Kevin Boehnke
Kevin Boehnke
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.
Fibromyalgia
Psilocybin
Psychotherapy
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 10 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | September 27, 2023 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Open Label Oral Psilocybin This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months. |
Drug: Psilocybin Behavioral: Psychotherapy |
Ages Eligible for Study: | 25 Years to 64 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Chronic Pain and Fatigue Research Center
Ann Arbor, road cancer, United States, 48106