Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

This open-label interventional trial (n=20) aims to assess the safety and efficacy of TRP-8802 (psilocybin) in combination with psychotherapy for treating chronic pain symptoms in adults with fibromyalgia. Participants will receive two doses of oral TRP-8802, a 15mg dose followed two weeks later by a 25mg dose, alongside psychotherapy sessions.

The study will measure vital signs and track adverse events over a period of 4 weeks following the second dose to ensure the safety of the TRP-8802 therapy. The total planned duration of the study for an individual participant from screening to last follow-up is approximately eight months.

Topic Fibromyalgia Pain
Compound Psilocybin
Country United States of America
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

Papers

Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial
This open-label, proof-of-concept trial (n=5) of psilocybin-assisted therapy for fibromyalgia finds the treatment to be well-tolerated, with only transient blood pressure elevations and headaches reported. Secondary outcomes show clinically meaningful improvements in pain severity, pain interference, and sleep disturbance one month after treatment, with all participants reporting some degree of symptom improvement.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.