Psilocybin + Psychotherapy for Fibromyalgia
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byKevin 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.
12345Is 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.
12467How 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.
128910Eligibility 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).
+20 more
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.
+18 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Open Label Oral PsilocybinExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Michigan - Functional MRI laboratoryAnn Arbor, MI
Chronic Pain and Fatigue Research CenterAnn Arbor, MI
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Who Is Running the Clinical Trial?
Kevin BoehnkeLead Sponsor
TRYP TherapeuticsLead Sponsor
References
An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. [2022]In this experimental randomized placebo-controlled 4-way crossover trial, we explored the analgesic effects of inhaled pharmaceutical-grade cannabis in 20 chronic pain patients with fibromyalgia. We tested 4 different cannabis varieties with exact knowledge on their [INCREMENT]-tetrahydrocannabinol (THC) and cannabidiol (CBD) content: Bedrocan (22.4-mg THC,
Ganoderma lucidum Effects on Mood and Health-Related Quality of Life in Women with Fibromyalgia. [2020]Fibromyalgia syndrome is a chronic rheumatic disorder characterized by generalized and widespread musculoskeletal pain. It is associated with several secondary symptoms such as psychological and pain-specific distress, which can directly impact daily functioning and quality of life, like anxiety and depression. The Ganoderma lucidum (GL) mushroom seems to be able to improve fibromyalgia symptoms, including depression and pain. The purpose of the study is to evaluate the effects of GL on happiness, depression, satisfaction with life, and health-related quality of life in women with fibromyalgia. A double-blind, randomized placebo pilot trial was carried out, with one group taking 6 g/day of micro-milled GL carpophores for 6 weeks, during which the second group took a placebo. Our results did not show any statistically significant between-group differences, although a distinct trend of improved levels of happiness and satisfaction with life and reduced depression were evident at the end of treatment compared to the baseline in the GL group. However, due to the limitations of the study protocol, additional studies are necessary to confirm these findings.
Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials. [2018]The purpose of this study was to systematically review the literature for randomized trials of complementary and alternative medicine (CAM) interventions for fibromyalgia (FM).
Efficacy and safety of medicinal plants or related natural products for fibromyalgia: a systematic review. [2022]To assess the effects of medicinal plants (MPs) or related natural products (RNPs) on fibromyalgia (FM) patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs) involving 475 patients. The methodological quality of all studies included was determined according to JADAD and "Risk of Bias" with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects.
Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. [2021]To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients.
Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. [2023]Fibromyalgia (FM) is a difficult to treat chronic pain condition for which there is strong interest in alternative treatments. There is growing interest in the potential of psychedelic substances (e.g., psilocybin) in conjunction with psychotherapy to treat chronic pain. Via a cross-sectional, anonymous, online survey, we aimed to characterize knowledge, perceptions, and past use of serotonergic ("classic") and non-serotonergic psychedelics among a population of individuals with FM, and to investigate interest in psychedelic-based FM treatments. Among a North American population of 354 participants with FM, 29.9% reported past use of a psychedelic, with lysergic acid diethylamide (LSD) and psilocybin mushrooms being most commonly used. Perceptions of benefit from psychedelic use were generally neutral (59.4%) or positive (36.8%), with
Assessment of clinical outcomes in patients with fibromyalgia: Analysis from the UK Medical Cannabis Registry. [2023]There are limited therapeutic options for individuals with fibromyalgia. The aim of this study is to analyze changes in health-related quality of life and incidence of adverse events of those prescribed cannabis-based medicinal products (CBMPs) for fibromyalgia.
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]Low back pain (LBP) occurs in many patients with fibromyalgia (FM). The current study aimed to assess the possible pain and function amelioration associated with medical cannabis therapy (MCT) in this setting.
[CHARACTERISTICS OF MEDICAL CANNABIS USAGE AMONG PATIENTS WITH FIBROMYALGIA]. [2020]Medical cannabis (MC) is becoming more and more popular among patients with chronic pain syndromes. In this study we evaluated the characteristics of MC use among patients with fibromyalgia.
Cannabis and cannabidiol (CBD) for the treatment of fibromyalgia. [2021]Fibromyalgia is a complex disease process that is as prevalent as it is poorly understood. Research into the pathophysiology is ongoing, and findings will likely assist in identifying new therapeutic options to augment those in existence today that are still insufficient for the care of a large population of patients. Recent evidence describes the use of cannabinoids in the treatment of fibromyalgia. This study provides a systematic, thorough review of the evidence alongside a review of the seminal data regarding the pathophysiology, diagnosis, and current treatment options. Fibromyalgia is characterized by widespread chronic pain, fatigue, and depressive episodes without an organic diagnosis, which may be prevalent in up to 10% of the population and carries a significant cost in healthcare utilization, morbidity, a reduced quality of life, and productivity. It is frequently associated with psychiatric comorbidities. The diagnosis is clinical and usually prolonged, and diagnostic criteria continue to evolve. Some therapies have been previously described, including neuropathic medications, milnacipran, and antidepressants. Despite some level of efficacy, only physical exercise has strong evidence to support it. Cannabis has been used historically to treat different pain conditions since ancient times. Recent advances allowed for the isolation of the active substances in cannabis and the production of cannabinoid products that are nearly devoid of psychoactive influence and provide pain relief and alleviation of other symptoms. Many of these, as well as cannabis itself, are approved for use in chronic pain conditions. Evidence supporting cannabis in chronic pain conditions is plentiful; however, in fibromyalgia, they are mostly limited. Only a handful of randomized trials exists, and their objectivity has been questioned. However, many retrospective trials and patient surveys suggest the significant alleviation of pain, improvement in sleep, and abatement of associated symptoms. Evidence supporting the use of cannabis in chronic pain and specifically in fibromyalgia is being gathered as the use of cannabis increases with current global trends. While the current evidence is still limited, emerging data do suggest a positive effect of cannabis in fibromyalgia. Cannabis use is not without risks, including psychiatric, cognitive, and developmental as well as the risks of addiction. As such, clinical judgment is warranted to weigh these risks and prescribe to patients who are more likely to benefit from this treatment. Further research is required to define appropriate patient selection and treatment regimens.