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.
Ketamine Infusion Therapy for PTSD 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.
Intervention / Treatment
-
Ketamine (DRUG)Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.
Condition or Disease
- Stress Disorders, Post-Traumatic
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 75 Years |
| Enrollment: | 30 (ACTUAL) |
| Funded by: | Industry |
| Time Perspective: | Prospective |
| Observational Model: | Case-Only |
Masking |
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Clinical Trial Dates
| Start date: | Nov 28, 2016 | ACTUAL |
|---|---|---|
| Primary Completion: | Sep 27, 2018 | ACTUAL |
| Completion Date: | Sep 29, 2018 | ACTUAL |
| Study First Posted: | Mar 23, 2017 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Sep 29, 2018 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
-
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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 75 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
Secondary Outcomes
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The PHQ-9 is a nine-question survey instrument which is used to quantify the level of depressive symptoms in participants.
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The DAST-10 is a ten-question self-report survey instrument which is used to assess participants' use of illicit drugs.
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The AUDIT is a ten-question self-reporting survey instrument which is used to identify participants' use of and potential dependence on alcohol
More Details
| NCT Number: | NCT03088384 |
|---|---|
| Other IDs: | KRP001 |
| Study URL: | https://clinicaltrials.gov/study/NCT03088384 |
Last updated: Sep 29, 2023