Ketamine Treatment Plans for Chronic Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRIVER Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
People with chronic conditions that need either their mental health or pain controlled.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Ketamine
DrugThe 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
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: Chronic Pain1 intervention
Group B: Depressive Disorders1 intervention
Group C: Anxiety Disorders1 intervention
Group D: Chronic Condtions1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
through study completion, an average of 1 year2
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.
Time frame
through study completion, an average of 1 year3
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.
Time frame
through study completion, an average of 1 year4
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov