Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Geschat)

800

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Stanford, California, Verenigde Staten, 94305
        • Stanford Health Care
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to read or understand English questionnaires

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
Geneesmiddel: Ketamine (Ketalar)
Intravenous ketamine infusion delivered as part of routine clinical care
Andere namen:
  • 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in PROMIS Pain Interference Score From Baseline
Tijdsspanne: 8, 10, and 12 weeks after the ketamine infusion
8, 10, and 12 weeks after the ketamine infusion

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Tijdsspanne: From enrollment to 12 weeks after the ketamine infusion
From enrollment to 12 weeks after the ketamine infusion

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Baseline Pain Medication Beliefs
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Stanford University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2034

Studie voltooiing (Geschat)

1 december 2034

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 87368

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD-tijdsbestek voor delen

Upon publication of study results with no end date

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren