Background & Aims
Fibromyalgia is a chronic nociplastic pain condition that often manifests with symptoms including disturbances in sleep, cognition, and mood. Current treatments provide modest benefits but significant side effects. One proposed therapy for fibromyalgia is psilocybin-assisted therapy (PAT), in which psilocybin, a psychedelic compound, is delivered in concert with supportive psychotherapy. Indeed, PAT clinical trials show positive effects among people with major depression and alcohol addiction. Direct neurobiological mechanisms of psilocybin, such as changes in neuroplasticity and inflammation, may be particularly relevant with nociplastic conditions like FM , and PAT may also reduce chronic pain symptoms through changes in mood and as an impetus for adaptive behavior change. Yet, no published clinical trials have explored PAT effects among people with FM. In this abstract, we present a protocol and preliminary findings of an open label clinical trial of PAT for fibromyalgia
Methods
We will enroll 10 participants (25-64 years old) who have fibromyalgia. Exclusionary conditions include significant lab abnormalities, psychotic disorders, bipolar I or II, and substance use disorders, and recent psychedelic use. Prior to and after PAT, participants will undergo neuroimaging, sensory testing, and answer various surveys. The PAT protocol consists of two psilocybin dosing sessions (15mg followed two weeks later by 25mg) with supportive psychotherapy sessions prior to and after dosing. The primary outcome is safety throughout the trial. Secondary outcomes include pain interference, sleep disturbance, pain severity (0-10 numeric rating scale, 0 = no pain, 10 = worst pain imaginable) using Patient Reported Outcome Measurement Information System (PROMIS) measures, and the Patient Global Impression of Change (PGIC). Additional secondary assessments include neuroimaging, quantitative sensory testing, and effects on sleep measured via actigraphy and sleep diaries.
Results
Data collection is ongoing. Two participants are currently on the protocol and one treatment completed as of the time of this submission. Thus far, the study intervention has been safe and well tolerated, with no serious adverse events. Comparing baseline with end of treatment, the one participant who completed the protocol reported decreased pain (7/10 vs. 1/10), pain interference (PROMIS T-score 66.6 vs. 41.6), and improved sleep (T-score 57.9 vs. 52.4), as well as significant improvement per the PGIC. Incidentally, this participant also regained their sense of smell, which they had reportedly lost after a COVID-19 infection three years prior. Data processing and cleaning is ongoing with the numerous other assessments used in this trial.
Conclusions
We anticipate completing recruitment by July 2024. Data thus far indicate that PAT is safe and well tolerated among individuals with fibromyalgia and demonstrate our ability to complete these complex studies. We look forward to presenting a more complete set of results at the time of presentation.
References
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Presenting Author
Kevin F. Boehnke
Poster Authors
Kevin Boehnke, PhD
PhD
University of Michigan
Lead Author
Jacob Aday
PhD
Lead Author
Deirdre Conroy
PhD
Lead Author
Alan Davis
PhD
Lead Author
George Mashour
MD
Lead Author
Daniel Clauw
University of Michigan Chronic Pain and Fatigue Research Center
Lead Author
Anne Baker
University of Michigan
Lead Author
Niloufar Pouyan
PharmD
Lead Author
Kathy Scott
RN
Lead Author
Chelsea Kaplan
PhD
University of Michigan
Lead Author
Helen Burgess
PhD
Lead Author
Steven Harte
PhD
University of Michigan Chronic Pain and Fatigue Research Center
Lead Author
Nicolas Glynos
PhD
University of Michigan
Lead Author
Dana Horowitz
MSW
Lead Author
Vijay Tarnal
M.D.
University of Michigan
Lead Author
Avinash Hosanagar
MD
Lead Author
Jamarie Geller
MD
Lead Author
Kasey Cox
MS
Lead Author
Jeffrey Guss
MD
Lead Author
Jenna McAfee
PhD
Lead Author
Topics
- Specific Pain Conditions/Pain in Specific Populations: Fibromyalgia