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

ConditionPTSD and Trauma-related Symptoms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIrma Fleming

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Ketamine-Assisted PsychotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Safety and Tolerability defined by the number of participants with treatment-related adverse events

Assess the safety and tolerability of KAP in the burn population. Safety and Tolerability will be measure by the frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.

Time frame
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Secondary outcomes

1

Feasibility - Recruitment rate

The proportion of eligible participants who provided informed consent

Time frame
From study opening to completion of recruitment, up to 24 months
2

Feasibility - Treatment Completion Rate

Proportion of participants who complete all scheduled KAP sessions.

Time frame
From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
3

Feasibility - Follow-up Completion Rate

Proportion of participants who complete follow-up assessments at 1, 3, and 6 months.

Time frame
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
4

Timeliness of Intervention Delivery

Time from injury to initiation of the KAP intervention, defined as the number of days between the date of injury and the date of first KAP session.

Time frame
Baseline (from injury to initiation of treatment; up to 12 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Irma Fleming

Lead sponsor

University of Utah

Sponsor institution

University of Utah

Collaborator

Source ClinicalTrials.gov
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