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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Irma Fleming
Study ID
NCT07563296
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • PTSD and Trauma-related Symptoms

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Preparatory Session — BEHAVIORAL
    A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
  • Ketamine-assisted Psychotherapy Session #1 — DRUG
    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.
  • Ketamine-assisted Psychotherapy Session #2 — DRUG
    The second study intervention for KAP will include a 2.5-3 hour therapy session.
  • Integration Session — BEHAVIORAL
    An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

Study Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine-Assisted Psychotherapy
    All 12 study participants will be assigned to receive KAP treatment.

Primary Outcome Measure

Safety and Tolerability defined by the number of participants with treatment-related adverse events [ Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah HealthSalt Lake CityUtah84102
Claire Ausbeck, BA
[email protected]
801-213-1223
Irma Fleming, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Utah Health· Salt Lake City, UT

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