Can Digital Health Technology Guide Medical Providers, in Treating Chronic Conditions With RIVER Ketamine Protocols Safely at Home?

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must have an identifiable chronic condition.

Locations
United States
Montana
RIVER Foundation
RECRUITING
Bigfork
RIVER Telehealth
RECRUITING
Helena
Contact Information
Primary
Ed Lesofski, M.S.
ed@riverofchange.org
406-431-4890
Backup
James Taggart, M.D.
info@riverofchange.org
415--713-6554
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 50000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: RIVER Foundation

This content was sourced from clinicaltrials.gov