Observational Study of Ketamine Protocols for Chronic Conditions
This study is looking at how ketamine, a medication, is used in people with chronic conditions like chronic pain, chronic disease, major depressive disorder, and post-traumatic stress disorder (PTSD). It aims to understand the best ways to use ketamine at home to help with these conditions. Researchers will measure your mental health using standard questionnaires (PHQ9, GAD7, PCL5) over an average of five years to see if the treatment is successful. You can join if you are 18 or older and have a chronic condition. The study plans to enroll up to 50,000 participants.
- Study design
- This is an observational study, meaning researchers will watch how ketamine is used in real-world settings. It plans to include up to 50,000 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- You will be charged minimal fees for the technology used in this pay-to-participate study.
- Follow-up
- Your mental health will be measured through study completion, which is an average of 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RIVER At Home Ketamine Protocols
At a glance
Conditions
NCT06070766
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
RIVER Foundation
Bigfork, Montanastudy coordinator listed
Recruiting
RIVER Telehealth
Helena, Montanastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dharma Rose, D.O. M.S. · PRINCIPAL_INVESTIGATOR · RIVER Foundation
- Frank Yurseak, Ph.D. · STUDY_CHAIR · RIVER Foundation
- Jeffery Newton · PRINCIPAL_INVESTIGATOR · RIVER Foundation
- Alejandro Fernandez · PRINCIPAL_INVESTIGATOR · RIVER Foundation
- James Taggart, MD · PRINCIPAL_INVESTIGATOR · RIVER Foundation
- Ed Lesofski, MS · STUDY_DIRECTOR · RIVER Foundation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Mental Health PHQ9Through study completion, an average of 5 years
The use of psychological scales to measure participants' mental health with the use of ketamine. 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. A multiline graph will show the results of PHQ9 will be produced.
- Mental Health GAD7Through study completion, an average of 5 years
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 throughout the study. A multiline graph will show the results of the GAD7 will be produced.
- Mental Health PCL5Through study completion, an average of 5 years
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. A multiline graph will show the results of the amount of ketamine and the PCL5 will be produced.