At a glance
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A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia
In Brief
A Phase 2 clinical trial evaluating Psilocybin and Psychotherapy for Fibromyalgia. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart.
1\. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.