KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury (NCT07563296) | Clinical Trial Compass
Not Yet RecruitingPhase 2
KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
United States12 participantsStarted 2026-04-01
Plain-language summary
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 crite…
What they're measuring
1
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Timeframe: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)