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

Summary

The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to treat chronic pain symptoms in patients with FM.

Timeline

Start

2023-09-27

Primary completion

2024-06-12

Completion

2024-06-12

Publications

• Aday JS, McAfee J, Conroy DA, Hosanagar A, Tarnal V, Weston C, Scott K, Horowitz D, Geller J, Harte SE, Pouyan N, Glynos NG, Baker AK, Guss J, Davis AK, Burgess HJ, Mashour GA, Clauw DJ, Boehnke KF. Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial. Front Pain Res (Lausanne). 2025 Mar 18;6:1527783. doi: 10.3389/fpain.2025.1527783. eCollection 2025.

Drugs

Indications