[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-abusedependence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-abusedependence":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,139,178,210,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":53},"100609614","safety-and-effectiveness-of-the-brainsway-deep-transcranial-magnetic-stimulation-deep-tms-for-treatment-of-alcohol-use-disorder-aud-100609614",false,"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.","ALL","18 Years","86 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32],"Alcohol Use Disorder","Alcoholism","Alcohol Abuse","Alcohol Dependence","Alcohol Abuse\u002FDependence","Alcohol Addiction",[34,35,36,37,38,39,40,41],"alcohol use disorder","alcoholism","alcohol abuse","alcohol dependence","alcohol addiction","DTMS","rfTMS","Brainsway","RECRUITING","2026-06-18",{"date":45,"type":46},"2026-06-22","ACTUAL",{"date":48,"type":46},"2025-11-07",{"date":50,"type":21},"2027-12-01",{"name":41,"class":52},"INDUSTRY",9,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":112,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100641475","qaiax-aihealth4u---ai-public-health-central-microcity-a-re-quantum-ai-agency-aka-ai-city-hall-project-upsto-app-nos-64074526-64063557-63903181-63729428-100641475","NCT07661823","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428: A Quantum AI Public Health Agency That Provides Free Public Health Services to Registered and Sponsored Visitors\u002FOccupants for RDT&E Under 28 U.S. Code 1498 (Classified as a PPA Under 10 U.S. Code 129a)","QAIAx","Inclusion Criteria:\n\n* Individuals aged 17 to 99 years old.\n* Referral by a licensed health services professional (e.g., R.N., N.P., Ph.D., M.D.).\n* Referral by a non-profit organization (e.g., 501c3, university, church).\n* Referral by a public agency (e.g., case manager, social worker, parole\u002Fprobation\u002FPTS officer, judge).\n\nExclusion Criteria:\n\n\\* Individuals under 17 or over 99 years of age.",true,"17 Years","99 Years",{"count":66,"type":21},1000000,[24],"BRIEF SUMMARY\n\nA. \"What is the purpose of this study?\"\n\nThis study will test whether the \"AI City Hall Project\" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called \"Microcities\". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance.\n\nB. \"What conditions does the study focus on?\"\n\nThe study focuses on adults with:\n\n* Autism spectrum disorders (Asperger's, autism, ADHD, ASD)\n* Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA\u002Fecstasy, tobacco\u002Fnicotine)\n* Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders)\n* Behavioral addictions (gambling, sex addiction) and related issues (sex offence history).\n\nC. \"What does the study involve?\"\n\nEligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital \"attitude inoculation\" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic.\n\n\\*\\*Who can participate?\\*\\*\n\nYou may be able to join if you:\n\n* Are an adult (18 years or older)\n* Have a diagnosis of one of the listed mental-health or addiction disorders\n* Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole\u002Fprobation officer, judge)\n* Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses.\n\nParticipants who are veterans, receive public assistance (e.g., VA disability, SSDI\u002FSSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised.\n\n\\*\\*Where is the study taking place?\\*\\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones.\n\n\\*\\*Who is sponsoring the study?\\*\\* The study is sponsored by \\*\\*Veterans Recovery Network Inc.\\*\\*, a non-profit organization, in collaboration with \\*\\*AI-119 Vulcan Project Research \\& Educational Technology Co. (PRETCO)\\*\\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM).\n\nThis summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.",[70,71,72,73,74,75,76,31,32,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111],"Asperger's Disorder","Asperger Disorder","Autism Disorder","Autism","ADHD - Attention Deficit Disorder With Hyperactivity","ADHD","ASD","Alcohol and Other Drug Use Disorders","Alcohol and Other Substance Use Prevention","Gambling Addiction","Gambling Disorder","Sex Abuse","Sex Behavior","Sex Crimes","Sex Disorder","Sex Disorders","Gender Dysphoria, Adult","Eating Behavior Disorders","Narcotic-Related Disorders","Narcotic Addiction","Narcissism","Psychiatric Disorder","Psychedelic Effects in Healthy Volunteers","Psychedelic Experiences","Psychedelic Drug Dependence","Marijuana Use Disorder","Marijuana Abuse and Dependence","Smoking (Tobacco) Addiction","Smoking Among Youth","Smoking Abstinence","Abstinence, Sex","Opiate Substitution Treatment","Opioid Abuse (Disorder)","Opioid Abuse and Addiction","Cocaine Abuse","MDMA ('Ecstasy')","Addiction Disorders","Homeless and Low Incomes People, Refugees","Homelessness","Reliability and Validity","Anger Problems","Child Abuse, Sexual",[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"ai city hall project","ai 119","ai119","qaia","qaiax","ai wat","veterans recovery network","veterans","addiction disorder","vulcan","artificial intelligence","agi","military","sex addiction","mental health treatment","NOT_YET_RECRUITING","2026-06-16",{"date":45,"type":46},{"date":132,"type":21},"2026-08-01",{"date":134,"type":21},"2028-12-31",{"name":136,"class":137},"Veterans Recovery Network Inc.","OTHER",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":175,"locationsCount":177},"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\\&#39;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":149,"type":21},108,[151],"PHASE2","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.",[27,31,30,28,154,155,156,157],"Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[159,160,161,162,163,164,165,166,167,34,168],"GLP-1","Glucagon-like peptide 1","fMRI","GIP","Glucose-dependent Insulinotropic Polypeptide","Tirzepatide","Mounjaro(R)","schizophrenia","alcohol","dual diagnosis","2026-02-05",{"date":171,"type":46},"2026-02-10",{"date":173,"type":46},"2025-05-05",{"date":134,"type":21},{"name":176,"class":137},"Anders Fink-Jensen, MD, DMSci",2,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":138},"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","65 Years",{"count":188,"type":21},75,[151],"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.",[31,192,28],"Alcohol Use Disorder (AUD)",[27,28,30,194,195,196,197,198,199,200],"Ketamine","Glutamate","Placebo-controlled","Neurofeedback Training","Realtime fMRI","Therapeutic effects","Mechanistic effects","2025-11-27",{"date":203,"type":46},"2025-12-05",{"date":205,"type":46},"2025-06-01",{"date":207,"type":21},"2026-12",{"name":209,"class":137},"Dr. med. Marcus Herdener",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":62,"sex":16,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":138},"100564332","social-facilitation-of-alcohol-effects-and-alcohol-misuse-in-young-adults-100564332","NCT06627803","Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults","Multi-Method Investigation of Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults","PALS","Inclusion Criteria:\n\n* 21-28 years of age\n* Drink regularly (1+ times\u002Fweek) with a same-sex platonic friend that also meets eligibility and is willing to participate\n* Regular alcohol use (3+ times\u002Fweek) with at least one binge drinking episode (5+ drinks \\[male\\] or 4+ drinks \\[female\\] in about 2 hours) in the past month\n* BMI of 18-30\n* Own a smart device operating on the iOS or Android operating system\n* Fluent in English\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding or intent to get pregnant in the next 60 days (females)\n* medical conditions counter-indicated for alcohol administration\n* seeking treatment for alcohol use","21 Years","28 Years",{"count":221,"type":21},200,[24],"The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 200 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).\n\nParticipation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.",[225,31],"Alcohol Consumption","2025-08-07",{"date":228,"type":46},"2025-08-12",{"date":230,"type":46},"2025-02-20",{"date":232,"type":21},"2029-08-31",{"name":234,"class":137},"University of Southern California",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":186,"enrollmentInfo":241,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":138},"100581447","examining-the-relationship-between-physical-activity-levels-and-chronotype-tendencies-in-individuals-with-alcohol-dependence-100581447","NCT06850428","Examining the Relationship Between Physical Activity Levels and Chronotype Tendencies in Individuals With Alcohol Dependence","Inclusion Criteria:\n\n* Age: Being between 18-65 years old.\n* Alcohol Dependence: Having alcohol dependence and this condition being confirmed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria or stated based on self-report.\n* Remission Status: Being in remission for at least 1 month (i.e., no active alcohol use).\n\nExclusion Criteria:\n\n* Active Psychiatric Diseases: For example, individuals with active psychiatric diseases such as schizophrenia or bipolar disorder will not be included in the study.\n* Physical Disability: Individuals with any physical disability will also be excluded from the study.",{"count":242,"type":21},207,"OBSERVATIONAL","Alcohol use disorders are characterized by excessive alcohol consumption and loss of control and are associated with high mortality and disease burden. The relationship between physical activity and alcoholism is complex, and low physical activity has been shown to be linked to alcohol consumption. Additionally, individuals' circadian rhythms (chronotypes) may influence alcohol consumption habits; Evening-type individuals are more likely to consume alcohol. This study aims to examine the relationship between physical activity levels and chronotype trends in individuals with alcohol addiction.",[31],[247,248,249,250],"chronotype","Alcohol abuse\u002FDependence","physical activity","physical activity level","2025-02-22",{"date":253,"type":46},"2025-02-27",{"date":255,"type":21},"2025-04-15",{"date":257,"type":21},"2025-09-15",{"name":259,"class":137},"Gulhane School of Medicine"]