RIVER At Home Ketamine Protocols
Can Digital Health Technology Guide Medical Providers, in Treating Chronic Conditions With RIVER Ketamine Protocols Safely at Home?
1 other identifier
observational
50,000
1 country
2
Brief Summary
Multiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
November 26, 2024
November 1, 2024
5 years
September 22, 2023
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mental Health PHQ9
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.
Through study completion, an average of 5 years
Mental Health GAD7
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.
Through study completion, an average of 5 years
Mental Health PCL5
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.
Through study completion, an average of 5 years
Secondary Outcomes (2)
Auricular Therapy
Through study completion, an average of 5 years
Millennium Health
Through study completion, an average of 5 years
Study Arms (13)
Chronic Pain
Drug: Ketamine The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine research within the treatment plan of those with chronic conditions. A RIVER Ketamine protocol will be developed
Anxiety
Drug: Ketamine The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine research within the treatment plan of those with chronic conditions. A RIVER Ketamine protocol will be developed
Veterans and First Responders
The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine research within the treatment plan of those with chronic conditions. A RIVER Ketamine protocol will be developed
Depression
Drug: Ketamine The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine research within the treatment plan of those with chronic conditions. A RIVER Ketamine protocol will be developed
Trauma
Drug: Ketamine The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine research within the treatment plan of those with chronic conditions. A RIVER Ketamine protocol will be developed
Auricular Chronic Pain
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Anxiety
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Depression
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Trauma
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Chronic Pain MH
4\. Millennium Health The Phase 2 Protocol (P2P) has entered its 4th year of application in those with symptoms associated with all forms of traumatic brain injury (T.B.I.). Listening to any of the following Joe Rogan Experience podcasts, 1589, 1056, or 700, will provide a number of discussions on this topic. Since the 2020 pilot study with active duty Marines (U.S.M.C.), looking at the benefits of a 100% nutraceutical approach to T.B.I., precipitated changes in mental and physical health, we had the start to developing the P2P. With over 8,000 participants, we see the benefits derived from the 2023 Phase 2 Protocol.
Anxiety MH
4\. Millennium Health The Phase 2 Protocol (P2P) has entered its 4th year of application in those with symptoms associated with all forms of traumatic brain injury (T.B.I.). Listening to any of the following Joe Rogan Experience podcasts, 1589, 1056, or 700, will provide a number of discussions on this topic. Since the 2020 pilot study with active duty Marines (U.S.M.C.), looking at the benefits of a 100% nutraceutical approach to T.B.I., precipitated changes in mental and physical health, we had the start to developing the P2P. With over 8,000 participants, we see the benefits derived from the 2023 Phase 2 Protocol.
Depression MH
4\. Millennium Health The Phase 2 Protocol (P2P) has entered its 4th year of application in those with symptoms associated with all forms of traumatic brain injury (T.B.I.). Listening to any of the following Joe Rogan Experience podcasts, 1589, 1056, or 700, will provide a number of discussions on this topic. Since the 2020 pilot study with active duty Marines (U.S.M.C.), looking at the benefits of a 100% nutraceutical approach to T.B.I., precipitated changes in mental and physical health, we had the start to developing the P2P. With over 8,000 participants, we see the benefits derived from the 2023 Phase 2 Protocol.
Tramua MH
4\. Millennium Health The Phase 2 Protocol (P2P) has entered its 4th year of application in those with symptoms associated with all forms of traumatic brain injury (T.B.I.). Listening to any of the following Joe Rogan Experience podcasts, 1589, 1056, or 700, will provide a number of discussions on this topic. Since the 2020 pilot study with active duty Marines (U.S.M.C.), looking at the benefits of a 100% nutraceutical approach to T.B.I., precipitated changes in mental and physical health, we had the start to developing the P2P. With over 8,000 participants, we see the benefits derived from the 2023 Phase 2 Protocol.
Interventions
The use of ketamine in chronic conditions.
Eligibility Criteria
People with chronic conditions need either their mental health or pain controlled.
You may qualify if:
- Must have an identifiable chronic condition.
You may not qualify if:
- Healthy Population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RIVER Foundationlead
Study Sites (2)
RIVER Foundation
Bigfork, Montana, 59911, United States
RIVER Telehealth
Helena, Montana, 59601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dharma Rose, D.O. M.S.
RIVER Foundation
- STUDY CHAIR
Frank Yurseak, Ph.D.
RIVER Foundation
- PRINCIPAL INVESTIGATOR
Jeffery Newton
RIVER Foundation
- PRINCIPAL INVESTIGATOR
Alejandro Fernandez
RIVER Foundation
- PRINCIPAL INVESTIGATOR
James Taggart, MD
RIVER Foundation
- STUDY DIRECTOR
Ed Lesofski, MS
RIVER Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
October 6, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
November 26, 2024
Record last verified: 2024-11