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NCT Number: NCT06038409

Ketamine Treatment Plans for Chronic Conditions

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RIVER Telehealth

Helena, Montana, 59601, United States

Location status: Recruiting

Location contact

Ed Lesofski, MS

CONTACT

[email protected]

406-465-9504

Edward Lesofski, MS

CONTACT

Frank Yurasek, PhD

CONTACT

James Taggart, MD

CONTACT

Jeffery Newton

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Must have an identifiable chronic condition.

Exclusion criteria

Healthy population

Treatment and study plan

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

Primary outcomes

  1. Ketamine route of use acceptability.

    Time frame: through study completion, an average of 1 year

    Compare and Contrast the different methods and uses of ketamine for acceptability for the route of use. (ie oral sublingual or nasal spray)

  2. Mental Health PHQ9

    Time frame: through study completion, an average of 1 year

    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.

  3. Mental Health GAD7

    Time frame: through study completion, an average of 1 year

    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.

  4. Mental Health PCL5

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ed Lesofski

CONTACT

[email protected]

406-465-9504

James Taggart, MD

CONTACT

[email protected]

415-713-6654

Sponsors and collaborators

Lead sponsor

RIVER Foundation

Other

Registry information

Official study title

Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 14, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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