Psilocybin + Psychotherapy for Fibromyalgia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether psilocybin, a compound found in certain mushrooms, combined with therapy, can reduce chronic pain in people with fibromyalgia. Fibromyalgia causes widespread pain and fatigue. Participants will take psilocybin in two doses over two weeks and attend therapy sessions. Individuals who have experienced fibromyalgia symptoms for some time, do not smoke, and are not on certain medications might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking certain medications. Participants cannot take psychoactive prescription medications regularly, including antidepressants, opioids, and medications with a primary centrally-acting serotonergic effect. If you are on such medications, you may need to taper off with your doctor's support before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin therapy might be safe for people with fibromyalgia. In an open-label study, participants tolerated psilocybin well, suggesting its safety for larger studies. Another study found that individuals with fibromyalgia often held neutral or positive views about using psychedelics like psilocybin. Overall, these findings suggest that psilocybin could be a safe option for managing fibromyalgia symptoms.12345
Why are researchers excited about this possible treatment for fibromyalgia?
Unlike the standard treatments for fibromyalgia, which typically include pain relievers, antidepressants, and anti-seizure drugs, TRP-8802 is unique because it combines psilocybin, a psychedelic compound, with psychotherapy. Most current treatments target symptoms indirectly through neurotransmitter pathways, but TRP-8802 is thought to directly enhance neural plasticity and connectivity, potentially addressing the root causes of fibromyalgia. Researchers are excited about this approach because psilocybin's ability to alter brain function could lead to long-lasting relief and improvement in quality of life for patients with fibromyalgia.
What evidence suggests that psilocybin therapy might be an effective treatment for fibromyalgia?
Research has shown that psilocybin, a substance that can alter perception, may alleviate fibromyalgia symptoms. An initial study found that patients with fibromyalgia tolerated psilocybin therapy well, laying the groundwork for further research. Participants reported improvements in pain levels, the impact of pain on daily life, and sleep issues. In this trial, participants will receive oral psilocybin. Previous studies have shown positive responses to oral psilocybin, suggesting it might effectively reduce fibromyalgia symptoms. Although more research is necessary, these early findings offer hope for those seeking new methods to manage chronic pain.12567
Who Is on the Research Team?
Kevin F Boehnke, PhD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Adults aged 25-64 with fibromyalgia for at least 3 months, stable in psychotherapy, non-smokers, and not using certain medications can join. They must avoid psychoactive substances before sessions and women of childbearing potential need effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose, in concert with psychotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psychotherapy
- TRP-8802
Trial Overview
The trial tests the combination of oral psilocybin (a psychedelic compound) with psychotherapy to see if it helps reduce chronic pain in fibromyalgia patients. Participants will take psilocybin under controlled conditions alongside their ongoing therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kevin Boehnke
Lead Sponsor
TRYP Therapeutics
Lead Sponsor
Published Research Related to This Trial
Citations
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.
Preliminary safety and effectiveness of psilocybin-assisted ...
Most participants also reported improvements in pain severity, pain interference, and sleep disturbance, with small improvements in chronic pain acceptance in ...
Psilocybin-facilitated Treatment for Chronic Pain
Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients. Participants will be randomized to two ...
4.
tryptherapeutics.com
tryptherapeutics.com/tryptamine-therapeutics-achieves-full-patient-response-in-trp-8802-phase-2a-fibromyalgia-trial/Tryptamine Therapeutics achieves full patient response in ...
Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has fielded strong results from a Phase 2a fibromyalgia trial testing oral psilocybin ...
5.
hcplive.com
hcplive.com/view/psilocybin-assisted-therapy-well-tolerated-in-patients-with-fibromyalgiaPsilocybin-Assisted Therapy Well-Tolerated in Patients ...
Psilocybin-assisted therapy showed good tolerability in fibromyalgia patients, with no serious adverse events reported during the trial.
NCT05128162 | Open-label Study to Assess the Safety and ...
Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM.
Preliminary safety and effectiveness of psilocybin-assisted ...
Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial
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