drugset / Trial / NCT07563296
KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
NaSingle-groupOpen-labelTreatment
Summary
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2027-12-01
- Completion
- 2028-04-01
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.5 mg/kg | Intramuscular |