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
|Condition or disease||Intervention/treatment|
|Stress Disorders, Post-Traumatic||Drug: Ketamine|
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|
|Actual Enrollment :||30 participants|
|Official Title:||The Effect of Therapeutic Ketamine Infusions on the Symptoms of Post-Traumatic Stress Disorder in Combat Veterans|
|Actual Study Start Date :||November 28, 2016|
|Actual Primary Completion Date :||September 27, 2018|
|Actual Study Completion Date :||September 29, 2018|
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.
Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088384
|United States, Texas|
|San Antonio, Texas, United States, 78240|