The Impact of Psilocybin on Pain in Fibromyalgia Patients - Trial NCT06368492

Timeline & Enrollment

Primary Outcome

Ischemic Pain perception,Pressure-evoked Pain perception,Self-reported pain

Summary

Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when
 administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain
 tolerance in a sample of healthy volunteers. Such results complement what was already
 observed with other serotonergic psychedelics such as psilocybin: survey studies and case
 series indicate that its use may lead to improvements in chronic pain conditions such as
 migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These
 effects have however not yet been investigated and confirmed in clinical populations under
 controlled experimental conditions.
 
 Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia,
 anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood
 disorders. Most suggested therapies are only associated with small improvements in pain
 ratings and quality of life. Currently, there is no data concerning the effectiveness of
 serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
 
 Objective: The present study will explore the effects that the administration of a placebo
 and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of
 fibromyalgia patients.
 
 Study design: The present study uses a double-blind, randomized, placebo-controlled design.
 All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will
 undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its
 analgesic effects.

ICD-10 Classifications