President Donald Trump signed an executive order April 18 directing federal agencies to accelerate research, regulatory review and access to psychedelic drugs, including ibogaine compounds, for serious mental illnesses.
The order comes as more than 14 million American adults live with serious mental illness and suicide rates have increased 37% from 2000 to 2018, according to an April 18 White House news release.
Ibogaine is a plant-based psychoactive compound. It was classified as a Schedule I controlled substance by the federal government in 1970 due to its high potential for abuse and no currently accepted medical use.
A 2024 Stanford (Calif.) University study suggested it may reduce symptoms of traumatic brain injury and mental disorders, though critics cited limitations, including the lack of a control group.
Several states are funding their own research programs and clinical trials on ibogaine to treat addiction, depression and traumatic brain injuries in veterans.
Here are four things to know:
- The order prioritizes FDA review of psychedelic drugs that have received breakthrough therapy designation and directs issuance of vouchers for psychedelic drugs that have designated as a breakthrough therapy.
- The FDA and Drug Enforcement Administration are tasked with creating pathways for eligible patients to access psychedelic drugs under the Right to Try Act.
- HHS will allocate at least $50 million from existing funds through the Advanced Research Projects Agency for Health to support state programs advancing these therapies.
- Federal agencies, including HHS, FDA and the Department of Veterans Affairs, are directed to expand clinical trial participation, data sharing and real-world evidence generation.
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