此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation (ORACLE)

2026年9月11日 更新者：Theresa Lii、Stanford University

Nationwide Observational Registry of Patient Outcomes Following Ketamine Infusion Therapy for Chronic Pain

Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain.

Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care.

We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Some key questions this study would like to answer:

  1. How do patients respond to ketamine over time? This study will use surveys to track pain, sleep, mood, function, and other experiences for up to 16 weeks after a ketamine infusion.
  2. Does the dose matter? This study aims to find out whether patients who get higher doses of ketamine have longer-lasting pain relief, and whether there is a point of diminishing returns.
  3. What makes some patients respond better than others? For example, there are some early data suggesting that patients who worry more about their pain might have more trouble reducing their opioids after ketamine treatment even if they had pain relief.
  4. Are ketamine infusions addictive when used for pain treatment? This study will track cravings and drug liking for up to 16 weeks after a ketamine infusion. Addiction risk is expected to be low, but this study will document this risk systematically.
  5. What happens to patients who were recommended ketamine but denied insurance coverage? This study will compare their outcomes to patients who received ketamine, to better understand the impact of insurance denials and the real-world effects of ketamine treatment.

STUDY PROCEDURES SUMMARY

Upon consenting to the study, eligible participants will be asked to share their contact information, some background health information, details about their scheduled infusion, prior ketamine experience, and baseline symptoms. All personal information will be kept private and secure. Participants will be assigned a unique study number, and their name and contact details will not be shared with anyone outside the core study team.

Afterwards, participants will:

  • Complete an online survey a few days before their infusion; then one survey each week for up to 16 weeks after their infusion. These surveys will track pain, mood, sleep, medication use, and other symptoms over time.
  • Optionally allow the study team to review medical records related to their ketamine treatment (such as the ketamine dose, side effects, and diagnoses linked with treatment).
  • Patients who were recommended ketamine but denied insurance coverage will have to opportunity to complete the same surveys

研究类型

观察性的

注册 (估计的)

800

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Stanford、California、美国、94305
        • Stanford Health Care
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain

描述

Inclusion Criteria:

  • Planning to receive an intravenous ketamine infusion for the treatment of chronic pain

Exclusion Criteria:

  • Unable to read or understand English questionnaires

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
药品：Ketamine (Ketalar)
Intravenous ketamine infusion delivered as part of routine clinical care
其他名称：
  • Ketamine Infusion
  • Intravenous Ketamine
Denied Treatment Cohort
Observational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in PROMIS Pain Interference Score From Baseline
大体时间：8, 10, and 12 weeks after the ketamine infusion
8, 10, and 12 weeks after the ketamine infusion

次要结果测量

结果测量
大体时间
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
大体时间：From enrollment to 12 weeks after the ketamine infusion
From enrollment to 12 weeks after the ketamine infusion

其他结果措施

结果测量
措施说明
大体时间
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Physical Function Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Sleep Disturbance Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Anxiety Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Depression Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Social Isolation Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in Pain Catastrophizing Scale Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in Pain Self-Efficacy Questionnaire Score From Baseline
大体时间：From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Baseline Pain Medication Beliefs
大体时间：Pre-Treatment Baseline
From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale
Pre-Treatment Baseline
Average Drug Liking and Craving Score
大体时间：From 1 to 16 weeks after the ketamine infusion
Drug Liking and Craving Questionnaire items modified for ketamine
From 1 to 16 weeks after the ketamine infusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2034年12月1日

研究完成 (估计的)

2034年12月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 87368

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享时间框架

Upon publication of study results with no end date

IPD 共享访问标准

A proposal that describes planned analyses must be approved and a data sharing agreement must be signed before accessing IPD from the study team

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅