Donald Trump has signed an executive order seeking to hasten research into the therapeutic benefits of LSD, ecstasy, psilocybin and other mind-altering drugs by ordering United States federal agencies to ease restrictions that have long limited the ability of scientists to study them.
The measure also provides $50 million (€42 million) for state-level research into ibogaine, a powerful psychedelic made from the root of a Central African shrub that has been drawing interest from researchers for its potential to treat opioid use disorder and other forms of substance abuse.
The funding will most immediately benefit Texas, which has already committed $50 million to studying ibogaine, but recently failed to secure matching funds from a private drug developer.
“I’m pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Trump said on Saturday from the Oval Office, where he was joined by a number of top Cabinet officials and podcaster Joe Rogan.
READ MORE
The move, long expected by researchers and drug reform advocates, aims to recast the US government’s largely adversarial relationship with psychedelics, most of which have been illegal since Richard Nixon, then president, launched a war on drugs in the 1970s.
The strict prohibitions have remained in place even as a growing number of studies suggest that psychedelic compounds can be effective in treating a range of mental health challenges, from severe depression and anxiety to post-traumatic stress disorder and the existential distress of a terminal illness.
Most psychedelic compounds are considered schedule one drugs – those with “no currently accepted medical use and a high potential for abuse” – making it difficult for scientists to conduct clinical trials.
Researchers have long bridled at that categorisation, noting the many studies suggesting that the drugs have significant therapeutic value.
The executive order directs the US Food and Drug Administration (FDA), the Drug Enforcement Administration, the Department of Justice and other federal agencies to reduce the red tape and restrictions that have long stymied researchers in the field.
It also paves the way for seriously ill patients to receive investigational drugs that have completed early clinical trials but have not yet been approved by the FDA.
One component of the executive order aims to expand participation in clinical trials by directing federal agencies to collaborate with the Department of Veterans Affairs, which is already funding research into psychedelic-assisted therapies for veterans with PTSD, depression and alcohol use disorder.
The executive order would not immediately result in the rescheduling of any drugs, but it creates a mechanism for easing restrictions on those that have successfully navigated most of the FDA’s long approval process.
That provision could most immediately apply to MDMA, the drug better known as ecstasy, which the FDA is considering as a treatment for PTSD.
The first psychedelic compound to come before the agency, MDMA is undergoing an additional Phase III clinical trial, after the FDA’s rejection nearly two years ago of an application by the drug’s sponsor, Lykos Therapeutics.
That rejection was widely criticised by many researchers in the field.
Administration officials, citing the epidemic of opioid deaths and the soaring number of veteran suicides, said the administration was committed to speeding up the approval process for compounds that demonstrate efficacy in treating such conditions.
In an interview shortly before the announcement, Dr Marty Makary, the FDA commissioner, highlighted one element of the executive order that would bring psychedelics into an FDA pilot programme that boosts promising drugs targeting unmet public health needs.
The goal of the programme, he said, was to accelerate the approval process from years to weeks.
“This is a clear statement from the administration that we’re taking the mental health crisis very seriously, particularly given what we’re hearing from veterans,” Makary said. “We need to have the same urgency in evaluating potentially promising treatments as we do with HIV, cancer and other debilitating conditions.”
Researchers who study ibogaine were especially gratified by the administration’s decision to single out that substance, which is largely unknown to most Americans.
Ibogaine has a long history of medicinal and ritual use in Gabon, and has drawn increasing interest from addiction experts and veterans groups in the US.
Although much about the drug remains unknown, several small studies have found that up to two-thirds of people who were addicted to opioids or crack cocaine were effectively cured of their habits after just a single ibogaine session.
Another study published last year found that ibogaine therapy could reduce accelerated brain ageing in veterans with traumatic brain injuries.
The drug, however, is not for the faint of heart. An ibogaine psychedelic “journey” is intense and can last many hours, and it carries significant cardiac risks. To obtain the drug, Americans often travel to clinics in Mexico, Costa Rica, Portugal and Brazil.
At $5,000 to $15,000 a session, ibogaine therapy is unaffordable to most of those who might benefit.
The drug appears to provide two seemingly distinct benefits. It quells the agony of opioid withdrawal and then gives patients a zeal for sobriety, some studies suggest.
Among those who attended the Oval Office announcement was W Bryan Hubbard, CEO of Americans for Ibogaine, an advocacy group that has been pushing state governments to fund research into the drug.
Hubbard has been instrumental in drawing national attention to ibogaine, and he recently appeared on Rogan’s show to make the case for federal intervention.
Hubbard credited Rogan with persuading the White House to issue the executive order on psychedelics. “Prohibition of psychedelics in America is over,” he said.
This article originally appeared in The New York Times.
