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

11 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Beräknad)

800

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Stanford, California, Förenta staterna, 94305
        • Stanford Health Care
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
Läkemedel: Ketamine (Ketalar)
Intravenous ketamine infusion delivered as part of routine clinical care
Andra namn:
  • 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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Stanford University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 december 2034

Avslutad studie (Beräknad)

1 december 2034

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 87368

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

Tidsram för IPD-delning

Upon publication of study results with no end date

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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