Ketamine Treatment Plans for Chronic Conditions

This observational study is looking at how different ways of using Ketamine, a medication, are working for people with chronic (long-lasting) conditions like chronic pain, depression, and anxiety disorders. The study wants to see how effective Ketamine is when it's part of a treatment plan for these conditions. Researchers will also look at how other therapies, like psychotherapy or music therapy, might affect the results of Ketamine treatment. They are also interested in how Ketamine treatments might impact suicidal thoughts. You may be able to join if you are 18 or older and have a chronic condition. The study will measure how acceptable the different ways of taking Ketamine are, and will use questionnaires (PHQ9 and GAD7) to check for changes in mental health over about one year. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It plans to include about 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of one year.

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NCT06038409

Ketamine Treatment Plans for Chronic Conditions

Recruiting
Not specifiedAges 18+Observational
RIVER Foundation
~500 participants
Updated 2024-11-26 on ClinicalTrials.gov
What's tested:Ketamine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ketamine route of use acceptability.
Measured over through study completion, an average of 1 year
+3 more outcomes measured
Chronic Pain
Depressive Disorder
Anxiety Disorders
Chronic Disease
1 sites across 1 states
Montana1
  • Edward Lesofski, MS · STUDY_DIRECTOR · RIVER Foundation

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  • Ketamine route of use acceptability.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)

  • Mental Health PHQ9through 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.

  • Mental Health GAD7through 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.

  • Mental Health PCL5through 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.