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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Ketamine
• Intervention / Treatment: Drug: Ketamine (Ketalar)

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Protocol Director; Phone Number: 650-264-9442; Email: tlii@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care
      • Contact: Protocol Director; Phone Number: 650-264-9442; Email: tlii@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to read or understand English questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ketamine Treated Cohort; Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain	Drug: Ketamine (Ketalar); Intravenous ketamine infusion delivered as part of routine clinical care; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in PROMIS Pain Interference Score From Baseline	From enrollment to 16 weeks after the ketamine infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Opioid Use From Baseline, Patient-Rated Global Assessment	From enrollment to 16 weeks after the ketamine infusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale		From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Physical Function Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Sleep Disturbance Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Anxiety Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Depression Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Social Isolation Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in Pain Catastrophizing Scale Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Change in Pain Self-Efficacy Questionnaire Score From Baseline		From enrollment to 16 weeks after the ketamine infusion
Baseline Pain Medication Beliefs	From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale	Pre-Treatment Baseline
Average Drug Liking and Craving Score	Drug Liking and Craving Questionnaire items modified for ketamine	From 1 to 16 weeks after the ketamine infusion

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Analgesia; Ketamine; Observational; Registry; Longitudinal; Surveys
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Agnosia; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Ketamine
• Other Study ID Numbers: 87368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Upon publication of study results with no end date
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No