Actively Recruiting
Study of Safe Home Use of RIVER Ketamine Protocols for Adults With Chronic Conditions Using Digital Health Technology
Led by RIVER Foundation · Updated on 2024-11-26
50000
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how digital health technology can help medical providers safely treat chronic conditions using RIVER Ketamine protocols at home. This observational study focuses on adults with chronic conditions, including chronic pain, major depressive disorder, anxiety disorders, and post-traumatic stress disorder. The study builds upon a previous pilot study of 500 participants that found oral and nasal ketamine safe for at-home use without therapy supervision and aims to further explore dosing schedules, add-on treatments, and symptom severity impacts. Participants will receive ketamine treatments based on symptom severity, chronic condition history, and current medications rather than weight. The study also explores auricular therapy ear acupuncture and a nutraceutical protocol for traumatic brain injury symptoms. The study plans to enroll up to 50,000 participants over five years, with a pay-to-participate model involving minimal fees for technology support. Multiple study arms assess different chronic condition subgroups and treatment approaches. During participation, individuals will complete assessments of mental health using the PHQ9, GAD7, and PCL5 scales over an average of five years. Additional monitoring includes auricular therapy and nutraceutical protocol effects. The study collects data on safety, dosing schedules, and symptom changes to develop effective home-use ketamine protocols. Participants contribute through regular questionnaires and digital monitoring, helping researchers understand ketamines role in managing chronic conditions and improving quality of life.
CONDITIONS
Brief Title
RIVER At Home Ketamine Protocols
Research Team
E
Ed Lesofski, M.S.
J
James Taggart, M.D.
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