Can Digital Health Technology Guide Medical Providers, in Treating Chronic Conditions With RIVER Ketamine Protocols Safely at Home?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 2
- 主要终点
- Mental Health PHQ9
研究概览
简要总结
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).
详细描述
The why, when, what, and how much needs to be studied. The new study is five years and up to 50,000 participants. With digital technology, many questions can be answered. The study is a pay-to-participate study in which minimal fees will be charged for the technology.
Lacking in the original RIVER pilot study was when and how often the participants would take their medication (Ketamine) and which additional add-on protocols make the treatments more effective. The RIVER protocol was not based on weight but on the severity of symptoms, history of chronic conditions, and current medications.
Adverse effects were standard nausea; however, there were only three minor adverse effects. None of the effects were severe enough to halt the research. The results were promising. Drops in PHQ9 depression scores were reduced overall between 25% and 61%. RIVER Ketamine protocols were developed, making home use safe and effective.
Suicide rates increased approximately 36% between 2000-2021. Suicide was responsible for 48,183 deaths in 2021, about one every 11 minutes. The number of people who think about or attempt suicide is even higher. In 2021, an estimated 12.3 million American adults seriously thought about suicide, 3.5 million planned a suicide attempt, and 1.7 million attempted suicides.
Oral Ketamine offers a promising pharmacologic adjunct to chronic condition treatments. It may offer a more approachable alternative to IV or I.M. Ketamine. The results of the RIVER pilot study warrant further investigation into the safety and efficacy of oral Ketamine for chronic conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have an identifiable chronic condition.
排除标准
- •Healthy Population
研究组 & 干预措施
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
干预措施: Ketamine (Drug)
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
干预措施: Ketamine (Drug)
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
干预措施: Ketamine (Drug)
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
干预措施: Ketamine (Drug)
Auricular Trauma
Auricular Therapy (Ear acupuncture)
- National Acupuncture Detoxification Association
- Battlefield Acupuncture
干预措施: Ketamine (Drug)
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
干预措施: Ketamine (Drug)
Auricular Chronic Pain
Auricular Therapy (Ear acupuncture)
- National Acupuncture Detoxification Association
- Battlefield Acupuncture
干预措施: Ketamine (Drug)
Auricular Anxiety
Auricular Therapy (Ear acupuncture)
- National Acupuncture Detoxification Association
- Battlefield Acupuncture
干预措施: Ketamine (Drug)
Auricular Depression
Auricular Therapy (Ear acupuncture)
- National Acupuncture Detoxification Association
- Battlefield Acupuncture
干预措施: Ketamine (Drug)
Chronic Pain MH
- 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.
干预措施: Ketamine (Drug)
Anxiety MH
- 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.
干预措施: Ketamine (Drug)
Depression MH
- 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.
干预措施: Ketamine (Drug)
Tramua MH
- 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.
干预措施: Ketamine (Drug)
结局指标
主要结局
Mental Health PHQ9
时间窗: Through 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 PCL5
时间窗: Through 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.
Mental Health GAD7
时间窗: Through 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.
次要结局
- Auricular Therapy(Through study completion, an average of 5 years)
- Millennium Health(Through study completion, an average of 5 years)