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.

Trial Details

Fibromyalgia is a chronic syndrome of widespread musculoskeletal pain that often manifests with a cluster of co-occurring symptoms, including sleep disturbances, fatigue, cognitive dysfunction, and mood problems including anxiety and depression. Recent studies have provided evidence of altered central pain pathways. Current management of FM typically takes a multidimensional approach including behavioral therapy, exercise, and medication. However, current medications provide only modest benefit and carry significant side effect burden, leading many people with FM to seek other alternatives. Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM. Indeed, psilocybin therapy has shown positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. The United States Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for psilocybin in treatment-resistant depression and major depressive disorder. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. While no clinical studies have explored psychedelic effects among people with FM, a recent review outlined potential mechanisms through which psychedelics could alleviate chronic pain symptoms.

NCT Number NCT05128162

Data attribution

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