Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Ketamine route of use acceptability.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have an identifiable chronic condition.
排除标准
- •Healthy population
研究组 & 干预措施
Chronic Pain
The use of ketamine in chronic pain
干预措施: Ketamine (Drug)
Depressive Disorders
The use of ketamine in depressive disorders
干预措施: Ketamine (Drug)
Anxiety Disorders
The use of ketamine in anxiety disorders
干预措施: Ketamine (Drug)
Chronic Condtions
The use of ketamine in chronic conditions
干预措施: Ketamine (Drug)
结局指标
主要结局
Ketamine route of use acceptability.
时间窗: 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)
Mental Health PHQ9
时间窗: 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.
Mental Health GAD7
时间窗: 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.
Mental Health PCL5
时间窗: 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.
次要结局
未报告次要终点