Recruiting

Testing a Psychedelic Treatment for Fibromyalgia Pain

Plain-English translation of NCT06368492 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether —a naturally occurring psychedelic compound—can help reduce pain in people with fibromyalgia. You would receive very low doses (5 mg or 10 mg) designed not to cause hallucinations, along with a placebo, on separate occasions. Researchers will measure how the medication affects your pain perception using standard pain tests.

Fibromyalgia is a hard-to-treat chronic pain condition, and current therapies only provide small improvements. Early research suggests that low doses of this medication may help reduce chronic pain in other conditions, but this has never been properly studied in fibromyalgia patients under controlled conditions.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you have been formally diagnosed with fibromyalgia
your fibromyalgia pain is at least 5 out of 10 on a pain scale
you have a healthy body weight (BMI between 18 and 28)
you are able to speak and understand Dutch or English
you are willing to avoid other psychoactive drugs and certain foods during the study

You likely don't qualify if…

you are currently taking psychiatric medications like antidepressants, anti-anxiety drugs, or opioids
you have a history of psychiatric conditions such as major depression, anxiety disorders, or substance use disorder
you have had a serious bad reaction to psychedelic drugs in the past
you have high blood pressure or a history of heart problems
you are pregnant, breastfeeding, or not using reliable contraception

What participation looks like

You would visit the study center three times, on separate occasions, to receive either the medication or placebo. At each visit, you would take a dose and then complete two pain tests: one involving brief contact with cold water, and another measuring your pain sensitivity to pressure. You would need to avoid certain foods and drinks beforehand, and you cannot drive or operate machines for 24 hours after each visit.

Testing a Psychedelic Treatment for Fibromyalgia Pain

What is this trial?

Do you qualify?

What participation looks like

Trial locations(2 sites)