About 21 million US adults have a major depressive disorder, and roughly 30% haven’t responded to treatments. Some research has shown that psilocybin, a hallucinogen found in “magic mushrooms,” can relieve severe depression when used in conjunction with psychotherapy. That’s why New Zealand became the latest nation to approve it for use by psychiatrists. Clinical trials require psilocybin in a consistent dose and formulation. But mushrooms vary in potency and contain other compounds. So last month, Compass Pathways released data from the first-ever late-stage trial of a synthesized version of psilocybin, a milestone for researchers and psychedelic drug advocates. The study showed that a single dose reduced depression symptoms by 3.6 points on a rating scale compared with a placebo. The statistically significant reduction in symptoms with no major safety concerns reported in the trial still disappointed Wall Street, which was looking for a 5 point improvement. But it was the furthest any classic psychedelic has advanced toward FDA approval since regulators rejected MDMA-assisted therapy to treat post-traumatic stress disorder last year. That rejection of MDMA, more commonly known as ecstasy or molly, was a major topic of conversation at the recent Psychedelic Science conference in Denver. Rick Doblin, founder of Multidisciplinary Association for Psychedelic Studies, or MAPS, arrived wearing black and blue, colors he said reflected how he felt after the agency’s decision. “I felt really crushed,” he told the crowd. FDA advisers said they were concerned about the MDMA trial design, therapist bias, underreported safety issues and possibility of serious harm to patients. These concerns led to its rejection, which triggered a wave of reflection on gaps in the evidence, the pace of development and what's needed to build credibility. “I was 98 percent disappointed and 2 percent relieved,” said Shereef Elnahal, former undersecretary for health at the US Department of Veterans Affairs, during one of the panels. The relief, he explained, came from knowing that the VA had been preparing in case the FDA approved MDMA. But he worried that the broader medical system wasn’t ready, with too few trained providers or sites equipped to meet demand. Meanwhile, Atai Life Sciences just reported promising mid-stage results for a psychedelic nasal spray called BPL-003 that eased depression symptoms within a day. Another substance that drew a lot of attention at the conference was ibogaine, a psychedelic derived from the root bark of the iboga plant. Some researchers and advocates believe it could help treat opioid addiction and other conditions. But in the US, ibogaine is classified as a Schedule I drug, considered to have no accepted medical use and a high potential for abuse. That’s made it nearly impossible to study. Meanwhile, momentum is building in the states. In Texas, lawmakers recently committed $50 million toward funding FDA-approved clinical trials of ibogaine as a treatment for opioid addiction and PTSD. Arizona advocates are pushing for similar funding. And Colorado is now looking to expand its law that allows for supervised use of psilocybin to include ibogaine. But advocates say they’re in a long game. Doblin, who has spent decades pushing to bring psychedelics into medicine, urged the crowd to keep going. “The psychedelic renaissance is alive and well,” he said at the conference. "All over the world, we see this growing acceptance and openness to psychedelic healing.” — Fiona Rutherford |