We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine Infusion Therapy for PTSD in Combat Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088384
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Klarisana Physician Services PLLC

Tracking Information
First Submitted Date February 26, 2017
First Posted Date March 23, 2017
Last Update Posted Date October 2, 2018
Actual Study Start Date November 28, 2016
Actual Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2017)
Participant score on the PTSD Checklist - 5 (PCL-5) after a series of six ketamine infusions. [ Time Frame: 3 weeks ]
The PCL-5 is a twenty question survey instrument which is used to quantify the level of symptomatology in participants with post-traumatic stress disorder.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 17, 2017)
  • Participant score on the Patient Health Questionnaire - 9 (PHQ-9) after a series of six ketamine infusions. [ Time Frame: 3 weeks ]
    The PHQ-9 is a nine-question survey instrument which is used to quantify the level of depressive symptoms in participants.
  • Participant score on the Drug Abuse Screening Test (DAST-10) after a series of six ketamine infusions. [ Time Frame: 3 weeks ]
    The DAST-10 is a ten-question self-report survey instrument which is used to assess participants' use of illicit drugs.
  • Participant score on the Alcohol Use Disorders Identification Test (AUDIT) after a series of six ketamine infusions. [ Time Frame: 3 weeks ]
    The AUDIT is a ten-question self-reporting survey instrument which is used to identify participants' use of and potential dependence on alcohol
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ketamine Infusion Therapy for PTSD in Combat Veterans
Official Title The Effect of Therapeutic Ketamine Infusions on the Symptoms of Post-Traumatic Stress Disorder in Combat Veterans
Brief Summary Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine.
Detailed Description

The prolonged conflicts in Iraq and Afghanistan have created a very large population of veterans who suffer from severe post traumatic stress disorder (PTSD). This has, in part, contributed to a rate of suicide that many clinicians and concerned citizens find alarming. In the last two decades, there has been some promising evidence coming to light showing that the medication ketamine can potentially suppress and/or alleviate some of the disturbing symptoms of PTSD such as hypervigilance, anxiety, anger, and recurrent nightmares. If ketamine could be shown to be be a valuable treatment option for PTSD then this could have potentially large positive ramifications for the treatment of PTSD in America's veteran population.

Ketamine has historically been used as a dissociative anesthetic in emergency departments, operating rooms, and in austere military environments. It is a proven medication with a reassuring safety profile. This current study seeks to add to the body of knowledge regarding ketamine therapy by specifically looking at the combat veteran population. Eligible veterans will undergo the standard six-infusion Induction Series of ketamine infusions at Klarisana in San Antonio, Texas. Klarisana is a healthcare center which offers outpatient ketamine infusion therapy for the treatment of severe depression, PTSD, and various chronic pain conditions such as rheumatoid arthritis, fibromyalgia, neuropathy, and migraine headaches. Klarisana serves patients from all over south Texas including Austin, Houston, San Antonio, and Corpus Christi.

Patients who enroll in the current PTSD study will receive a standard battery of survey instruments which Klarisana implements before and after a series of infusions. These instruments will assess each patient's level of depression, degree of PTSD symptoms, as well as their use of alcohol and recreational drugs. The specific instruments are the...

Patient Health Questionnaire (PHQ-9) PTSD Checklist (PCL-5) Drug Abuse Screening Test (DAST-10) Alcohol Use Disorders Identification Test (AUDIT)

The investigator's goal is to formally analyze what changes may occur the participants' symptoms of PTSD and try to better establish the role which ketamine infusion therapy may play in the treatment of PTSD in the combat veteran population.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Veterans of the United States or foreign militaries who have served in combat and who now suffer from post traumatic stress disorder as a result of that military service.
Condition Stress Disorders, Post-Traumatic
Intervention Drug: Ketamine
Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.
Study Groups/Cohorts Combat Veterans
Eligible participants must be military veterans who have served in a combat zone as evidenced by documentation on the subject's DD214 (or equivalent if he/she served in a foreign military). Participants must have a diagnosis of post traumatic stress disorder that was as a result of their military combat experience.
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 17, 2017)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date September 29, 2018
Actual Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The Veteran must be medically screened by Klarisana and be an appropriate candidate for ketamine therapy
  • The Veteran must be between the ages of 18 and 75. The study is open to men and women.
  • The Veteran must be able to speak and read the English language
  • The Veteran must have a diagnosis of post-traumatic stress disorder assigned by the Department of Veterans Affairs. Veterans of a foreign military are also eligible but they must have been diagnosed with PTSD by the equivalent veteran healthcare organization in their country of military service
  • The Veteran must have served in the US Military or a foreign military service in a designated combat zone. Documentation by a DD214 or equivalent is required
  • The PTSD that The Veteran is suffering from has to have been caused by service in combat
  • The PTSD that the Veteran is suffering from must be exerting a significant negative effect on his/her life

Exclusion Criteria:

  • The Veteran must NOT be taking lamotrigine (Lamictal) or any monoamine oxidase inhibitor antidepressants
  • The Veteran must not be currently enrolled in any other studies offering therapy for PTSD
  • Veteran may NOT have uncontrolled blood pressure or congestive heart failure
  • Veteran may NOT have a diagnosis of psychosis or any diagnosis on the psychosis spectrum
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03088384
Other Study ID Numbers KRP001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Klarisana Physician Services PLLC
Original Responsible Party Same as current
Current Study Sponsor Klarisana Physician Services PLLC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Klarisana Physician Services PLLC
Verification Date September 2018