Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

February 24, 2021 updated by: Klarisana Physician Services PLLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78240
        • Klarisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three weeks
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.
three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klarisana Physician Services PLLC

Investigators

  • Principal Investigator: Carl J Bonnett, MD, Klarisana Physician Services PLLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2019

Primary Completion (ACTUAL)

February 22, 2021

Study Completion (ACTUAL)

February 22, 2021

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (ACTUAL)

May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRP002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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