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RIVER At Home Ketamine Protocols

NCT06070766 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50000

Last updated 2024-11-26

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ketamine

The use of ketamine in chronic conditions.

Sponsors & Collaborators

  • RIVER Foundation

    lead OTHER

Principal Investigators

  • Dharma Rose, D.O. M.S. · RIVER Foundation

  • Frank Yurseak, Ph.D. · RIVER Foundation

  • Jeffery Newton · RIVER Foundation

  • Alejandro Fernandez · RIVER Foundation

  • James Taggart, MD · RIVER Foundation

  • Ed Lesofski, MS · RIVER Foundation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2028-10-01
Completion
2029-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070766 on ClinicalTrials.gov