KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury (NCT07563296, ketamine)

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 a...