Trump signs order to speed review of psychedelics, including the controversial drug ibogaine

President Donald Trump signed an executive order Monday aimed at expediting the review process for potentially therapeutic psychedelic drugs, including the controversial substance ibogaine, which has shown promise in treating addiction but carries significant cardiac risks.

The directive instructs federal agencies to develop a plan within 180 days to accelerate research into psychedelics while maintaining regulatory standards. The order specifically mentioned MDMA, psilocybin, and ibogaine as substances deserving prioritized review for potential medical applications.

“Many Americans who have served our Nation honorably are experiencing mental health challenges, including depression, Post-Traumatic Stress Disorder, and Traumatic Brain Injury,” Trump said in the order. “This order will accelerate clinical trials for promising new therapies to treat veterans and other Americans suffering from mental health disorders.”

The inclusion of ibogaine marks a significant development in the evolving landscape of psychedelic research. Derived from the root bark of the African shrub Tabernanthe iboga, ibogaine has generated interest for its reported ability to reduce opioid withdrawal symptoms and cravings. However, it remains highly controversial due to documented associations with life-threatening cardiac arrhythmias and several fatalities.

Dr. Charles Nemeroff, Chair of the Department of Psychiatry at the University of Texas at Austin, called the order “a double-edged sword” in an interview.

“While accelerating research into psychedelics could lead to breakthrough treatments, ibogaine specifically presents serious safety concerns that shouldn’t be overlooked in a rush to market,” Nemeroff said. “Its cardiac toxicity profile is well-established.”

The executive order comes amid a broader national shift in attitudes toward previously stigmatized substances. Several states and municipalities have already moved to decriminalize certain psychedelics, while the FDA has granted “breakthrough therapy” designation to psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.

Investment in psychedelic medicine has surged in recent years, with the sector attracting over $2 billion in capital since 2020. Companies like Compass Pathways and MAPS Public Benefit Corporation have made significant advances in clinical trials, while pharmaceutical giants including Johnson & Johnson have entered the space with ketamine-derived treatments.

Veterans’ advocacy groups largely welcomed the announcement. The Veterans of Foreign Wars issued a statement calling it “a potential pathway to address the mental health crisis affecting our community.” According to VA statistics, approximately 17 veterans die by suicide daily in the United States.

However, regulatory experts caution that the executive order doesn’t fundamentally change the scientific standards required for drug approval. Dr. Janet Woodcock, former acting commissioner of the FDA, emphasized that while review timelines might accelerate, safety and efficacy requirements remain unchanged.

“Expedited review doesn’t mean lowered standards,” Woodcock noted. “These compounds will still need to demonstrate safety and efficacy through rigorous clinical trials.”

The directive represents a rare area of bipartisan agreement. Last year, bipartisan legislation called the “Breakthrough Therapies Act” was introduced in Congress with similar aims of streamlining psychedelic research for mental health conditions.

Market analysts predict the order could significantly impact the burgeoning psychedelics industry. “This signals to investors that regulatory pathways are becoming clearer,” said Michael Auerbach, founder of Subversive Capital, which invests in psychedelic companies. “We expect increased capital flow into the sector as a result.”

For ibogaine specifically, the order may revitalize research that has largely taken place outside the United States. Countries including Mexico, New Zealand, and Brazil have treatment centers offering ibogaine therapy, often operating in legal gray areas or under special permissions.

Critics of the order, including some addiction medicine specialists, worry about potential misinterpretation of the directive. “My concern is that this creates false hope about immediate access to these treatments,” said Dr. Anna Lembke, Medical Director of Addiction Medicine at Stanford University. “We’re still years away from widespread therapeutic use, especially for compounds with ibogaine’s risk profile.”

The White House emphasized that the order aims to accelerate research, not immediate approval or access. Implementation details will emerge as agencies develop their plans over the coming months, with particular attention to how the FDA and DEA will coordinate their approaches to these still-controlled substances.