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NCT Number: NCT07648771

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

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.

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Key information

Conditions

Chronic Pain Agnosia Ketamine Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Some key questions this study would like to answer:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Unable to read or understand English questionnaires

Treatment and study plan

Ketamine (Ketalar)

Drug

Intravenous ketamine infusion delivered as part of routine clinical care

Other names: Ketamine Infusion, Intravenous Ketamine

Primary outcomes

  1. Change in PROMIS Pain Interference Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

Secondary outcomes

  1. Change in Opioid Use From Baseline, Patient-Rated Global Assessment

    Time frame: From enrollment to 16 weeks after the ketamine infusion

Other outcomes

  1. Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  2. Change in PROMIS Physical Function Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  3. Change in PROMIS Sleep Disturbance Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  4. Change in PROMIS Anxiety Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  5. Change in PROMIS Depression Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  6. Change in PROMIS Social Isolation Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  7. Change in Pain Catastrophizing Scale Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  8. Change in Pain Self-Efficacy Questionnaire Score From Baseline

    Time frame: From enrollment to 16 weeks after the ketamine infusion

  9. Baseline Pain Medication Beliefs

    Time frame: Pre-Treatment Baseline

    From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale

  10. Average Drug Liking and Craving Score

    Time frame: From 1 to 16 weeks after the ketamine infusion

    Drug Liking and Craving Questionnaire items modified for ketamine

Study contacts

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

Protocol Director

CONTACT

[email protected]

650-264-9442

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: ORACLE

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

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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