[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-life-adversity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-life-adversity":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100614354","phase-1-study-of-cannabidiol-and-neuroimaging-on-stress-100614354",false,"NCT07278505","Study of Cannabidiol and Neuroimaging on Stress","Pathophysiological Mechanisms of Cannabidiol in Stress Regulation","SCANS","Inclusion Criteria:\n\n* Ability to understand and give informed consent.\n* Individuals between 18 and 25 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).\n* English speakers.\n* Cognitive performance at threshold of greater than or equal to 23 as assessed by the Montreal Cognitive Assessment (MoCA).\n* Presence of ELA at threshold of at least one type of maltreatment measured by the Maltreatment and Abuse Chronology of Exposure (MACE) Scale and\u002For one type of maltreatment scored moderate\u002Fsevere as measured by the Childhood Trauma Questionnaire (CTQ)\n* Presence of moderate\u002Fheightened stress as measured with a score of greater than or equal to 14 on the Perceived Stress Scale and\u002For high trait anxiety at threshold score of greater than or equal to 40 as measured with the State-Trait Anxiety Inventory (STAI) and no greater than moderate anxiety scores (max. 14) as measured by the Generalized Anxiety Disorder-7 (GAD7)\n\nExclusion Criteria:\n\n* Have a medical condition that would make study participation unsafe, and\u002For which would make treatment compliance difficult, and\u002For would prevent adherence to study procedure. This includes but is not limited to the following criteria: history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures.\n* Meet criteria for any current psychiatric diagnosis as per DSM-5 \\[determined with the Mini International Neuropsychiatric Interview for DSM-5 (M.I.N.I. version 7.2)\\].\n* Using any psychoactive drug (other than nicotine and\u002For alcohol) in the past seven days (determined by lack of acute withdrawal symptoms, the negative result of a urine drug screen, timeline follow back, and alcohol breathalyzer to detect alcohol intoxication).\n* Positive urine drug screen (tetrahydrocannabinol, cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, buprenorphine, methylenedioxymethamphetamine)\n* Use of cannabis products, including CBD, during the past three weeks (determined with urine screen and self-report). Urine drug screen will be performed at each encounter. (Note: Epidiolex is known to sometimes cause a false positive for THC on urine toxicology; drug screen in visit after first CBD administration will not include THC as not to diminish the study blind. Stored urine will be tested for THC after study blind is opened).\n* Use of medication altering BOLD response, neurometabolic\u002Fglutamatergic levels, and endocrine function, including psychotropic medications (e.g., SSRIs), during the past three months.\n* Participation in non-medication-based treatments for anxiety or heightened stress, including cognitive behavioral therapy or other evidence-based treatments, in the past three months.\n* Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids) or any of the ingredients in the product (sesame oil).\n* Being pregnant or breastfeeding.\n* Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e., condom, spermicide, diaphragm).\n* Participating in another pharmacotherapeutic trial in the past three months.\n* History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x normal AST\u002FALT, 1.5x bilirubin or \\\u003C30mL\u002Fmin\u002F1.73m2 eGFR, or QTc\\>500.\n* Participants who have used any medication, dietary supplements (and\u002For grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.\n* Any condition that would make study participation unsafe and\u002For which would prevent adherence to study procedure (e.g., suicidal or homicidal ideation requiring immediate attention, severe inadequately treated mental health condition) as determined by the study clinician and\u002For PI.",true,"ALL","18 Years","25 Years",{"count":22,"type":23},160,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE1","PHASE2","Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational neuroscience study in a clinical high-risk population to define the roles of CBD in stress response with mechanisms of mesocorticolimbic-network function and hierarchy, neurometabolic, endocrine, and behavior, building upon convergent evidence from animal models and human evidence from our laboratories.",[30,31,32],"Early Life Adversity","Trauma","Stress",[34,35,32,31,36,37],"Cannabidiol","Childhood Trauma","Anxiety","Adversity","RECRUITING","2025-12-03",{"date":41,"type":42},"2025-12-12","ACTUAL",{"date":44,"type":42},"2025-10-28",{"date":46,"type":23},"2030-02-28",{"name":48,"class":49},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":62,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":50},"100587006","between-the-belly-and-the-brain-distorted-gut-brain-crosstalk-in-early-life-adversity-100587006","NCT06922773","Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity","BellyBrain","Inclusion Criteria:\n\n* Primary school-aged children (6 to 13 years of age) who have experienced at least one early-life traumatic event, based on the Childhood Trust Events Survey (CTES) questionnaire\n* The child and at least one of his\u002Fher parents (or guardian) speak Dutch sufficiently well to complete all of the questionnaires and the semi-structured child psychiatric interview (SCID-5-Junior)\n\nExclusion Criteria:\n\n* any chronic disorders or diseases known to affect the gut micobiome\n* inablity to complete questionnaires and\u002For semi-structured interview because of linguistic and\u002For cognitive barrier\n* congenital or acquired immunodeficiencies\n* use of medication(s) that affect gastrointestinal function (e.g., antibiotics) within the last 6 weeks, or laxatives within the last 4 weeks, or probiotic or prebiotic supplements within the last 4 weeks\n* current involvement in another clinical or food study","6 Years","13 Years",{"count":61,"type":23},50,"1 Month","OBSERVATIONAL","The goal of this observational study is to learn about the effects of early-life adversity (ELA) on the composition of children's microbiome and on their psychosocial functioning. The main questions it aims to answer are:\n\n* Do children who have experienced ELA have lower gut microbial diversity and\u002For an altered gut microbial composition?\n* Do these microbiome alterations correlate with adverse neurodevelopmental outcomes, including increased levels of stress, social and\u002For affective problems?",[30,66,67,68,69],"Microbiome, Human","Anxiety Symptoms","Depressive Symptoms","Posttraumatic Stress Symptoms",[71,72,73,74,75],"early life adversity","gut microbiome","anxiety symptoms","depressive symptoms","posttraumatic stress symptoms","NOT_YET_RECRUITING","2025-04-03",{"date":79,"type":42},"2025-04-10",{"date":81,"type":23},"2025-05",{"date":83,"type":23},"2026-06",{"name":85,"class":49},"Universitair Ziekenhuis Brussel"]