After descending into the basement level of the sparklingly new UCSF Nancy Friend Pritzker Psychiatry Building, you’re greeted by a number of freshly-painted, sparsely-adorned “dosage rooms.”
Throughout one long corridor sits an array of humming computers linked to those rooms by video and microphone feeds. Decorations meant to create a calming, serene environment are in the works.
To an outside observer, the area doesn’t read as particularly “mind-expanding,” but the site will soon play host to a first-of-its-kind clinical trial for psychedelics that will gauge the effects of a naturally-derived form of psilocin—an active ingredient in magic mushrooms—versus the more widely known psilocybin.
“This is the first study of any psychedelic botanical product; that alone is a big deal to me,” said Dr. Joshua Woolley, a UCSF professor who leads the university’s Translational Psychedelic Research Program (TrPR). “Because of the millions of people that have used this drug, the vast majority are taking mushrooms that have been grown. But the number of clinical trials using mushrooms is zero.”
Psilocybin is converted in the body to psilocin after ingestion, and Woolley’s research is meant to test whether direct administration of the active ingredient impacts onset times or reduces negative side effects like nausea and cardiac issues. The study is also the first to test a sublingual form of psilocin in humans, which will test how the drug enters the bloodstream through the inner lining of the mouth.
The research will delve into the foundational science behind how psychedelics actually function in the body and where they impact neuroplasticity, or the brain’s ability to adapt and modify itself.
Unsurprisingly, they’ve already found many willing volunteers in the Bay Area. Woolley said the trial’s recruitment process started about a week ago, and already around 200 interested people have reached out. Participants are currently being screened, and researchers plan to start dosing patients early next month.
Long stigmatized, psychedelics have seen a revival in the popular consciousness—along with a potentially lucrative business opportunity. Dozens of psychedelic companies focused on developing drugs using the substances are now publicly listed. They’ve been buoyed by a growing collection of clinical research on the impact drugs like MDMA (molly) and psilocybin have on mental health conditions ranging from substance abuse to depression to PTSD. Research, however, has centered on synthetic versions of the drug rather than one directly derived from an organic product.
Woolley didn’t find his way into the burgeoning field of psychedelics through a Burning Man camp or a college dorm room, but rather a frustration around the limited options for the treatment of mental health disorders.
“I was studying Oxytocin and that was basically my gateway drug,” Woolley said. “I got into this space because I saw how limited our treatments for psychiatric disorders were and if there was something that really worked, I wanted to know about it, how it worked and who it worked for.”
The UCSF study is the result of a partnership with Vancouver-based Filament Health, which has developed a process for extracting active psychedelic drugs from their natural sources.
To hear it from Filament Health CEO, Ben Lightburn, that’s perfectly aligned with the history of psychedelics, which were discovered in nature and have been consumed by the vast majority of people in that natural form.
“As we saw the rise of the psychedelics industry, we thought it was very very peculiar that there didn’t seem to be many—or any—companies focused on the natural side of psychedelics,” Lightburn said.
Still, even getting to the point of initiating a study posed its host of challenges. Both psilocybin and psilocin are categorized as Schedule I drugs under the Controlled Substances Act, a legacy of the War on Drugs.
Lightburn and Woolley listed a litany of regulatory agencies they had to navigate to get their study approved, including the DEA, the FDA, the IRB and RAPCal.
Filament’s approach relies on the process it uses to extract active ingredients from organic mushrooms. Lightburn used the analogy of brewing a cup of coffee, which extracts the active ingredient of caffeine from the coffee bean using hot water.
In the case of magic mushrooms, the product is grown and harvested in the company’s warehouse before the active ingredients are extracted using a liquid solvent. Filament then concentrates the extract further before mixing it with a nonactive agent to create a desired dosage of the drug. Much like a cup of coffee, which also extracts compounds that impact flavor, the process also includes the secondary materials that are generally ignored when synthesizing a psychedelic in a chemistry lab.
“We're very careful to make sure that we include all of the active ingredients from the magic mushroom in the same ratio and quantity as if you were to consume just a raw mushroom on its own,” Lightburn said.
The traditional drug development industry protects their products via a complex thicket of patents. As naturally occurring compounds, drugs like LSD, psilocybin or ayahuasca are by definition unpatentable. That, in turn, has led to controversial efforts by some companies to patent the “set and setting” for psychedelic therapy like the color of the wallpaper or the use of comfortable furniture.
Lightburn argues that Filament’s proprietary process allows for a competitive business advantage, while giving end-users a more natural product.
“Given the burning urgency of the mental health crisis, we know that we need to get these substances into the hands of the people that need them as soon as possible,” Lightburn said. “We know that the molecules that are found in nature, that they work and that they're safe. All that means a much faster development timeline.”
Moving forward, Lightburn says he sees favorable signs on the horizon, both on the scientific, as well as on the regulatory front.
Case in point: Oregon will be the first state with widely legalized psychedelics starting in 2023. There have also been efforts by State Sen. Scott Wiener to decriminalize possession of psychedelic drugs like psilocybin in California, although they have stalled in Sacramento.
As for headwinds? The current macroeconomic situation has made it difficult to raise money and fund a field largely dependent on industry support and private philanthropy.
Still, the overwhelming need for new therapies to help treat the growing number of people dealing with mental health issues continues to drive researchers and the industry forward.
“The idea that there’s this whole buffet of related compounds that we haven’t studied because of political reasons, that has promise and no one has really used, is very exciting for people like me,” Woolley said. “It’s exciting because maybe we could really move the needle. If we could tweak the brain to allow psychotherapy to work faster and better and more completely, it could be a game changer.”
Kevin Truong can be reached at firstname.lastname@example.org