President Donald Trump on Saturday ordered his administration to accelerate the review of certain psychedelic drugs, including ibogaine, which has recently been enthusiastically embraced by war veterans and conservative lawmakers despite posing serious health risks.
Ibogaine and other psychedelic substances remain banned in the federal government’s most restrictive category for high-risk illegal substances. However, the Trump Administration is taking steps to ease restrictions and boost research into its use for medical purposes, including conditions such as major depression.
“Today’s order will ensure that people suffering from debilitating symptoms finally have the opportunity to reclaim their lives and be happier,” Trump said as he signed an executive order. The president noted that the order will help “dramatically accelerate” access to potential treatments. “If they turn out to be as effective as people say, they will have a tremendous impact,” he said.
Veterans organizations and psychedelic advocates have long claimed that ibogaine, extracted from a bush native to West Africa, holds promise for difficult-to-treat conditions such as post-traumatic stress disorder and opioid addiction.
Trump’s announcement follows promises by Health Secretary Robert F. Kennedy Jr. and other administration officials to facilitate access to psychedelics for medical use, an issue that has garnered unusual bipartisan support.
In the Oval Office were Trump’s top health officials, the podcaster conservative Joe Rogan and Marcus Luttrell, the former Navy SEAL whose autobiography about a deadly mission in Afghanistan was the basis for the film Lone Survivor. Rogan said she texted the president with information about ibogaine and he responded: “Sounds great. Do you want FDA approval? Go ahead.”
“You’re going to save a lot of lives thanks to this,” Luttrell told Trump during the ceremony. “It certainly improved my life.”
Next week the Food and Drug Administration (FDA) will issue national priority certificates for three psychedelic substances, which agency Commissioner Marty Makary said will allow certain drugs to be approved quickly “if they fit our national priorities.” Under this route, review times can be reduced from several months to a few weeks. This is the first time the FDA has offered this option to any psychedelic substance.
The FDA is also taking steps to clear the way for the first human trials of ibogaine in the United States.
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Trump’s decision surprised many veteran advocates and researchers in the field of psychedelic substances, as it is known that ibogaine can sometimes cause life-threatening heart problems. The National Institutes of Health briefly funded research on the drug in the 1990s, but discontinued work due to its “cardiovascular toxicity.”
“Ibogaine has been incredibly difficult to study in the United States because of its known cardiotoxicity,” said Frederick Barrett, director of the Johns Hopkins Center for Research on Psychedelics and Consciousness. “If the presidential decree can pave the way for objective scientific research with this compound, it would help us understand if it really is a better psychedelic therapy than others.”
No psychedelics have been approved in the United States, but several are being studied in large-scale trials to treat various mental health disorders, including psilocybin, MDMA and LSD. All of those substances remain illegal and are classified as Schedule I drugs, along with heroin. Two states—Oregon and Colorado—have legalized psychedelic therapy with psilocybin.
Ibogaine was first used by members of the Bwiti religion in African countries such as Gabon during their religious ceremonies. In recent years, American veterans have reported benefiting from the drug after traveling to clinics in Mexico that administer it.
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Backing from veterans groups and former Texas Gov. Rick Perry led to legislation last year that allocates $50 million to ibogaine research in that state. Perry, co-founder of a group called Americans for Ibogaine, participated in the podcast of Rogan and advocated for easing federal restrictions on the drug. It is the second time in the last two years that he spoke on the subject in that space.
Ibogaine is known to cause cardiac arrhythmias and has been linked to more than 30 deaths in the medical literature, according to the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that conducted some of the first studies in patients outside the United States.
The group’s co-executive director, Ismail Lourido Ali, said Trump’s order could encourage other states to follow Texas’ model.
“The stigma surrounding Schedule I drugs is significant,” Ali said. “It sounds like this would provide a pretty strong cushion for Republican governors and legislatures to get on board in terms of funding research programs at their universities.”
Ibogaine clinic owners said the impact of the order will not be immediate.
“It won’t be covered by insurance, it will still be considered unapproved, uncovered care,” explained Tom Feegel of Beond Ibogaine, which runs a clinic in Cancun, Mexico. “But what it does imply is that ibogaine goes from being marginal and clandestine to being recognized at the federal level.”
Feegel said his clinic treated 2,000 people with the substance last year, at a cost of between $15,000 and $20,000 per person. The company also saw about 100 veterans for free.
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Clinics that use this drug usually monitor patients’ vital signs and have emergency medical equipment.
One of the few recent studies by American researchers revealed that veterans treated with ibogaine showed improvements in symptoms of traumatic brain injury, including post-traumatic stress disorder, depression and anxiety.
The Stanford University study was small, with 30 veterans receiving the drug in Mexico. It did not include a placebo group for comparison, an essential part of rigorous medical research. Patients received a combination of ibogaine with magnesium to reduce cardiac risks.
