Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

NCT ID: NCT03947099

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-02

Study Completion Date

2021-02-22

Brief Summary

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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

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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

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Stress Disorders, Post-Traumatic Anxiety Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klarisana Physician Services PLLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl J Bonnett, MD

Role: PRINCIPAL_INVESTIGATOR

Klarisana Physician Services PLLC

Locations

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Klarisana

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Luftman K, Aydelotte J, Rix K, Ali S, Houck K, Coopwood TB, Teixeira P, Eastman A, Eastridge B, Brown CV, Davis M. PTSD in those who care for the injured. Injury. 2017 Feb;48(2):293-296. doi: 10.1016/j.injury.2016.11.001. Epub 2016 Nov 10.

Reference Type RESULT
PMID: 27871770 (View on PubMed)

Jacobowitz W. PTSD in psychiatric nurses and other mental health providers: a review of the literature. Issues Ment Health Nurs. 2013 Nov;34(11):787-95. doi: 10.3109/01612840.2013.824053.

Reference Type RESULT
PMID: 24131410 (View on PubMed)

Stanley IH, Hom MA, Joiner TE. Suicide mortality among firefighters: Results from a large, urban fire department. Am J Ind Med. 2016 Nov;59(11):942-947. doi: 10.1002/ajim.22587. Epub 2016 May 24.

Reference Type RESULT
PMID: 27219513 (View on PubMed)

Bing-Canar H, Ranney RM, McNett S, Tran JK, Berenz EC, Vujanovic AA. Alcohol Use Problems, Posttraumatic Stress Disorder, and Suicide Risk Among Trauma-Exposed Firefighters. J Nerv Ment Dis. 2019 Mar;207(3):192-198. doi: 10.1097/NMD.0000000000000947.

Reference Type RESULT
PMID: 30724832 (View on PubMed)

Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.

Reference Type RESULT
PMID: 30999057 (View on PubMed)

Related Links

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http://www.klarisana.com

The sponsoring treatment facility for this study

Other Identifiers

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KRP002

Identifier Type: -

Identifier Source: org_study_id

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