RIVER Telehealth
Helena, Montana, 59601, United States
Location status: Recruiting
Location contact
Ed Lesofski, MS
CONTACT
Edward Lesofski, MS
CONTACT
Frank Yurasek, PhD
CONTACT
James Taggart, MD
CONTACT
Jeffery Newton
CONTACT
NCT Number: NCT06038409
A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Helena, Montana, 59601, United States
Location status: Recruiting
Ed Lesofski, MS
CONTACT
Edward Lesofski, MS
CONTACT
Frank Yurasek, PhD
CONTACT
James Taggart, MD
CONTACT
Jeffery Newton
CONTACT
Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others), and there have been few if any, studies that have compared the impact of Ketamine at home without any thearpy.
The study will identify other treatment modalities used in concurrence with Ketamine. Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these adjunct therapies affect the outcomes of Ketamine treatments?
Secondarily, the study will focus on these significant issues to observe the impact of Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and anxiety have been identified as underlying causes and may be improvable with Ketamine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Must have an identifiable chronic condition.
Exclusion criteria
Healthy population
The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions
Time frame: through study completion, an average of 1 year
Compare and Contrast the different methods and uses of ketamine for acceptability for the route of use. (ie oral sublingual or nasal spray)
Time frame: through study completion, an average of 1 year
The use of psychological scales to measure participants' mental health with the use of ketamine. Three scales will be charted to examine the mental health of the participant.
The Patient Health Questionnaire-9 (PHQ9), Patient Health Questionnaire 9 has a possible range of 0-27. Zero being no depression and 27 being severe depression.
Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PHQ9 will be produced.
Time frame: through study completion, an average of 1 year
Participants will be screened using the Generalized Anxiety Disorder-7 (GAD7) with a total score for the seven items ranging from 0 to 21. Scores 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.
Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the GAD7 will be produced.
Time frame: through study completion, an average of 1 year
Participants will be screened using the Posttraumatic Stress Disorder Checklist (PCL-5) PCL-5. On a 4-point scale, scores can be tabulated for individual items to give information about the severity of the four DSM-5 symptom clusters. If a score of 2 (moderate) is considered to be a positive endorsement of a given criterion, the PCL-5 can be used in combination with a clinical interview to make a provisional DSM-5 diagnosis. Testing the PCL-5 with veterans has determined a score of 31 to 33 to be a valid cutoff for a positive screen. The scores range from 0-80, 0 being no symptoms to extreme issues with post-traumatic stress disorder.
Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PCL5 will be produced.
Contact information is provided by the study sponsor or research team.
Ed Lesofski
CONTACT
James Taggart, MD
CONTACT
RIVER Foundation
Other
Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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