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KALM-B: Ketamine-assisted Psychotherapy for Burn Injury Recovery

This study, called KALM-B, is looking at how safe and tolerable Ketamine-assisted Psychotherapy (KAP) is for people who have experienced severe burns and are dealing with PTSD (Post-Traumatic Stress Disorder) and other trauma-related symptoms. KAP combines ketamine, a medication, with therapy sessions. You might be able to join if you are between 18 and 65 years old, have had burns covering more than 15% of your body, and show signs of acute stress disorder. The study aims to see how many participants experience side effects from the treatment over six months. The current status of this study is unclear, and it plans to enroll 12 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
You would have a preparatory therapy session, two Ketamine-assisted Psychotherapy sessions (each 2.5-3 hours long), and a final integration therapy session. You would also have follow-up assessments at 1, 3, and 6 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability for six months after treatment, with assessments at 1, 3, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07563296

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Irma Fleming
~12 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Preparatory SessionKetamine-assisted Psychotherapy Session #1Ketamine-assisted Psychotherapy Session #2Integration Session

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Measured over From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Conditions

PTSD and Trauma-related Symptoms

Explore related trials

Acute Stress DisorderPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Irma Fleming, MD · PRINCIPAL_INVESTIGATOR · The University of Utah
  • Benjamin Lewis, MD · PRINCIPAL_INVESTIGATOR · The University of Utah

Who to contact

Claire Ausbeck, BA
[email protected]
18014033671
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety and Tolerability defined by the number of participants with treatment-related adverse eventsFrom baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

    Assess the safety and tolerability of KAP in the burn population. Safety and Tolerability will be measure by the frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.