The Impact of Psilocybin on Pain in Fibromyalgia Patients and Healthy Volunteers: a Multicenter Trial

This therapeutic exploratory Phase II trial (n=44) aims to assess the effects of low doses of psilocybin (5-10mg) on pain endurance and ratings of painfulness in fibromyalgia patients and healthy volunteers.

Conducted across multiple centres, including Maastricht University, the study is investigating the impact of psilocybin on pain tolerance, pressure pain threshold, and subjective pain ratings. Additionally, the trial will evaluate secondary outcomes such as mood, cognition, personality, and psychedelic experience.

Fibromyalgia patients and healthy volunteers meeting specific criteria will participate, with assessments conducted at various time points during each experimental session. The trial, sponsored by Maastricht University and supported by the Usona Institute, is authorised by the Competent Authority and has a favourable opinion from the Ethics Committee.

Topic Fibromyalgia Healthy Subjects
Compound Psilocybin
Country Netherlands
Visit trial
Status Recruiting
Results Published No
Start date 22 December 2021
End date 31 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 44
Sex All
Age 18- 65
Therapy No

Trial Details

This Phase II trial, led by Maastricht University and supported by the Usona Institute, explores the effects of low-dose psilocybin on pain in fibromyalgia patients and healthy volunteers. Conducted across multiple centres, it assesses pain tolerance, mood, cognition, and psychedelic experiences. Approved by the Competent Authority and Ethics Committee, the trial involves 44 participants and aims to advance understanding of psilocybin's therapeutic potential for managing fibromyalgia symptoms.

NCT Number 2021-002909-10

Sponsors & Collaborators

Maastricht University
Maastricht University is host to the psychopharmacology department (Psychopharmacology in Maastricht) where various researchers are investigating the effects of psychedelics.

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

Data attribution

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