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Not yet recruitingPhase 2

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

NCT07563296 · KALM-B · Irma Fleming

Closed to entry
Status
Not accepting participants
Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • 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)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
University of Utah HealthSalt Lake CityUtahUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07563296 on ClinicalTrials.gov →

Last updated in the registry 2026-05-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in