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

NCT07648771 — Not yet recruiting, 800 participants, Stanford University

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

RegistryNCT07648771, acronym ORACLE
StatusNot yet recruiting
Study typeObservational
Enrollment800 (Estimated)
SponsorStanford University (Other)
ConditionsChronic Pain, Ketamine
InterventionsKetamine (Ketalar) (Drug)
Datesstart 2026-10-01 (estimated), primary completion 2034-12-01 (estimated), completion 2034-12-01 (estimated), first posted 2026-06-15, last updated 2026-09-15
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Pain All trials for Ketamine All trials of Ketamine (Ketalar)

-Summary

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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+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

+Arms and interventions

ArmTypeInterventionsDescription
Ketamine Treated CohortDrug: Ketamine (Ketalar)Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
Denied Treatment CohortObservational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage
  • Ketamine (Ketalar) (Drug), also known as Ketamine Infusion, Intravenous Ketamine: Intravenous ketamine infusion delivered as part of routine clinical care

+Outcome measures

Primary outcomes

  • Change in PROMIS Pain Interference Score From Baseline [8, 10, and 12 weeks after the ketamine infusion]

Secondary outcomes

  • Change in Opioid Use From Baseline, Patient-Rated Global Assessment [From enrollment to 12 weeks after the ketamine infusion]

Other outcomes

  • 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 [Pre-Treatment Baseline]: From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale
  • Average Drug Liking and Craving Score [From 1 to 16 weeks after the ketamine infusion]: Drug Liking and Craving Questionnaire items modified for ketamine

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Unable to read or understand English questionnaires

+Locations (1)

FacilityCityCountryStatus
Stanford Health CareStanford, CaliforniaUnited States