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President Trump Signs Order Advancing Ibogaine To 'Right To Try Act'

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An influential Stanford study conducted in 2024 and reported in 2025 found that the Drug Enforcement Administration (DEA) Schedule 1 psychedelic ibogaine can help dispel post-traumatic stress disorder (PTSD) among combat veterans.  On Friday, President Trump signed Executive Order 14401 directing the FDA to facilitate further studies of ibogaine to dispel PTSD.

The State of Texas authorized $50 million to fund clinical trials of ibogaine last year. Texas House Bill 3717 and Senate Bill 2308 passed and were signed by the Governor at the behest of former Governor Rick Perry.  The Trump XO will probably also facilitate the research going on in Texas:

https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/

ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS
Executive Orders
April 18, 2026

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose and Policy. Policymakers and the medical field have long struggled to address the burden of suicide and serious mental illness rates in America. Today, over 14 million American adults have a serious mental illness, defined as having a diagnosable mental, behavioral, or emotional disorder that substantially interferes with a person’s life and ability to function, and about 8 million are on prescription medication for these conditions. Suicide rates tragically increased by 37 percent from 2000 to 2018. During my first term, we made historic progress in helping those struggling with some of the most insidious mental illnesses, and suicide rates decreased by 5 percent from 2018 to 2020. The COVID-19 pandemic and the Biden Administration’s prolonged shutdown stunted this progress and suicide rates rebounded upwards again to their peak rate in 2022. Critically, veterans often suffer in greater measure from this tragedy. For over 20 years, there have been more than 6,000 veteran suicides per year, and the current veteran suicide rate is more than twice as much as the non-veteran adult population.

Individuals suffering from major depressive disorder and substance abuse disorder, among other serious mental illnesses, can relapse or not fully respond to standard medical and psychiatric therapies. Despite massive Federal investment into researching potential advancements in mental health care and treatment, our medical research system has yet to produce approved therapies that promote enduring improvements in the mental health condition of these most complex patients. Innovative methods are needed to find long-term solutions for these Americans beyond existing prescription medications.

Psychedelic drugs, including ibogaine compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy. It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.

Sec. 2. FDA Review Prioritization and Right to Try. (a) The Commissioner of Food and Drugs shall provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program.

(b) The FDA and Drug Enforcement Administration shall facilitate and establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act (21 U.S.C. 360bbb-0a), including any necessary Schedule I handling authorizations for treating physicians and researchers, consistent with 21 U.S.C. 823, and any applicable waiver authority under the Controlled Substances Act.

Sec. 3. Department of Health and Human Services Funding for Federal-State Collaboration. The Secretary of Health and Human Services shall, through the Advanced Research Projects Agency for Health, allocate at least $50 million from existing funds to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses, including through Federal funding, technical assistance, and data sharing as appropriate and consistent with applicable law.

Sec. 4. Department of Health and Human Services and FDA Collaboration with the Department of Veterans Affairs and the Private Sector. The Department of Health and Human Services (HHS) and FDA shall collaborate with the Department of Veterans Affairs (VA) and, as appropriate and consistent with applicable law, including any privacy restrictions from the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996, with the private sector, to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs, and shall prioritize drugs that have received a Breakthrough Therapy designation. The HHS, FDA, and VA are directed to sign data-sharing memoranda as appropriate to ensure that data from relevant clinical studies conducted by other executive departments and agencies is made available to FDA to facilitate the timely evaluation and approval of drugs that meet standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.

Sec. 5. Timely Rescheduling. The Attorney General shall, in consultation with HHS, initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder, so that rescheduling, if appropriate under 21 U.S.C. 811, may proceed as quickly as practicable for such specific products that are ultimately approved under section 505 of the Federal Food, Drug, and Cosmetic Act.

Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Health and Human Services.

DONALD J. TRUMP

THE WHITE HOUSE,

April 18, 2026.


This topic was modified 2 months ago by 10x25mm

   
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The abstract from the Stanford study:

https://www.nature.com/articles/s44220-025-00463-x

Magnesium–ibogaine therapy effects on cortical oscillations and neural complexity in veterans with traumatic brain injury

Jennifer I. Lissemore, Anna Chaiken, Kirsten N. Cherian, Derrick Buchanan, Flint Espil, Jackob N. Keynan, Malvika Sridhar, Camarin E. Rolle, Manish Saggar, Corey J. Keller & Nolan R. Williams

24 July 2025
Nature Mental Health volume 3, pages 918–931 (2025)

Abstract

Traumatic brain injury can lead to chronic psychiatric and cognitive symptoms, coupled with changes to the nature of cortical oscillations and neural complexity. Treatment with magnesium–ibogaine was recently found to improve the sequelae of traumatic brain injury, yet the effects of ibogaine on human cortical oscillations and complexity are unknown. Resting-state electroencephalography was performed prospectively before, 3.5 days after and 1 month after magnesium–ibogaine therapy in an observational, open-label study of 30 combat veterans. We assessed the effects of ibogaine on cortical oscillations and complexity and how these neurophysiological effects relate to psychiatric and cognitive outcomes of ibogaine treatment. After treatment, slower oscillations (theta–alpha) increased in power, and power at higher frequencies (beta–gamma) decreased. Accordingly, the theta/beta ratio increased post-treatment, which correlated with improved cognitive inhibition. Peak alpha frequency and neural complexity were lower after treatment, which persisted at 1-month follow-up. These neurophysiological markers correlated with improved executive function, post-traumatic stress disorder and anxiety after ibogaine. Altogether, these findings suggest reduced spatiotemporal complexity of brain activity and ‘slowing’ of cortical oscillations in the brain at rest after magnesium–ibogaine therapy, which may relate to psychiatric and cognitive improvements after ibogaine, thus providing key insight into the effects of ibogaine on brain function in humans. Follow-up controlled clinical trials are needed to confirm the findings from this initial single-arm trial.



   
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Pursuant to Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, the FDA has fast tracked three different studies of psychedelics:

https://www.hhs.gov/press-room/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order.html

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

FOR IMMEDIATE RELEASE - April 24, 2026
By HHS Press Office

President Trump on April 18 issued an Executive Order directing the U.S. Department of Health and Human Services to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.

Building on this directive, the U.S. Food and Drug Administration today announced a series of regulatory actions to support the development of serotonin-2A agonists and related products, a class of perception-altering psychedelic medications.

“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”

“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” said FDA Commissioner Marty Makary, M.D., M.P.H. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”

The FDA is issuing national priority vouchers to three companies studying:

  • Psilocybin for treatment-resistant depression.
  • Psilocybin for major depressive disorder.
  • Methylone for post-traumatic stress disorder (PTSD).

In addition, the agency is allowing an early phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug (IND) submission. The sponsor is investigating noribogaine as a potential treatment for alcohol use disorder, a condition with high relapse rates and limited treatment options. This is the first instance in which the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, a psychoactive indole alkaloid derived from the African Tabernanthe iboga shrub. This decision allows the company developing the novel drug, DemeRx NB, to begin a phase I clinical study of the drug in a closely monitored clinical setting in the United States.

The FDA’s decision allows the study to proceed and does not mean the drug has been approved or found to be safe or effective. The agency will continue to review data as it becomes available and support efforts to develop new treatments for alcohol use disorder and other mental health conditions.

Finally, the FDA intends to release final guidance imminently to provide recommendations to sponsors developing these products. Designing clinical trials to evaluate serotonin-2A agonists and related products presents unique scientific and methodological challenges. The final guidance reflects input from public comments and outlines foundational considerations for sponsors, including recommendations related to study design, data collection and generation, patient monitoring and conducting adequate and well-controlled clinical investigations.

“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.”



   
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