Psychedelic drug research breaks out of deep freeze as researchers head for the clinic with ambitious trial plans
David Nichols entered graduate school in 1969 with dreams of cracking LSD. He was a child of the 60s, his friends dropping tabs and going on about the visions they saw – the big bang, god, infinity projected – and how it changed them in ways only major life events could. Nichols was going to figure out how it all worked.
And then in 1970, Congress passed the Controlled Substance Act. LSD, which the government had studied extensively for two decades, became a Schedule I drug. The dollars washed up. For 30 years, psychedelics became all but untouchable for clinical trials.
“The Controlled Substances Act was passed, and I thought, ‘Oh, well there goes that [idea],” Nichols told Endpoint News.
Now half a century later, Johns Hopkins Medicine is opening up the nation’s first major center for psychedelic research, a $17 million, privately-backed bet that reflects a 20-year-long sea change in how psychedelic research is viewed by clinicians and the promise the drugs have shown in treating a host of psychiatric disorders. The Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine will also explore the drugs’ impact on creativity and well-being.
“Oh, it’s huge,” says Nichols, who as a professor at Purdue University became one of the only psychedelic researchers (he focused on animals) and one of the top advocates for reopening clinical trials during the three-plus decades the drugs were almost entirely marginalized. “Where money has been the obstacle, now money is no longer the problem.”
After years in the sidelines, psychedelics beganto creep back into the pharmaceutical imagination in 2000, when Johns Hopkins obtained approval to administer psychedelics to healthy human subjects.
Scientists at a handful of prominent institutions have since entered the field, conducting trials on how psychedelics can treat long-intractable disorders – sometimes with dramatic success: psilocybin (the chemical found in magic mushrooms) for addiction and a slew of ailments, LSD for depression, MDMA for PTSD.
Early results have appeared as a panacea to psychiatric patients who have gone years on SSRIs and other treatments without significant improvement and opened the door to a string of startups seeking to advance and capitalize on the emerging market. Researchers touted the results of one pair of NYU and Hopkins studies on psilocybin to treat “existential dread” in cancer patients as “mind-blowing,”
“I think we’re looking at a paradigm shift,” says Nichols, who founded the Heffter Research Institute in 1993 to advocate for and eventually fund clinical trials. “I think it’ll be a revolutionary change for people who suffer from these disorders. We didn’t have anything that worked until now.”
Researchers characterized the center as a sign of how mainstream the field has become and an announcement that will only legitimize it further.
But immediately, the money will fuel several clinical trials at Hopkins – including those for opioid addiction, Alzheimer’s disease, PTSD and co-occurring mood and alcohol problems – equipping scientists with funds that remain scarce for psychedelic research.
Almost all psychedelics are still Schedule I drugs, meaning officially they have “no currently accepted medical use” and the NIH will not fund studies on them. The problem has plagued the field since its resurgence.
“Usually science is a lot of begging for money,” Albert Garcia, who will lead the Hopkins Alzheimer’s study, told Endpoints News, “and this means we won’t have to do that for a couple years at least.”
The future beyond clinical trials remains murky, though, and the exuberance of some researchers and advocates has led to pushback by critics of the science (psychedelic studies are necessarily not double-blind) and those, including health writer and proponent of psychedelic research Michael Pollan, who say advocates for magic mushroom decriminalization send a message that the drugs are not dangerous.
“This is not some sort of magic bullet that will be solving all these mental health problems,” Garcia said.
In March, the FDA approved its first psychedelic drug: Esketamine for treating depression. And in 2017 and 2018, the agency granted breakthrough status to an MDMA protocol for treating PTSD and to UK startup Compass Pathways’ psilocybin protocol for treating depression. But there’s been little indication of change to the underlying federal law.
Similar questions remain about precisely how these drugs would come to market, especially as the field has caught the eye of investors in Silicon Valley and Europe. The list of Hopkins donors includes TOMS founder Blake Mycoskie and popular entrepreneur Tim Ferriss but other investors have funneled money into private, for-profit ventures like Compass and ATAI.
“Scaling and accessibility of treatments are questions on everyone’s mind at the moment,” Ingmar Gorman, director of the Psychedelic Education and Continuing Care Program at the Center for Optimal Living and co-principal investigator on a stage III MDMA study for treating PTSD, told Endpoints News in an email.
Psychedelics such as psilocybin won’t operate on the pill-a-day formula that dominates most current psychiatrics. Rather, a patient would go in a few times per year to receive doses in a controlled environment with medical professionals. It’s unclear yet what the costs would be, though Nichols and others are optimistic widespread knowledge of how to manufacture psilocybin, for instance, will make it difficult to patent and keep prices down.
Last year, Compass Pathways made headlines after insiders accused them in Quartz of trying to form a monopoly on the global supply of psilocybin. They denied the charges but said securing a large supply was essential to their business model of integrating their therapies systems.
They told Endpoints they weren’t a psychedelic company, but simply looking for the best ways to tackle mental health problems.
“Right now, I don’t see anything more promising than research in psychedelics,” says CIO and co-founder Ekaterina Malievskaia. “But things can change.”