The Trump administration’s interest in psychedelics as medicine has continued to come into focus over the past several weeks, with two developments suggesting that momentum at the federal level continues to grow. Both President Trump and Secretary of Health and Human Services Robert F. Kennedy Jr. continue to take actions signaling their support for the movement, even amid what could, to date, be called most charitably, um, measured efforts to move marijuana from Schedule I to Schedule III.
First, Trump signed an executive order Saturday encouraging more research into ibogaine — a psychedelic we’ve talked about before and that continues to be of particular interest to proponents of psychedelics as medicine. According to its supporters, ibogaine has shown promise in treating opioid withdrawal symptoms and may also be used to address depression, anxiety, and PTSD. Conservative lawmakers have taken a particular interest in its ability to treat these symptoms in veterans. The executive order directs (1) “the federal government to study ibogaine, a potent psychedelic compound derived from an African shrub, as a potential treatment for post-traumatic stress disorder, traumatic brain injury and opioid dependence in veterans;” and (2) “the FDA and DEA to establish a specific pathway for eligible patients to access investigational psychedelic drugs, including psilocybin and ibogaine, under the Right to Try Act.”
Second, and separately, RFK told podcast host Joe Rogan that the Trump administration is “very anxious” to allow psychedelic therapy “as quickly as possible.” According to our friends at Marijuana Moment who summarized the highlights, “Kennedy said he’s confident ‘we’re going to get it done,’ with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a ‘very controlled setting.’” And we understand it’s not just HHS that’s taken notice of the potential benefits of psychedelics; the U.S. Department of Veterans Affairs (VA), Food and Drug Administration (FDA), and National Institutes of Health (NIH) have all taken an interest.
RFK’s comments combined with the executive order paint a picture of an administration that is at minimum rhetorically committed to advancing psychedelic medicine.
Not Coming Out of Nowhere
Regular Budding Trends readers will recall that we have been tracking the federal government’s gradual movement toward potential psychedelic rescheduling and almost certain more mainstream acceptance for some time. This month’s developments are consistent with that broader trend but represent a meaningful escalation. Prior signals came largely from individual agency officials or legislative supporters. An executive order signed by the president, combined with public statements from a cabinet-level official like RFK, carries considerably more institutional weight. On the other hand, RFK is not without critics, and it very well could be that his advocacy is not a net-positive — at least in the short term — for mainstream acceptance.
What the Executive Order Does — and Does Not — Do
Precision matters here and, to be clear, the executive order is limited.
The executive order touts the potential to address “serious mental illness for patients,” stating:
Psychedelic drugs, including ibogaine compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy. It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.
Section 2 directs the agency to fast-track psychedelic drugs that have already received breakthrough therapy designation through the National Priority Voucher Program and instructs FDA and DEA to carve out a Right to Try pathway for eligible patients seeking access to psychedelics, including ibogaine. You may recall the Right to Try pathway is the same angle Dr. Sunil Aggarwal pursued, which the DEA and ultimately the Ninth Circuit shut down.
Section 3 would leave a 1990s Cuba Gooding, Jr. satisfied — it puts real money on the table, directing HHS to allocate at least $50 million “from existing funds to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.” The federal-state collaboration framework is an interesting one that we have not seen in the cannabis space before.
Sections 4 and 5 are arguably the most consequential. Section 4 directs HHS, FDA, the VA and, where permitted, the private sector to work together to “increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs,” prioritizing “drugs that have received a Breakthrough Therapy designation.” Section 5 then closes the loop: Once a Schedule I substance successfully completes Phase 3 trials for a serious mental health disorder, the attorney general is directed to initiate and complete rescheduling review as quickly as practicable, if appropriate under 21 U.S.C. § 811.
To be sure, encouraging research into ibogaine is not the same as rescheduling it, approving it for medical use, or authorizing physicians to administer it. Ibogaine remains a Schedule I substance, and the legal and regulatory obstacles that have complicated efforts to expand access to psilocybin — which we’ve seen before — apply equally to ibogaine.
That said, administrative signaling has real consequences. The DEA and HHS operate within a political environment, and an administration that is visibly and publicly supportive of psychedelic research creates different conditions for petitions, rulemaking, and clinical trial approvals than one that is not. We noted in our coverage of FDA Administrator Martin Makary’s recent statements that companies supporting psychedelic research may become more aggressive in seeking trials and approvals under this administration. This week’s news reinforces that assessment (and encourages our optimism).
What to Watch
As Outkast reminded us, you can plan a pretty picnic, but you can’t predict the weather. If we’ve learned anything from watching the potential rescheduling of marijuana, we know these types of decisions and actions can take on an unpredictable life of their own. The distance between an executive order encouraging research and a patient receiving an FDA-approved ibogaine therapy remains significant. We think the more consequential developments to watch will be at the agency level, as well as at the private clinical trial level. We’ll be looking at whether HHS moves expeditiously on the psilocybin rescheduling petition currently before it, how the FDA approaches future applications for psychedelic-assisted therapies in light of its administrator’s stated priorities, and whether the DEA signals any willingness to revisit Schedule I designations for substances with growing clinical (and potentially public) support. We will also be keeping our eye on the private market, including whether the push and willingness for clinical trials continues (and whether the money follows).
As always, we will keep watching so you don’t have to. Stay tuned.
