[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anders Fink-Jensen, MD, DMSci\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100633203","phase-2-effect-of-semaglutide-on-cannabis-use-in-adults-with-cannabis-use-disorder-100633203",false,"NCT07523633","Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder","A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder","HASHTAG","Inclusion Criteria:\n\n1. Informed oral and written consent.\n2. Meets the criteria for cannabis use disorder (CUD) according to DSM-5 or ICD-10.\n3. Currently seeking to cut down or stop cannabis use.\n4. Positive urine test for cannabinoids.\n5. Body mass index (BMI) ≥ 23 kg\u002Fm².\n6. Age 18-70 years.\n7. Recent frequent cannabis use, defined as use on ≥16 days out of the past 28 days.\n8. Cannabis use (smoked, vaped, edibles) equivalent to THC doses of ≥14 grams in the past 28 days before baseline.\n9. Ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Currently meeting non-cannabis\u002Ftobacco substance use disorder (ICD-10 or DSM-5).\n2. Current or past diagnosis of severe psychiatric illness, defined as schizophrenia, bipolar disorder, or other psychoses, within the past five years.\n3. Suicide attempt or suicidal behavior within the past five years.\n4. Severe neurological disorders, including previous severe traumatic brain injury, stroke, or intracranial hemorrhage.\n5. Type 1 diabetes and type 2 diabetes.\n6. Pregnant or potentially pregnant women: Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, planning to become pregnant within the next eight months (including 20 weeks of treatment plus two months after discontinuation of semaglutide), or not using effective contraception throughout the study period. Effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, implant, injection), intrauterine device\u002Fsystem (IUD\u002FIUS), bilateral tubal occlusion, partner with vasectomy, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level \\>3 U\u002FL at inclusion will also be excluded.\n7. Impaired liver function (liver transaminases \\>3 times the upper reference limit)\n8. Impaired renal function (eGFR \\\u003C50 ml\u002Fmin and\u002For plasma creatinine \\>150 µmol\u002FL).\n9. Impaired pancreatic function (past or current acute or chronic pancreatitis and\u002For amylase \\>2 times the upper limit).\n10. History of medullary thyroid carcinoma (MTC) and\u002For family history of MTC and\u002For Multiple Endocrine Neoplasia type 2 (MEN 2).\n11. Heart disease is defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, and\u002For myocardial infarction within the past 12 months.\n12. Uncontrolled hypertension (systolic blood pressure \\>180 mmHg, diastolic blood pressure \\>110 mmHg).\n13. Receipt of experimental medication within the past 30 days.\n14. Use of weight-loss medication within the past 3 months.\n15. Hypersensitivity to the active substance or any of the excipients.\n16. For patients undergoing brain scanning only:\n\n    Contraindications to MRI scanning (magnetic implants, pacemaker, claustrophobia, etc.).\n17. Inability to speak and\u002For understand Danish.\n18. Other conditions: Any other condition that, in the investigator's opinion, may interfere with participation in the trial.","ALL","18 Years","70 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The HASHTAG Study is investigating whether the medicine semaglutide can help adults with cannabis use disorder (CUD) reduce their cannabis use. Participants will be randomly assigned to receive either semaglutide or a placebo. The first 50 participants will have functional brain scans (fMRI) to investigate how the brain responds to cannabis-related cues. The main outcome after 20 weeks is whether semaglutide reduces cannabis use compared to placebo. Changes in brain activity in response to cannabis cues will be explored as a secondary outcome.",[28,29,30,31,32],"Cannabis Use Disorder","Cannabis Use Disorders","Cannabis Abuse","Cannabis Dependence","Cannabis Addiction",[34,35,36,37,38,39,40,41,42,43,44,45,46,47],"GLP-1","Glucagon-like peptide 1","semaglutide","fMRI","cannabis","GLP-1 receptor agonist","Randomized Controlled Trial","Double-Blind Method","Placebo-Controlled","Neuroimaging","Brain activity","Cue reactivity","Craving","Drug therapy","RECRUITING","2026-05-12",{"date":51,"type":52},"2026-05-14","ACTUAL",{"date":54,"type":52},"2026-04-30",{"date":56,"type":22},"2028-04-30",{"name":58,"class":59},"Anders Fink-Jensen, MD, DMSci","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":82,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"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":70,"type":22},108,[25],"Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide\u002FGLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied.\n\nThe key anticipated outcomes include:\n\n* decreased alcohol consumption and\n* reduced alcohol cue-induced brain activity in the GIP\u002FGLP-1-treated patient group compared with the placebo group. To the best of the investigators knowledge, this has never been examined before.",[74,75,76,77,78,79,80,81],"Alcohol Use Disorder","Alcohol Abuse\u002FDependence","Alcohol Dependence","Alcoholism","Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[34,35,37,83,84,85,86,87,88,89,90],"GIP","Glucose-dependent Insulinotropic Polypeptide","Tirzepatide","Mounjaro(R)","schizophrenia","alcohol","alcohol use disorder","dual diagnosis","2026-02-05",{"date":93,"type":52},"2026-02-10",{"date":95,"type":52},"2025-05-05",{"date":97,"type":22},"2028-12-31",{"name":58,"class":59},2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":60},"100582674","involvement-of-the-septal-nuclei-of-the-human-brain-in-alcohol-use-disorder-100582674","NCT06866379","Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder","Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder - a Functional Magnetic Resonance Imaging Study","Inclusion criteria:\n\n* Diagnosed with alcohol use disorder (AUD) according to DSM-5, and alcohol dependence according to ICD-10\n* An Alcohol Use Disorder Identification Test (AUDIT) score ≥ 15\n* At least six heavy drinking days for the last 30 days, measured with the Time Line Follow Back (TLFB) method\n\nExclusion criteria:\n\n* Diagnosis of schizophrenia spectrum disorder, paranoid psychosis, bipolar disorder, or mental retardation\n* Previous or current substance use disorder other than AUD and nicotine use disorder\n* History of alcohol withdrawal seizures within the past 5 years\n* Alcohol withdrawal symptoms defined as a CIWA-Ar score \\> 9 at screening or at the fMRI session\n* Treatment with chlordiazepoxide or other benzodiazepine within the past 30 days\n* Other pharmacological treatment for AUD within the past 30 days\n* Treatment with GLP-1 analogues within the last 6 months\n* Urine tests positive for psychoactive drugs (cocaine, amphetamine, TCH, methadone, opioids, and benzodiazepines) at screening\n* DUDIT score ≥ 2\u002F6 for females\u002Fmales\n* Contraindications for undergoing an fMRI scan (magnetic implants, metal splinters, pacemaker, claustrophobia, etc.)\n* Females of childbearing potential who are either pregnant, breastfeeding or have the intention of becoming pregnant within the next month or are not using contraception appropriate for participating in a clinical study\n* Pregnancy (positive urine pregnancy test)\n* Unable to speak or understand Danish\n* Any condition that the investigator feels would interfere with trial participation","30 Years","65 Years",{"count":110,"type":22},25,[112],"NA","Alcohol activates reward systems in different brain areas, i.e., the nucleus accumbens, dorsal striatum, extended amygdala, and prefrontal cortex. These areas are all part of the reward neurocircuitry, which plays an important role in the development of addiction.\n\nA former study performed on rodents has shown that a specific area of the forebrain, the septal nuclei, is associated with the feeling of reward and, hence, addiction when stimulated. However, whether the septal area is involved in reward and addiction in humans is sparsely investigated.\n\nThe purpose of this brain-imaging study is to assess how the septal nuclei react to alcohol-related pictures shown to participants diagnosed with alcohol use disorder while lying in an MRI scanner, compared to people without a diagnosis of alcohol use disorder. This might give us a better understanding of how the septal nuclei is involved in reward and addiction.",[74],[116,117,118,37,119],"Alcohol use disorder","AUD","septum","Brain imaging","2025-06-10",{"date":122,"type":52},"2025-06-11",{"date":124,"type":52},"2025-05-07",{"date":126,"type":22},"2025-11-30",{"name":58,"class":59},""]