ARPA-H backs psychedelic research

The federal government is putting up to $139.4 million behind new mental-health projects that include studies of psilocybin and ibogaine. (hhs.gov) The money comes through the Advanced Research Projects Agency for Health, or ARPA-H, which on April 21 announced the first research teams in its EVIDENT initiative. The agency said the program is meant to spur “new, effective therapies for behavioral health.” (hhs.gov) ARPA-H said EVIDENT will generate “Food and Drug Administration-ready” clinical endpoints — measurable signals meant to show whether a treatment is working, for whom, and how quickly. The agency said today’s mental-health care still relies too heavily on subjective reports and a trial-and-error approach. (arpa-h.gov) The April 21 announcement tied the initiative to President Donald Trump’s executive order on accelerating treatments for serious mental illness. ARPA-H said at least $50 million will be used to match state government investments in psychedelic research for people with serious mental illness. (hhs.gov) EVIDENT does not fund only psychedelics. ARPA-H said the effort also covers digital therapeutics, neuromodulation and other rapid-acting approaches, with the agency collecting psychological, social, digital and biological data from registered clinical trials and real-world care settings. (arpa-h.gov) Veterans are a central target population in the federal pitch. ARPA-H said rates of addiction are higher for veterans than for the general population, and the Department of Veterans Affairs began soliciting proposals in January 2024 to study psychedelic compounds for post-traumatic stress disorder and depression in veterans. (arpa-h.gov) (va.gov) Psilocybin is the psychoactive compound in so-called magic mushrooms, and ibogaine is a psychoactive drug derived from an African shrub. Federal regulators have not approved either as a prescription treatment, though the Food and Drug Administration has issued guidance for companies studying psychedelic drugs in clinical trials. (nida.nih.gov) (fda.gov) The Food and Drug Administration said in its 2023 draft guidance that sponsors studying psychedelic drugs need to address risks including abuse potential and other adverse events. The National Institute on Drug Abuse says psychedelics can affect perception, mood and other mental processes, and it describes both therapeutic interest and safety questions around the class. (fda.gov) (nida.nih.gov) ARPA-H was built to fund projects that “would otherwise never happen,” using milestone-based awards that can be expanded or stopped based on results. With EVIDENT, that model is now being applied to psychiatric treatments that Washington had largely kept at arm’s length for decades. (arpa-h.gov 1) (arpa-h.gov 2)