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RecruitingN/A

RIVER At Home Ketamine Protocols

NCT06070766 · RIVER Foundation

Recruiting
Status
Accepting participants
Not applicable
Phase
50,000
Target enrolment
2
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Mental Health PHQ9

    Measured over Through study completion, an average of 5 years

  • Mental Health GAD7

    Measured over Through study completion, an average of 5 years

  • Mental Health PCL5

    Measured over Through study completion, an average of 5 years

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: Must have an identifiable chronic condition. Exclusion Criteria: Healthy Population

Where

2 study sites

FacilityCityRegionCountry
RIVER FoundationBigforkMontanaUnited States
RIVER TelehealthHelenaMontanaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06070766 on ClinicalTrials.gov →

Last updated in the registry 2024-11-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits