Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

Anxiety Disorders Clinical Trial

Official title:

Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947099
• Other study ID #: KRP002
• Status: Completed
• Start date: May 2, 2019
• Est. completion date: February 22, 2021

Study information

• Verified date: February 2021
• Source: Klarisana Physician Services PLLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Klarisana	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Klarisana Physician Services PLLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, López-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repe — View 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. — View 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. Review. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-9 Score to assess for symptoms of depression	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
Primary	PCL-5 Score to assess for symptoms of PTSD	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	Assessment of the experiential impact of ketamine therapy	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

External Links

•   The sponsoring treatment facility for this study