RIVER At Home Ketamine Protocols

Part of paid clinical trials in Bigfork, Montana.

Sponsor
RIVER Foundation
Study ID
NCT06070766
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    The use of ketamine in chronic conditions.

Study Details

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).

Key Dates

Start date
Oct 1, 2023
Status verified
Nov 2024
Primary completion
Oct 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
50,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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
  • Arm: 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
  • Arm: 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
  • Arm: 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
  • Arm: Auricular Chronic Pain
    Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
  • Arm: Auricular Anxiety
    Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
  • Arm: Auricular Depression
    Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
  • Arm: Auricular Trauma
    Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Mental Health PHQ9 [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
RIVER FoundationBigforkMontana59911
Ed Lesofski, MS
[email protected]
406-431-4890
Jeff Newton
[email protected]
406-431-4890
RIVER TelehealthHelenaMontana59601
Ed Lesofski, MS
[email protected]
406-465-9504
James Taggart, MD (PRINCIPAL_INVESTIGATOR)
Frank Yurasek, PhD (PRINCIPAL_INVESTIGATOR)
Edward Lesofski, MS (PRINCIPAL_INVESTIGATOR)
Jeffery Newton (SUB_INVESTIGATOR)

Find similar trials in Bigfork, MT

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By specialty
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By research site
RIVER Foundation· Bigfork, MTRIVER Telehealth· Helena, MT

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