NCT03947099

Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Klarisana Physician Services PLLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This is an observational study to assess the change in several psychological screening tools before and after a series of six ketamine infusions in paramedics who suffer from post traumatic stress disorder as a result of working in emergency medical services.

Detailed description

Working as a paramedic in a prehospital emergency medical services system (EMS) has been shown to lead to increased incidence of post traumatic stress disorder (PTSD) and increased risk of suicide in prehospital personnel. In recent years a growing body of literature has shown that ketamine hydrochloride can be an effective treatment for PTSD. This study seeks to look specifically at paramedic level emergency medical technicians ("paramedics") with PTSD related to their prehospital work and assess whether ketamine infusion therapy can be an effective treatment for them. This is an observational study where the results of psychological screening tools that are administered before and after a six-infusion series are reported. Additionally the same assessment tools will be administered again 30 days after the final treatment to measure the durability of any changes. The participants will receive the Periodic Health Questionnaire-9 (PHQ-9), the PTSD Checklist for Diagnostic and Statistical Manual, DSM-5 (PCL-5), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck Anxiety Inventory (BAI) before the infusions, after the series of six, and thirty days later. Additionally, after the series of six infusions, participants will receive the Revised Mystical Experience Questionnaire-30 (RMEQ-30) and a one question survey to assess the impact of the experiential aspect of ketamine.

Conditions

• Stress Disorders, Post-Traumatic
• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Participants are treated with six one-hour infusions of ketamine hydrochloride over a three week period in hopes of treating symptoms of PTSD.

Timeline

• Start date: 2019-05-02
• Primary completion: 2021-02-22
• Completion: 2021-02-22
• First posted: 2019-05-13
• Last updated: 2021-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study