Ketamine Treatment Plans for Chronic Conditions

NCT06038409 | Recruiting FDA Drug

• 1 other identifier: RIVERFoundation 001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Depressive Disorder; Anxiety Disorders; Chronic Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

Chronic Pain

The use of ketamine in chronic pain

Drug: Ketamine

Depressive Disorders

The use of ketamine in depressive disorders

Drug: Ketamine

Anxiety Disorders

The use of ketamine in anxiety disorders

Drug: Ketamine

Chronic Condtions

The use of ketamine in chronic conditions

Drug: Ketamine

Interventions

Ketamine DRUG

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

Anxiety Disorders; Chronic Condtions; Chronic Pain; Depressive Disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with chronic conditions that need either their mental health or pain controlled.

You may qualify if:

• Must have an identifiable chronic condition.

You may not qualify if:

• Healthy population

Sponsors & Collaborators

• RIVER Foundation: lead

Study Sites (1)

RIVER Telehealth

Helena, Montana, 59601, United States

RECRUITING

Related Links

• RIVER's research web site

MeSH Terms

Conditions

Chronic Pain; Depressive Disorder; Anxiety Disorders; Chronic Disease

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Edward Lesofski, MS

  RIVER Foundation

  STUDY DIRECTOR

Central Study Contacts

Ed Lesofski

CONTACT

406-465-9504; ed@riverofchange.org

James Taggart, MD

CONTACT

415-713-6654; jrtaggartmd@aol.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: September 14, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 26, 2024

Record last verified: 2024-01

Locations

US (1)