Ketamine-Assisted Psychotherapy for Post-Traumatic Stress Disorder

(KALM-B Trial)

This trial examines whether ketamine-assisted psychotherapy is safe and tolerable for individuals with significant burn injuries who also experience stress disorders. It focuses on those with burns covering more than 15% of their body and ongoing stress symptoms. Participants must not have a history of serious heart issues or mental health problems such as schizophrenia or bipolar disorder, and they must be able to travel for therapy sessions. The trial seeks to explore a new treatment option that could help manage stress-related symptoms in burn survivors. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

You may need to stop taking certain medications before joining the trial. Specifically, if you are on antipsychotic medications or high doses of benzodiazepines, you will need to stop them for a period of at least five half-lives (time it takes for the drug's concentration to reduce by half) before starting the study.

Research has shown that ketamine-assisted psychotherapy (KAP) is generally safe and well-tolerated for treating PTSD. Studies have found it effective and safe for individuals with long-term PTSD. Any feelings of detachment from reality are usually temporary. Other research has linked KAP to improvements in PTSD symptoms over time.

Researchers are excited about ketamine-assisted psychotherapy for treating PTSD because it offers a unique approach compared to traditional therapies. Unlike standard treatments such as SSRIs and talk therapy, which can take weeks or months to show effects, ketamine works rapidly and targets the brain's glutamate system. This novel action can potentially lead to quicker relief of PTSD symptoms, offering hope for those who haven't found success with conventional options. Additionally, the combination of ketamine with psychotherapy may enhance the therapeutic process, potentially leading to more lasting improvements.

Research has shown that Ketamine-Assisted Psychotherapy (KAP) can effectively treat Post-Traumatic Stress Disorder (PTSD). Studies have found that KAP leads to lasting improvements in PTSD symptoms, even after treatment concludes. In one study, 86% of participants with PTSD experienced symptom relief. Another study demonstrated that KAP is particularly effective when combined with therapy, providing significant help for those unresponsive to traditional treatments. Overall, evidence suggests that KAP is a promising option for managing PTSD symptoms.¹²³⁶⁷