NCT07563296 · Irma Fleming
KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
(KALM-B)
What this study is about
A study looking at the safety and how well patients handle the treatment of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
View original scientific description
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
Interventions
BEHAVIORAL
Preparatory Session
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
DRUG
Ketamine-assisted Psychotherapy Session #1
Ketamine will be administered intra-muscularly at a starting dose of 0.5 mg/kg and can be titrated up to 1.0 mg/kg, 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.
DRUG
Ketamine-assisted Psychotherapy Session #2
The second study intervention for KAP will include a 2.5-3 hour therapy session.
BEHAVIORAL
Integration Session
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration
Primary outcome measures
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Time frame: From 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Salt Lake City, Utah
Collaborators
University of Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations