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President Trump signed an executive order aimed at expanding research and improving access to psychedelic drug therapies.<\/p>\n<\/div>\n
The April 18 order also aims to streamline and expedite the Food and Drug Administration\u2019s approval process for certain high-priority treatments.<\/p>\n<\/div>\n
The Trump administration has touted the executive order<\/a> as an important step toward addressing the nation\u2019s mental health crisis<\/a>, especially among U.S. veterans, who bear an outsized share of that burden.<\/p>\n<\/div>\n A diverse coalition, including psychedelic research organizations, medical professionals, veterans groups, and podcaster Joe Rogan, has publicly celebrated the decision.<\/p>\n<\/div>\n The order also allocates $50 million to support state-level psychedelic research. The shift in policy coincides with Trump\u2019s recent move to reclassify medical cannabis<\/a> as a less dangerous drug.<\/p>\n<\/div>\n Matthew Johnson<\/a>, PhD, professor of psychiatry and behavioral sciences at Johns Hopkins University, called the decision \u201cwelcome news,\u201d adding that it is \u201cbuilding upon decades of science.\u201d<\/p>\n<\/div>\n Psychedelics are a class of drugs that act on the body\u2019s serotonin<\/a> system. They can produce well-known effects, including changes to visual perception, hallucinations<\/a>, an altered sense of self, and feelings of insight or connection. Primary examples of psychedelics include LSD<\/a>, psilocybin (\u201cmagic mushrooms\u201d)<\/a>, and DMT<\/a>.<\/p>\n<\/div>\n The President\u2019s executive order is one of the boldest federal actions on psychedelic drugs to date.<\/p>\n<\/div>\n However, it is also being met with caution by some experts who expressed concern that expedited FDA approval of experimental therapies could be harmful to patients.<\/p>\n<\/div>\n \u201cIt\u2019s important to explore the use of psychedelics to treat [hard-to-treat] disorders like PTSD, that\u2019s completely reasonable,\u201d said Richard Friedman<\/a>, MD, psychiatrist and director of the Psychopharmacology Clinic at Weill Cornell Medicine.<\/p>\n<\/div>\n \u201cWhat we don\u2019t want to do is speed up the testing and evaluation of drugs if it means that we\u2019re giving short shrift to the rigorous analysis of safety,\u201d Friedman told Healthline.<\/p>\n<\/div>\n<\/div>\n Trump\u2019s executive order is intended to target \u201cthe burden of suicide and serious mental illness rates in Ameica\u201d through a number of levers involving research, access, and FDA review.<\/p>\n<\/div>\n Here are the main points:<\/p>\n<\/div>\n Breakthrough Therapy is an expanded The voucher program is designed to shorten the FDA\u2019s review period for such drugs; a process that might typically take six months or more could be reduced to 1 or 2 months. <\/p>\n<\/div>\n Taken together, these two programs could significantly accelerate the development and approval of high-priority psychedelic therapies with promising clinical data.<\/p>\n<\/div>\n Next, the order seeks to expand psychedelic research by allocating $50 million through the Advanced Research Projects Agency for Health (ARPA-H)<\/a> to match state investments in psychedelic research programs. It also requires collaboration among the FDA, the Department of Health and Human Services (HHS), the Department of Veterans Affairs, and the private sector to increase interest and participation in psychedelic research clinical trials.<\/p>\n<\/div>\n For patients, the executive order emphasizes the use of the A White House fact sheet<\/a> explicitly includes experimental psychedelic therapies within the scope of the Right to Try Act, so long as they \u201chave met basic safety requirements.\u201d<\/p>\n<\/div>\n While psychedelic therapy<\/a> drugs, including psilocybin, MDMA<\/a>, and ibogaine, all remain illegal Schedule I drugs, the executive order preemptively addresses potential rescheduling and legality based on therapeutic potential. <\/p>\n<\/div>\n According to the White House<\/a>, the order will direct the Attorney General of the United States to prepare for the rescheduling of specific drugs \u201cas soon as possible,\u201d following the successful completion of Phase 3 clinical trials.<\/p>\n<\/div>\n \u201cIn most places, psychedelic possession is still a felony. The drug war on psychedelics is not over,\u201d Johnson said.<\/p>\n<\/div>\n <\/div>\n Then there\u2019s the issue of one drug in particular, the only one specifically named in the executive order: ibogaine<\/a>.<\/p>\n<\/div>\n Ibogaine is a naturally occurring psychoactive compound derived from the roots of the Tabernanthe iboga, a shrub native to Central Africa.<\/p>\n<\/div>\n Ibogaine has become a cause c\u00e9l\u00e8bre among veteran groups for its supposedly transformative effects on those who live with PTSD and substance use disorder<\/a>. <\/p>\n<\/div>\n \u201cMany of these individuals have essentially made it their life\u2019s mission to send their fellow vets down [to Mexico] to get access to ibogaine clinics and treatment, as well as sowing the seeds in the United States to kind of move things along so we can get that approved here,\u201d Johnson said.<\/p>\n<\/div>\n Prominent individuals, including former Texas Governor Rick Perry and Robert O\u2019Neill, the former Navy SEAL who killed Osama Bin Laden, have become outspoken supporters of ibogaine therapy. Then there\u2019s Joe Rogan, the most widely listened-to podcaster in the United States and a noted psychedelic advocate, who has expressed support for ibogaine therapy. <\/p>\n<\/div>\n The field is also moving forward in other domains of mental health. In perhaps the most high-profile study on ibogaine<\/a> to date, researchers at Stanford found that ibogaine therapy had profound effects on PTSD, depression, and anxiety symptoms in U.S. combat veterans with traumatic brain injury (TBI)<\/a>.<\/p>\n<\/div>\n The treatment had an immediate impact on mood and function in several domains of mental health. The average disability rating of the veterans prior to treatment was more than 30, but one month after treatment, it had dropped to just 5.1, a score that no longer indicated disability. <\/p>\n<\/div>\n Other areas improved too; veterans experienced noticeable improvements in depression (87% reduction), PTSD symptoms (88% reduction), and anxiety (81%) reduction. <\/p>\n<\/div>\n However, the trial was small \u2014 just 30 participants. While there were no serious adverse effects in that trial, the safety profile of ibogaine is a serious red flag for some in the field.<\/p>\n<\/div>\n The wrinkle, according to experts, is that despite full-throated support from many in Trump\u2019s circle, research on the drug remains significantly more limited than on other psychedelic therapies. There are serious concerns about its safety profile as well.<\/p>\n<\/div>\n \u201cIn this field, in terms of FDA-approved trials, there\u2019s been far more work and more advanced-stage work with psilocybin. And you could say the same thing for MDMA. Ibogaine is at a very different stage, in part because it\u2019s been a more difficult challenge to get funding for the research and to get approval because it does have some additional safety concerns,\u201d Johnson said. <\/p>\n<\/div>\n<\/div>\n Ibogaine, which is not a \u201cIt is probably the most dangerous of all psychedelic-like compounds,\u201d Friedman said. \u201cIbogaine is well known to have cardiotoxicity, which is not part of the public conversation, and that worries me.\u201d<\/p>\n<\/div>\n He points out that while its safety profile has been well documented, its therapeutic value has not. <\/p>\n<\/div>\n \u201cIt\u2019s not clear that ibogaine has distinctly advantageous pharmacologic benefits that classic psychedelics that are safer have,\u201d he said.<\/p>\n<\/div>\n Johnson, on the other hand, is generally more supportive of continued research despite other psychedelics being further along in the approval pipeline.<\/p>\n<\/div>\n \u201cAll of these substances have been understudied,\u201d he said. \u201cIt\u2019s still an open question whether there\u2019s something really special about ibogaine, but I\u2019m very open to it.\u201d<\/p>\n<\/div>\n Set against the backdrop of the U.S. mental health crisis \u2014 especially among veterans<\/a>, who have significantly higher rates of suicide<\/a>, substance use disorders, and other mental health conditions than civilian populations \u2014 the Trump administration\u2019s support for ibogaine suggests a willingness to accept potential risks.<\/p>\n<\/div>\n Others, however, say that the focus on ibogaine in particular is both simplistic and dangerous:<\/p>\n<\/div>\n \u201c[Veterans] need more than just a magic molecule. They need an entire package of psychiatric treatment that includes empirically tested psychotherapies,\u201d Friedman said.<\/p>\n<\/div>\n