Ketamine Infusion Therapy for PTSD in Combat Veterans

September 29, 2018 updated by: Klarisana Physician Services PLLC

The Effect of Therapeutic Ketamine Infusions on the Symptoms of Post-Traumatic Stress Disorder in Combat Veterans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

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

Yes

Genders Eligible for Study

All

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Ketamine
Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
3 weeks
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
3 weeks

Collaborators and Investigators

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

Sponsor

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)

November 28, 2016

Primary Completion (ACTUAL)

September 27, 2018

Study Completion (ACTUAL)

September 29, 2018

Study Registration Dates

First Submitted

February 26, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (ACTUAL)

March 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 29, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRP001

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.

Clinical Trials on Stress Disorders, Post-Traumatic

Clinical Trials on Ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe