Chronic PainORACLENCT07648771
Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation
An observational study of Chronic Pain and Ketamine, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Ketamine
- What is being tested?
- Ketamine (Ketalar)
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2034
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain
Who may be able to join
- Planning to receive an intravenous ketamine infusion for the treatment of chronic pain
Who cannot join
- Unable to read or understand English questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford Health Care
Stanford, California, 94305
Protocol Director, 650-264-9442, tlii@stanford.edu
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Chronic Pain, Ketamine
- Being tested
- Ketamine (Ketalar)
- Keywords
- Observational, Registry, Longitudinal, Surveys, Ketamine, Chronic Pain, Analgesia
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (Ketalar)Drug
Also called Ketamine Infusion, Intravenous Ketamine
Intravenous ketamine infusion delivered as part of routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Treated Cohort | Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain Receives: Drug: Ketamine (Ketalar) | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS Pain Interference Score From Baseline
Measured: 8, 10, and 12 weeks after the ketamine infusion
Secondary outcomes (1)
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Measured: From enrollment to 12 weeks after the ketamine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Lii, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648771
- Sponsor's protocol ID
- 87368
- Acronym
- ORACLE
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Observational Registry of Patient Outcomes Following Ketamine Infusion Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT07648771
- Acronym / sponsor ID
- ORACLE / 87368
- Conditions
- Chronic Pain, Ketamine
- Keywords
- Observational, Registry, Longitudinal, Surveys, Ketamine, Chronic Pain, Analgesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Treated Cohort | – | Drug: Ketamine (Ketalar)Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain
Key inclusion criteria (1 listed)
- Planning to receive an intravenous ketamine infusion for the treatment of chronic pain
Key exclusion criteria (1 listed)
- Unable to read or understand English questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine (Ketalar)Also: Ketamine Infusion, Intravenous KetamineIntravenous ketamine infusion delivered as part of routine clinical care | Drug | Ketamine Treated Cohort |
Primary outcome
Change in PROMIS Pain Interference Score From Baseline
Time frame: 8, 10, and 12 weeks after the ketamine infusion
1 secondary outcome
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Time frame: From enrollment to 12 weeks after the ketamine infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Ketamine, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Protocol Director (650-264-9442, tlii@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Pain Interference Score From Baseline (time frame: 8, 10, and 12 weeks after the ketamine infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.