RECRUITING

RIVER At Home Ketamine Protocols

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-10-01
Study Completion:2029-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06070766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ed Lesofski, M.S.
CONTACT
406-431-4890
ed@riverofchange.org
James Taggart, M.D.
CONTACT
415--713-6554
info@riverofchange.org

Principal Investigator

Dharma Rose, D.O. M.S.
PRINCIPAL_INVESTIGATOR
RIVER Foundation
Frank Yurseak, Ph.D.
STUDY_CHAIR
RIVER Foundation
Jeffery Newton
PRINCIPAL_INVESTIGATOR
RIVER Foundation
Alejandro Fernandez
PRINCIPAL_INVESTIGATOR
RIVER Foundation
James Taggart, MD
PRINCIPAL_INVESTIGATOR
RIVER Foundation
Ed Lesofski, MS
STUDY_DIRECTOR
RIVER Foundation

Study Locations (Sites)

RIVER Foundation
Bigfork, Montana, 59911
United States
RIVER Telehealth
Helena, Montana, 59601
United States

Collaborators and Investigators

Sponsor: RIVER Foundation

  • Dharma Rose, D.O. M.S., PRINCIPAL_INVESTIGATOR, RIVER Foundation
  • Frank Yurseak, Ph.D., STUDY_CHAIR, RIVER Foundation
  • Jeffery Newton, PRINCIPAL_INVESTIGATOR, RIVER Foundation
  • Alejandro Fernandez, PRINCIPAL_INVESTIGATOR, RIVER Foundation
  • James Taggart, MD, PRINCIPAL_INVESTIGATOR, RIVER Foundation
  • Ed Lesofski, MS, STUDY_DIRECTOR, RIVER Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2029-04-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2029-04-01

Terms related to this study

Keywords Provided by Researchers

  • Ketamine
  • Neuroinflammation
  • Auricular

Additional Relevant MeSH Terms

  • Chronic Condition
  • Chronic Pain
  • Chronic Disease
  • Major Depressive Disorder
  • Post Traumatic Stress Disorder
  • Anxiety Disorders