Can a single ketamine infusion rewrite the story of fibromyalgia pain?
NCT ID NCT06916403
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether slow intravenous ketamine infusions can safely reduce pain in people with fibromyalgia. Researchers will measure pain levels before and after treatment, and track how long any relief lasts. They will also look for traits that predict who responds best, aiming to personalize future treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketamine given as an intravenous infusion
- What this could lead to
- If effective, ketamine infusions could offer a new option for managing fibromyalgia pain, potentially providing longer-lasting relief than current treatments.
- What could go wrong
- This is a small, early-stage trial. Ketamine can cause dissociative side effects, and pain relief may be short-lived or not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients will be recruited from Wilderman Medical Clinic, a chronic pain clinic located in Thornhill, Ontario. The clinic consists of state-of-the-art out-patient facilities, an interdisciplinary team and nursing support.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: To be included in Part 1 of the study, patients must fulfil the following criteria: * Given written consent to permit Wilderman Medical Clinic investigators to use their medical and demographic information in research studies. * Male or female \>18 years of age * Having been diagnosed with fibromyalgia * Received at least 4 IV ketamine infusion(s) * Made at least one rating of pain (NRS) immediately before the intervention and one after the intervention * Had follow-up data recorded on the follow-up visit: percentage and duration of pain relief To be included in Part 2 of the study, patients must fulfil the following criteria: * Male or female \>18 years of age * Given the written Informed Consent Form to participate in the study * Having been diagnosed with fibromyalgia * Having been prescribed IV ketamine infusions treatment * Passed safety screening for ketamine infusions * Had at least 3 IV ketamine infusions for dose optimization * Willingness and ability to comply with the study procedure and the ability to follow verbal and written instructions Exclusion Criteria: Patients will be excluded from Part 1 of the study if they meet any of the following criteria: * Age less than 18 years old * Absence of signed Informed Consent Form * Patients who received less than 4 IV ketamine infusion(s) * Insufficient information to conduct analysis (e.g. absence of pain ratings or follow up measurements) Patients will be excluded from the Part II of the study if they meet any of the following criteria: * Age less than 18 years old * Absence of signed Informed Consent Form * Received less than 3 IV ketamine infusions * Have any contradictions to the administration of intravenous ketamine (known allergy to ketamine or fail to pass Ketamine treatment screening) * Diagnosis of dementia or other cognitive impairments * Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude the use of intravenous ketamine or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study. * Participation in any other clinical study within 3 months prior to screening and during the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wilderman Medical Clinic
Thornhill, Ontario, L4J 1W3, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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