Ketamine for Chronic Illnesses
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how ketamine, used at home without therapy, can assist individuals with chronic conditions such as depression, anxiety, trauma, and chronic pain. The researchers aim to determine if ketamine can serve as a safe, affordable treatment option outside a clinical setting. In addition to ketamine, some participants will try ear acupuncture to assess its effectiveness for conditions like anxiety and pain. Individuals with a chronic condition experiencing symptoms that affect daily life might be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the understanding of ketamine's potential benefits.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found low-dose ketamine infusions to be safe and effective for treating long-term pain. However, side effects can include hallucinations, memory problems, nausea, and increased blood pressure. The FDA has approved ketamine as an anesthetic for surgery, but it remains under study for other uses.
Research on ear acupuncture shows no major harmful effects. Some individuals might experience brief pain, dizziness, or minor bleeding at the needle site. Overall, it appears well-tolerated.
Both ketamine and ear acupuncture offer potential benefits with manageable safety concerns, but considering possible side effects is important when deciding to join a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the RIVER At Home Ketamine Protocols because they offer a fresh approach to managing conditions like depression, anxiety, and chronic pain. Ketamine, typically used off-label, provides rapid relief compared to standard antidepressants, which often take weeks to work. This protocol also explores at-home administration, making it more accessible for patients who struggle with frequent clinic visits. Additionally, the trial includes auricular therapy, a form of ear acupuncture, which presents a non-drug option that could complement or enhance treatment outcomes. Overall, these innovative methods aim to personalize and improve mental health care, especially for those with chronic or treatment-resistant conditions.
What evidence suggests that this trial's treatments could be effective?
This trial will evaluate the efficacy of different treatment approaches for conditions such as depression, anxiety, trauma, and chronic pain. Participants may receive ketamine, which studies have shown can effectively manage chronic pain and depression. Research indicates that ketamine can significantly reduce pain and depressive symptoms, with effects lasting up to six months. One study found that oral ketamine helped ease depression and pain for individuals with long-term conditions.
Other participants may receive auricular therapy, which involves acupuncture on the ear. Research supports its effectiveness in reducing symptoms of post-traumatic stress disorder (PTSD) and providing relief from chronic pain. Studies have shown that six acupuncture treatments over three weeks offer better pain relief than fewer sessions.
Both ketamine and auricular therapy have shown promise in treating conditions like depression, anxiety, and chronic pain. This trial will further explore their potential benefits.678910Who Is on the Research Team?
Frank Yurseak, Ph.D.
Principal Investigator
RIVER Foundation
Jeffery Newton
Principal Investigator
RIVER Foundation
Alejandro Fernandez
Principal Investigator
RIVER Foundation
James Taggart, MD
Principal Investigator
RIVER Foundation
Ed Lesofski, MS
Principal Investigator
RIVER Foundation
Dharma Rose, D.O. M.S.
Principal Investigator
RIVER Foundation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral and nasal ketamine at home with no therapy, monitored through digital health technology
Follow-up
Participants are monitored for safety and effectiveness after treatment using psychological scales such as PHQ9, GAD7, and PCL5
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
How Is the Trial Designed?
13
Treatment groups
Experimental Treatment
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
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
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.
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.
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
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.
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 Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
Auricular Therapy (Ear acupuncture) 1. National Acupuncture Detoxification Association 2. Battlefield Acupuncture
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
RIVER Foundation
Lead Sponsor
Citations
Efficacy and Safety of Auricular Acupuncture for Depression
Most participants reported mild pain at the needle application site (33 patients [94%] in the SA group vs 32 patients [91%] in the NSA group).
2.
journals.lww.com
journals.lww.com/md-journal/fulltext/2020/02210/effectiveness_and_safety_of_ear_acupuncture_for.84.aspxEffectiveness and safety of ear acupuncture for trauma- ...
Ear acupuncture improved overall post-traumatic stress disorder (PTSD) related symptoms in patients with PTSD after disasters.
Efficacy of Auricular Therapy for Pain Management: A ...
In acupuncture, six treatments over a 3-week period provide better pain relief than does the administration of fewer than six treatments [73].
Effects of Auricular Point Acupressure on Pain Relief
The findings of this systematic review suggest that APA, often in combination with other interventions, reduced most acute pain, regardless of preintervention ...
Auricular Acupuncture for Chronic Pain and Insomnia
This study was carried out to assess the feasibility and effectiveness of auricular acupuncture using a standard protocol both for chronic pain and insomnia.
The National Acupuncture Detoxification Association ...
The respondents reported no major adverse effects following treatments. Minor negative experiences included brief transitory sensation of pain ...
Adverse Events of Auricular Therapy: A Systematic Review
For auricular acupuncture, the most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and ...
Battlefield Acupuncture (BFA) Handbook - Joint Trauma System
The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: ...
Ear acupuncture: A tool for recovery - Yale School of Medicine
Research has shown that acupuncture is effective for addiction treatment. The best evidence is when used as an adjunctive treatment for opioid detoxification.
Managing Stress Through Acupuncture: Acudetox
Acudetox involves a simple, standardized five-point auricular acupuncture treatment. The National Acupuncture Detoxification Association ...
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