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RIVER At Home Ketamine Protocols

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "An estimated 36% of 18-29-year-olds were experiencing symptoms of depression in early May 2021, compared to 22% of those 40-49 and 15% of those age 50-59, according to the Centers for Disease Control and Prevention's (C.D.C.) Household Pulse Survey." Research is up-and-coming on the use of Ketamine."
  • "Ninety minutes after infusion, eight of nine subjects of the ketamine group had remission (88%) compared with three of nine (33%) in the placebo group (p \< .05 …The change in depression is a secondary outcome."
  • "This reduction was rapid with the nadir effect three days after infusion." Depressed patients often present to the emergency department with complaints of suicidal thoughts, which accounts for more than half a million admissions annually to the emergency department in the United States."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the safety of ketamine taken by mouth or through the nose at home, without therapy or supervision. It is for adults with a long-term health condition.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must have a known long-term health condition.

Who can't join

  • Healthy people without a long-term health condition.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Must have an identifiable chronic condition. Exclusion Criteria: Healthy Population

Study sites (2)

MT