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Ketamine-Assisted Psychotherapy for Post-Traumatic Stress Disorder

(KALM-B Trial)

CA
Overseen ByClaire Ausbeck, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Irma Fleming
Must not be taking: Antipsychotics, Benzodiazepines
Disqualifiers: Schizophrenia, Bipolar, PTSD, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

IF

Irma Fleming, MD

Principal Investigator

The University of Utah

BL

Benjamin Lewis, MD

Principal Investigator

The University of Utah

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 65 years old and have burns on more than 15% of my body.
* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During hospitalization
1 visit (in-person)

Treatment

Participants receive up to two Ketamine-Assisted Psychotherapy (KAP) sessions following discharge

Up to 12 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, and 6 months

6 months
3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine-assisted Psychotherapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ketamine-Assisted PsychotherapyExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Irma Fleming

Lead Sponsor

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

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