Psilocybin + Psychotherapy for Fibromyalgia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Kevin F Boehnke, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kevin Boehnke

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

Disqualifiers: Cardiovascular disease, Epilepsy, Diabetes, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Psilocybin + Psychotherapy for Fibromyalgia?

There is no direct data on Psilocybin + Psychotherapy for fibromyalgia, but studies on similar treatments suggest potential benefits. For example, medicinal plants and natural products have shown significant improvements in pain, depression, and quality of life for fibromyalgia patients, indicating that alternative therapies might be effective. ^{1 2 3 4 5}

Is psilocybin with psychotherapy safe for humans?

There is growing interest in using psilocybin with psychotherapy for chronic pain, and past users generally report neutral to positive perceptions of its benefits. However, specific safety data for this combination in fibromyalgia is not provided in the available research. ^{1 2 4 6 7}

How does the drug TRP-8802 (Psilocybin) differ from other treatments for fibromyalgia?

TRP-8802 (Psilocybin) is unique because it combines psilocybin, a psychedelic compound, with psychotherapy to potentially address both the physical pain and psychological distress associated with fibromyalgia, unlike traditional treatments that often focus solely on pain relief. ^{1 2 8 9 10}

Research Team

Kevin F Boehnke, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

I can avoid nonprescription drugs and supplements for 7 days before each psilocybin session.

Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea, cola) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of TRP-8802 session days. If the participant does not routinely consume caffeinated beverages, he/she must agree to not do so on TRP-8802 session days.

Participant must be a non-smoker (tobacco).

Exclusion Criteria

Participant is currently in another clinical trial.

I am currently on antidepressant medication.

I am taking diabetes medication and have had low blood sugar episodes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose, in concert with psychotherapy

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• Psychotherapy (Behavioral)
• TRP-8802 (Psychedelic)

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.

Participant Groups

Group I: Open Label Oral Psilocybin Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Kevin Boehnke

Lead Sponsor

Trials

2

Recruited

480+

TRYP Therapeutics

Lead Sponsor

Trials

4

Recruited

30+

Findings from Research

In a study involving 20 chronic pain patients with fibromyalgia, inhaled cannabis did not show significant analgesic effects compared to placebo, although the Bediol variety led to a 30% decrease in pain scores for some patients.

Cannabis containing THC increased pressure pain thresholds, but the presence of CBD appeared to reduce the overall pain-relieving effects of THC, highlighting complex interactions between these cannabinoids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. van de Donk, T., Niesters, M., Kowal, MA., et al.[2022]

In a double-blind, randomized pilot trial involving women with fibromyalgia, taking 6 g/day of Ganoderma lucidum (GL) for 6 weeks showed trends towards improved happiness and life satisfaction, as well as reduced depression, although these results were not statistically significant.

The study highlights the potential of GL as a complementary treatment for fibromyalgia symptoms, but emphasizes the need for further research to validate these preliminary findings due to limitations in the study design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ganoderma lucidum Effects on Mood and Health-Related Quality of Life in Women with Fibromyalgia. Pazzi, F., Adsuar, JC., Domínguez-Muñoz, FJ., et al.[2020]

A systematic review of 60 randomized controlled trials on complementary and alternative medicine (CAM) for fibromyalgia found that balneotherapy and mind-body therapies were effective in reducing FM pain.

Despite the promising results for some CAM therapies, many studies were preliminary with small sample sizes, indicating a need for larger, more robust trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials. Terhorst, L., Schneider, MJ., Kim, KH., et al.[2018]

A systematic review of eight randomized placebo-controlled trials involving 475 fibromyalgia patients found that medicinal plants (MPs) or related natural products (RNPs) significantly improved symptoms such as pain, sleep disruption, and quality of life compared to conventional treatments.

The findings suggest that MPs and RNPs could serve as effective alternative therapies for fibromyalgia, potentially offering benefits with fewer side effects, although further long-term studies are needed to assess their safety and treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of medicinal plants or related natural products for fibromyalgia: a systematic review. de Souza Nascimento, S., Desantana, JM., Nampo, FK., et al.[2022]

In an eight-week clinical trial involving 17 women with fibromyalgia, a THC-rich cannabis oil significantly reduced symptoms and improved quality of life compared to a placebo, as measured by the Fibromyalgia Impact Questionnaire.

The cannabis group showed notable improvements in specific symptoms such as pain, fatigue, and overall well-being, with no intolerable adverse effects reported, suggesting that phytocannabinoids could be a safe and effective treatment option for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Chaves, C., Bittencourt, PCT., Pelegrini, A.[2021]

In a survey of 354 individuals with fibromyalgia, nearly 30% reported past use of psychedelics like LSD and psilocybin, with most perceiving neutral or positive effects on their health and pain symptoms.

Among those who used psychedelics specifically to treat chronic pain, 11 out of 12 reported symptom improvement, indicating a strong interest and potential for further research into psychedelic-based treatments for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. Glynos, NG., Pierce, J., Davis, AK., et al.[2023]

In a study of 306 patients with fibromyalgia, those treated with cannabis-based medicinal products (CBMPs) showed significant improvements in health-related quality of life over 1, 3, 6, and 12 months (p < .0001).

The most common side effects reported were fatigue, dry mouth, concentration impairment, and lethargy, indicating that while CBMPs were generally well-tolerated, some patients experienced notable adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of clinical outcomes in patients with fibromyalgia: Analysis from the UK Medical Cannabis Registry. Wang, C., Erridge, S., Holvey, C., et al.[2023]

In a study of 31 fibromyalgia patients with low back pain, the addition of medical cannabis therapy (MCT) after 3 months of standard analgesic therapy (SAT) resulted in significantly greater improvements in pain and function, as measured by various patient-reported outcomes.

Patients experienced continued improvement in lumbar range of motion after 3 months of MCT, suggesting that MCT may be more effective than SAT alone for managing low back pain in fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of adding medical cannabis to analgesic treatment in patients with low back pain related to fibromyalgia: an observational cross-over single centre study. Yassin, M., Oron, A., Robinson, D.[2019]

In a study of 101 fibromyalgia patients, medical cannabis (MC) was found to be an effective treatment, with over 77% reporting improvements in pain and sleep, and nearly half able to discontinue other fibromyalgia medications.

The majority of participants (nearly 25%) reported mild adverse effects, but these did not lead to treatment discontinuation, indicating a favorable safety profile for MC in managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CHARACTERISTICS OF MEDICAL CANNABIS USAGE AMONG PATIENTS WITH FIBROMYALGIA]. Habib, G., Levinger, U.[2020]

Cannabinoids show potential in alleviating symptoms of fibromyalgia, including pain relief and improved sleep, although current evidence is limited and primarily based on retrospective studies and patient surveys rather than robust randomized trials.

While cannabis may offer benefits for fibromyalgia patients, it also carries risks such as psychiatric and cognitive effects, necessitating careful clinical judgment in prescribing and further research to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis and cannabidiol (CBD) for the treatment of fibromyalgia. Berger, AA., Keefe, J., Winnick, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ganoderma lucidum Effects on Mood and Health-Related Quality of Life in Women with Fibromyalgia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of medicinal plants or related natural products for fibromyalgia: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of clinical outcomes in patients with fibromyalgia: Analysis from the UK Medical Cannabis Registry. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Effect of adding medical cannabis to analgesic treatment in patients with low back pain related to fibromyalgia: an observational cross-over single centre study. [2019]

9. Israel pubmed.ncbi.nlm.nih.gov

[CHARACTERISTICS OF MEDICAL CANNABIS USAGE AMONG PATIENTS WITH FIBROMYALGIA]. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cannabis and cannabidiol (CBD) for the treatment of fibromyalgia. [2021]