This Upcoming Clinical Trial Will Assess the Use of Psychedelics for Fibromyalgia
Tryp Therapeutics, a Californian pharmaceutical company with a focus on psychedelics, and the University of Michigan Medical School Chronic Pain and Fatigue Research Center are teaming up to conduct the world’s first phase 2a clinical trial on the efficacy of psilocybin and psychotherapy to treat fibromyalgia.
Announced last week, the new open-label phase 2a trial will look at the use of TRYP-8802, an oral formulation of synthetic psilocybin, and evaluate its safety and efficacy in a small number of patients with fibromyalgia. The trial aims to inform the design of a future phase 2b trial using Tryp Therapeutics’ proprietary psilocybin-based drug product, TRP-8803.
New phase 2a trial will assess TRYP-8802 alongside psychotherapy
Fibromyalgia is a long-term condition that causes widespread pain and discomfort in the body. The cause of the condition is still unknown, but people with fibromyalgia generally will experience trouble with muscle stiffness, extreme fatigue, difficulty sleeping, and headaches alongside the main symptoms of chronic pain and increased pain sensitivity. It is estimated that, globally, nearly 1 in 20 people may be affected by fibromyalgia at some point in their lives.
Despite studies showing little support for the long-term use of opioids in treating fibromyalgia patients, it is thought that nearly 30 percent of patients with the condition will resort to using opioids to manage their pain. The new phase 2a trial, led by principal investigator Kevin Boehnke of the University of Michigan will investigate whether the synthetic psilocybin drug TRYP-8802 in tandem with psychotherapy might present a more promising avenue of treatment.
Psychotherapy, most commonly cognitive behavioral therapy (CBT), is often recommended as a non-drug treatment for fibromyalgia. It is often given alongside drug treatment as a complementary therapy and is beneficial for those who cannot take part in complementary physical therapies or exercise programs.
“Existing treatment options for fibromyalgia are often ineffective and show significant side effects,” Daniel Clauw, director of the Chronic Pain & Fatigue Research Center, said in a statement. “Kevin Boehnke and I are excited to be working with the team at Tryp Therapeutics, who have shown exceptional scientific rigor in their approach to evaluate a new treatment paradigm for the millions of patients suffering from fibromyalgia and other pain-related indications.”
There is some evidence that psychedelics such as psilocybin are able to enhance neuroplasticity in humans and animals. According to Tryp Therapeutics, psychedelics-based treatments for fibromyalgia could leverage these neuroplasticity benefits to target nociplastic pain (pain as a result of altered nociception, where there is no actual physical tissue damage) originating in the central nervous system.
“We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia,” commented Jim Gilligan, president of Tryp Therapeutics.
“The Chronic Pain and Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients.”
Tryp Therapeutics expects that it will be able to submit the required Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the phase 2a clinical trial later in the year.
Psychedelics for therapeutic use
Psilocybin is the active psychedelic component in magic psilocybe mushrooms. As interest in psychedelics research has taken off, psilocybin has become one of the most studied psychedelic compounds for potential medicinal use; the drug has been used in nearly 60 active or completed clinical trials worldwide.
“With psilocybin, the main areas that are being studied are mood disorders and depression. There’s been work looking at treatment of addiction, like tobacco or nicotine addiction, alcohol dependence, and cocaine,” Albert Garcia-Romeu, an assistant professor at the Center for Psychedelic and Consciousness Research at Johns Hopkins University, recently told Analytical Cannabis.
“The other big areas [are] more in the palliative care side, for patients with terminal illnesses who also have mental health challenges like anxiety, depression, and usually don't tend to respond very well to the normal course of antidepressant medications.”
Psilocybin is not the only psychedelic compound currently under investigation for the treatment of fibromyalgia; research has shown that ketamine can reduce muscle pain, temporal summation, and referred pain in fibromyalgia patients. Indeed, the “off-label” use of ketamine for various chronic pain conditions is already available in some ketamine infusion clinics.