Psychedelics Deserve Real Science

COMMENTARY

Psychedelic medicine is one of the most promising frontiers psychiatry has seen in a generation. Psilocybin holds US Food and Drug Administration (FDA) breakthrough designation for treatment-resistant depression.¹ MDMA-assisted therapy has produced durable response rates in posttraumatic stress disorder (PTSD) that our existing pharmacopeia has struggled to match.² Ibogaine, despite a complicated safety profile, has generated preliminary signals in opioid use disorder and traumatic brain injury that serious researchers at Stanford,³ NYU,⁴ and Johns Hopkins⁵ consider worth pursuing. As a psychiatrist, I want these trials to succeed. My patients need better tools, and the field needs them badly.

On April 18, 2026, President Donald Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness.”⁶ The order directs the FDA to issue National Priority Vouchers for Breakthrough Therapy-designated psychedelics, targets a 1- to 2-month review timeline, creates patient access pathways under the Right to Try Act, and mandates rescheduling on the heels of successful phase 3 trials. At face value, an administration prioritizing psychedelic research should be welcome news in a field that has spent 50 years fighting for serious study.

The trouble is the evidentiary basis being offered for that acceleration. The administration’s own public explanation, delivered by podcaster Joe Rogan at the signing ceremony, is that he texted the president about ibogaine’s “80 to 90%” success rate for opioid addiction and Trump replied, “Sounds great. Do you want FDA approval? Let’s do it.”⁷ That is not a critic’s caricature, it is the story the White House chose to tell, with the podcaster standing next to the president in the Oval Office.

I am not against studying psychedelics. I am not against finding new tools for PTSD, treatment-resistant depression, or opioid use disorder, conditions that kill my patients and exhaust their families. I am against skipping the science to get there.

The Numbers Rogan Quoted Are Not What He Thinks They Are

The "80 to 90%" figure did not come from a randomized controlled trial. A significant portion of it traces back to clinics like MindScape Retreat, which reports a 91.7% success rate, defined as successful detoxification at 90-day follow-up, in a self-selected cohort of 150 participants.⁸ Other observational studies find that roughly 80% of patients report elimination or reduction of withdrawal symptoms immediately after treatment.⁹

US academic research tells a more methodologically honest story. In 2024, Stanford published an open-label study of 30 veterans with traumatic brain injuries that found an 88% reduction in PTSD symptoms.¹⁰ Promising? Yes. Definitive? No. An open-label study of 30 individuals with no placebo arm is not the foundation on which you restructure American drug regulation.

This is the core problem: a number that sounds compelling to someone untrained in clinical literature becomes the evidentiary basis for federal policy. Observational data and open-label trials generate hypotheses. They do not confirm efficacy. In any other medication class, we would never accept this standard.

Ibogaine Is Not a Vitamin

Then there is the part that gets waved away whenever psychedelics come up: safety. Ibogaine prolongs the QT interval and has been associated with fatal arrhythmias. The drug has been linked to more than 30 deaths in the published medical literature, and NIH-funded ibogaine research in the 1990s was discontinued over cardiovascular toxicity concerns.¹¹ It interacts dangerously with opioids and other sedatives. It is contraindicated in patients on long-acting opioid therapy and in those with preexisting conduction abnormalities. Magnesium coadministration has been explored as a cardiotoxicity mitigator in some observational reports, but no randomized trial has established that this makes the drug safe for broader clinical use. Any serious ibogaine program requires rigorous cardiac screening, trained monitoring, and careful exclusion criteria. "Right to Try" access and a compressed FDA review timeline are precisely the wrong tools for a drug with this risk profile.

This Is Not Really About Ibogaine

Since 2025, the medical community has watched HHS, under Secretary Robert F. Kennedy Jr, systematically dismantle institutional safeguards. Seventeen members of the federal vaccine advisory committee were replaced with antivaccine activists. The recommended childhood vaccine schedule was cut from 17 diseases to 11 in January, before a federal judge blocked the change in March. Long-settled scientific consensuses, that vaccines do not cause autism, that antidepressants do not cause mass shootings, have been treated as open for debate.

The damage is not just to the agencies; It is to the trust patients place in their own physicians. I see it every week: you are just saying that to bill my insurance; you just want to push pills. The assumption is that I am a cog in a corrupt machine. And while the health care system has legitimate failures, the answer is not to hand policy to the most confident, charismatic voices on the podcast circuit.

We have entered a moment where an influencer with a large audience and no medical training can read an observational paper, send a text message, and rewrite federal drug policy. Where scientific nuance loses to viral conviction. Where I tried it and it worked carries more political weight than a phase 3 trial.

What a Serious Psychedelics Policy Would Look Like

Psychedelic research deserves rigorous funding. It deserves adequately powered randomized trials with active placebo controls, standardized endpoints like the CAPS-5 and MADRS, and meaningful follow-up durations. Safety monitoring, especially in populations with co-occurring traumatic brain injury, PTSD, and substance use, should be central, not an afterthought.

Most researchers in this space are not villains. They are thoughtful people trying to answer hard questions, and they are the first to tell you the observational data is preliminary. What they do not need is a podcast host declaring the case closed.

Here is the part that bothers me most, as someone who has spent a career pushing back on clinical orthodoxy: I never thought I would be the one arguing for a measured approach. I have advocated for expanded access to ketamine, for taking psilocybin research seriously, for treating psychedelics as legitimate objects of study. I am still there. But there is a difference between challenging a rigid system and blowing up the parts of that system that exist to keep patients safe.

We already have effective treatments for opioid use disorder. Overdose deaths fell nearly 27% in 2024 alone, according to the CDC, driven in large part by buprenorphine, methadone, and naloxone access. That progress was built on evidence. If we want to add psychedelics to the toolkit, let's do it right. Let's run the trials. Let's screen for cardiac risk. Let's not confuse enthusiasm with proof.

Dr Rossi is a board-certified psychiatrist specializing in inpatient and consultation-liaison psychiatry. His work focuses on evidence-based treatment, complex mood and psychotic disorders, and practical clinical decision-making. He is passionate about education, thoughtful skepticism, and advancing psychiatry through honest, nuanced discussion.

References

1. COMPASS Pathways receives FDA breakthrough therapy designation for psilocybin therapy for treatment-resistant depression. News release. October 23, 2018. Accessed April 21, 2026. https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html

2. Jenkins K. Breaking trauma: mechanisms of MDMA-assisted psychotherapy for PTSD. Psychiatric Times. 2026;43(2).

3. Lissemore JI, Chaiken A, Cherian KN, et al. Magnesium–ibogaine therapy effects on cortical oscillations and neural complexity in veterans with traumatic brain injury. Nat Ment Health. 2025;3:918-931.

4. Alper KR, Lotsof HS, Frenken GM, et al. Ibogaine in acute opioid withdrawal. an open label case series. Ann N Y Acad Sci. 2000:909:257-259.

5. Richard J, Garcia-Romeu A. Psychedelics in the treatment of substance use disorders and addictive behaviors: a scoping review. Current Addiction Reports. 2025;12(15).

6. Accelerating medical treatments for serious mental illness. The White House. April 18, 2026. Accessed April 21, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/

7. Jaramillo A. Trump signs executive order urging more research into ibogaine and other psychedelics. CNN. April 18, 2026. Accessed April 21, 2026. https://www.cnn.com/2026/04/18/politics/trump-signs-executive-order-urging-more-research-into-psychedelic-ibogaine

8. Ibogaine for opioid addiction & detoxification. MindScape Retreat. Accessed April 21, 2026. https://www.mindscaperetreat.com/ibogaine-case-study-for-opioid-addiction

9. Davis AK, Barsuglia JP, Windham-Herman AM, et al. Subjective effectiveness of ibogaine treatment for problematic opioid consumption: short- and long-term outcomes and current psychological functioning. J Psychedelic Stud. 2017;1(2):65-73.

10. Cherian KN, Keynan JN, Anker L, et al. Magnesium-ibogaine therapy in veterans with traumatic brain injuries. Nat Med. 2024;30(2):373-381.

11. Luz M, Mash DC. Evaluating the toxicity and therapeutic potential of ibogaine in the treatment of chronic opioid abuse. Expert Opin Drug Metab Toxicol. 2021;17(9):1019-1022.