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โ† Trials
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KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury

RecruitingPhase 2Ages 18 Years - 65 YearsAllIrma Fleming
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In plain words

What the trial is, and whether it could suit you

A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects 18 - 65 yrs with \> 15 % Total Body Surface Area Burns. * 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. Exclusion Criteria: * Allergy or previous adverse reactions to ketamine * Pending surgical interventions * Active systemic infection, sepsis, or hemodynamic instability * Physical limitations from burn injury that preclude safe travel to outpatient visits or positioning for therapy. * Lack of reliable transportation, caregiver support, or housing stability. * Language barrier * Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness. * 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. * Currently meeting DSM-5 criteria for Cluster B Personality Disorder. * Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization). * 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 * Current or prior history of PTSD diagnosis * Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). * Current substance use disorders may be identified through the drug urine screening test or undergoing treatment (methadone/Suboxone) . * Congestive heart failure, including all New York Heart Association Classes. * Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction * Uncontrolled hypertension at the time of enrollment (BP\>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve * Prolonged or congenital long QT syndrome (\>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality * History of hypersensitivity to ketamine * Receiving ketamine treatments for psychiatric condition within the past 6 months * Seizure disorder * Moderate to severe dementia * History of significant traumatic brain injury * Requires the use of supplemental oxygen. * Require Propranolol for Burn Hypermetabolism * 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/inflammation, intestinal obstruction, unable to swallow medication, \[patients may not receive the drug through a feeding tube\], social/ psychological issues, etc.) * 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.
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What it tests

  • Preparatory Session
  • Ketamine-assisted Psychotherapy Session #1
  • Ketamine-assisted Psychotherapy Session #2
  • Integration Session
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Where

1 site
University of Utah Health
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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