This observational cohort study (n=500) conducted by the RIVER Foundation aims to understand the safety and efficacy of home ketamine treatment plans for chronic conditions, including chronic pain, depressive disorders, anxiety disorders, and other chronic conditions.
Ketamine, administered through various routes such as IV, IM, SubQ, and Sublingual, is being studied within the context of different treatment modalities including psychotherapy, music therapy, and acutherapy. The study seeks to determine how these adjunct therapies affect the outcomes of ketamine treatments.
Additionally, the study will focus on assessing the impact of ketamine treatments on suicidal ideation, a multifaceted issue often associated with chronic conditions such as depression, pain, and anxiety.
Participants, aged 18 and older, with identifiable chronic conditions requiring mental health or pain management, are eligible to participate. Exclusion criteria include healthy individuals.
Primary outcome measures include assessing the acceptability of ketamine route of use and measuring participants’ mental health using scales such as the Patient Health Questionnaire-9 (PHQ9), Generalized Anxiety Disorder-7 (GAD7), and Posttraumatic Stress Disorder Checklist (PCL-5).
The study started on January 1, 2023, with an estimated primary completion date of January 1, 2024, and an estimated completion date of June 1, 2024. It is conducted at RIVER Telehealth in Helena, Montana, United States.
Trial Details
A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.Trial Number NCT06038409