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NCT06070766Recruiting

RIVER At Home Ketamine Protocols

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

Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
50000 (estimated)
First submitted
22 Sept 2023
Start date
1 Oct 2023
Primary completion date
1 Oct 2028
Lead sponsor
RIVER Foundation
Diseases
Depression
NCT number
NCT06070766

What you commit to

  • Study type: Observational
  • Planned participants: 50000
  • From 1 Oct 2023 to the primary completion date, 1 Oct 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Healthy Population

Who the study is looking for

  • Must have an identifiable chronic condition.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RIVER Foundation
Coordinator of this site? Confirm its status
BigforkUnited StatesRecruiting
RIVER Telehealth
Coordinator of this site? Confirm its status
HelenaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.