[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636254":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":72,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":23,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":23,"overallStatus":93,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Utah","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine-Assisted Psychotherapy","EXPERIMENTAL","All 12 study participants will be assigned to receive KAP treatment.",[13,14,15,16],"Behavioral: Preparatory Session","Drug: Ketamine-assisted Psychotherapy Session #1","Drug: Ketamine-assisted Psychotherapy Session #2","Behavioral: Integration Session",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL","Preparatory Session","A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"DRUG","Ketamine-assisted Psychotherapy Session #1","Ketamine will be administered intra-muscularly at a starting dose of 0.5 mg\u002Fkg and can be titrated up to 1.0 mg\u002Fkg, to a maximum of 60 mg, based on patient response. The first study intervention for KAP will include a preparatory session a 2.5-3 hour therapy session.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Ketamine-assisted Psychotherapy Session #2","The second study intervention for KAP will include a 2.5-3 hour therapy session.",[9],{"type":19,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Integration Session","An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration",[9],[38,42],{"name":39,"affiliation":40,"role":41},"Irma Fleming, MD","The University of Utah","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":40,"role":41},"Benjamin Lewis, MD",[45],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},"Claire Ausbeck, BA","CONTACT","18014033671","claire.ausbeck@hsc.utah.edu",[51],{"facility":52,"status":23,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Utah Health","Salt Lake City","Utah","84102","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-111.89105,40.76078,{"lat":62,"lon":61},[65,67],{"name":46,"role":47,"phone":66,"phoneExt":23,"email":49},"801-213-1223",{"name":39,"role":41,"phone":23,"phoneExt":23,"email":23},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Irma Fleming","Assistant Professor",[73],{"name":5,"class":6},"100636254","phase-2-kalm-b-ketamine-assisted-psychotherapy-kap-to-lessen-morbidity-after-burn-injury-100636254",false,"NCT07563296","KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury","KALM-B","Inclusion Criteria:\n\n* Subjects 18 - 65 yrs with \\> 15 % Total Body Surface Area Burns.\n* National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS) average total score\\>= 2 (severity scale of none (0), mild (1), moderate (2), severe (3), or extreme (4) ) prior to discharge from UUH.\n\nExclusion Criteria:\n\n* Allergy or previous adverse reactions to ketamine\n* Pending surgical interventions\n* Active systemic infection, sepsis, or hemodynamic instability\n* Physical limitations from burn injury that preclude safe travel to outpatient visits or positioning for therapy.\n* Lack of reliable transportation, caregiver support, or housing stability.\n* Language barrier\n* Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.\n* Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to ketamine.\n* Currently meeting DSM-5 criteria for Cluster B Personality Disorder.\n* Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization).\n* Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section\n* Current or prior history of PTSD diagnosis\n* Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine).\n* Current substance use disorders may be identified through the drug urine screening test or undergoing treatment (methadone\u002FSuboxone) .\n* Congestive heart failure, including all New York Heart Association Classes.\n* Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction\n* Uncontrolled hypertension at the time of enrollment (BP\\>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve\n* Prolonged or congenital long QT syndrome (\\>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality\n* History of hypersensitivity to ketamine\n* Receiving ketamine treatments for psychiatric condition within the past 6 months\n* Seizure disorder\n* Moderate to severe dementia\n* History of significant traumatic brain injury\n* Requires the use of supplemental oxygen.\n* Require Propranolol for Burn Hypermetabolism\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[patients may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration. These medications include antipsychotic medications, doses of benzodiazepines in excess of 20mg diazepam equivalents per day.","ALL","18 Years","65 Years",{"count":85,"type":86},12,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.",[92],"PTSD and Trauma-related Symptoms","NOT_YET_RECRUITING","2026-04-28",{"date":96,"type":97},"2026-05-04","ACTUAL",{"date":99,"type":86},"2026-04-01",{"date":101,"type":86},"2028-04-01",{"name":70,"class":6},1]