[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-dependence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-dependence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,52,78,100,135,161,182,210,248,274,295,320,348,394,420,466,495,528,554,578,601],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100217453","behavioral-and-functional-task-development-implementation-and-testing-100217453",false,"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,"ALL","18 Years","65 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Alcohol Dependence","Alcohol Drinking","Alcoholism","Alcohol Use Disorder","Addiction",[33,29,34,35,36,37,38],"fMRI","Phenotype","Imaging","EEG","Psychophysiology","Near Infrared","RECRUITING","2026-06-27",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2014-05-28",{"date":47,"type":21},"2026-12-31",{"name":49,"class":50},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":51},"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":60,"type":21},1000,"OBSERVATIONAL","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.",[27,28,64,29,65],"Alcohol-Related Disorders","Brain Mapping",[67,68,69,34,35,70],"Alcohol","Biomarkers","Adults","Natural History","2026-06-23",{"date":73,"type":43},"2026-06-24",{"date":75,"type":43},"2014-07-10",{"date":47,"type":21},{"name":49,"class":50},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":51},"100622828","feasibility-of-integrating-olfactory-stimuli-into-virtual-reality-cue-exposure-for-patients-with-alcohol-dependence-100622828","NCT07388693","Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence","Inclusion Criteria:\n\n* age: 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* history of alcohol craving\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* hyposmia\n* dependence on substances other than alcohol and nicotine\n* current alcohol intoxication (randomly tested by measurement of breath alcohol concentration)\n* unable to understand the study information, consent form or principles of the study\n* abstinence for less than 7 days or ongoing consumption of alcohol\n* severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment\n* serious illnesses affecting brain or heart function that influence physiological study parameters\n* acute suicidality (or acute endangerment of others)\n* concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate",{"count":85,"type":21},20,[24],"Alcohol dependence (AD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol, which can be evoked by both real-world and virtual cues in immersive Virtual Reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based Cue Exposure (VR-CE) influence cue-elicited craving. As part of the OLFA-VR (Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence) research project, the present feasibility study aims to evaluate the feasibility, tolerability and acceptability of implementing olfactory stimuli into VR-CE.\n\nIn addition, this study not only examines the general feasibility of alcohol-related olfactory stimuli in VR-CE but also explores which specific alcohol-related olfactory stimuli prove to be feasible.\n\nThe investigators hypothesize that implementing olfactory stimuli into VR-CE will be feasible and tolerable for patients with AD, with no preventable serious side effects caused by VR-CE. The investigators also hypothesize that VR-CE will induce craving in most patients.",[27],[90],"Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory","2026-06-21",{"date":71,"type":43},{"date":94,"type":43},"2026-03-07",{"date":96,"type":21},"2026-07-31",{"name":98,"class":99},"Charite University, Berlin, Germany","OTHER",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"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":109,"type":21},186,[24],"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.",[30,29,113,27,114,115],"Alcohol Abuse","Alcohol Abuse\u002FDependence","Alcohol Addiction",[117,118,119,120,121,122,123,124],"alcohol use disorder","alcoholism","alcohol abuse","alcohol dependence","alcohol addiction","DTMS","rfTMS","Brainsway","2026-06-18",{"date":127,"type":43},"2026-06-22",{"date":129,"type":43},"2025-11-07",{"date":131,"type":21},"2027-12-01",{"name":124,"class":133},"INDUSTRY",9,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":15,"sex":16,"minAge":143,"maxAge":18,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":159,"locationsCount":51},"100575305","transcranial-magnetic-stimulation-tms-effects-using-magnetoencephalography-meg-study-100575305","NCT06770556","Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study","An Investigation of TMS Effects Using Magnetoencephalography (MEG) Among Individuals With and Without Heavy Alcohol Use","TMS","Inclusion Criteria non-AUD Participants:\n\n* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score for AUD = 0\n* Alcohol Use Disorders Identification Test (AUDIT) score ≤ 7\n* Is not a heavy alcohol consumer\n\nInclusion Criteria AUD Participants:\n\n* DSM-5 score for AUD ≥ 3\n* AUDIT score ≥ 8\n* Is a heavy alcohol consumer\n\nExclusion Criteria:\n\n* Current substance use disorder other than alcohol use disorder and\u002For frequent use of non-prescribed psychoactive substances.\n* Current serious psychiatric disorder, and\u002For any history of a psychotic disorder\n* Any health problem that would interfere with the study or could be aggravated by study procedures (e.g., history of migraines, claustrophobia).\n* Is currently taking or initiates a medication known to affect alcohol intake and\u002For craving.\n* History of traumatic brain injury resulting in hospitalization, loss of consciousness, and\u002For having ever been informed he\u002Fshe has an epidural, subdural, or subarachnoid hemorrhage.\n* Does not meet safety criteria for TMS or MRI.\n* Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control.\n* Is at an elevated risk of seizure (i.e. has a history of seizures, is currently prescribed medications known to lower seizure threshold and has had a change in their medication).\n* Clinical Intake Withdrawal Assessment (CIWA\\>5) (to prevent delivering TMS to individuals in withdrawal).\n* Not able to read and understand questionnaires, assessments, and\u002For the informed consent.","21 Years",{"count":145,"type":21},10,[24],"Alcohol use disorder (AUD) is a complex chronic brain disease characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states. Extensive research has identified the general neural circuitry underlying AUD. There is an exciting opportunity to intervene in AUD using neuromodulation. Transcranial magnetic stimulation (TMS) offers a non-invasive method to modulate brain activity, making it a promising tool for investigating, modulating, and potentially treating AUD. However, the precise effects of TMS on neural circuits involved in AUD and the mechanisms underlying these effects must first be understood. Magnetoencephalography (MEG) is a neuroimaging method that provides direct measurement of brain activity within neural circuits with high temporal resolution. Critically, MEG can measure brain activity in a wide range of frequencies that are consistent with those targeted by TMS. The goal of this proposal is therefore to collect preliminary and feasibility data to support a future NIH grant application that would use MEG to investigate TMS effects in individuals with AUD (iAUD).",[30,27,149],"Alcohol Consumption",[151,152,30],"Transcranial Magnetic Stimulation (TMS)","Magnetoencephalography (MEG)","2026-04-15",{"date":155,"type":43},"2026-04-17",{"date":157,"type":43},"2025-03-21",{"date":47,"type":21},{"name":160,"class":99},"Wake Forest University Health Sciences",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":51},"100539795","neuromodulation-and-mindfulness-patients-with-aud-100539795","NCT06308484","Neuromodulation and Mindfulness Patients With AUD","Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD","Inclusion Criteria:\n\n* Alcohol Dependence (ICD-10)\n* abstinence between 3 days and 12 months\n\nExclusion Criteria:\n\n* current (last 12 months) substance use disorder\u002Fdependence\n* neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis)\n* current severe major depressive disorder, manic episode or schizophreniform disorder\n* intake of anticonvulsive or high-potency antipsychotic medication","70 Years",{"count":170,"type":21},140,[24],"Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2).",[27],"2026-03-18",{"date":176,"type":43},"2026-03-20",{"date":178,"type":43},"2024-03-20",{"date":180,"type":21},"2027-06-30",{"name":98,"class":99},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":51},"100568688","the-impact-of-heavy-alcohol-use-on-saliva-and-oral-health-100568688","NCT06684483","The Impact of Heavy Alcohol Use on Saliva and Oral Health","Quantifying Associations of Stress and Inflammation-Associated Oral Biomarkers With Oral Health, Oral Health Behaviors, Systemic Biomarkers and Clinical Phenotype in Individuals With Alcohol Use Disorder (AUD)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\nAUD participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Treatment-seeking individuals aged 18 years or older.\n* Able to read and speak English.\n* Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n\nHealthy Control Participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals aged 18 years or older.\n* Able to read and speak English.\n* Self-reported to be in good physical health.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n* AUDIT score of 7 or below.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nPatients with AUD and Healthy Control Participants:\n\n* The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).\n* Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).\n* Part 2 Only: Currently taking or have taken any of the following medications within the last month by self-report; Antibiotics, Corticosteroids, Immunosuppressive or Cytotoxic agents. Topical antibiotics and\u002For corticosteroids on areas other than the oral cavity are not exclusion criteria.\n* Pregnant or breastfeeding\n* Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.\n* Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.","100 Years",{"count":191,"type":21},72,"Background:\n\nPeople with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD.\n\nObjective:\n\nThis study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD.\n\nEligibility:\n\nPeople aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nThe study is divided into 2 parts: People will participate in either one part or the other.\n\nIn part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth.\n\nIn part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient.\n\nHealthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.",[30,27],[195,30,196,197,198,199,200,201],"Oral Health Behaviors","Salivary Bioscience","Stress","Health Behaviors","Salivary Biomarker","Inflammation","Neuropsychological Symptoms","2026-02-14",{"date":204,"type":43},"2026-02-17",{"date":206,"type":43},"2025-01-09",{"date":47,"type":21},{"name":209,"class":50},"National Institutes of Health Clinical Center (CC)",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":222,"conditions":223,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"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.",{"count":219,"type":21},108,[221],"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.",[30,114,27,29,224,225,226,227],"Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[229,230,33,231,232,233,234,235,236,117,237],"GLP-1","Glucagon-like peptide 1","GIP","Glucose-dependent Insulinotropic Polypeptide","Tirzepatide","Mounjaro(R)","schizophrenia","alcohol","dual diagnosis","2026-02-05",{"date":240,"type":43},"2026-02-10",{"date":242,"type":43},"2025-05-05",{"date":244,"type":21},"2028-12-31",{"name":246,"class":99},"Anders Fink-Jensen, MD, DMSci",2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":18,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":51},"100547256","phase-2-psilocybin-or-ketamine-for-alcohol-use-disorder-an-active-comparator-trial-100547256","NCT06405607","Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial","Psilocybin vs Ketamine for Alcohol Use Disorder","Psi or Ket","Inclusion criteria:\n\n* Weight between 50kg and 150kg\n* No known allergies to rescue medication\n* For people capable of becoming pregnant, not pregnant and using contraception\n* Not currently breastfeeding\n* Meets criteria for DSM-V moderate to severe AUD.\n* Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.\n* Not currently participating in formal treatment for AUD.\n* No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history\n* No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease\n* No hallucinogen or ketamine use in past 12 months\n* No self-reported, personal, or familial history of specific psychotic disorders\u002Fepisodes.\n* No serious traumatic brain injury (TBI) in the past 2 years\n* No substance use disorder other than AUD over the past 12 months\n* If taking a GLP-1 agonist, stable dosage for past 3 months\n* Family member\u002Ffriend for pick-up, overnight post-drug session monitoring.\n* No MRI contraindications\n\nExclusion Criteria:\n\nDrug\u002Fmedication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines).\n\nPsychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 5) history of co-occurring psychotic episode\u002Fdiagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and\u002For serious personality disorders amongst other conditions.\n\nMedical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation \\[QTc \\> .045\\]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function), or pregnancy.\n\nMRI contraindication (pacemaker, etc.)",{"count":257,"type":21},80,[221],"This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg\u002Fkg dose of ketamine.",[30,27,113],[262,263,264],"psychedelic","psilocybin","ketamine","2025-11-21",{"date":267,"type":43},"2025-11-28",{"date":269,"type":43},"2025-06-12",{"date":271,"type":21},"2028-04",{"name":273,"class":99},"University of Iowa",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":51},"100495974","high-dose-accelerated-theta-burst-stimulation-for-the-treatment-of-alcohol-addiction-100495974","NCT05738174","High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction","Theta Burst Zur Behandlung Der Alkoholabhängigkeit","TBA","Inclusion Criteria:\n\n* alchohol dependence according to ICD-10 (F10.2)\n* desire to reduce or abstain from alcohol drinking\n* male or female\n* 18-65 years\n* residency in Germany, German speaking\n* written informed consent\n\nExclusion Criteria:\n\n* contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker)\n* relevant neurological or internistic diseases according to study investigator\n* treatment with TMS in the past\n* participation in other trials during treatment\n* pregnancy or breatfeeding\n* positive breath test for alcohol\n* legal care and placement in a psychiatric hospital\n* co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene\n* acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (\\\u003C1 month)\n* severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder)\n* patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)",{"count":191,"type":21},[24],"This is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (TBS).",[27],"2025-09-18",{"date":288,"type":43},"2025-09-19",{"date":290,"type":43},"2023-03-01",{"date":292,"type":21},"2026-02-28",{"name":294,"class":99},"Berthold Langguth, MD, Ph.D.",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":15,"sex":302,"minAge":17,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":299,"conditions":308,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":51},"100486966","phase-1-a-clinical-trial-to-assess-pharmacokinetic-profiles-safety-and-tolerability-of-ivl3004-and-ivl4002-in-healthy-male-subjects-100486966","NCT05620940","A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.","A PHASE 1, OPEN-LABEL, EXPLORATORY, FIXED-SEQUENCE, PHARMACOKINETIC SINGLE ASCENDING DOSE STUDY OF IVL3004 VERSUS VIVITROL® (NALTREXONE) LONG-ACTING INJECTABLE (LAI) AND IVL4002 IN HEALTHY SUBJECTS","Inclusion Criteria:\n\n1. Healthy adult male, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, and willing to abstain from smoking during confinement at the clinical site).\n2. BMI ≥18.0 and ≤32.0 kg\u002Fm2 and body weight ≥55.0 kg.\n3. Healthy as defined by:\n\n   1. The absence of clinically significant illness, infection, or medical\u002Fsurgical procedure within 4 weeks prior to dosing or planned inpatient surgery (including dental surgery) or hospitalization during the study period.\n   2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological (including autoimmune), psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.\n4. Subjects who are not vasectomized for at least 3 months prior to dosing, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from dosing and for 90 days after dosing:\n\n   a. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used for at least 4 weeks or intrauterine device placed for at least 4 weeks prior to dosing.\n5. Subjects who have had a vasectomy must be willing to use a condom until study exit.\n6. Subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.\n7. Subjects must be willing not to donate sperm for 90 days after dosing.\n8. Willing to undergo SC abdominal injection or IM ventral gluteal injection to allow for investigational drug administration.\n9. Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol- specific study procedures.\n\nExclusion Criteria:\n\n1. Any clinically significant abnormal finding at physical examination at screening or Day -1.\n2. Clinically significant abnormal laboratory test results at screening or Day -1, or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.\n3. Is prone to skin rashes, irritation, or has a skin condition such as recurrent eczema that is likely to impact the injection site area or demonstrates any abnormal skin tissue in the proposed injection area, as determined by the Investigator.\n4. Any history of malignancy or neoplastic disease.\n5. History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug, or to any excipient present in the formulations.\n6. ALT, AST, or total bilirubin \\>1.5x upper limit of normal (ULN) at screening or Day -1.\n7. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2 as calculated by the 2021 Chronic Kidney Disease-Epidemiology (CKD-EPI) equation at screening or Day -1.\n8. Clinically significant ECG abnormalities (QTc \\>450 ms or PR interval \\>220 ms) or vital sign abnormalities (systolic blood pressure \\\u003C90 or \\>140 mmHg, diastolic blood pressure \\\u003C40 or \\>90 mmHg, or heart rate \\\u003C40 or \\>100 bpm) at screening or Day -1.\n9. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%), or positive alcohol test at screening or Day -1.\n10. History of drug abuse within 1 year prior to screening or positive test for drugs of abuse (e.g., phencyclidine, opiates, benzodiazepines, barbiturates, amphetamines, methamphetamines, cocaine, and tetrahydrocannabinol) at screening or Day -1.\n11. Presence of any underlying physical or psychological (e.g., depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6 months prior to screening is accepted.\n12. Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety:\n\n    1. Depot injection or implant within 3 months prior to dosing;\n    2. Strong CYP inhibitors or inducers within 30 days prior to dosing;\n    3. Prescription medications within 14 days prior to dosing;\n    4. Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing;\n    5. OTC medications (including topical and nasal formulations with active pharmaceutical ingredients) within 7 days prior to dosing, except for occasional use of acetaminophen\u002Fparacetamol (up to 2 g\u002Fday);\n    6. Natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to dosing;\n    7. Anesthetic agents within 24 hours prior to dosing.\n    8. Anticoagulant medications from 15 days prior to dosing to 6 weeks post- dose.\n13. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.\n14. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to dosing.\n15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.","MALE","55 Years",{"count":305,"type":21},40,[307],"PHASE1",[309,27,310],"Opioid Dependence","Multiple Sclerosis","2025-09-09",{"date":313,"type":43},"2025-09-15",{"date":315,"type":43},"2024-09-11",{"date":317,"type":21},"2025-12-30",{"name":319,"class":133},"Inventage Lab., Inc.",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":336,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":51},"100603023","can-selfcompassion-training-reduce-alcohol-consumption-in-patients-with-alcohol-use-disosrder--100603023","NCT07131124","Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ?","Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? Randomized Controlled Trial","COMPAL","Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Subjects meeting DSM-5 criteria for Alcohol Use Disorder (AUD).\n* Subjects receiving outpatient care in addiction services, CSAPA, CMP, day hospitals, mental health care institutions, community mental health centers.\n* Subjects affiliated with the social security system.\n* Subjects who have a good understanding of French languague, allowing them to provide informed consent, respond to self-questionnaires, and participate in the MSC program.\n\nExclusion Criteria:\n\n* Subjects unable to understand the questionnaires.\n* Subjects presenting moderate or severe suicidal ideation (assessed by the Suicide item of the MINI scale).\n* Subjects with a score \\\u003C10 on the MoCA version 7.1 test.\n* Subjects admitted to inpatient units (since hospitalization alters alcohol consumption).\n* Subjects unable to provide informed or voluntary consent to participate in the study.\n* Subjects under guardianship or curatorship.","75 Years",{"count":330,"type":21},152,[24],"The objective of this interventional study is to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population of individuals with Alcohol Use Disorder (AUD), six months after the intervention. The MSC program was designed to enhance self-compassion skills. It has demonstrated a mediating effect on symptoms of stress, depression, and anxiety, which are known to contribute to the maintenance of AUD.\n\nOutpatients with AUD will be included after providing informed consent and will be randomized into two groups (MSC+TAU vs TAU). The follow-up includes 13 visits over a 9-month period, with group sessions according to allocation. Three follow-up visits are scheduled up to six months after the end of the sessions. Participants will complete several scales and surveys (AUDIT, TLFB, SCS, HAD, SSS-S, TOSCA-3, AQoLS, MAAS, Fagerström, CUDIT-R, EVA craving).",[31,334,335,27],"Addiction Disorders","Alcohol Use Disorders",[337,335],"Self-compassion","NOT_YET_RECRUITING","2025-08-12",{"date":341,"type":43},"2025-08-20",{"date":343,"type":21},"2025-10",{"date":345,"type":21},"2027-10",{"name":347,"class":99},"Etablissement Public de Santé Barthélemy Durand",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":51},"100536490","virtual-incentive-treatment-for-alcohol-100536490","NCT06265506","Virtual Incentive Treatment for Alcohol","Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD","VITA","Inclusion Criteria:\n\n1. Had 2 heavy drinking episodes (assigned male at birth \\> 4 standard drinks (SDs), assigned female at birth \\> 3 SDs) or ≥14 SDs in the prior 14 days verified by PEth 16:0\u002F18:1 biomarker \\> 20 ng\u002FmL (indicates at least 2 heavy drinking episodes in past two weeks);\n2. Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5;\n3. 18+ (individuals over 65 will be assessed for cognitive impairments)\n4. Are not receiving treatment for AUD\n5. Are able to complete virtual study visits via Zoom\n\nExclusion Criteria:\n\n1. have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);\n2. PEth biomarker ≤ 20 ng\u002FmL (indicates no heavy drinking in past month)\n3. inability to provide informed consent based on the UBACC or MacCAT-CR;\n4. alcohol withdrawal-related seizure or hospitalization in prior 12 months;\n5. psychiatrically or medically unsafe to participate, as assessed by the PI; and\u002For\n6. currently enrolled in alcohol treatment or another alcohol treatment study.",{"count":357,"type":21},200,[24],"The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \\>= 200 ng\u002FmL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health.",[30,28,113,27],[362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384],"Contingency Management","Alcohol Abstinence","Adult","Biological Markers","Blood","Clinical effectiveness","Cognitive Therapy","Blood collection","Ethyl glucuronide","Health Care Costs","Heavy Drinking","Addictions Neuroclinical Assessment","Cognition","Incentives","Phosphatidylethanol","Incentive salience","Anhedonia","Longitudinal Studies","Prediction of Response to Therapy","Randomized Clinical Trial","Telehealth","Virtual Health","Video conference","2025-05-23",{"date":387,"type":43},"2025-05-30",{"date":389,"type":43},"2024-06-18",{"date":391,"type":21},"2028-04-04",{"name":393,"class":99},"Washington State University",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":404,"conditions":405,"keywords":408,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":419,"locationsCount":51},"100568002","validation-of-the-french-version-of-the-prediction-of-the-alcohol-withdrawal-severity-scale-pawss-100568002","NCT06675539","Validation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS)","PAWSS-VF","Inclusion Criteria:\n\n* Male or female, aged 18 to 60 years\n* Subjects with DSM-5 criteria for alcohol use disorders (AUD)\n* Subjects hospitalized for scheduled withdrawal or patients developing alcohol withdrawal hospitalized for another reason.\n* Subjects who understand French\n* Subject affiliated to the French social security system\n* Subject having given their written consent to the study\n\nExclusion Criteria:\n\n* Subjects transferred from other hospitalization services for whom a withdrawal syndrome could have already been treated.\n* Subjects scheduled for discharge within 48 hours.\n* Subjects with known uncontrolled epilepsy.\n* Subjects unable to understand the questionnaire.\n* Subjects unable to give consent or not volunteering for the study.\n* Subjects under guardianship or curatorship.","60 Years",{"count":403,"type":21},545,"The goal of this observational study is to validate the French version of the PAWSS scale in a population of patients with Alcohol Use Disorders. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) has an excellent psychometric characteristics and predictive value of complicated alcohol withdrawal.\n\nThe main question it aims to answer is:\n\nAre the psychometric properties of the French version of the PAWSS scale comparable to those of the English version in a population of alcohol use disorders subjects?\n\nAUDs participants are included and followed for three days during their hospitalization, They will performed several scales and surveys (DSM-5 AUD criteria, AUDIT, French version of PAWSS and CIWA-AR).",[406,30,27,407],"Addiction, Substance","Alcohol Withdrawal",[30,409,410,411,412],"Scale","alcohol withdrawal","prediction","withdrawal syndrome","2025-02-24",{"date":415,"type":43},"2025-02-25",{"date":417,"type":43},"2024-11-11",{"date":345,"type":21},{"name":347,"class":99},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":51},"100363607","safety-and-efficacy-of-fecal-microbiota-transplantation-100363607","NCT04014413","Safety and Efficacy of Fecal Microbiota Transplantation","Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study","Inclusion Criteria:\n\nConfirmed diagnosis of any of the following diseases:\n\n* Crohn's disease\n* Ulcerative colitis\n* Celiac disease\n* Irritable bowel syndrome\n* Functional dyspepsia\n* Constipation\n* Antibiotic-associated diarrhea or any antibiotic- associated complications\u002Fsymptoms\n* Metabolic syndrome such as diabetes mellitus and obesity\n* Multidrug-resistant infection\n* Hepatic encephalopathy\n* Multiple sclerosis\n* Pseudo-obstruction\n* Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection\n* Multiple organ dysfunction\n* Dysbiotic bowel syndrome\n* MRSA enteritis\n* Pseudomembranous enteritis\n* Alopecia, autism\n* Graft-versus-host disease\n* Idiopathic thrombocytopenic purpura (ITP)\n* Atopy or allergy\n* Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)\n* Alcohol dependence\n* Psoriatic arthropathy that has suboptimal control of disease despite standard treatment.\n\nExclusion Criteria:\n\n* Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema\n* Any conditions that may render the efficacy of FMT or at the discretion of the investigators\n* Current pregnancy",{"count":428,"type":21},450,[24],"The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.\n\nRecent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series\u002Freports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.\n\nDespite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.",[432,433,434,435,436,437,438,439,440,441,442,310,443,444,445,446,447,448,449,450,451,452,453,454,455,27,456],"Crohn Disease","Ulcerative Colitis","Celiac Disease","Irritable Bowel Syndrome","Functional Dysphonia","Constipation","Clostridium Difficile Infection","Diabetes Mellitus","Obesity","Multidrug -Resistant Infection","Hepatic Encephalopathy","Pseudo-Obstruction","Carbapenem-Resistant Enterobacteriaceae Infection","Vancomycin Resistant Enterococci Infection","Multiple Organ Dysfunction Syndrome","Dysbiotic Bowel Syndrome","MRSA Enteritis","Pseudomembranous Enterocolitis","Alopecia","Autism","Graft-versus-host Disease","Idiopathic Thrombocytopenic Purpura","Atopy or Allergy","Liver Disease","Psoriatic Arthropathy","2024-08-21",{"date":459,"type":43},"2024-08-22",{"date":461,"type":43},"2019-07-15",{"date":463,"type":21},"2030-10-31",{"name":465,"class":99},"Chinese University of Hong Kong",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":480,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":4},"100550220","phase-2-psilocybin-assisted-therapy-for-alcohol-use-disorder-100550220","NCT06444243","Psilocybin-assisted Therapy for Alcohol Use Disorder","A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n1. Moderate to severe AUD according to the DSM-5 criteria\n2. A desire to reduce or stop drinking\n3. Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks\u002Fday for men; ≥4 for women) in the past week prior to screening\n4. Aged ≥18 years old\n5. Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)\n6. Received prior treatment for AUD (not including study interventions)\n7. Stable housing within reasonable distance to a clinical site for the duration of the study\n8. Able to identify a significant other (such as a family\u002Ffriend\u002Fpartner) who could accompany them from clinic\u002Fprovide transport and\u002For be contacted by the study team if required\n9. Willing to give written informed consent\n\nExclusion Criteria:\n\n* a. History of or currently meeting DSM-5 criteria for:\n\n  * Any psychotic disorder\n  * Bipolar disorder type 1 or 2\n  * Major depression with psychotic features\n  * Any personality disorders\n  * Post-traumatic stress disorder\n  * Hallucinogen persisting perception disorder b. A family history of:\n  * Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or\n  * Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV.\n\n    d. Abnormal and\u002For serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort\u002Ftryptophan), lithium, anticonvulsants).\n  * Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion).\n  * Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures).\n\n    h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and\u002For defined by DSM-5 criteria (measured by SCID-RV).\n\n    i. Substantial lifetime use (\\>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month.\n\n    k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.",{"count":474,"type":21},90,[221],"To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.",[30,27,478,479],"Depression","Anxiety",[481,482,483,484,485],"Psilocybin-assisted therapy","Randomised-Controlled Trial","Psilocybin","Psychedelic-Assisted Therapy","Alcohol Use Disorder Therapy","2024-06-07",{"date":488,"type":43},"2024-06-10",{"date":490,"type":21},"2024-09",{"date":492,"type":21},"2025-12",{"name":494,"class":99},"University of Sydney",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":15,"sex":16,"minAge":503,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":514,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":51},"100536294","recognition-and-early-intervention-for-alcohol-and-substance-abuse-in-adolescence-in-adolescent-100536294","NCT06262958","Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent","REAL-SMART: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence, REAL\u002FSystemic Metabolic Alterations Related to Different Psychiatric Disease Categories in Adolescent","REAL-SMART","Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019\n\nExclusion Criteria: Unable to understand the questionnaires","14 Years","19 Years",{"count":506,"type":21},800,[24],"ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it",[29,510,27,64,511,512,513],"Substance Abuse","Substance Use Disorders","Adolescent Behavior","Adolescent Problem Behavior",[236,515,516,517,518],"substance","abuse","mini-intervention","adolescent","2024-02-08",{"date":521,"type":43},"2024-02-16",{"date":523,"type":43},"2017-08-07",{"date":525,"type":21},"2030-06-01",{"name":527,"class":99},"Kuopio University Hospital",{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":401,"enrollmentInfo":535,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":537,"conditions":538,"keywords":542,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":51},"100090609","substance-abuse-pre-treatment-screening-study-100090609","NCT00439049","Substance Abuse Pre-Treatment Screening Study","General Evaluation of Eligibility for Substance Abuse\u002FDependence Research","Inclusion Criteria:\n\n* Willing and able to participate in 3- to 6-month treatment program.\n* At least 18 years of age.\n* Seeking treatment for substances of abuse including (cocaine, opiates, and alcohol).\n* Generally physically healthy.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Mandated by the courts\u002Fparole officers to attend treatment.\n* Not seeking treatment for substances of abuse.\n* Plans to move from the Houston area within the 3- to 6-month treatment period.\n* Seeking treatment for a substance for which the Treatment Research Clinic (TRC) has no current trial.",{"count":536,"type":21},7500,"The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.",[539,540,541,27,510],"Cocaine Abuse","Cocaine Dependence","Opiate Dependence",[510,543,544],"Treatment","Eligibility","2023-12-19",{"date":547,"type":43},"2023-12-20",{"date":549,"type":4},"2005-10",{"date":551,"type":21},"2026-06",{"name":553,"class":99},"The University of Texas Health Science Center, Houston",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":4,"enrollmentInfo":561,"targetDuration":563,"studyType":61,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":51},"100375166","patient-trajectories-for-older-adults-admitted-to-hospital-for-alcohol-related-problems-100375166","NCT04164940","Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems","A Multi-centre Registry Study on Patient Trajectories After Interventions for Alcohol-related Health Problems in Somatic Hospital Wards, for People in Late Adulthood (60+)","Inclusion Criteria:\n\n* Age 21 or older, no previous alcohol use disorder or substance use disorder, admitted to hospital which has implemented screening and brief alcohol intervention strategies, written consent to participate\n\nExclusion Criteria:\n\n* specialized treatment for alcohol use disorder og drug use disorder during the three years prior to recruitment",{"count":562,"type":21},500,"3 Years","Alcohol is contributing to many health problems and disorders, as well as accidents and social problems. Alcohol consumption has been on the rise the past 25 years, especially in Norway. The highest increase is found in older adults, in line with the development in most other countries in the western world. Older adults have a higher risk for alcohol related health problems, due to age related physiological changes, medical conditions and medications. Still, alcohol use is seldom addressed for older people. This means that older people rarely receive help to change alcohol habits.\n\nNorwegian health authorities have issued mandates ordering the regional health trusts to implement strategies in somatic hospital wards, mental health services and drug treatment services to identify and treat alcohol and drug problems affecting the patients' health.\n\nIn this observational study we will explore patient trajectories three years prior to and three years after an admittance to hospital where risky or harmful alcohol consumption is identified and brief interventions are delivered. Hospitals that have implemented such strategies are invited to the study. Patient trajectories are studied in national health registries. This will provide important knowledge on what characterizes the patients identified, and what happens after they have received a brief intervention related to a hospital admittance.",[149,566,567,27],"Alcohol; Harmful Use","Health Risk Behaviors","2023-11-21",{"date":570,"type":43},"2023-11-24",{"date":572,"type":43},"2019-10-23",{"date":574,"type":21},"2030-12",{"name":576,"class":577},"Helse Stavanger HF","OTHER_GOV",{"id":579,"slug":580,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":16,"minAge":585,"maxAge":18,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":51},"100504927","trans-cranial-direct-current-stimulation-on-alcohol-craving-100504927","NCT05854693","Trans-cranial Direct Current Stimulation on Alcohol Craving","Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence","Inclusion Criteria:\n\n1. Be between 20-65 years of age\n2. have sufficient cognitive function to understand the study and complete the informed consent process\n3. Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.)\n\nExclusion Criteria:\n\n1. Intellectual disabilities\n2. bipolar disorder\n3. Psychosis (schizophrenia)\n4. Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures)\n5. intracorporeal electronic or metal implants (e.g., cardiac pacemaker)\n6. Pregnant or breastfeeding women\n7. Allergy to headgear and electrode materials\n8. Trauma or infection to the head\n9. Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis\n10. Patients who are expected to undergo brain and major surgery during the trial period","20 Years",{"count":587,"type":21},60,[24],"The goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol.\n\nParticipants will be randomized into active group and sham group. Researchers will compare the severity of craving in these groups.",[27],[592],"Transcranial Direct Current Stimulation, craving","2023-05-02",{"date":595,"type":43},"2023-05-11",{"date":597,"type":43},"2023-04-17",{"date":551,"type":21},{"name":600,"class":577},"Taipei City Hospital",{"id":602,"slug":603,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":608,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":616,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100431377","neurobiological-effects-of-transcranial-direct-current-stimulation-treatment-in-alcohol-use-disorder-100431377","NCT04897295","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder: a Sham-controlled Trial.","Inclusion Criteria:\n\n* diagnosis of Alcohol Use Disorder (at least 12 months);\n* drug free\u002Fstable psychopharmacological therapy (one month), with the exception of guidelines treatments for alcoholic abstinence (treatment-as-usual);\n* any assumption of substances for at least 48 hours.\n\nExclusion Criteria:\n\n* presence of organic pathologies (capable of interfering with the safety of the procedure) in comorbidities;\n* presence of intellectual disability;\n* history of epileptic seizures (also in first degree relatives);\n* score\\> 12 on the Young Mania Rating Scale (Y-MRS).",{"count":609,"type":21},30,[24],"Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption.\n\nObjectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use.\n\nEligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe).\n\nDesign: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation.\n\nParticipants will be screened with:\n\n* Psychometric Scales\n* Medical history\n* Physical exam\n* Urine tests and breathalyzer\n* After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo:\n* Psychometric Scales\n* Venous blood sample (BDNF\u002FproBDNF levels)\n\nParticipants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected.\n\nTreatment includes:\n\n* tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area.\n* BDNF\u002FproBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.\n* Repeat of screening tests and questionnaires\n* Urine toxicological screen and breathalyzer",[613,113,27,64,614,511,615],"Alcohol Use Disorder (AUD)","Drug Abuse","Mental Disorder",[30,617,618,619,620,621],"transcranial Direct Current Stimulation","Non-Invasive Brain Stimulation","Craving","Brain Derived Neurotrophic Factor","Pro-Brain Derived Neurotrophic Factor","2021-10-25",{"date":624,"type":43},"2021-10-26",{"date":626,"type":21},"2021-12-01",{"date":628,"type":21},"2026-11-30",{"name":630,"class":99},"ITAB - Institute for Advanced Biomedical Technologies"]