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Completed

NCT Number: NCT03947099

Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klarisana

San Antonio, Texas, 78240, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have worked as a paramedic (EMT-P) on a 911 prehospital service for at least five years.
  • Must be diagnosed with post traumatic stress disorder that happened as a result of working as a paramedic
  • Diagnosis must have been made by a mental health professional
  • The symptoms of PTSD must be having a significant adverse effect on the subject's life
  • Subjects must be able to speak and read English

Exclusion criteria

  • Currently participating in another PTSD treatment program and/or research study
  • Diagnosis of psychosis
  • Uncontrolled hypertension or a history of heart failure

Treatment and study plan

Ketamine Hydrochloride

Drug

Participants are treated with six one-hour infusions of ketamine hydrochloride over a three week period in hopes of treating symptoms of PTSD.

Primary outcomes

  1. PHQ-9 Score to assess for symptoms of depression

    Time frame: three weeks

    Assess for an improvement in the Periodic Health Questionnaire nine (PHQ-9) score after a series of six ketamine infusions. The PHQ-9 is a nine question scale followed by a single question that assesses functional impairment. Each of the nine questions are scored on a basis of zero to four. The higher the score the more severe the symptoms of depression are. The highest score is 27 and the lowest is zero.

  2. PCL-5 Score to assess for symptoms of PTSD

    Time frame: three weeks

    Assess for an improvement in the PTSD Checklist for Diagnostic and Statistical Manual version five (PCL-5) score after a series of six ketamine infusions. The PCL-5 is a 20 question scale and each question is scored on a zero to four scale. A higher score indicates more severe symptoms of PTSD. The highest score possible is 80 and the lowest is zero.

Secondary outcomes

  1. Assessment of the experiential impact of ketamine therapy

    Time frame: three weeks

    The investigators seek to determine the role that the experiential (psychedelic) aspect of ketamine plays in the treatment of PTSD. This will utilize the Mystical Experience Questionnaire 30. This is a 30 question screening instrument where each question is scored on a scale of one to five. The maximum score is 150. A higher score indicates that the participant reports a more powerful mystical experience. There is also a single question that asks the participants to rate on a scale of one to five how important they feel the experiential (or psychedelic) aspect of the therapy was to their treatment. Five would indicate that they felt it was an important part of the treatment.

Sponsors and collaborators

Lead sponsor

Klarisana Physician Services PLLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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