KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
KALM-B
1 other identifier
interventional
12
1 country
1
Brief Summary
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 6, 2026
CompletedFirst Posted
Study publicly available on registry
May 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 4, 2026
April 1, 2026
1.7 years
April 6, 2026
April 28, 2026
Conditions
Outcome Measures
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.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Secondary Outcomes (9)
Feasibility - Recruitment rate
From study opening to completion of recruitment, up to 24 months
Feasibility - Treatment Completion Rate
From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
Feasibility - Follow-up Completion Rate
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Timeliness of Intervention Delivery
Baseline (from injury to initiation of treatment; up to 12 months)
Opioid Use
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
- +4 more secondary outcomes
Study Arms (1)
Ketamine-Assisted Psychotherapy
EXPERIMENTALAll 12 study participants will be assigned to receive KAP treatment.
Interventions
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
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.
The second study intervention for KAP will include a 2.5-3 hour therapy session.
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahcollaborator
- Irma Fleminglead
Study Sites (1)
University of Utah Health
Salt Lake City, Utah, 84102, United States
Related Publications (12)
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.
PMID: 30283029RESULTSingh 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.
PMID: 27056608RESULTCastellanos 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.
PMID: 32371500RESULTLe 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.
PMID: 38285446RESULTDu 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.
PMID: 35356723RESULTFremont 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.
PMID: 37404968RESULTRomanowski 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.
PMID: 32885244RESULTStojanovic 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.
PMID: 38337458RESULTLewis 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.
PMID: 37302533RESULTDakwar 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.
PMID: 31786934RESULTDore 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.
PMID: 30917760RESULTFeder 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.
PMID: 24740528RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irma Fleming, MD
The University of Utah
- PRINCIPAL INVESTIGATOR
Benjamin Lewis, MD
The University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 6, 2026
First Posted
May 4, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.