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Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

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ClinicalTrials.gov Identifier: NCT03947099
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Klarisana Physician Services PLLC

Brief 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.

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic Anxiety Disorders Drug: Ketamine Hydrochloride

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Men and women who are trained as paramedics (EMT-P) and have worked in 911 emergency medical service systems for at least five years.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947099


Contacts
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Contact: Carl J Bonnett, MD 210-556-1430 info@klarisana.com

Locations
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United States, Texas
Klarisana Recruiting
San Antonio, Texas, United States, 78240
Contact: Carl J Bonnett, MD    210-556-1430    info@klarisana.com   
Contact: Gerson Barahona    210-556-1430    info@klarisana.com   
Principal Investigator: Carl J Bonnett, MD         
Sponsors and Collaborators
Klarisana Physician Services PLLC
Investigators
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Principal Investigator: Carl J Bonnett, MD Klarisana Physician Services PLLC

Additional Information:
Publications of Results:
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Responsible Party: Klarisana Physician Services PLLC
ClinicalTrials.gov Identifier: NCT03947099     History of Changes
Other Study ID Numbers: KRP002
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Klarisana Physician Services PLLC:
ketamine
ptsd
depression
prehospital
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action