Ketamine Treatment Plans for Chronic Conditions

Chronic Pain Clinical Trial

Official title:

Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038409
• Other study ID #: RIVERFoundation 001
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: RIVER Foundation
• Contact: Ed Lesofski
• Phone: 406-465-9504
• Email: ed[@]riverofchange.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others), and there have been few if any, studies that have compared the impact of Ketamine at home without any thearpy. The study will identify other treatment modalities used in concurrence with Ketamine. Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these adjunct therapies affect the outcomes of Ketamine treatments? Secondarily, the study will focus on these significant issues to observe the impact of Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and anxiety have been identified as underlying causes and may be improvable with Ketamine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Must have an identifiable chronic condition. Exclusion Criteria: Healthy population

Related Conditions & MeSH terms

• Anxiety Disorders
• Chronic Disease
• Chronic Pain
• Depressive Disorder

Intervention

Drug:
• Ketamine
The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions

Locations

Country	Name	City	State
United States	RIVER Telehealth	Helena	Montana

Sponsors (1)

Lead Sponsor	Collaborator
RIVER Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ketamine route of use acceptability.	Compare and Contrast the different methods and uses of ketamine for acceptability for the route of use. (ie oral sublingual or nasal spray)	through study completion, an average of 1 year
Primary	Mental Health PHQ9	The use of psychological scales to measure participants' mental health with the use of ketamine. Three scales will be charted to examine the mental health of the participant.; The Patient Health Questionnaire-9 (PHQ9), Patient Health Questionnaire 9 has a possible range of 0-27. Zero being no depression and 27 being severe depression.; Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PHQ9 will be produced.	through study completion, an average of 1 year
Primary	Mental Health GAD7	Participants will be screened using the Generalized Anxiety Disorder-7 (GAD7) with a total score for the seven items ranging from 0 to 21. Scores 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.; Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the GAD7 will be produced.	through study completion, an average of 1 year
Primary	Mental Health PCL5	Participants will be screened using the Posttraumatic Stress Disorder Checklist (PCL-5) PCL-5. On a 4-point scale, scores can be tabulated for individual items to give information about the severity of the four DSM-5 symptom clusters. If a score of 2 (moderate) is considered to be a positive endorsement of a given criterion, the PCL-5 can be used in combination with a clinical interview to make a provisional DSM-5 diagnosis. Testing the PCL-5 with veterans has determined a score of 31 to 33 to be a valid cutoff for a positive screen. The scores range from 0-80, 0 being no symptoms to extreme issues with post-traumatic stress disorder.; Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PCL5 will be produced.	through study completion, an average of 1 year

External Links

•   RIVER's research web site