President Trump signed an executive order to fast-track trials and reviews of psychedelic substances as therapeutic interventions. This order could lead to increased accessibility to new mental health treatments using certain psychedelic substances and faster reviews and approvals for those that prove to be beneficial.
Breakdown of Trump’s executive order on psychedelics
On 18 April 2026, President Trump signed an executive order that aims to accelerate accessibility to psychedelic substances for mental health treatment. The executive order will increase the availability of these types of treatments, fast-track reviews, and rescheduling of these substances, and increase funds allocated to these developments. [1]
Key aspects of this order include: [2]
- The Food and Drug Administration (FDA) Commissioner will provide National Priority Vouchers (NPV) to drugs with “Breakthrough Therapy” (BT) designation.
- The FDA and Drug Enforcement Administration (DEA) will establish accessibility to these drugs to eligible people under the Right to Try Act.
- The United States Department of Health and Human Services (DHHS), through the Advanced Research Projects Agency for Health, will allocate $50 million in funds to support programs and research working towards the advancement of psychedelic drugs for mental health treatment.
- DHHS will work with the Department of Veterans Affairs (VA) to increase accessibility to clinical trials.
- The Attorney General and DHHS will review and reschedule any Schedule I substance that completes Phase 3 clinical trials for mental health as quickly as possible.
Fast-tracking psychedelics from Schedule I to therapy
The executive order aims to fast-track psychedelics with a BT designation. This means the FDA has determined that these substances have potential therapeutic uses, although they are currently Schedule I controlled substances. [3]
A Schedule I controlled substance is considered to have no medicinal benefit and high risks of addiction and abuse, thereby making it the most highly restricted substance.
This new executive order forces accelerated research and development around the therapeutic uses of BT-designated drugs. This could result in rescheduling of these substances, if they are approved as medicinal drugs, so that they can be accessed by the public. [4]
Does this mean psychedelics are legal?
No, this does not mean that psychedelics are legal. This executive order increases the ability for researchers to investigate the therapeutic use of psychedelics and allows for more prompt reviews and actions as a result of this research.
What it does NOT do is: [4][5]
- Make psychedelics legal.
- Permit the purchase and use of psychedelics recreationally or by unapproved persons.
- Automatically reschedule any substances; rescheduling may occur as a result of the actions of this order, only if it is proven to be safe and appropriate.
- Guarantee substance rescheduling; this change might occur if the FDA approves it, but approval is not guaranteed.
- Immediately make psychedelics viable mental health treatments; this may occur at a later stage, although some eligible individuals may have increased access in the coming months or years within the context of approved studies.
- Prevent the need for investigations and safety guidelines around long-term effects.
Psychedelics’ potential for mental health & addiction treatment
Recent research has demonstrated potential for drugs such as psilocybin and MDMA in the treatment of mental health conditions and substance use disorders. [3]
Under this executive order, certain companies developing psychedelic treatments are being provided with NPVs by the FDA Commissioner to accelerate reviews, access, and development. This could decrease the time for review programs from an average of 10 to 12 months to 1 to 2 months. [6]
NPVs are being issued to three companies that are studying: [4]
- Psilocybin for major depressive disorder
- Psilocybin for treatment-resistant depression
- Methylone (similar to MDMA) for post-traumatic stress disorder (PTSD)
The FDA is also permitting an early-phase clinical study, following an Investigational New Drug (IND) submission, of noribogaine hydrochloride as a potential treatment for alcohol use disorder. This is the first FDA-approved study of ibogaine and its derivatives, allowing the commencement of a Phase I clinical study. [4]
Risks and concerns
The risks and concerns that have been identified in relation to this executive order and its actions include: [5][7]
- People may view this executive order as an indication that government organizations consider these drugs safe to use, which might increase recreational use.
- The influences leading to the development and signing of this executive include some prominent, non-clinical individuals, such as Joe Rogan, rather than being exclusively prompted by formal clinical organizations focused on thoroughly regulated pathways and reviews.
- Ibogaine is the primary source of concern, as it is known to cause a risk of serious cardiovascular effects that can be fatal. Additionally, unlike other psychedelics like psilocybin, there are yet to be comprehensive and conclusive clinical trials for the therapeutic use of ibogaine.
- Utilizing the Right to Try Act might encourage individuals to use experimental treatments before they have been adequately researched and understood, which could lead to dangerous consequences.
- Fast-tracked information gathering and review might prevent the recognition of long-term effects or careful review processes, potentially exposing individuals to unknown risks.
Eligibility and access
The Right To Try Act of 2018 can be utilized under this new order, allowing terminally ill individuals, as well as veterans with severe PTSD and suicidal ideation, access to drugs that have not yet been approved by the FDA. These drugs must have: [8]
- Passed Phase I trials
- Not been approved by the FDA
- Be under investigation for therapeutic effectiveness
The individual must have:
- A life-threatening condition
- Tried many other treatment options with no success
- Given consent
What this means for patients
People utilizing these substances under the Right to Try Act should be aware that the drugs remain Schedule I controlled substances, may pose serious or unknown risks, and are unlikely to be fully covered by insurance providers.
Under the new executive order, the DEA and FDA can utilize the Right to Try Act to help increase access for veterans with severe mental health conditions, including high risks of suicide and severe PTSD. [2]
As such, this order could increase accessibility to various types of new mental health and substance use disorder treatments. This could be life-changing for many people who have yet to experience a successful treatment option.
Recommendations for safe use
People who are interested in utilizing these new therapies should be aware that, at present, these substances are still Schedule I and their potential risks of harm, abuse, and addiction remain.
It is important to discuss these therapeutic options with a professional involved in clinical trials or Right to Try pathways, who can advise on safe use. Veterans can consult with the VA for guidance around these options.
People should not use these drugs without professional advice and should be aware of the potential physical and mental health risks.
Final thoughts
The newly signed executive order could result in some positive changes in the development of potential mental health treatments, specifically including ibogaine, psilocybin, and MDMA, and particularly for veterans and those with serious mental illness.
While this reduces the “red tape” preventing the furthering of psychedelic research, it does not change their legal status, accessibility, or risks. Anyone using these substances recreationally or therapeutically should be aware of the legal and health implications.
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