Ketamine-assisted Psychotherapy to Lessen Morbidity After Burn Injury
Official title: KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
Run by University of Utah · NCT07563296 · Data updated 2026-11-12
This study tests whether ketamine-assisted psychotherapy can be safely given to adults with significant burn injuries to help reduce trauma-related symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | August 24, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07563296 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-65 with more than 15% TBSA burns who are near discharge and have moderate to severe distress on NSESSS prior to discharge.
✕Probably not a fit
Patients with contraindicating medical or psychiatric conditions, or those who do not respond to ketamine-based therapy, may receive no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional study explores the safety and tolerability of ketamine-assisted psychotherapy (KAP) in adults with extensive burn injuries. Participants receive preparatory sessions followed by two ketamine-assisted psychotherapy sessions and a final integration session, aiming to support emotional processing during early recovery. Eligible adults aged 18-65 with more than 15% total body surface area burns are enrolled prior to discharge and assessed for distress using NSESSS. Key exclusions include allergy to ketamine, active infection, unstable medical status, housing instability, and certain psychiatric histories. Conducted at University of Utah Health, led by Irma Fleming, the trial seeks to determine feasibility and potential benefits of KAP in this high-need population.
Why it matters
Potential benefit: If successful, participants may experience reduced trauma-related distress and improved psychological adjustment during burn recovery.
How similar studies have gone: Prior studies in other trauma-affected groups suggest potential benefits of ketamine-assisted psychotherapy, but data in burn populations remain limited and exploratory here.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Utah Health
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Irma Fleming, MD — The University of Utah
- Study coordinator: Claire Ausbeck, BA
- Email: claire.ausbeck@hsc.utah.edu
- Phone: 18014033671
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.