Clinical trial NCT03947099: Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics
Official title: Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Anxiety Disorders
Keywords: ketamine
ptsd
depression
prehospital
Lead sponsor: Klarisana Physician Services PLLC
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: PHQ-9 Score to assess for symptoms of depression
timeFrame: three weeks
measure: PCL-5 Score to assess for symptoms of PTSD
timeFrame: three weeks
Secondary outcomes:
measure: Assessment of the experiential impact of ketamine therapy
timeFrame: three weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Klarisana
state: Texas
Study officials:
affiliation: Klarisana Physician Services PLLC
name: Carl J Bonnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.