Clinical TrialSingle-armPTSDKetamineNot yet recruiting

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

This Phase II, single-group trial (n=12) will assess the safety and tolerability of ketamine-assisted psychotherapy (KAP) in adults aged 18 to 65 years with burn injuries and acute stress symptoms. Participants will receive KAP after screening positive for acute stress symptoms before discharge, with the study focused on treatment-related adverse events and feasibility in this burn population. All participants will be assigned to the same intervention package, beginning with a preparatory psychotherapy session, followed by a 2.5–3 hour ketamine-assisted psychotherapy session in which ketamine is given intramuscularly at 0.5 mg/kg and may be titrated up to 1.0 mg/kg to a maximum of 60 mg according to patient response. A second 2.5–3 hour KAP session is also planned, and an integration session with a trained psychotherapist will be held after the second ketamine administration. Safety outcomes will be tracked from baseline through 6 months after treatment, with follow-up assessments at 1, 3 and 6 months.

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Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

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

Study Arms & Interventions

Ketamine-Assisted Psychotherapy

experimental

All 12 study participants will be assigned to receive KAP treatment.

Interventions

  • Ketamine0.5 - 1 mg/kg
    via IM• 1 doses total

Participants

Ages
18 – 65
Sexes
Male & Female

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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2026-04-01
    End: 2028-04-01
  • Compound
    Ketamine
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Locations

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