President Donald Trump on Saturday directed his administration to speed up review of certain psychedelic drugs, including ibogaine. Ibogaine has recently been embraced by veterans and conservative lawmakers, despite significant safety risks.
Ibogaine is banned under the federal government’s most restrictive category of illegal, high-risk drugs. But the Trump administration said it was taking steps to ease access to psychedelic drugs, which have already been designated as potential breakthrough drugs by federal regulators.
President Trump signed the executive order on drugs, saying, “Today’s order will finally give people who suffer from debilitating conditions the chance to get their lives back and live happier lives.” The Republican president said his directive would help “dramatically accelerate” psychedelic drug research and access to treatment. “If these things turn out to be as good as people say they are, they’re going to have a huge impact,” he said.
Veterans groups and psychedelic advocates have long argued that ibogaine, made from a shrub native to West Africa, has great benefits for hard-to-treat conditions such as post-traumatic stress disorder and opioid addiction.
President Trump’s announcement follows a pledge by Health Secretary Robert F. Kennedy Jr. and other administration officials to ease access to psychedelics for medical use, an issue that has received rare bipartisan support.
Trump’s top health official, conservative podcaster Joe Rogan, and former Navy SEAL Marcus Luttrell, whose memoirs of a dangerous mission in Afghanistan were the basis for the movie “Lone Survivor,” also joined Trump in the Oval Office. Logan said he texted President Trump information about ibogaine, and the president responded, “Great. You want FDA approval? Let’s approve it.”
“This is going to save a lot of lives,” Luttrell told President Trump at the ceremony. “It completely changed my life for the better.”
The Food and Drug Administration plans to issue national priority vouchers for three psychedelic drugs next week, which Food and Drug Administration Administrator Marty McCulley said would allow certain drugs to be approved quickly “if they are consistent with national priorities.” This is the first time the FDA has proposed expedited action for psychedelic drugs.
The FDA is also taking steps to clear the way for ibogaine’s first human clinical trial in the United States.
President Trump’s actions surprised many longtime advocates and researchers in the psychedelic field, as ibogaine is known to cause potentially fatal heart problems. The National Institutes of Health briefly funded research into the drug in the 1990s, but halted research due to ibogaine’s “cardiovascular toxicity.”
“It’s been incredibly difficult to study ibogaine in the United States because of its known cardiotoxicity,” said Frederick Barrett, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University. “If the executive order can pave the way for objective, scientific research with this compound, it will help us understand whether it is truly a better psychedelic therapy than others.”
Although no psychedelic drugs are approved in the United States, large-scale clinical trials are underway with drugs such as psilocybin, MDMA, and LSD for a variety of mental health conditions. All of these drugs remain illegal and are classified as Schedule I substances, along with drugs such as heroin. Two states, Oregon and Colorado, have legalized psychedelic therapy with psilocybin.
Ibogaine was first used during religious ceremonies by followers of the Bwiti religion in African countries such as Gabon.
In recent years, U.S. veterans have visited clinics in Mexico that administer the drug and reported receiving benefits from it.
With support from veterans groups and former Texas Gov. Rick Perry, legislation was passed last year to provide $50 million for ibogaine research in the state. Perry, co-founder of the group Americans for Ibogaine, recently appeared on Logan’s podcast and advocated for less federal regulation of the drug. It was the second time in the past two years that he has talked about ibogaine on the popular podcast.
The drug is known to cause irregular heart rhythms and has been linked to more than 30 deaths in the medical literature, according to the nonprofit Interdisciplinary Association for Psychedelic Research, which conducted the initial study on patients outside the United States.
Ismail Lourid Ali, the group’s co-executive director, said Trump’s order could prompt other states to follow Texas’ model.
“The stigma against Schedule I drugs is significant,” Ali said. “This would likely provide pretty substantial coverage for Republican governors and legislatures in terms of funding university research programs.”
Ibogaine clinic owners said the order’s impact would not be felt immediately.
“Insurance won’t cover it. It will still be considered unapproved and uninsured treatment,” said Tom Fiegel of Biondo Ibogaine, a clinic in Cancun, Mexico. “But what it means is that ibogaine has gone from being fringe and underground to being recognized by the federal government.”
Fiegel said his clinic treated 2,000 people with ibogaine last year at a cost of $15,000 to $20,000 each. The company also provided free treatment to approximately 100 veterans.
Clinics that use this drug typically monitor patients’ heart readings and are equipped with emergency medical equipment.
One of the only recent studies conducted by researchers in the United States found that veterans treated with ibogaine showed improvement in traumatic brain injury symptoms such as PTSD, depression, and anxiety. The Stanford University study was small and involved 30 veterans who were given the drug in Mexico. This did not include a placebo group, which is essential for rigorous medical research. Patients in this study were given a combination of ibogaine and magnesium to reduce heart risk.
