Psilocybin for Fibromyalgia

Overseen By Kathleen Hodgin, M.A.

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Opioids, Antidepressants, Antipsychotics, others

Disqualifiers: Males, Psychotic disorders, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if psilocybin, a compound in certain mushrooms, can reduce fibromyalgia symptoms such as pain and fatigue and improve overall quality of life. Participants will receive either psilocybin or an active placebo, which mimics treatment effects without the active ingredient, to compare results. Eligible participants are women who have experienced widespread muscle pain for at least a year and whose daily life is disrupted by fibromyalgia symptoms. As an Early Phase 1 trial, this research focuses on understanding how psilocybin works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial requires discontinuation of some medications at least two weeks before the drug administration day, and you cannot use specific medications like opioids, anti-inflammatory drugs, or certain antidepressants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that psilocybin, the treatment under study for fibromyalgia, is generally safe. Previous studies indicate it is usually well-tolerated. Trials with fibromyalgia patients have reported no serious unwanted effects. Psilocybin has a high safety margin, meaning it requires a much larger amount to cause harm than the usual dose. Although research continues, these findings suggest that psilocybin might be safe for those considering this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fibromyalgia?

Unlike the standard treatments for fibromyalgia, such as antidepressants, anticonvulsants, and pain relievers, psilocybin is derived from psychedelic mushrooms and offers a novel approach by potentially targeting the brain's serotonin receptors. This mechanism may help modulate mood and perception, which could alleviate chronic pain and improve overall well-being. Researchers are excited about psilocybin because it could offer faster relief and a different therapeutic angle compared to conventional treatments that often take weeks to show effects. Additionally, the use of an active placebo with dextromethorphan (DXM) ensures that the effects are due to psilocybin's unique properties rather than general placebo effects.

What evidence suggests that psilocybin might be an effective treatment for fibromyalgia?

This trial will compare psilocybin with an active placebo, dextromethorphan (DXM), for fibromyalgia. Studies have shown that psilocybin-assisted therapy is generally safe for people with fibromyalgia. In a small open-label study, participants noticed improvements in their symptoms one month after treatment. Although specific evidence that psilocybin directly reduces pain in fibromyalgia is lacking, it led to significant improvements in various symptoms. Researchers aim to determine whether psilocybin can help with pain, tiredness, and overall quality of life for those with fibromyalgia. This research is still new but shows promise for alleviating fibromyalgia symptoms. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women aged 25-65 with chronic pain conditions like fibromyalgia, meeting specific diagnostic criteria. Participants must have had widespread musculoskeletal pain for over a year and report an average daily pain score of at least 5 out of 10. They should be able to attend all appointments, read/write in English, not have used hallucinogens recently (or at least not in the past three years), and have someone to drive them home after treatment sessions.

Inclusion Criteria

I stopped taking certain medications at least two weeks ago, or for their required time.

I have had widespread body pain for at least 12 months.

I have been diagnosed with fibromyalgia according to the latest criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparation

Participants undergo 2-4 weekly preparation sessions to educate them on the study protocol and psilocybin administration

2-4 weeks

2-4 visits (in-person)

Treatment

Participants receive either psilocybin or active placebo in a monitored session lasting 8 hours

1 day

1 visit (in-person)

Immediate Post-Session

Participants meet with the guide to discuss and reflect on their experience the day after drug administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final study visit approximately 6 weeks later

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dextromethorphan
• Psilocybin

Trial Overview The study is testing if psilocybin can help reduce symptoms of fibromyalgia such as pain and fatigue. It will compare the effects of psilocybin-facilitated treatment against dextromethorphan to see which one improves patients' quality of life and functioning better.

How Is the Trial Designed?

Group I: Psilocybin Experimental Treatment 1 Intervention

Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.

Group II: Active Placebo Active Control 1 Intervention

Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

Psilocybin, a compound found in 'magic mushrooms', has shown potential in recent studies for treating various mental health conditions, including obsessive-compulsive disorder, alcohol and tobacco addiction, and major depressive disorder, particularly in terminally ill cancer patients.

Despite its classification as a Schedule I drug in 1970, which halted much research, there is a renewed interest in psilocybin's therapeutic effects, highlighting its importance in both historical and contemporary neuroscience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DARK Classics in Chemical Neuroscience: Psilocybin. Geiger, HA., Wurst, MG., Daniels, RN.[2019]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

Psilocybin, a prodrug for psilocin, shows strong agonist activity at the serotonin 5-HT2A receptor, which is responsible for its psychedelic effects, and has been shown to have nanomolar affinity for various serotonin receptor subtypes in both in vitro and in vivo studies.

In mouse experiments, psilocybin and related compounds induced head twitch responses, a sign of psychedelic activity, which were blocked by a 5-HT2A antagonist, confirming the involvement of this receptor in their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structure-Activity Relationships for Psilocybin, Baeocystin, Aeruginascin, and Related Analogues to Produce Pharmacological Effects in Mice. Glatfelter, GC., Pottie, E., Partilla, JS., et al.[2023]

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. Whinkin, E., Opalka, M., Watters, C., et al.[2023]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

Citations

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an open-label pilot clinical trial This small open-label trial preliminarily supports that PAT is well-tolerated by people with FM, establishing a basis for larger randomized controlled trials.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06368492

The Impact of Psilocybin on Pain in Fibromyalgia Patients Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present ...

3. patents.google.com patents.google.com/patent/AU2023343416A1/en

Methods of treating fibromyalgia with compositions comprising ... Provided are methods for treating fibromyalgia or one or more symptoms thereof, that involve the administration of psilocybin or a metabolite thereof, ...

4. researchgate.net researchgate.net/publication/385537029_Preliminary_safety_and_effectiveness_of_psilocybin-assisted_therapy_in_adults_with_fibromyalgia_An_open-label_pilot_clinical_trial

Preliminary safety and effectiveness of psilocybin-assisted ... Compared to baseline, participants reported clinically meaningful improvements in the following secondary outcomes one month following their ...

5. hcplive.com hcplive.com/view/psilocybin-assisted-therapy-well-tolerated-in-patients-with-fibromyalgia

Psilocybin-Assisted Therapy Well-Tolerated in Patients ... Psilocybin-assisted therapy showed good tolerability in fibromyalgia patients, with no serious adverse events reported during the trial.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/62/NCT05128162/Prot_SAP_001.pdf

A Phase 2a, Open-label, Pilot Study to Assess the Safety ... The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11481402/

Psilocybin for clinical indications: A scoping review A systematic review of the safety of psilocybin concluded that it appears to be safe, given that the reported adverse effects are typically ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210844024001837

Narrative review of psilocybin, an important psychoactive ... It has a high safety prof0ile, with a large disparity between a physiologic dose and that required to cause overdose symptoms. Its structure allows it to ...