PTSD and Trauma-related SymptomsPhase 2KALM-BNCT07563296

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

A Phase 2 study testing Preparatory Session, Ketamine-assisted Psychotherapy Session #1 and Ketamine-assisted Psychotherapy Session #2 in people with PTSD and Trauma-related Symptoms, run by Irma Fleming at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: PTSD and Trauma-related Symptoms
What is being tested?: Preparatory Session, Ketamine-assisted Psychotherapy Session #1 and Ketamine-assisted Psychotherapy Session #2
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2026to 1 Apr 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claire Ausbeck, BA contact

18014033671

claire.ausbeck@hsc.utah.edu

United States1 site, 1 recruiting

University of Utah Health
Salt Lake City, Utah, 84102
Claire Ausbeck, BA, 801-213-1223, claire.ausbeck@hsc.utah.edu
Irma Fleming, MD
Recruiting

Other trials in United States

About this study

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

Read the detailed description

BACKGROUND AND RATIONALE Burn injuries are among the most devastating forms of trauma, often resulting in significant physical pain and long-term psychological distress. Survivors frequently experience acute stress disorder (ASD), which may progress to post-traumatic stress disorder (PTSD), depression, anxiety, and chronic opioid dependence. PTSD has been documented in up to 45% of military burn survivors and approximately one-third of civilians with severe burn trauma. Despite improvements in surgical and rehabilitative care, the psychological sequelae of burn injuries remain under-recognized and under-treated.

The immediate post-injury period is marked by elevated stress and emotional dysregulation, yet access to timely, structured mental health interventions is limited. Traditional approaches often fail to reach patients during this critical window. At the University of Utah Burn Center, which treats over 450 inpatients and 6,500 outpatients annually, there is an urgent need for feasible and scalable approaches to address psychological distress early in the recovery process.

Ketamine-assisted psychotherapy (KAP) combines the administration of ketamine, a dissociative anesthetic with well-documented rapid-onset antidepressant properties, with psychotherapeutic support in a controlled clinical environment. KAP has shown potential in other trauma-affected populations and is being explored for its ability to support emotional processing, reduce distress, and potentially interrupt the progression from acute stress to more persistent mental health disorders. However, its use in the context of acute burn injury has not been systematically evaluated.

The KALM-B Study (Ketamine-Assisted Therapy to Lessen Morbidity after Burn Injury) is a pilot project designed to assess the safety and feasibility of implementing KAP in recently burned patients with acute stress symptoms. The study will recruit 12 adult patients who screen positive for acute stress symptoms during their hospitalization and offer participation in up to two KAP sessions following discharge, delivered in partnership with the Huntsman Mental Health Institute.

The primary objective is to evaluate the safety and tolerability of KAP after burn and the feasibility of recruitment, enrollment, and completion of the study intervention. Secondary objectives include assessing the safety and tolerability of KAP in this unique patient population. Exploratory objectives will descriptively assess changes in symptoms of acute stress, anxiety, depression, and opioid use through 6 months post-intervention.

This study represents a first step toward understanding how novel trauma-informed interventions might be integrated into early burn care. By characterizing feasibility, safety, and symptom trends over time, KALM-B will provide foundational data to inform future research and potential care models aimed at supporting psychological recovery after burn injury.

Conditions: PTSD and Trauma-related Symptoms
Being tested: Preparatory Session, Ketamine-assisted Psychotherapy Session #1, Ketamine-assisted Psychotherapy Session #2, Integration Session
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preparatory SessionBehavioural
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 #1Drug
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 #2Drug
The second study intervention for KAP will include a 2.5-3 hour therapy session.
Integration SessionBehavioural
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

Study groups in NCT07563296
Study group	Role	What they receive
Ketamine-Assisted Psychotherapy	Experimental	All 12 study participants will be assigned to receive KAP treatment. Receives: Behavioral: Preparatory Session; Drug: Ketamine-assisted Psychotherapy Session #1; Drug: Ketamine-assisted Psychotherapy Session #2; Behavioral: Integration Session

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Secondary outcomes (9)

Feasibility - Recruitment rate
The proportion of eligible participants who provided informed consent
Measured: From study opening to completion of recruitment, up to 24 months
Feasibility - Treatment Completion Rate
Proportion of participants who complete all scheduled KAP sessions.
Measured: From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
Feasibility - Follow-up Completion Rate
Proportion of participants who complete follow-up assessments at 1, 3, and 6 months.
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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.
Measured: Baseline (from injury to initiation of treatment; up to 12 months)
Opioid Use
Total opioid use (MME) at discharge and up to 6 months post-KAP.
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Acute Stress Symptoms based on National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS)
Change in acute stress symptoms from baseline to post-treatment follow-up, measured using the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS).
Scoring and Interpretation: Each item is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 28, with higher scores indicating greater severity of acute stress disorder.
The raw scores on the 7 items should be summed to obtain a total raw score. In addition, the clinician is asked to calculate and use the average total score. The average total score reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's acute stress disorder in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4).
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Incidence of PTSD based on PTSD Checklist for DSM-5 (PCL-5)
Incidence of progression from acute stress to PTSD at follow-up, based on DSM-5 criteria and assessed using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 can be scored to provide a provisional PTSD diagnosis.
Scoring and Interpretation: The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, scored from 0-80 by summing items rated 0 ("Not at all") to 4 ("Extremely"). A total score of 31-33 or higher typically indicates a probable PTSD diagnosis, though 32 is often used. A 5-point change represents a clinically significant change.
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Anxiety Symptoms based on the Generalized Anxiety Disorder 7-item scale
Change in anxiety symptoms from baseline to follow-up, measured using the Generalized Anxiety Disorder 7-item scale (GAD-7).
Scoring and Interpretation: The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-report scale used to measure anxiety severity, with a total score range of 0-21. Scores are calculated by summing the ratings (0-3) for seven questions, with cut-offs of 5, 10, and 15 representing:
0-4: Minimal or no anxiety 5-9: Mild anxiety (monitor; consider lifestyle changes) 10-14: Moderate anxiety (clinically significant; consider counseling/medication) 15-21: Severe anxiety (refer to a mental health professional) Cut-off for Diagnosis: A score of 10 or higher is generally used to identify potential Generalized Anxiety Disorder.
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Depressive Symptoms based on Patient Health Questionnaire-9 Screening tool
Change in depressive symptoms from baseline to follow-up, measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is scored by summing 9 items (0-3 each) to a total of 0-27, with higher scores indicating severe depression.
Interpretation of Total Score:
0-4: Minimal or None 5-9: Mild depression (suggests monitoring) 10-14: Moderate depression (suggests treatment) 15-19: Moderately severe depression (often requires active treatment) 20-27: Severe depression (usually requires immediate intervention)
Measured: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 20261 Apr 2028

First posted4 May 2026
Study start24 Aug 2026
Primary completion1 Dec 2027 (estimated)
Study completion1 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for PTSD and Trauma-related SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07563296
Sponsor's protocol ID: 192679
Acronym: KALM-B
Status last verified: Aug 2026
First submitted: 6 Apr 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared. This investigator-initiated feasibility study is not funded by an agency that requires data sharing, and the small sample size combined with the sensitive nature of the data limits the ability to adequately de-identify individual participants.

Publications

Fava M, Freeman MP, Flynn M, Judge H, Hoeppner BB, Cusin C, Ionescu DF, Mathew SJ, Chang LC, Iosifescu DV, Murrough J, Debattista C, Schatzberg AF, Trivedi MH, Jha MK, Sanacora G, Wilkinson ST, Papakostas GI. Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD). Mol Psychiatry. 2020 Jul;25(7):1592-1603. doi: 10.1038/s41380-018-0256-5. Epub 2018 Oct 3.
PubMed 30283029
Singh JB, Fedgchin M, Daly EJ, De Boer P, Cooper K, Lim P, Pinter C, Murrough JW, Sanacora G, Shelton RC, Kurian B, Winokur A, Fava M, Manji H, Drevets WC, Van Nueten L. A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression. Am J Psychiatry. 2016 Aug 1;173(8):816-26. doi: 10.1176/appi.ajp.2016.16010037. Epub 2016 Apr 8.
PubMed 27056608
Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.
PubMed 32371500
Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, Janiere C, Brenckmann V, Guillerm A, Deciron F, Kabbaj A, Jenvrin J, Pere M, Montassier E. Ketamine Compared With Morphine for Out-of-Hospital Analgesia for Patients With Traumatic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352844. doi: 10.1001/jamanetworkopen.2023.52844.
PubMed 38285446
Du R, Han R, Niu K, Xu J, Zhao Z, Lu G, Shang Y. The Multivariate Effect of Ketamine on PTSD: Systematic Review and Meta-Analysis. Front Psychiatry. 2022 Mar 9;13:813103. doi: 10.3389/fpsyt.2022.813103. eCollection 2022.
PubMed 35356723
Fremont R, Brown O, Feder A, Murrough J. Ketamine for Treatment of Posttraumatic Stress Disorder: State of the Field. Focus (Am Psychiatr Publ). 2023 Jul;21(3):257-265. doi: 10.1176/appi.focus.20230006. Epub 2023 Jun 28.
PubMed 37404968
Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion, and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1129-1151. doi: 10.1093/jbcr/iraa119.
PubMed 32885244
Stojanovic M, Marinkovic M, Milicic B, Stojicic M, Jovic M, Jovanovic M, Isakovic Subotic J, Jurisic M, Karamarkovic M, Dekic A, Radenovic K, Mihaljevic J, Radosavljevic I, Sudecki B, Savic M, Kostic M, Garabinovic Z, Jeremic J. The Role of Ketamine as a Component of Multimodal Analgesia in Burns: A Retrospective Observational Study. J Clin Med. 2024 Jan 29;13(3):764. doi: 10.3390/jcm13030764.
PubMed 38337458
Lewis BR, Garland EL, Byrne K, Durns T, Hendrick J, Beck A, Thielking P. HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. J Pain Symptom Manage. 2023 Sep;66(3):258-269. doi: 10.1016/j.jpainsymman.2023.06.006. Epub 2023 Jun 10.
PubMed 37302533
Dakwar E, Levin F, Hart CL, Basaraba C, Choi J, Pavlicova M, Nunes EV. A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial. Am J Psychiatry. 2020 Feb 1;177(2):125-133. doi: 10.1176/appi.ajp.2019.19070684. Epub 2019 Dec 2.
PubMed 31786934
Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
PubMed 30917760
Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
PubMed 24740528

Interested in taking part?

Claire Ausbeck, BA

18014033671

claire.ausbeck@hsc.utah.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
ClinicalTrials.gov ID: NCT07563296
Acronym / sponsor ID: KALM-B / 192679
Conditions: PTSD and Trauma-related Symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Irma FlemingUniversity, hospital or other
Collaborators: University of Utah
Study start: 24 Aug 2026 (actual)
Primary completion: 1 Dec 2027 (estimated)
Study completion: 1 Apr 2028 (estimated)
First posted: 4 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ketamine-Assisted Psychotherapy	Experimental	Behavioral: Preparatory Session, Drug: Ketamine-assisted Psychotherapy Session #1, Drug: Ketamine-assisted Psychotherapy Session #2, Behavioral: Integration SessionAll 12 study participants will be assigned to receive KAP treatment.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (27 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preparatory SessionA preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment	Behavioural	Ketamine-Assisted Psychotherapy
Ketamine-assisted Psychotherapy Session #1Ketamine 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
Ketamine-assisted Psychotherapy Session #2The second study intervention for KAP will include a 2.5-3 hour therapy session.	Drug	Ketamine-Assisted Psychotherapy
Integration SessionAn integration session will be held with a trained psychotherapist after the 2nd Ketamine administration	Behavioural	Ketamine-Assisted Psychotherapy

Primary outcome

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)
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.

9 secondary outcomes

Feasibility - Recruitment rate
Time frame: From study opening to completion of recruitment, up to 24 months
Feasibility - Treatment Completion Rate
Time frame: From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
Feasibility - Follow-up Completion Rate
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Timeliness of Intervention Delivery
Time frame: Baseline (from injury to initiation of treatment; up to 12 months)
Opioid Use
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Acute Stress Symptoms based on National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS)
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Incidence of PTSD based on PTSD Checklist for DSM-5 (PCL-5)
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Anxiety Symptoms based on the Generalized Anxiety Disorder 7-item scale
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Depressive Symptoms based on Patient Health Questionnaire-9 Screening tool
Time frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Results publication: PubMed 30283029Fava M, Freeman MP, Flynn M, Judge H, Hoeppner BB, Cusin C, Ionescu DF, Mathew SJ, Chang LC, Iosifescu DV, Murrough J, Debattista C, Schatzberg AF, Trivedi MH, Jha MK, Sanacora G, Wilkinson ST, Papakostas GI. Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD). Mol Psychiatry. 2020 Jul;25(7):1592-1603. doi: 10.1038/s41380-018-0256-5. Epub 2018 Oct 3.
Results publication: PubMed 27056608Singh JB, Fedgchin M, Daly EJ, De Boer P, Cooper K, Lim P, Pinter C, Murrough JW, Sanacora G, Shelton RC, Kurian B, Winokur A, Fava M, Manji H, Drevets WC, Van Nueten L. A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression. Am J Psychiatry. 2016 Aug 1;173(8):816-26. doi: 10.1176/appi.ajp.2016.16010037. Epub 2016 Apr 8.
Results publication: PubMed 32371500Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.
Results publication: PubMed 38285446Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, Janiere C, Brenckmann V, Guillerm A, Deciron F, Kabbaj A, Jenvrin J, Pere M, Montassier E. Ketamine Compared With Morphine for Out-of-Hospital Analgesia for Patients With Traumatic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352844. doi: 10.1001/jamanetworkopen.2023.52844.
Results publication: PubMed 35356723Du R, Han R, Niu K, Xu J, Zhao Z, Lu G, Shang Y. The Multivariate Effect of Ketamine on PTSD: Systematic Review and Meta-Analysis. Front Psychiatry. 2022 Mar 9;13:813103. doi: 10.3389/fpsyt.2022.813103. eCollection 2022.
Results publication: PubMed 37404968Fremont R, Brown O, Feder A, Murrough J. Ketamine for Treatment of Posttraumatic Stress Disorder: State of the Field. Focus (Am Psychiatr Publ). 2023 Jul;21(3):257-265. doi: 10.1176/appi.focus.20230006. Epub 2023 Jun 28.
Results publication: PubMed 32885244Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion, and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1129-1151. doi: 10.1093/jbcr/iraa119.
Results publication: PubMed 38337458Stojanovic M, Marinkovic M, Milicic B, Stojicic M, Jovic M, Jovanovic M, Isakovic Subotic J, Jurisic M, Karamarkovic M, Dekic A, Radenovic K, Mihaljevic J, Radosavljevic I, Sudecki B, Savic M, Kostic M, Garabinovic Z, Jeremic J. The Role of Ketamine as a Component of Multimodal Analgesia in Burns: A Retrospective Observational Study. J Clin Med. 2024 Jan 29;13(3):764. doi: 10.3390/jcm13030764.
Results publication: PubMed 37302533Lewis BR, Garland EL, Byrne K, Durns T, Hendrick J, Beck A, Thielking P. HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. J Pain Symptom Manage. 2023 Sep;66(3):258-269. doi: 10.1016/j.jpainsymman.2023.06.006. Epub 2023 Jun 10.
Results publication: PubMed 31786934Dakwar E, Levin F, Hart CL, Basaraba C, Choi J, Pavlicova M, Nunes EV. A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial. Am J Psychiatry. 2020 Feb 1;177(2):125-133. doi: 10.1176/appi.ajp.2019.19070684. Epub 2019 Dec 2.
Results publication: PubMed 30917760Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
Results publication: PubMed 24740528Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
University of Utah Health Ketamine Assisted Psychotherapy ProgramLink provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data will not be shared. This investigator-initiated feasibility study is not funded by an agency that requires data sharing, and the small sample size combined with the sensitive nature of the data limits the ability to adequately de-identify individual participants.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Claire Ausbeck, BA contact

18014033671

claire.ausbeck@hsc.utah.edu

Irma Fleming, MD principal investigator

The University of Utah

Benjamin Lewis, MD principal investigator

The University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire Ausbeck, BA (18014033671, claire.ausbeck@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07563296, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.