Can ketamine therapy heal burn trauma? small trial aims to find out
NCT ID NCT07563296
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether ketamine-assisted psychotherapy (KAP) can safely ease PTSD and trauma symptoms in adults with severe burns covering more than 15% of their body. Twelve participants will receive two KAP sessions plus a preparatory talk therapy session. The main goal is to check safety and tolerability, with secondary goals looking at feasibility and symptom improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketamine
- What this could lead to
- If it works, this could point toward a new way to reduce PTSD and trauma-related distress after severe burn injuries.
- What could go wrong
- This is a very small, early-phase trial with only 12 participants, so results may not apply broadly. Ketamine can cause side effects like dissociation or nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Lack of reliable transportation, caregiver support, or housing stability. * Language barrier * Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness. * Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to ketamine. * Currently meeting DSM-5 criteria for Cluster B Personality Disorder. * Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization). * Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section * Current or prior history of PTSD diagnosis * Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). * Current substance use disorders may be identified through the drug urine screening test or undergoing treatment (methadone/Suboxone) . * Congestive heart failure, including all New York Heart Association Classes. * Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction * Uncontrolled hypertension at the time of enrollment (BP\>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve * Prolonged or congenital long QT syndrome (\>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality * History of hypersensitivity to ketamine * Receiving ketamine treatments for psychiatric condition within the past 6 months * Seizure disorder * Moderate to severe dementia * History of significant traumatic brain injury * Requires the use of supplemental oxygen. * Require Propranolol for Burn Hypermetabolism * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[patients may not receive the drug through a feeding tube\], social/ psychological issues, etc.) * Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration. These medications include antipsychotic medications, doses of benzodiazepines in excess of 20mg diazepam equivalents per day.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Utah Health
RECRUITINGSalt Lake City, Utah, 84102, United States
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