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

Starting soon · Phase 2

Conditions studied: PTSD and Trauma-related Symptoms

In brief

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

Key facts

Study ID

NCT07563296

Run by

Irma Fleming

People needed

12

Starts

2026-04-01

Expected to finish

2028-04-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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