Recruiting

Ketamine

Sponsor:

RIVER Foundation

Code:

NCT06070766

Conditions

Chronic Condition

Chronic Pain

Chronic Disease

Major Depressive Disorder

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

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).

Conditions

Chronic Condition

Chronic Pain

Chronic Disease

Major Depressive Disorder

Post Traumatic Stress Disorder

Study ID

NCT06070766

Start date

Oct 1, 2023

Status verified date

Nov, 2024

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Must have an identifiable chronic condition.

Exclusion Criteria:

Healthy Population

Study Design

Enrollment

50000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Ketamine

The use of ketamine in chronic conditions.

Primary outcome measure

  • Mental Health PHQ9 [ Time Frame: Through study completion, an average of 5 years ]
  • Mental Health GAD7 [ Time Frame: Through study completion, an average of 5 years ]
  • Mental Health PCL5 [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

Ed Lesofski, M.S.

406-431-4890ed@riverofchange.org

James Taggart, M.D.

415--713-6554info@riverofchange.org

Locations

RIVER Foundation

Recruiting

Bigfork, Montana, United States, 59911

Contacts

Ed Lesofski, MS

406-431-4890ed@riverofchange.org

Jeff Newton

406-431-4890info@riverofchange.org

RIVER Telehealth

Recruiting

Helena, Montana, United States, 59601

Contacts

Ed Lesofski, MS

406-465-9504ed@riverofchange.org

Principal Investigator:

James Taggart, MD

More Information

Sponsor

RIVER Foundation

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

  • Ketamine
  • Neuroinflammation
  • Auricular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RIVER Foundation on 2024-11-26.