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

12. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford Health Care
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to read or understand English questionnaires

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
Medicin: Ketamine (Ketalar)
Intravenous ketamine infusion delivered as part of routine clinical care
Andre navne:
  • 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in PROMIS Pain Interference Score From Baseline
Tidsramme: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion

Sekundære resultatmål

Resultatmål
Tidsramme
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Tidsramme: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Baseline Pain Medication Beliefs
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. december 2034

Studieafslutning (Anslået)

1. december 2034

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 87368

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

Upon publication of study results with no end date

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk smerte

Kliniske forsøg med Ketamine (Ketalar)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

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