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

1.Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O’Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022;387(18):1637-48. Epub 2022/11/03. doi: 10.1056/NEJMoa2206443. PubMed PMID: 36322843.
2.Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021;78(5):481-9. Epub 2020/11/05. doi: 10.1001/jamapsychiatry.2020.3285. PubMed PMID: 33146667; PMCID: PMC7643046.
3.Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O’Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022. Epub 2022/08/25. doi: 10.1001/jamapsychiatry.2022.2096. PubMed PMID: 36001306.
4.Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020;45(7):486-94. Epub 2020/05/07. doi: 10.1136/rapm-2020-101273. PubMed PMID: 32371500.
5.Glynos NG, Pierce J, Davis AK, McAfee J, Boehnke KF. Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. Journal of psychoactive drugs. 2022:1-12.
6.Siegel JS, Daily JE, Perry DA, Nicol GE. Psychedelic Drug Legislative Reform and Legalization in the US. JAMA Psychiatry. 2023;80(1):77-83. Epub 2022/12/09. doi: 10.1001/jamapsychiatry.2022.4101. PubMed PMID: 36477830.

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