[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-stress-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-stress-reaction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,73,105,132,155,178,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641647","the-efficacy-of-vitamin-d-supplementation-to-sustain-performance-outcomes-100641647",false,"NCT07654777","The Efficacy of Vitamin D Supplementation to Sustain Performance Outcomes","Assessment of the Efficacy of Vitamin D Supplementation to Sustain Performance of Military-Relevant Laboratory Tasks Under Acutely Stressed Conditions: A Randomized, Double-Blind, Placebo-Controlled Study","Inclusion Criteria:\n\n* Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age.\n* Females of child-bearing potential must be using some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)\n* Score of 80% or greater on a \"Volunteer Comprehension Assessment\" test. A maximum of two attempts is permitted.\n* Blood 25 hydroxy vitamin D \\[25(OH)D\\] levels at the Screening visit of 30 nmol\u002FL (12 ng\u002FmL) (inclusive) - \\\u003C 75 nmol\u002FL (30 ng\u002FmL).\n\nExclusion Criteria:\n\n* Contraindications due to vitamin D supplementation, including a history of hypercalcemia, malabsorption syndrome, hypervitaminosis D, or allergic\u002Fhypersensitivity reactions to vitamin D or a history of other adverse reactions to vitamin D supplementation.\n* Taking a vitamin D3 or D2 supplement or a supplement containing vitamin D3 or D2 (excluding vitamin D-fortified foods) during the participation. Volunteers who take vitamin D3 or D2 supplement before their participation can be eligible if they agree to stop taking the supplement(s) starting 1 month prior to the enrollment\u002Fbaseline visit until the end of the post-supplementation visit. Blood 25(OH)D levels of the volunteers who stopped taking the supplements after the screening visit will be tested before the Enrollment\u002FBaseline visit to ensure their 25(OH)D fall within the inclusionary ranges. Volunteers who are not able to stop taking vitamin D supplements or supplements containing vitamin D due to medical\u002Fhealth or any other reasons (especially if the volunteer is taking supplements containing vitamin D under the direction of a healthcare provider) are not eligible.\n* Not being able to tolerate electric shocks delivered through the stress belt.\n* Self-reported propensity for adverse skin reactions, such as excessive irritation, burning, itching, hives, and redness, in response to physical or heat stimuli.\n* A history of abuse or addiction to recreational or illicit drugs (including marijuana and alcohol) or prescribed medications (e.g., opioids) (diagnosed or suspected based on the medical history).\n* Use a nicotine product (e.g., cigarette, cigar, vape) more than 3 days per week or not be able to go without using these products during any lab visits.\n* Self-reported caffeine use in excess of 600 mg (e.g., approximately 10 caffeinated sodas or approximately 29 ounces of brewed coffee) per day on average or not being able to go without caffeine during the in-lab visits.\n* History of neurologic disorder (to include but not limited to epilepsy, hydrocephalus, multiple sclerosis). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) or a history of mild traumatic brain injury may be deemed non-exclusionary at the discretion of the examining study medical investigator.\n* Score of 10 or above on the Beck Depression Inventory (BDI) or a score of \\> 0 on item 9 \"Suicidal Thoughts or Wishes\" of the BDI.\n* Score of 33 or above on the Posttraumatic Stress Disorder (PTSD) Checklist, 5th Edition.\n* Score 20 or above on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety-7-Item Short form.\n* History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction).\n* Asthma, any type of reactive airways disease, or any pulmonary disease requiring daily inhaler use.\n* Regularly work night shifts or have a habitual sleep\u002Fwake schedule that is not conducive for the optimal performance on cognitive, physical, and\u002For emotional tasks during the study visits (e.g., extremely early or late habitual bedtime or rise time; to be determined on a case-by-case basis by the principal investigator or an associate investigator).\n* A diagnosis of sleep apnea.\n* Kidney disease or kidney abnormalities, liver disease or liver abnormalities, or any other metabolic derangements (endocrine disorders, hyperglycemia, etc.) that could alter neurophysiological function.\n* History of kidney stones.\n* Osteoporosis or low bone density.\n* Self-reported history of hospitalization for a psychiatric disorder within the past year or with a previous history of a psychotic, bipolar disorder or personality disorder. For a history of a diagnosis of any other psychiatric disorder, the potential participant's symptoms must either be resolved to a degree that a diagnosis is no longer applied or their symptoms must have been stabilized by pharmacological or nonpharmacological treatments for a period of at least 90 days or greater as deemed exclusionary or non-exclusionary at the discretion of the examining study medical investigator.\n* Self-reported or suspected current use of antipsychotics, anticonvulsants, or mood stabilizers, to be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected current use of products or drugs that have central nervous system depressant effects, to be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected use of products or drugs that are contraindicated to the study supplement or significantly affect the participant's study performance and that cannot be safely discontinued during the study participation. To be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected current heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week for males and 7 drinks per week for females or as determined by the examining study medical investigator).\n* (Females only) Positive urine pregnancy test result.\n* (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk.\n* Resting blood pressure above 140\u002F90 or resting pulse \\> 110 beats per minute.\n* Body Mass Index (BMI) ≥ 31. The inclusion of individuals with BMI between 30 and 31 (Obese Class I) will be determined using medical investigator's discretion.\n* Clinically significant values (as determined by the reviewing study medical investigator) for any hematology or chemistry parameter.\n* Positive urine drug result at any study visits. If tetrahydrocannabinol is positive at the screening visit and the volunteer wishes to have the second drug test, the volunteer will be allowed to have one additional urine drug test after a 1 to 5-month waiting period.\n* Positive saliva alcohol result at any study visits.\n* Inability to read (i.e., failing in the Volunteer Comprehension Assessment twice) and sign consent.\n* Failure to obtain required approved official leave to participate (federal civilian employees and active-duty military only).\n* Failure to cooperate with requirements of the study.\n* Self-reported or suspected current use of illicit drugs (including but not limited to benzodiazepines, amphetamines, and cocaine). In case of marijuana\u002Ftetrahydrocannabinol product use, the frequency up to twice a month will not be excluded. Current use of any other drugs at any frequency is excluded.\n* Current use and\u002For prescription for any medication the medical investigator determines would interact adversely with vitamin D supplementation, including but not limited to: orlistat, statins, corticosteroid medications, and thiazide diuretics.\n* Current diabetes.\n* Gastrointestinal disorders - motility disorders that might affect vitamin D absorption.\n* Failure to provide a social security number or tax identification number in order to be paid for screening and participation in the study.\n* Current participation in another ongoing clinical trial.\n* Prior participation in this study.",true,"ALL","18 Years","40 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to find out if vitamin D supplements help healthy adults maintain their cognitive and simple physical task performance and emotional state during highly stressful situations.\n\nThe main question it aims to answer is:\n\n\\- Does vitamin D help maintain cognitive and physical task performance and emotional state during highly stressful situations?\n\nResearchers will compare vitamin D to placebo (a look-alike tablet that contains no active ingredients) to see if vitamin D better maintain cognitive and physical task performance and emotional state during highly stressful situations.\n\nParticipants will:\n\n* Take vitamin D or placebo tablets daily for 8 weeks.\n* Perform cognitive and simple physical tasks and rate their emotional state under highly stressful situations.\n* Wear a stress belt that delivers mild electric shocks 1 - 5 times while participants are performing laboratory tasks.\n* Wear a wristwatch-shaped activity monitor for 9 weeks.\n* Visit the laboratory 5 times.",[28],"Acute Stress Reaction",[30,31,32,33,34],"acute stress reaction","vitamin D","electrical shocks","neuropsychological tests","randomized controlled trial","RECRUITING","2026-06-15",{"date":38,"type":39},"2026-06-17","ACTUAL",{"date":41,"type":22},"2026-06",{"date":43,"type":22},"2027-09",{"name":45,"class":46},"Walter Reed Army Institute of Research (WRAIR)","FED",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100591573","phase-4-the-effects-of-propranolol-and-hydrocortisone-on-military-relevant-performance-outcomes-100591573","NCT06982183","The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes","The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes: A Randomized, Blinded, Placebo Controlled Study","Inclusion Criteria:\n\n* Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age.\n* Females of child-bearing potential must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)\n* Score of 80% or greater on a \"Volunteer Comprehension Assessment\" test.\n* Score equal to or greater than 54 on the Fear of Spiders Questionnaire.\n* Body weight between 91 and 250 pounds (inclusive).\n* Live close enough to be able to commute to Walter Reed Army Institute of Research during the study participation.\n\nExclusion Criteria:\n\n* Contraindications due to study medications, including a history of allergic\u002Fhypersensitivity reactions to a beta blocker or a steroid, or a history of other adverse reactions to these classes of drugs (such as an episode of steroid psychosis).\n* A history of allergic reactions to a spider bite.\n* A history of abuse or addiction to illicit drugs (including marijuana) or prescribed medication (e.g., opioid) (diagnosed or suspected based on the medical history).\n* Use a nicotine product (e.g., cigarette, cigar, vape) more than 3 days per week.\n* Self-reported caffeine use in excess of 600 mg (e.g., approximately 10 caffeinated sodas or approximately 29 ounces of brewed coffee) per day on average or not being able to go without caffeine during the In-Lab visits.\n* History of neurologic disorder (to include but not limited to epilepsy, hydrocephalus, MS). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) or a history of mild traumatic brain injury may be deemed non-exclusionary at the discretion of the examining study medical investigator\n* Score of 10 or above on the Beck Depression Inventory (BDI) or a score of \\> 0 on item 9 \"Suicidal Thoughts or Wishes\" of the BDI\n* Score of 41 or above on the State-Trait Anxiety Inventory - Trait (STAI-T).\n* Score of 20 or above on the PROMIS Emotional Distress - Anxiety - Short Form.\n* Score of 33 or above on the PTSD Checklist, 5th Edition (PCL-5)\n* History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction).\n* A history of asthma or any type of reactive airways disease or any acute or chronic pulmonary disorder that could lead to a compromise of blood oxygenation in the setting of a modest reduction in tidal volume or respiratory rate, to include neuromuscular disorders.\n* Regularly work night shifts or have a habitual sleep\u002Fwake schedule that is not conducive to compliance with the recommended sleep time (11:00 pm - 6:00 am) during participation (e.g., extremely early or late habitual bedtime or rise time, to be determined on a case-by-case basis by the principal investigator or an associate investigator).\n* A diagnosis of sleep apnea.\n* Kidney disease or kidney abnormalities, liver disease or liver abnormalities, or any other metabolic derangements (endocrine disorders, hyperglycemia, etc.) that could alter neurophysiological function.\n* Liver disease or significant liver abnormalities as determined by examining study medical investigator.\n* Self-reported history of hospitalization for a psychiatric disorder within the past year or with a previous history of a psychotic, bipolar disorder or personality disorder. For a history of a diagnosis of any other psychiatric disorder, a potential participant's symptoms must either be resolved to a degree that a diagnosis is no longer applied or their symptoms must have been stabilized by pharmacological or nonpharmacological treatments for a period of at least 90 days or greater as deemed exclusionary or non-exclusionary at the discretion of the examining study medical investigator.\n* Self-reported or suspected current use of antipsychotics, anticonvulsants, or mood stabilizers, to be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected current use of products or drugs that have CNS depressant effects, to be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining study medical investigator.\n* Self-reported or suspected current heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week for males and 7 drinks per week for females or as determined by the examining study medical investigator).\n* (Females only) Positive urine pregnancy result\n* (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk.\n* Resting blood pressure above 140\u002F90 or resting pulse \\> 110 beats per minute. Note that if a repeat measurement is within range, the volunteer will not be excluded.\n* Resting blood pressure below 100\u002F60 or pulse oxygenation \\\u003C92%. Volunteers with a resting pulse \\\u003C 60 bpm will be excluded unless a history of regular vigorous aerobic exercise and findings on the physical examination (including BMI) suggest a high level of cardiovascular fitness, in which case a resting pulse in the range of 50 - 59 bpm may not be exclusionary.\n* BMI ≥ 31. The inclusion of individuals with BMI between 30 and 31 (Obese Class I) will be determined using medical investigator's discretion.\n* Clinically significant values (as determined by the reviewing study medical investigator) for any hematology or chemistry parameter. Reviewing study medical investigator may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.\n* Currently on or recently ended immunotherapy (e.g., allergy shots).\n* Have taken a vaccine within 30 days prior to enrollment to the study. For volunteers who report recently taking a vaccine during the screening visit, their In-Lab Day 1 visit will be scheduled at least 30 days after the date of the most recent vaccination.\n* Positive urine drug result during screening visit or In-Lab Days 1- 2; Exhibiting behaviors consistent with illicit drug use on In-Lab Day 3.\n* Positive saliva alcohol result during screening visit or In-Lab Days 1-3.\n* Inability to read and sign consent.\n* Failure to obtain required approved official leave to participate (federal civilian employees and active duty military only)\n* Failure to cooperate with requirements of the study\n* Failure to provide viable emergency contact(s) for the duration of the study\n* Self-reported or suspected current use of illicit drugs (including but not limited to benzodiazepines, amphetamines, cocaine, marijuana).\n* Current use and\u002For prescription for opioid, steroid or anti-hypertensive and\u002For any medication the Medical Investigator deems would interact adversely with study compounds.\n* Current use of medications that can adversely interact with propranolol, hydrocortisone and\u002For morphine to include anti-depressants that are cytochrome P450 2D6 inhibitors.\n* Current diabetes.\n* GI disorders - motility disorders\n* Failure to pass certain tests\n* Failure to provide a social security number or tax identification number in order to be paid for screening and participation in the study.\n* Current participation in another ongoing clinical trial",{"count":56,"type":22},88,[58],"PHASE4","This clinical trial aims to evaluate the nature and duration of effects of three FDA-approved medications (propranolol and hydrocortisone) on military-relevant cognitive, emotional, and motor performance following an exposure to a stressful situation (i.e., exposure to a tarantula) in physically healthy adult volunteers (aged 18 - 40) with fear of spiders to help the future development of medications for treating Acute Stress Reactions.\n\nThe main questions this study aims to answer are:\n\nWill placebo treatment (oral placebo) result in significant decrements in Psychomotor Vigilance Task (PVT) performance compared to propranolol treatment?\n\nWill placebo treatment \\[intramuscular (IM) placebo\\] result in significant decrements in PVT performance compared to hydrocortisone treatment?\n\nParticipants will receive one of five study medications (oral propranolol, oral placebo, IM hydrocortisone, or IM placebo) after a brief exposure to a tarantula. Participants will complete cognitive and simple motor tasks and psychological assessments before and after the study medication administration.",[61,28],"Fear of Spiders",[61,63,64,34,33,30],"propranolol","hydrocortisone","2026-05-08",{"date":67,"type":39},"2026-05-13",{"date":69,"type":39},"2025-05-27",{"date":71,"type":22},"2026-09",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100633645","breathwork-and-stress-investigating-the-mechanisms-of-action-and-effectiveness-of-breathing-interventions-in-modulating-the-psychophysiological-response-to-acute-stress-test-100633645","NCT07529379","Breathwork and Stress: Investigating the Mechanisms of Action and Effectiveness of Breathing Interventions in Modulating the Psychophysiological Response to Acute Stress Test","Inclusion Criteria:\n\n* Healthy adults\n* Aged 18 to 60 years\n* Willingness to participate in all study phases, including preparation and laboratory session.\n* Professionally active individuals or university students.\n\nExclusion Criteria:\n\n* Severe chronic diseases, including metabolic disorders (e.g., diabetes) and mental disorders.\n* Cardiac arrhythmia, history of heart attacks, strokes, or heart surgery.\n* Regular use of medications such as anxiolytics or beta-blockers (excluding hormonal contraception)\n* Pregnancy.\n* Current participation in other scientific experiments.\n* Significant previous experience with breathing techniques or current independent breathwork\u002Fmeditation practice (defined as regular practice for more than 7 days in total within the last 12 months).\n* Professional sports practice.\n* Raynaud's disease\n* Inability to abstain from alcohol, caffeine, and nicotine for the required periods before the experiment","60 Years",{"count":81,"type":22},120,[25],"This study investigates whether the psychophysiological benefits of breathing exercises are driven by a specific physiological rhythm (6 breaths per minute) or by the general psychological experience of performing a structured, mindful activity. Researchers aim to determine if \"coherent breathing\", which is hypothesized to synchronize heart and respiratory rhythms, offers unique physiological protection against stress compared to breathing at a natural pace or simple resting. The main questions it aims to answer are:\n\n* Does slow, steady breathing at 6 breaths per minute lower physical stress markers (like heart rate variability and cortisol) better than faster, but structured breathing or just sitting still?\n* Is the calming effect caused by the specific breathing rhythm or simply by performing a structured, relaxing activity?\n\nResearchers will compare three groups to see if the specific rhythm of \"coherent breathing\" offers unique benefits:\n\n1. Group (Interventional): Coherent Breathing: Slow breathing at 6 breaths per minute.\n2. Group (Sham Breathing): Regular breathing at 15 breaths per minute (matching a natural pace).\n3. Spontaneous Breathing (Control Group): Natural, unguided breathing.\n\nParticipants will:\n\n* Complete a one-day preparation phase to become familiar with the breathing technique.\n* Visit the research center for one experimental session.\n* Perform their assigned breathing method before and after a stress test.\n* Take the Maastricht Acute Stress Test (MAST), which involves putting a hand in cold water and doing mental math.\n* Provide saliva samples and have their heart rate variability, and mood measured multiple times.",[85,28,86,87],"Healthy Adult Participants","Stress Biomarkers","Healthy",[89,90,91,92,93,94],"Breathwork","Coherent Breathing","Resonance Breathing","Heart Rate Variability","Maastricht Acute Stress Test (MAST)","Cortisol","2026-04-16",{"date":97,"type":39},"2026-04-21",{"date":99,"type":22},"2026-04",{"date":101,"type":22},"2026-11",{"name":103,"class":104},"Medical University of Bialystok","OTHER",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100588592","phase-2-bxcl501-after-stress-to-increase-recovery-success-100588592","NCT06943404","BXCL501 After Stress to Increase Recovery Success","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)","RISE","Inclusion Criteria:\n\n1. ≥ 18 years and ≤ 65 years of age\n2. Admitted to ED within 72 hours of MVC\n3. Anticipated to be discharged home from the ED\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n5. Consent to receive unencrypted communications\n6. Has a smartphone with continuous service for ≥ 1 year\n7. Has a personal email address they regularly access\n8. Able to speak and read English\n9. Females of childbearing potential (not surgically sterilized (tubal ligation\u002Fhysterectomy) or not post-menopausal (no menstrual period for \\> 12 months)) must be willing to use a medically acceptable and effective birth control method for 3 months before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms\n\nExclusion Criteria:\n\n1. Substantial comorbid injury (e.g., long bone fracture)\n2. People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation\n3. Prisoner status\n4. Chronic daily opioid use prior to MVC (\\> 20 mg oral daily morphine equivalents)\n5. Bipolar disorder, psychotic disorder, active psychosis, suicidal ideation, or homicidal ideation\n6. Hospital admission\n7. Clinically significant history of cardiac disease including (a) history of syncope or other syncopal attacks; (b) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10mm Hg within 3 minutes); (c) resting heart rate of \\\u003C55 beats per minute; (d) systolic blood pressure \\\u003C110mmHg or diastolic BP \\\u003C70mmHg; (e) participants with a QTC interval \\>440msec (males) or \\>460msec (females) not in sinus rhythm; or 1st, 2nd or 3rd degree hearth block; or (f) history of severely impaired ventricular function (ejection fraction \\\u003C 30%).\n8. Hypomagnesia (\\\u003C1.7 mg\u002FdL) or hypokalemia (\\\u003C 3.0 mEq\u002FL)\n9. Substantial hepatic impairment (e.g. AST or ALT \\> 3 times the upper limit of normal or history of cirrhosis).\n10. Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative\u002Fhypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); d) adrenergic agents prescribed for other reasons (prazosin); e) or medications known to cause QT prolongation. (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD)\n11. Hypersensitivity or history of allergic reaction to dexmedetomidine\n12. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)\n13. Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)\n14. Participation in any other clinical trial of a pharmacological agent within 30 days prior to screening.","65 Years",{"count":115,"type":22},100,[117],"PHASE2","This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats\u002Freduces ASR\u002FASD symptoms (primary outcome), improves neurocognitive function, and prevents\u002Freduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.",[28,120,121],"Acute Stress Disorder","Post-traumatic Stress Disorder","2026-04-09",{"date":124,"type":39},"2026-04-14",{"date":126,"type":39},"2026-02-23",{"date":128,"type":22},"2026-09-29",{"name":130,"class":104},"University of North Carolina, Chapel Hill",3,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":154},"100565023","phase-2-preventionreduction-of-asrs-and-ptsd-to-sustain-civilian-performance-with-sublingual-cyclobenzaprine-hcl-tnx-102-sl-100565023","NCT06636786","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) - (Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS)","OASIS","Inclusion Criteria:\n\n1. ≥ 18 years and ≤ 55 years of age\n2. Presentation to ED within 72 hours of MVC\n3. Anticipated to be discharged home from the ED\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n5. Consent to receive unencrypted communications\n6. Has a smartphone with continuous service for ≥ 1 year\n7. Has a personal email address they regularly access\n8. Able to speak and read English\n9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)\n10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)\n11. People with the capacity to conceive a pregnancy must agree to employ a highly effective form of birth control throughout the first 21 days of study participation (e.g., oral, injected, transdermal, or implanted hormonal methods of contraception for at least one full menstrual cycle prior to study drug administration; placement of an intrauterine device (IUD) or intrauterine system (IUS); or double barrier methods such as condoms and diaphragms)\n\nExclusion Criteria:\n\n1. Substantial comorbid injury (e.g., long bone fracture)\n2. People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation\n3. Prisoner status\n4. Any chronic daily opioid use prior to MVC\n5. Active psychosis, suicidal ideation, or homicidal ideation\n6. Plans for hospital admission\n7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure\n8. Currently in the acute recovery phase of myocardial infarction\n9. Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations\n10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (TSH \\\u003C lower limit of normal)\n11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions\n12. Current or planned use of the following prohibited concomitant medications during study participation: anticholinergic medications, guanethidine, selective serotonin reuptake inhibitors (SSRIs) , serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, MAO inhibitors, anticholinergic medications, guanethidine, potent cytochrome P450 subtype 3A4 inhibitor, St. John's wort, chronic use muscle relaxants or planned use after MCV or other prohibited concomitant medications listed in section 5.6. PI to assess individual cases where single dose of muscle relaxant is prescribed in ED for inclusion\n13. Any hepatic impairment or renal disease (defined as AST OR ALT \\> 3 times the upper limit of normal) or renal disease (defined as GFR ≤ 80 mL\u002Fmin)\n14. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)\n15. Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)\n16. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg and or elevated heart rate of ≥115\n17. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc \\> 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated\n18. Substance or alcohol use disorder, bipolar disorder, or schizophrenia\n19. History of severe or unexplained oral, or oropharyngeal swelling or edema","55 Years",{"count":142,"type":22},180,[117],"This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats\u002Freduces acute stress reaction (ASR)\u002Facute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents\u002Freduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.",[28,120,146,147],"Neurocognitive Function","Post-traumatic Stress",{"date":149,"type":39},"2026-04-13",{"date":151,"type":39},"2025-03-25",{"date":71,"type":22},{"name":130,"class":104},9,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":47},"100631975","impact-of-metacalm-on-stress-of-healthy-people-with-acute-stress-100631975","NCT07507669","Impact of MetaCalm on Stress of Healthy People With Acute Stress","Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study","Inclusion Criteria:\n\n* Providing written informed consent\n* Males and females of at least 18 years old\n* Obtaining a reference score of ≥ 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)\n\nExclusion Criteria:\n\n* Being on anxiolytic and beta blocker treatment\n* Individuals who use illicit or recreational drugs\n* Having consumed adaptogen plants in one week prior to enrollment\n* Participating in another clinical trial\n* Patients diagnosed with cancer\n* Allergic to any of the ingredients in this product\n* Obtaining a reference score of less than 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)",{"count":163,"type":22},280,[25],"This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.",[167,28],"Adults","NOT_YET_RECRUITING","2026-04-08",{"date":149,"type":39},{"date":172,"type":22},"2026-04-15",{"date":174,"type":22},"2026-08-31",{"name":176,"class":177},"Metagenics, Inc.","INDUSTRY",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100553167","promoting-improved-functioning-among-people-experiencing-stressful-situations-100553167","NCT06482567","Promoting Improved Functioning Among People Experiencing Stressful Situations","iCOVER","Inclusion Criteria:\n\n* ≥ 18 years and ≤ 50 years of age (if age not known, appears to be)\n* In the emergency department as a patient or loved one of a patient\n* If a patient, anticipated to be discharged to home from the emergency department after evaluation\n* Exhibiting visible signs of distress Richmond Agitation and Sedation Scale ((RASS) (+1 to +3)) or dissociation (awake and alert but reduced responsiveness)\n* Likely able to speak English\n\nExclusion Criteria:\n\n* Known pregnancy\n* Prisoner or in custody\n* Known history of psychosis or bipolar disorder\n* Known or suspected drug intoxication\n* Known history of substantial cognitive impairment\n* Known or suspected altered mental status due to traumatic brain injury\n* Known active psychosis, suicidal ideation, or homicidal ideation\n* Unable to use both hands (e.g. due to sprain)\n* Any other history or condition that would, in the site investigator's judgement, indicate that the individual would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger participant)","50 Years",{"count":187,"type":22},450,[25],"The iCOVER intervention was developed to rapidly restore functioning in individuals experiencing an Acute Stress Reaction (ASR). iCOVER is undergoing widespread adoption but has not been tested for efficacy. iCOVER was designed to be administered by peers, paraprofessionals, or medical personnel in 60-120 seconds, including in military operational environments. The term iCOVER is an acronym that summarizes the six specific steps of the intervention: (1) identify that an individual is experiencing an ASR; (2) Connect with the individual through word, eye contact, and physical touch to draw them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., \"I'm right here with you\"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish order of events - briefly review what has happened, what is happening, and what will happen to orient the individual; and (6) Request action to re-engage the individual in purposeful behavior.\n\nParticipants will be randomly assigned to one of three groups: iCOVER, usual care, or physical presence with reassurance. Investigators have elected to use two different control conditions, in order to examine the reliability of the iCOVER intervention in comparison with two typical responses to individuals experiencing an ASR (i.e., physical presence with reassurance, no specific treatment).",[28],[192,120,28,193,194,195,196,197,198],"Trauma","Post Traumatic Stress","Post Traumatic Stress Disorder","Substantial Distress","Dissociation","Distress","Neurocognitive function","2025-12-08",{"date":201,"type":39},"2025-12-09",{"date":203,"type":39},"2024-08-15",{"date":205,"type":22},"2027-03",{"name":130,"class":104},5,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":16,"sex":17,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":47},"100598283","cannabidiol-cbd-and-stress-response-psychobiological-mechanisms-100598283","NCT07069478","Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms","Inclusion Criteria:\n\n* Adults who are relatively healthy and aged 21-70 years.\n* Must keep a normal sleep schedule (sleep during nighttime, awake during daytime).\n* Must either (1) use CBD daily\u002Fregularly or (2) not use CBD regularly.\n\nExclusion Criteria:\n\n* Participated in previous acute stress studies that included a similar stress induction.\n* Current, unstable: major psychiatric disorder or medical condition (e.g., uncontrolled hypertension above 160\u002F100).\n* Self-reported current pregnancy.\n* Self-reported current use of illicit substances (other than cannabis).\n* Non-compliance with instructions for study visit (abstinence from alcohol, caffeine, physical activity, etc.)\n* Students of the principal researcher","21 Years","70 Years",{"count":217,"type":22},125,[25],"The aim of this study is to determine the effects of regular cannabidiol (CBD) use on the psychobiological mechanisms of the stress response. This will be achieved by comparing acute stress responses of adults who either use or do not use CBD regularly. Correlates of CBD use, including tobacco use, will be collected.",[221,222,223,28],"CBD","Cannabidiol","Stress",[225,226,227,228,229],"cardiovascular reactivity, , , ,","hypothalamic-pituitary-adrenal axis","stress","mood","CBD use","2025-07-07",{"date":232,"type":39},"2025-07-16",{"date":234,"type":39},"2025-06-01",{"date":236,"type":22},"2026-11-30",{"name":238,"class":104},"University of Minnesota"]