Clinical trial

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

Name

RIVER IRB IRB00013708 2023-2

Description

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).

Trial arms

Trial start

2023-10-01

Estimated PCD

2028-10-01

Trial end

2029-04-01

Status

Recruiting

Treatment

Ketamine

The use of ketamine in chronic conditions.

Arms:

Anxiety, Anxiety MH, Auricular Anxiety, Auricular Chronic Pain, Auricular Depression, Auricular Trauma, Chronic Pain, Chronic Pain MH, Depression, Depression MH, Tramua MH, Trauma, Veterans and First Responders

Other names:

Ketalar

Size

50000

Primary endpoint

Mental Health PHQ9

Through study completion, an average of 5 years

Mental Health GAD7

Through study completion, an average of 5 years

Mental Health PCL5

Through study completion, an average of 5 years

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 50000, 'type': 'ESTIMATED'}}

Updated at

2023-10-06

1 organization

1 drug

6 indications

Organization

River Foundation

Drug

Ketamine

Indication

Chronic Condition

Indication