Home use of ketamine for chronic conditions
Can Digital Health Technology Guide Medical Providers, in Treating Chronic Conditions With RIVER Ketamine Protocols Safely at Home?
This study is testing whether taking ketamine at home can help people with chronic pain, depression, or PTSD feel better and improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RIVER Foundation Academic / other |
| Locations | 2 sites (Bigfork, Montana and 1 other locations) |
| Trial ID | NCT06070766 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the safety and efficacy of oral and nasal ketamine administered at home for individuals with chronic conditions, including chronic pain, major depressive disorder, and PTSD. The study aims to recruit up to 50,000 participants over five years, utilizing digital technology to gather data on treatment protocols and outcomes. Participants will be assessed using psychological scales to evaluate the impact of ketamine on their symptoms, with interim results expected in November 2023 and final results in June 2024.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with identifiable chronic conditions who are seeking alternative treatments.
Not a fit: Patients who are healthy or do not have a chronic condition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for patients suffering from chronic conditions and mental health issues.
How similar studies have performed: While there have been pilot studies on ketamine, this large-scale approach focusing on home administration and chronic conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Must have an identifiable chronic condition. Exclusion Criteria: Healthy Population
Where this trial is running
Bigfork, Montana and 1 other locations
- RIVER Foundation — Bigfork, Montana, United States (Recruiting)
- RIVER Telehealth — Helena, Montana, United States (Recruiting)
Study contacts
- Principal investigator: Dharma Rose, D.O. M.S. — RIVER Foundation
- Study coordinator: Ed Lesofski, M.S.
- Email: ed@riverofchange.org
- Phone: 406-431-4890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.