MedTrace Logo

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

NCT07563296 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-04

No results posted yet for this study

Summary

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

Conditions

  • PTSD and Trauma-related Symptoms

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

Sponsors & Collaborators

Principal Investigators

  • Irma Fleming, MD · The University of Utah

  • Benjamin Lewis, MD · The University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-01
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563296 on ClinicalTrials.gov