lives in the UK\n   * Patients with direct and in-direct experience with prostate, pancreatic, GI cancers.\n   * Patients at an increased risk of developing prostate, pancreatic, GI cancer in accordance with known risk factors, which includes age, smoking, being overweight or obese, family history and genetic factors, pancreatitis, and diabetes.\n\n   Other key stakeholders\u002Fprofessionals\n\n   • Aged \\> 18 and over (on date of invitation to participate)\n\n   • Speak English\n   * Works within the UK\n   * Professions: medical devices and biomedical researchers, scientists, representatives for major regulatory and funding bodies\n   * Knowledgeable of Early Detection initiatives (tests, outreach programes)\n\n   Exclusion criteria:\n\n   GPs\n\n   • Individuals who are unwilling to take part in the study.\n   * Individuals with no experience in adopting new cancer tests and guidelines into practice.\n   * Individuals with no experience in in detecting, managing, and referring patients with symptoms of cancer and\u002For are at an increased risk of developing prostate, pancreatic, GI cancer.\n   * Individuals who do not adequately understand verbal explanations or written information in English.\n\n   Patients • Individuals who are unwilling to take part in the study.\n\n   • Individuals who do not adequately understand verbal explanations or written information in English.\n\n   • Unable to provide written and verbal consent.\n\n   • No direct or indirect lived experience with prostate, pancreatic, GI cancers.\n\n   Non-clinical key stakeholders\u002Fprofessionals • Individuals who are unwilling to take part in the study • Individuals who are not familiar with cancer biomarkers and medical tests • Individuals with no knowledge of early detection\n\n   • Individuals who do not adequately understand verbal explanations or written information in English","MALE",{"count":686,"type":21},4000,[69],"National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor.\n\nThe aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar\u002Fdiabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project.\n\nPatients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important).\n\nThe clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider.\n\nPatients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer.\n\nThe NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways.\n\nWe also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van.\n\nThe reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer.",[690,691,692,693,694,695,696,25,697,698,699],"Prostate Cancer","Urologic Cancer","Urologic Diseases","Bladder Cancer","Diabetes","Hypertension","Mental Health Issue","Smoking","Renal Cancer","Testis Cancer",[701,702],"mobile health","targeted screening","2024-04-29",{"date":705,"type":35},"2024-05-01",{"date":707,"type":35},"2022-04-13",{"date":709,"type":21},"2026-12-01",{"name":711,"class":204},"Royal Marsden NHS Foundation Trust"]