Psychedelics Archives https://reason.org/topics/drug-policy/psychedelics/ Thu, 04 Dec 2025 21:56:46 +0000 en-US hourly 1 https://reason.org/wp-content/uploads/2017/11/cropped-favicon-32x32.png Psychedelics Archives https://reason.org/topics/drug-policy/psychedelics/ 32 32 New study details how legal psychedelic services can treat depression, anxiety https://reason.org/commentary/new-study-details-how-legal-psychedelic-services-can-treat-depression-anxiety/ Tue, 09 Dec 2025 11:30:00 +0000 https://reason.org/?post_type=commentary&p=87245 A new study has found notable improvements in mental health among participants who underwent legal, supervised sessions with psychedelics in Oregon.

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A new study has found notable improvements in mental health among participants who underwent legal, supervised sessions with psychedelics in Oregon, the first state to legalize such services for adults. Published by Osmind, a mental health research and electronic health record company, the study analyzed treatment outcomes from individuals seeking relief from depression and anxiety under Measure 109 in Oregon. This 2020 voter-approved initiative decriminalized psilocybin, the psychoactive compound in psychedelic mushrooms, for therapeutic use by adults over 21 in state-licensed centers. While clinical trials have hinted at psilocybin’s potential at scale, this report offers early evidence from a commercial setting.

The Osmind study relies on voluntary self-reports, making it “naturalistic” research that captures how these services perform outside the strict protocols of randomized trials (measuring outcomes through self-reported surveys is standard practice in real-world scientific research). The study tracked 88 participants and used standardized tools to measure changes: the PHQ-8 questionnaire for depression (a scale from 0 to 24, where higher scores indicate worse symptoms), the GAD-7 for anxiety, and the WHO-5 for overall well-being. Assessments occurred before the session, one day after, and a month later. No dosages were specified, but sessions followed state guidelines for supervised administration.

Results showed meaningful gains across the board. Depression scores on the PHQ-8 fell by an average of 4.6 points, shifting participants from moderate to mild severity, a change that meets the threshold for clinical significance. Anxiety dropped by 4.8 points (on the GAD-7 scale), and well-being rose by 10.7 points (on the WHO-5 index). No serious adverse events occurred during sessions, though 3 percent reported lingering issues, like heightened anxiety or family strain, a month later. These preliminary improvements suggest that psilocybin could offer rapid relief in a legal therapeutic setting, aligning with the compound’s reputation for fostering emotional resilience.

Direct comparisons to other psilocybin studies or clinical trials are tricky, as many rely on different scales, populations, and measures. Some studies report quantified outcomes (“effect size”) in the proportion of participants who had meaningful changes, while others report changes in a particular scale. As an example, in one randomized study, about two-thirds of participants continued to experience relief from major depressive disorder (MDD) remission five years after receiving treatment. That study only included participants diagnosed with major depression and measured outcomes with a different metric (the GRID-HAMD scale) than the Oregon study.

Nonetheless, Osmind’s review of real-world data reveals significant results on depression and anxiety, consistent with more medicalized clinical trials. Oregon’s approach to psychedelic treatment is a novel experiment, not just because it uses psychedelics, but because it created an entirely new mental health services framework. The state had to design training criteria for schools so that non-medical professionals could learn to administer a drug that is currently undergoing drug trials. By law, these “facilitators” did not need prior mental or medical training.

This new study shows promise for both the impact of psychedelics as a mental health treatment and for lowering the cost of licensed mental health services. Psychedelic therapy can be very expensive (over $15,000) when using a medical model, where two licensed therapists see a single patient for three extended sessions (based on countries where it is federally legal). In Oregon, professionals do not need to attend medical school and can administer group sessions, reducing the total cost per patient.

The Drug Enforcement Administration (DEA) has requested that Health and Human Services (HHS) review whether psilocybin should continue to be banned as a Schedule I drug (the DEA request was publicly confirmed by Kathryn Tucker, JD, who is involved with the case; it was also confirmed privately by legal counsel to Reason staff). A Schedule I designation reflects the government’s opinion that the substance has no medical value and is highly susceptible to abuse. Businesses that traffic in Schedule I substances, including Oregon psilocybin clinics, are considered federal criminal enterprises, are generally unable to access financial services, and are prohibited from claiming deductions on their federal income taxes using the “ordinary and necessary” standard that applies to other businesses. These federal penalties significantly increase the cost and risk faced by these businesses, and these additional financial burdens must be passed on to customers.

Data collected by Reason Foundation shows that states with legal psychedelic services do not display increased rates of criminal activity or hospitalizations. Taken together with this latest study, data from Oregon makes a strong case that psilocybin holds clear medical value and does not endanger public health, calling into question whether it should be considered a Schedule I drug.

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Model legislation would authorize groundbreaking research into ibogaine for mental health https://reason.org/backgrounder/model-legislation-would-authorize-groundbreaking-research-into-ibogaine-for-mental-health/ Tue, 25 Nov 2025 11:30:00 +0000 https://reason.org/?post_type=backgrounder&p=87010 Model legislation would authorize groundbreaking research into ibogaine for mental health

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Growing research has demonstrated the promise of ibogaine in treating a wide range of intractable conditions, from post-traumatic stress disorder (PTSD) to traumatic brain injury (TBI). But because ibogaine is classified as a Schedule I drug through the federal Controlled Substances Act, it remains out of reach for both researchers and patients. Model legislation from Reason Foundation, titled the Veterans Mental Health Innovations Act (VMHI), will bypass this restriction by authorizing a multistate research collaboration to advance treatment and healing.

State-based research and clinical trials

  • After years of advocacy by veterans’ organizations and researchers, a bipartisan coalition of state legislators in Texas voted to fund ibogaine research programs (Texas Senate Bill 2308). In 2025, Texas launched a multimillion-dollar endeavor that will allow any state that enacts the VMHI to join the effort on ibogaine clinical trials.
  • The most effective way to ensure those in need benefit from ibogaine is to conduct clinical trials using ibogaine as an investigational new drug. Clinical trials are a costly and lengthy endeavor for any one entity, but through VMHI, multiple states will conduct their own local trials, advancing a single unified application to the Food and Drug Administration (FDA).
  • Under the VMHI, each participating state selects and funds a research grantee of their choice to conduct ibogaine clinical trials locally with in-state participants.

Multistate collaboration and shared success

  • A multistate consortium allows states with limited resources to take part in what could be nearly a billion-dollar endeavor. This public effort to conduct FDA-approved clinical trials will be in partnership with a private drug developer, which will assume financial risk and responsibility for advancing the treatment through the clinical trial process. 
  • Under VHMI, states retain the long-term benefits of the research they fund. Instead of handing over value to pharmaceutical companies, the bill keeps the research and development process rooted locally and ensures states are compensated if an application is successful.

Federal government and the role of the FDA

  • Ibogaine is deemed a Schedule I drug by the federal government. Engaging in FDA-approved research is the surest way to prove its medicinal and treatment value.
  • Once ibogaine is approved by the FDA to treat a medical condition, the VMHI would allow licensed physicians to prescribe ibogaine administration for a patient under supervision.
  • The VMHI leaves direct engagement with the FDA to the drug developer, eliminating the need for states to navigate the complex clinical trial application process.

The model legislation for the Veterans Mental Health Innovations Act is available below. The template is designed to be easily adapted by states, with the sections that need customization highlighted.

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Ibogaine could transform public spending on opioid treatment https://reason.org/backgrounder/ibogaine-could-transform-public-spending-on-opioid-treatment/ Wed, 05 Nov 2025 11:30:00 +0000 https://reason.org/?post_type=backgrounder&p=86244 Using ibogaine as a treatment for opioid use disorder could be significantly more cost-effective than traditional medication-assisted treatments.

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What is ibogaine?
  • Ibogaine is a psychoactive alkaloid from the western Central African iboga shrub that can rapidly reduce, and sometimes eliminate, opioid withdrawal and craving symptoms within a single dose.
  • Ibogaine is a potential breakthrough treatment for opioid use disorder (OUD) due to its unique ability to heal the neurochemical brain injury caused by opioid use and alleviate withdrawal symptoms.
  • Opioid withdrawal syndrome (OWS) is the debilitating physical and neurological symptoms that are induced by the cessation of opioid consumption.
  • Ibogaine has shown promising results in resolving OWS within 36 to 48 hours of administration under safe, clinically controlled conditions.

Ibogaine could reduce lifetime direct costs of OUD by nearly 90%

  • A growing body of research suggests that ibogaine treatment for opioid use disorder (OUD) could be significantly more cost-effective than traditional medication-assisted treatments (MATs), such as methadone and buprenorphine (suboxone).
  • Unlike MATs—which require long-term, or even lifelong, use—ibogaine offers a clear root-cause intervention, capable of disrupting OUD within a single dose. In one study, 30% achieved complete opioid abstinence after only one ibogaine session.
  • Patients who discontinue MATs often relapse when opioid withdrawal and craving symptoms return. MAT success is therefore measured on program retention (or continuation) instead of abstinence.
  • The comparative cost-analysis below predicts that ibogaine treatment for OUD could reduce the 20-year direct lifetime costs of MATs involving methadone and buprenorphine by 87% and 86%. Concurrently, this analysis reveals just how quickly per-patient costs for MATs exceed $100,000.

Cost-Effectiveness for OUD Treatment: Ibogaine vs. MATs

TreatmentAbstinence (Retention) RatesYear 1 Direct CostYear 20 Direct CostsIbogaine Cost Savings Per Patient
Ibogaine Treatment30% complete opioid abstinence after single session (with 31% reporting 2+ years of abstinence)$17,000 estimate includes prescreening, travel, and an all-inclusive treatment program for mid-length stay$17,000 – $51,000 (assumes 1 – 3 recovery attempts)N/A
Methadone Maintenance Treatment~ 19% treatment retention within 24 months$6,552 includes treatment, psychosocial, and medical intervention costs$131,040 (on-going treatment costs)61% – 87%
Buprenorphine Maintenance Treatment~ 11% treatment
retention within 24 months
$5,980 includes treatment, bi-weekly visits, and standard interventions$119,600 (on-going treatment costs)57% – 86%

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FAQ: Timeline for FDA ibogaine approval https://reason.org/faq/faq-timeline-for-fda-ibogaine-approval/ Tue, 04 Nov 2025 11:30:00 +0000 https://reason.org/?post_type=faq&p=86234 It can take between 5 and 12 years to complete a drug trial, but the timeline to drug approval can vary significantly depending on the type of treatment.

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What is the FDA process?
  • To commercialize a new drug, the Food and Drug Administration requires three ‘phases’ of testing to demonstrate that a molecule is both safe and effective for the treatment of a specified condition. Drug makers (“sponsors”) finance and run trials for which the study design must be pre-approved by the FDA.
  • Upon successful completion of the final phase, the sponsor can submit a New Drug Application to the FDA. If if the FDA approves the application, the sponsor gains the right to market the drug as a treatment for the specified condition.

How long does it usually take, by phase?

  • In all, it can take between 5 and 12 years to complete a drug trial. The timeline to drug approval can vary significantly depending on the type of treatment, according to a report from Health and Human Services (HHS). Initial discovery of a molecule and treatment in animals may take an indeterminate amount of time, but a molecule cannot enter trials in human beings until a sponsor has submitted an Investigational New Drug application to the FDA.
  • Phase 1 is the first stage in which an investigational drug is permitted to be administered to a healthy sample of human beings, to determine proper dosing and potential toxicity levels, and averages 1.8 years.
  • Phase 2, which includes placebo-controlled randomized trials in a small sample of human beings suffering from the specified condition, takes about 2.1 years.
  • Phase 3 requires a drug to demonstrate effectiveness statistically greater than a placebo in two large-scale, well-designed clinical trials. The statistical significance thresholds often require a trial to include thousands of participants in each Phase 3 trial and to include double-blind control groups that receive a placebo. This phase frequently takes up to 4 years.

How is drug approval accelerated with a ‘Breakthrough’ designation?

  • The FDA can award a “Breakthrough” designation for drugs that demonstrate exceptional preliminary results. The designation grants the sponsor a more efficient process that includes ongoing agency collaboration on trial design, “rolling” review of trial evidence in lieu of compiling years’ worth of evidence into a completed application, and priority review of a New Drug Application. These changes drastically reduce costs and uncertainty facing drug sponsors and can facilitate capital formation by the sponsor. One study found that a breakthrough designation can shorten the average time to approval to five years.

Have psychedelic drugs received Breakthrough status?

  • Since 2017, a number of psychedelic drugs, including synthetic versions of MDMA (“ecstasy”), psilocybin (“magic mushrooms”), and lysergic acid diethylamide (LSD), have been granted breakthrough status by the FDA. Psychedelic drugs have a pattern of showing strong preliminary results in treating mental health issues.
  • Non-FDA supervised clinical trials using ibogaine in foreign jurisdictions have also shown very strong results. If a drug sponsor used the same formulation of ibogaine used in these early clinical trials, it could argue that data already exists to show ibogaine offers a substantial improvement over existing therapies.

Are any manufacturers taking ibogaine-like drugs through the FDA process?

  • Yes. Manufacturers Atai’s and DemRX’s ibogaine-like drug have already completed Phase I and may soon move on to Phase II. Another manufacturer, Gilgamesh, was awarded a $14 million grant from the National Institutes of Health to finance Phase I trials of its compound for the treatment of opioid disorder. State participation in an ibogaine research collaborative could steer funding toward a new drug or potentially support an existing clinical trial.

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Ibogaine and veterans’ mental health https://reason.org/backgrounder/ibogaine-and-veterans-mental-health/ Mon, 03 Nov 2025 11:30:00 +0000 https://reason.org/?post_type=backgrounder&p=86225 Innovative psychedelics therapy offers military veterans struggling with their mental health newfound hope.

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VA mental health treatment is lacking
  • According to the Department of Veterans Affairs (VA) annual report on suicide prevention, there are an average of 17.6 veteran suicides a day, indicating a significant gap between available mental healthcare and veterans’ needs. Some advocacy groups estimate the true number is closer to 44 Veterans a day when accounting for overdose deaths and other self-destructive behaviors linked to untreated trauma.
  • VA has a backlog in mental healthcare services due to over 1.7 million veterans with only about 10,000 psychologists and psychiatrists to treat them.
  • Veterans wait an indeterminable amount of time to secure an appointment and receive limited care if they are deemed “functionally stable.” Many current or former VA clinical psychologists report great pressure to cap individual therapy sessions to vets deemed “functionally stable.”
  • VA works with veterans over 8-15 initial therapy sessions, then offloads the patient back to primary care as they are deemed “functionally stable.” However, many veterans only reach “functional stability” temporarily during the therapy sequence and decline once services are discontinued.

Current PTSD treatment = lifetime sentence of medication

  • While selective serotonin reuptake inhibitors (SSRIs) are considered a common and safe treatment for post-traumatic stress disorder (PTSD)—and are routinely prescribed to veterans on a daily, perpetual basis—many experts and PTSD patients report that SSRIs have limited efficacy and effectiveness.
  • Many veterans are prescribed multiple psychotropic drugs, receiving prescriptions for medication after medication that do not solve the underlying condition(s).
  • This breakdown breeds mistrust and despair, as Veterans begin to wonder not only if they can recover, but if the system meant to help them is even capable of healing them.

One ibogaine treatment can replace a lifetime of medication

  • Ibogaine is an extract of Tabernanthe iboga, a Central African shrub, and is a psychoactive compound that has long been used in spiritual practices and shows promising results in mental health treatments.
  • Ibogaine’s Schedule I status in the U.S. has forced thousands of American Veterans to seek treatment abroad—most often in Mexico, where ibogaine is unregulated and available through private clinics.
  • The profound results of ibogaine are seen in the study done by Stanford Medicine, showing an 88% decrease in PTSD symptoms, 87% in depression symptoms, and 81% in anxiety symptoms one month after an ibogaine treatment in a cohort of 30 special operations veterans with a history of traumatic brain injuries (TBI).
  • Additional trial results published in Nature Medicine showed significant improvements in concentration, information processing, memory, and impulse control following ibogaine treatment.

Bottom line

Promising breakthrough treatments like ibogaine can provide military veterans with PTSD and other mental health conditions by eliminating the need to take medication every day and targeting the root conditions driving suicidal ideation, hyper-aggression, depression, or the many other conditions many veterans face.

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Ibogaine offers breakthrough treatment for mental health, addiction, and TBIs https://reason.org/backgrounder/ibogaine-offers-breakthrough-treatment-for-mental-health-addiction-and-tbis/ Fri, 31 Oct 2025 10:00:00 +0000 https://reason.org/?post_type=backgrounder&p=86199 Ibogaine, a psychedelic, holds promise as a potential treatment for numerous conditions, ranging from PTSD to multiple sclerosis.

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Traditional treatments

Current treatments for post-traumatic stress disorder (PTSD)—including cognitive behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs)—achieve only 30–40% remission rates, with many patients discontinuing treatment early, limited long-term efficacy, and significant side effects, particularly for those with treatment-resistant cases.

Association for Psychological Science (2021): “Approximately two-thirds of veterans with PTSD remain with the disorder following treatment. […] Treatments for veterans with PTSD show limited overall effectiveness in real-world settings.”

Promise of ibogaine

Psychological Healing occurs through the boosts in neurotrophic factors to promote neural regeneration and repair, profoundly revolutionizing the approach to treatment for addiction, traumatic brain injuries (TBI), and neurodegenerative diseases.

Research by Stanford University published in Nature Medicine in 2024 found that ibogaine treatment led to significant improvement in a cohort of 30 veterans. After one month of following treatment, these participants experienced average reductions of 88% of PTSD symptoms, 87% in depression symptoms, and 81% in anxiety symptoms relative to their initial conditions. The results held at 6 months. In a small-scale study, 75% of patients remained abstinent from opioids for an entire year following treatment.

Typical ibogaine treatment protocol

A standard ibogaine treatment protocol consists of a 5 to 10-day inpatient program conducted in a medically supervised environment. Participants undergo comprehensive medical evaluation, safety preparation, and therapeutic support prior to treatment, followed by a recommended 12 months of ongoing, structured integration and support services.

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Psychedelics Policy Newsletter: DEA considers rescheduling psilocybin, FDA releases rejection decision, and more https://reason.org/psychedelics-policy/psychedelics-policy-newsletter-dea-considers-rescheduling-psilocybin-fda-releases-rejection-decision-and-more/ Mon, 06 Oct 2025 04:30:00 +0000 https://reason.org/?post_type=psychedelics-policy&p=85350 Plus: Reason Foundation testifies in Mississippi, author Joe Dolce talks about his new psychedelics book, and more.

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Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

  • DEA petition to reschedule psilocybin
  • Reason testimony on ibogaine in Mississippi
  • FDA releases MDMA decision
  • Interview for a new book on psychedelics

DEA petition requests psilocybin rescheduling

The Drug Enforcement Administration (DEA) has requested that the Department of Health and Human Services (HHS) review the scheduling of psilocybin under the Controlled Substances Act. This means that the federal government could choose to change psilocybin from Schedule I (where all use is banned) to a lower schedule (where use may be allowed under certain guidelines).

Schedules III through V are for approved pharmaceuticals subject to varying levels of controlled access. Companies or individuals that traffic in these substances can access basic financial services and are not subject to special penalties on their federal income taxes, even if state laws allowing the sale of these substances differ from federal law. A key takeaway of the potential change is that psilocybin service centers in state-regulated markets, such as Oregon, would be able to deduct business expenses on their federal income taxes under the “ordinary and necessary” standard that applies to most businesses.

This request from the DEA follows a protracted legal battle by proponents, including Sunil Aggarwal, a Washington State-based doctor, who sought to treat a patient with psilocybin under “Right to Try,” a federal law that permits the use of drugs not approved by the Food and Drug Administration (FDA) under certain conditions. There is no word yet from HHS regarding when or how it will respond to the DEA’s request. Legally, the U.S. attorney general has the authority to change the status of a drug, provided that DEA and HHS have jointly considered a number of factors outlined in statute.

Reason testimony in the state roundup

Reason Foundation’s Geoff Lawrence traveled to Mississippi to testify during a hearing related to ibogaine. Lawrence discussed the medical benefits of ibogaine as a potential treatment for opioid addiction. He also discussed recent states that have approved millions of dollars in funding for clinical trials involving ibogaine, such as those in Texas and Arizona.

These public grants could contribute enough funding to take ibogaine through the initial phase of the Food and Drug Administration’s (FDA) drug approval process.

Read this and more about state-level policies in the state round-up here.

FDA releases rejection decision

The FDA has released details of its decision to reject a New Drug Application for MDMA. Last August, the FDA made headlines for rejecting the application of Lykos, a pharmaceutical company that had long been the frontrunner for medicalizing psychedelics with a patented version of MDMA for the treatment of post-traumatic stress disorder. The Multidisciplinary Association of Psychedelic Sciences (MAPS) published a critique of the decision, arguing that the FDA “moved the goal posts” on the clinical trial design.

According to MAPS, the FDA was fully aware of many of the limitations when it greenlit the organization’s clinical trial design. For instance, the FDA was ultimately concerned that too many participants ”broke” blinding because they were able to guess whether they received the drug or a placebo. Genuine blinding is a gold standard of clinical trials, but a challenge with mental health-related drugs that have acute effects (like potent psychedelics).

The FDA is now requiring more research. MAPS leadership had created a for-profit company, Lykos, to conduct the trials. Currently, it is unknown if and how Lykos will address these challenges in further research.

Book interview

Reason Magazine Editor-at-Large Nick Gillespie interviewed Joe Dolce about his new book, Modern Psychedelics: The Handbook for Mindful Exploration. Dolce argues that psychedelics have moved from an obscure interest of the counterculture to a mainstream treatment.

“No matter what happens, people are going to use these substances,” says Dolce, when asked about possible legalization policies. Gillespie noted that better public policies would help users make more informed decisions.

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State psychedelics legalization and policy roundup — October 2025 https://reason.org/commentary/state-psychedelics-legalization-and-policy-roundup-october-2025/ Mon, 06 Oct 2025 04:01:00 +0000 https://reason.org/?post_type=commentary&p=85345 Kentucky debates clinical ibogaine trials, Mississippi considers ibogaine, Massachusetts bill would decriminalize psilocybin, and more.

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This post is part of an ongoing series summarizing state-based psychedelic reforms intended for policy professionals.

Kentucky

On Aug. 27, the Interim Joint Committee on Health Services discussed whether Kentucky should join a multi-state collaborative to conduct clinical trials of ibogaine as a treatment for certain neurological conditions, including opioid addiction. In 2023, the Kentucky Opioid Abatement Advisory Commission first broached the idea of directing a portion of the state’s opioid settlement funds toward ibogaine research to develop a novel, and potentially far more effective, treatment than what is currently available. That initiative was scrapped after a new state attorney general was elected. According to the Lexington Herald-Leader, Gov. Andy Beshear has expressed skepticism about the safety of ibogaine treatment. The legislature has not yet scheduled any further action on the issue (such as the introduction of a bill like in Texas to grant public funds for research).

Mississippi

Reason Foundation Research Director Geoff Lawrence testified at a state legislature Public Health Joint Committee hearing on Aug. 28, in which lawmakers learned about the possibilities of ibogaine as a potential treatment for a wide range of neurological conditions. Lawrence discussed the known benefits of ibogaine as a potential treatment for opioid use disorder, traumatic brain injury, and neurodegenerative disease, along with efforts in other states, including Texas, to fund FDA-supervised clinical trials (testimony begins around here at the 1:36 minute mark).

Massachusetts

House Bill 2506 from state Rep. Steve Owens (D-29) would allow limited personal possession and transfer of psilocybin for military veterans, law enforcement officers, and those with a ”qualifying condition,” which is defined by the bill as ”a medical condition for which at least two and a majority of relevant clinical studies suggest psilocybin therapy in a clinical environment is safe and tolerable and which is not a disqualifying condition.’ Individuals may not have a disqualifying condition, which is defined in the bill as “bipolar disorder, a schizophrenia spectrum disorder, a Cluster A personality disorder, a Cluster B personality disorder, or a medical condition for which at least two and a majority of relevant clinical studies suggest psilocybin therapy in a clinical environment is not safe.”

S1400, sponsored by state Sen. Cindy Friedman (D-Middlesex), would task the Department of Health with creating a pilot program for treatments with psychedelics. On Sept. 11, it received a favorable vote from the Joint Committee on Mental Health, Substance Use, and Recovery and has been referred to the Committee on Healthcare Financing.

Oregon

House Bill 3043 (introduced at the request of Gov. Tina Kotek’s office) states that a licensed medical practitioner may not be disciplined for using psilocybin under the state’s regulated program. The bill amends the state’s program to allow for reentry into medical professions for those who were once declared “impaired” by substance abuse. Specifically, a medical professional cannot be disciplined for legal psilocybin use if they used it “before entry into the impaired health professional program, if the licensee did not practice while impaired.”

Senate Bill 844 (introduced at the request of the governor’s office) requires the Oregon Health Authority to keep personally identifiable information confidential related to complaints against a psilocybin service center or licensee.

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Psychedelics Policy Newsletter: RFK Jr. gives hopeful approval timeline, Arizona advances ibogaine, and more https://reason.org/psychedelics-policy/psychedelics-policy-newsletter-rfk-jr-gives-hopeful-approval-timeline-arizona-advances-ibogaine-and-more/ Tue, 12 Aug 2025 20:04:33 +0000 https://reason.org/?post_type=psychedelics-policy&p=84073 Plus: Former Texas Gov. Rick Perry penned an op-ed about his commitment to advancing ibogaine as a treatment option.

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Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

  • The Trump administration’s psychedelics push
  • Arizona’s ibogaine funding law
  • Gov. Perry’s op-ed offering support for ibogaine

The Trump administration’s push for psychedelics

During a House Energy and Commerce Committee hearing, Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. said that he hopes that a psychedelic pharmaceutical is approved within the next 12 months. However, he did not specify which drug or how the Food and Drug Administration (FDA) would make this determination. “This line of therapeutics has tremendous advantage if given in a clinical setting, and we are working very hard to make sure that happens within 12 months,” RKF Jr. said.

“These are all very promising signs that the administration is aware of the potential of psychedelics and is trying to make overtures that they’re ready to approve them,” Reason Foundation’s Greg Ferenstein told the Associated Press.

HHS also made a key new hire who could help spur positive reforms. Mike Davis, who previously served as chief medical officer of the psychedelics research organization Usona Institute, is now the deputy director of the FDA’s Center for Drug Evaluation and Research, which evaluates drug applications and reviews standards for clinical trials.

Arizona funds ibogaine

The psychedelic compound ibogaine is a promising potential treatment for opioid addiction and brain disorders. Arizona lawmakers recently budgeted $5 million toward a public-private partnership that will perform clinical trials to determine the safety and efficacy of the treatment. Arizona becomes the second state, following Texas, to allocate funding for this purpose. “Arizona is showing the nation how to solve real problems by putting cutting-edge science first,” former U.S. Senator Krysten Sinema told Reason Foundation about the program. For more on Arizona and other developments, visit our most recent state psychedelics legalization and policy roundup.

Former Texas Gov. Rick Perry supports psychedelics

Former Texas Gov. Rick Perry penned an op-ed in The Washington Post about his commitment to advancing ibogaine as a treatment. Perry concludes the op-ed with a personal note:

“I traveled to see ibogaine clinics in Mexico myself. I met the doctors and researchers. I listened to the patients. I studied the clinical data. I don’t care if you’re a Republican or a Democrat. Every one of us knows someone who’s struggling, whether with addiction, trauma or mental health. This is the cause I will dedicate the rest of my life to fighting for, because too many lives hang in the balance to do anything less.”

Perry’s column links to recent Reason Foundation research by Madison Carlino examining the potential for psychedelics to allay the symptoms of neurodegenerative diseases like Alzheimer’s. Perry has co-founded a new nonprofit, Americans for Ibogaine, to pursue his advocacy.

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State psychedelics legalization and policy roundup — August 2025 https://reason.org/commentary/state-psychedelics-legalization-and-policy-roundup-august-2025/ Tue, 12 Aug 2025 15:50:21 +0000 https://reason.org/?post_type=commentary&p=84079 Arizona allocates funding for ibogaine research, Reason Foundation to testify at Mississippi informational hearing about ibogaine, and more.

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This post is part of an ongoing series summarizing state-based psychedelic reforms intended for policy professionals.

Arizona

House Bill 2871 by state Rep. Justin Wilmeth (R-Phoenix), which would have allocated funding to ibogaine research, was folded into the state’s general appropriations bill and signed by the governor on June 27th. Reason Foundation has published an analysis on why Arizona’s joining Texas to fund ibogaine clinical trials marks an important step in the momentum to gain federal approval for the drug.

Senate Bill 1555 by state Sen. T.J. Shope (R-16) will legalize a pharmaceutical version of synthetic psilocybin at the state level if approved by the Food and Drug Administration (FDA). The bill passed on June 26th. The bill, as originally written, would have authorized a market for state-regulated psilocybin-assisted therapy, but was heavily amended.

Colorado

Colorado regulators are reportedly considering therapeutic use of iboga within the state’s regulated psychedelics program. Colorado would be the first state to offer legal iboga services. Under Proposition 122, a ballot initiative that created a regulated market for psilocybin therapy, the state can consider other botanical psychedelics. The Colorado Natural Medicines Advisory Board must first determine how to manage potential safety concerns and how licensees would be able to produce the compound.

Louisiana

Senate Resolution 186 from state Sen. Patrick McMath (R-11) would create a task force to study the use of psychedelics for veterans.

Massachusetts

H1858 (previously House Docket 188) from state Rep. Marc Lombardo (R-22nd Middlesex) would reduce the penalties for possession of psilocybin. It would impose a $100 fine for possession of less than one gram.

H1726 (previously House Docket 3895), from state Rep. Homar Gómez (D-2nd Hampshire), would direct courts to dismiss any arrest for possession of psilocybin by adults over 21 as long as their actions had no visible defects to the health or safety of another person.  

H1624 (previously House Docket 4243) from state Rep. Mike Connolly (D-26th Middlesex) would create a psychedelics task force to study equity in psychedelic access.

All three bills received a joint session hearing on July 15th, 2025, but show no indication yet of next steps.

Michigan

House Bill 4686 from state Rep. Mike McFall (D-14) would effectively legalize the possession of psilocybin for Michiganders diagnosed with post-traumatic stress disorder. The bill does not create an affirmative legalization of psilocybin but exempts possession for treatment of PTSD from state law relating to the prohibition of illicit substances.

Mississippi

Mississippi lawmakers will hold an informational hearing about ibogaine on August 28. Reason Foundation research director Geoffrey Lawrence is expected to testify. Bryan Hubbard, CEO of Americans for Ibogaine, is also set to testify.

Oregon

House Bill 3817 (multiple sponsors) would have authorized the Oregon Health Authority to study the use of ibogaine for a range of mental health issues, such as anxiety. It failed to pass before the legislature adjourned.

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Arizona joins Texas in ibogaine clinical trial research push for veteran, first responder mental health https://reason.org/commentary/arizona-joins-texas-in-ibogaine-clinical-trial-research-push-for-veteran-first-responder-mental-health/ Mon, 21 Jul 2025 17:06:41 +0000 https://reason.org/?post_type=commentary&p=83730 Arizona is now the second state seeking to accelerate U.S. Food and Drug Administration clinical trials for ibogaine.

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Arizona recently joined Texas to become the second state in 2025 to appropriate public funds for clinical research trials into the use of ibogaine, a transformative Central West African psychedelic compound, in the treatment of neurological conditions. 

Ibogaine is a psychoactive alkaloid derived from the root of the Tabernanthe iboga plant, which has been used ceremonially for centuries. It has rapidly attracted interest from U.S. policymakers, veterans’ advocates, and addiction specialists for its potentially transformative benefits in alleviating post-traumatic stress disorder (PTSD), depression, traumatic brain injury, opioid use disorder, and a range of other neurological conditions that are impacting lives and burdening public budgets.

Arizona’s Fiscal Year 2026 state budget, signed into law in late June, includes a $5 million grant appropriation to study “ibogaine for the treatment of neurological diseases” at a research facility with “the ability to facilitate pioneering research and innovation in diagnosis and treatment of neurological conditions.”

The appropriation for ibogaine clinical trials may have ended up in the enacted state budget, but it originated as House Bill 2871, introduced in February by state Rep. Justin Wilmeth (R-Phoenix). 

“Every single day, we lose veterans to PTSD and traumatic brain injuries, and the treatment options available now just aren’t good enough,” Wilmeth stated in a March press release. “We have an opportunity here in Arizona to push for a treatment that could truly help those suffering from PTSD and traumatic brain injury.”

Former Arizona U.S. Senator Kyrsten Sinema testified on behalf of the bill as part of a national push to educate state lawmakers about the promise of ibogaine-assisted therapy. 

“Arizona is showing the nation how to solve real problems by putting cutting-edge science first,” Sinema told Reason Foundation. “We have no legal, effective treatments today for traumatic brain injuries and other neurological disorders. Ibogaine has shown incredible results for special forces veterans, and Arizona’s investment in clinical research that starts a path for ibogaine’s FDA [U.S. Food and Drug Administration] approval will save thousands more veterans’ lives—and the lives of Americans living with these diseases.”

Arizona is now the second state seeking to accelerate FDA clinical trials for ibogaine, after Texas Gov. Greg Abbott signed into law a similar $50 million appropriation for ibogaine clinical trials just two weeks before Arizona’s budget approval. Reason Foundation provided testimony in support of a Texas study bill, Senate Bill 2308, finding that ibogaine has shown tremendous promise as an alternative treatment for opioid use disorder and other persistent mental disorders.

The Arizona House modified Wilmeth’s original bill this spring to explicitly reflect that the state’s $5 million appropriation would serve as a match to an equal private sector match to effectuate a $10 million clinical trial, similar to how Texas’ $50 million appropriation is expected to match an equal amount of private contributions. Although Arizona’s match language was ultimately omitted from the final enacted budget, both Arizona and Texas are expected to see public and private philanthropic dollars paired to create major public-private partnerships.

Both Texas and Arizona can now be considered the first two states signing on to what advocates hope will become a larger, coordinated effort to accelerate ibogaine clinical trials and potential U.S. Food and Drug Administration approval. Former Texas Gov. Rick Perry recently launched and serves as board chair of a new advocacy group, Americans for Ibogaine, that will support state and federal efforts to fund and accelerate clinical research—what some have described as a “Manhattan Project” for ibogaine in the United States.

For more information on ibogaine and the emerging interest from state policymakers, see Reason Foundation’s 2024 policy study, Ibogaine Treatment for Opioid Use Disorder.

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Psychedelics Policy Newsletter: FDA prioritizes drug reform for psychedelics, Texas advances ibogaine research, and more https://reason.org/psychedelics-policy/psychedelics-policy-newsletter-fda-prioritizes-drug-reform-for-psychedelics-texas-advances-ibogaine-research-and-more/ Mon, 16 Jun 2025 18:34:05 +0000 https://reason.org/?post_type=psychedelics-policy&p=83028 Plus: New psychedelics-related hire at the Department of Health and Human Services, update on state progress, and more.

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Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

  • The FDA commission’s statement on psychedelics
  • New psychedelics-related hire at HHS
  • Roundup of state policies
  • DEA permit for a church
  • Meet with Reason Foundation staff in Denver

Research reform for psychedelics is a ‘top priority’ for the FDA

In an Interview with Jillian Michaels on NewsNation, Food and Drug Administration (FDA) Commissioner Dr. Marty Makary discussed psychedelics and clinical trial reform. “This is one of our top priorities at the FDA: to listen to doctors, to listen to patients, and to make sure we don’t get in the way with red tape,” noted Makary, referring to doctors who have seen positive results with psychedelics.

New psychedelics-focused hire at the Department of Health and Human Services

Attorney Matthew Zorn has been hired by the U.S. Department of Health and Human Services (HHS) as deputy general counsel and will reportedly be working on psychedelics-related reforms. Zorn has been active in psychedelics policy, including in a court case in 2021 attempting to require the Drug Enforcement Agency (DEA) to permit psilocybin-assisted therapy for a terminally ill patient. Though HHS Secretary Robert F. Kennedy Jr. has been vocal in the past on expanding access to psychedelics, his agency has not announced any major policy reforms. Zorn’s hiring signals that HHS may soon start working on policy changes that could impact psychedelic pharmaceuticals.

Additionally, on June 5, James O’Neill received enough votes in the Senate to be confirmed as deputy secretary of HHS. O’Neill has commented that drugs ought to be approved by the FDA based primarily on the agency’s review of safety data and that evaluations of “efficacy” could be completed after more patients have access to approved drugs.

Church gets DEA greenlight to administer ayahuasca

A Washington-based religious organization, the Church of Gaia, has reportedly been permitted by the Drug Enforcement Agency to administer ayahuasca in a ceremonial setting. Previous petitions have faced agency opposition. Soul Quest, for instance, needed to pursue its petition through lengthy court proceedings before it was ultimately denied by the DEA.

It is unclear if this signals a new approach to approving religious exemptions for the use of psychedelic substances under the Trump administration or whether Gaia approached the approval process differently. According to The Spokesman-Review, a DEA spokesperson said the agency will not disclose details of the petition but confirmed that the Church of Gaia “was among only a few churches that had or were nearing such approval.”

More state policy progress

There were significant wins for psychedelics reform at the state level this spring. The Texas legislature appropriated $50 million for grants to study the medical applications of ibogaine through FDA-supervised clinical trials. Gov. Greg Abbott signed the appropriation, Texas Senate Bill 2308, into law on June 11. Ibogaine has shown tremendous promise as an alternative treatment for opioid use disorder. Reason Foundation provided testimony in support of the study bill.

Next door to Texas, New Mexico became the first state to legalize psychedelic services through a state legislature (instead of a ballot measure). Read more about state-level reform in our state roundup.

Come meet Reason Foundation’s drug policy team

Reason Foundation Vice President of Policy Len Gilroy and Research Director Geoff Lawrence will speak at this week’s Psychedelic Science Conference in Denver, Colorado. Come say hi to the drug policy team at this large gathering of professionals in the psychedelics industry.

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State psychedelics legalization and policy roundup — June 2025 https://reason.org/commentary/state-psychedelics-legalization-and-policy-roundup-june-2025/ Mon, 16 Jun 2025 17:23:31 +0000 https://reason.org/?post_type=commentary&p=83001 While many good psychedelics reforms failed to pass, there were a few notable wins from 2025 state legislative sessions.

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This post is part of an ongoing series summarizing state-based psychedelic reforms intended for policy professionals.

Arizona

Arizona Senate Bill 1555, by state Sen. T.J. Shope (R-16), would have authorized a regulated market for psilocybin-assisted therapy. However, the bill was heavily amended and pared down to legalize a pharmaceutical version of synthetic psilocybin, conditional upon its approval by the Food and Drug Administration (FDA). The bill passed the Arizona Senate but never received a floor vote in the House.

California

California Senate Bill 751, introduced by state Sen. Josh Becker (D-13), would have established a pilot program allowing veterans and first responders to receive psilocybin treatment. California lawmakers have made several attempts to regulate or legalize psychedelics, including a 2023 bill that Gov. Gavin Newsom ultimately vetoed.

This new proposal shifted the focus toward therapy, granting the University of California system authority to train therapists and gather research, aligning with the governor’s call for a more “therapeutic” framework. (Read more about Reason Foundation’s recommendations here.)

The bill died in committee on May 23.

Colorado

Colorado Senate Bill 297 (multiple sponsors) would allow the governor to grant clemency to those convicted of offences related to psychedelic drugs, such as psilocybin, that the state has subsequently legalized through Ballot Measure 122. The bill would also require the state to collect data on public health outcomes, such as hospital discharge data related to psychedelics.

Gov. Jared Polis signed the bill on June 3. Healing centers (organizations that administer psychedelic sessions) are required to send information on sessions by July 1, 2026.

Connecticut

Connecticut House Bill 7065 (introduced through the House Judiciary Committee) would remove jail time for personal possession of up to half an ounce of psilocybin. The first offense would be a $150 fine. The bill has passed the Connecticut House of Representatives and was placed on the Senate calendar for consideration, but there was no further recorded action before the legislature adjourned for the 2025 session.

Florida

Florida House Bill 651 criminalizes the sale and distribution of spores capable of producing psilocybin. While psilocybin is a controlled substance, many states do not have laws explicitly banning the “seeds” of mushrooms that, once cultivated, become potent with psychedelic compounds. In this case, providers may not sell spores and cultivation kits. Florida Gov. Ron DeSantis signed the bill into law on May 15. It will go into effect in July.

Iowa

Iowa House Bill 383, put forth by the Senate Health and Human Services Committee, would legalize a pharmaceutical version of synthetic psilocybin, conditional upon its approval by the FDA. It was sent to Gov. Kim Reynolds for her signature on May 19, but she vetoed the bill.

House Bill 620, sponsored by state Rep. John Wills (R-10), would have authorized a psilocybin facilitated-access program for individuals suffering from a range of mental health conditions. The Iowa House approved it on an 84-6 vote in April, but the bill did not receive a floor vote in the Iowa Senate prior to the legislature’s conclusion.

Illinois

Illinois Senate Bill 2184, from state Sen. Rachel Ventura (D-43), is the companion bill to House Bill 1143, sponsored by state Rep. LaShawn Ford (D-8). It would allow a regulated market for professional psilocybin services. As noted in a previous state roundup, individuals would not need a mental illness diagnosis to gain access. However, it failed to secure full Senate approval before the legislature adjourned.

Hawaii

Hawaii Senate Bill 1042 by state Sen. Chris Lee (D-32) would establish a pilot program to study psychedelic therapies, including those using MDMA and psilocybin. The proposal was transmitted from the Hawaii House to the Senate; the bill received a conference committee hearing on April 25 and has not yet been scheduled for another hearing

Maine

House Bill 1034 (multiple sponsors) would decriminalize the personal possession of psilocybin. The state website says the measure received a “divided” committee vote from the House Committee on Criminal Justice and Public Safety, with members disagreeing about whether it should pass as is, as amended, or not pass at all. On June 4, it was tabled in the House without a plan to discuss when it would be considered.

Massachusetts

House Bill 4050 (previously known as House Docket 1003), from state Rep. Patrick Joseph Kearney (D-4), would authorize a regulated psilocybin market in which individuals could acquire purchase licenses for at-home consumption and gifting would be allowed between license holders. It was referred to the Committee on Revenue on April 22.

Missouri

House Bill 951, from state Rep. Matthew Overcast (R-155), would authorize a medicalized framework to access psilocybin-assisted therapy for patients suffering from certain specified conditions, including terminal illness, major depressive disorder, or post-traumatic stress disorder (PTSD). It did not receive a committee hearing prior to the legislature’s adjournment on May 16.

New Hampshire

House Bill 528 from state Rep. Kevin Verville (R-Rockingham) would reduce penalties for the possession of psilocybin. It has been amended to include severe penalties, including minimum jail time, for individuals who knowingly traffic large amounts of fentanyl. Verville told Marijuana Moment the amendment, which he did not initiate, is a fair compromise if it means the bill can pass. It was laid on the table by the Senate on June 5, pending a committee amendment. There are no reported plans to advance the bill before the legislature adjourns in June.

New Mexico

Senate Bill 219  (multiple sponsors) became the first state legislative measure related to the legalization of psychedelics to receive a governor’s signature and become law. All preceding state legalization measures were enacted by citizen initiative. This bill will allow qualifying patients to be seen by a licensed medical practitioner under a regulated system. Unlike regulations developed in other states, the bill does not specify a minimum number of hours of training that are required to administer psychedelics but instead gives the government broad discretion to determine “necessary initial and ongoing training for producers and clinicians.” The Department of Health is required to implement the program by 2027.

Oregon

Oregon House Bill 2387, from state Rep. Dacia Grayber (D-28), modifies Oregon’s psilocybin laws. One major provision prevents medical license holders from being disciplined by certain medical boards for providing psilocybin services, aligning Oregon with Colorado by allowing both medical and non-medical professional facilitators. Gov. Tina Kotek signed the bill on May 23. The portion of the bill related to clinical facilitators takes effect on January 1, 2026. The bill contains other provisions, such as keeping confidential investigations into abuse by a licensed facilitator center. These provisions took effect immediately on passage.

House Bill 3817 (multiple sponsors) would authorize a medical market offering treatment with ibogaine. Details about how the program would be administered and its timeline are left up to interpretation by the state departments for health and veterans’ affairs. The bill doesn’t specify how the state would acquire ibogaine. Its naturally occurring source, the iboga shrub, does not natively grow in Oregon. It could potentially require an import license from the federal government or the local manufacture of a synthetic version. On April 16, it was referred to the Ways and Means Committee. There is no indication that the bill will progress or be rejected before Oregon adjourns in June.

Senate Bill 907 (multiple sponsors) makes technical changes to disclosure requirements regarding the physical locations of individuals seeking to grow psilocybin. Among the reforms is a requirement that candidate psilocybin manufacturers disclose the address and the owner of the growing facility in their application to the state health authority. The governor signed the bill on May 28. This provision goes into effect January 1, 2026.

Texas

Senate Bill 2308 appropriates the funding for clinical trials into potential pharmaceutical applications of the psychedelic compound ibogaine. The bill authorizes the disbursement of $50 million in grants to recipients capable of conducting FDA-supervised trials. Read Reason Foundation’s testimony in favor of the bill here. Gov. Greg Abbott signed the bill on June 11.

Virginia

Senate Bill 1135, from State Sen. Jennifer Boysko (D-District 33), proposed to authorize a pharmaceutical analog of psilocybin contingent upon approval by the FDA. It was vetoed by Gov. Glenn Youngkin on April 2. The veto letter noted, “This legislation is premature to the appropriate FDA approval and DEA drug scheduling. No other drugs are anachronistically codified by the state before federal approval.”

Summary

As was the case in 2024, most good psychedelics reforms introduced during the 2025 state legislative sessions did not pass.

However, 2025 saw a few notable wins, such as legalizing a regulated market in New Mexico and funding for Ibogaine research in Texas. Perhaps 2026 will be a year with even more impactful legislation.

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Iowa House File 978 would regulate psilocybin access and benefit veterans’ mental health https://reason.org/testimony/iowa-house-file-978-would-regulate-psilocybin-access-and-benefit-veterans-mental-health/ Tue, 29 Apr 2025 10:00:00 +0000 https://reason.org/?post_type=testimony&p=83702 House File 978 would create a regulated program to access psilocybin, which has shown promise in the treatment of neurological and mental health conditions.

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Iowa House File 978 overview

HF978 would create a framework for limited, legal access to therapeutic psilocybin services for approved patients, provided by state-licensed qualified medical providers.

  • The Iowa Department of Health and Human Services (HHS) will develop rules, regulations, and licensure requirements for health providers. HHS will establish a licensing board for psilocybin production establishments, with requirements for licensing, operation, and inspections. The board will begin accepting license applications on July 1, 2026.
  • Only qualified health professionals, licensed and granted a provider registration card by HHS, may recommend psilocybin services to select patients over 21 years of age. Before being recommended treatment, a patient must be evaluated in person by a registered qualified medical psilocybin provider, who must be a physician, surgeon, physician’s assistant, nurse practitioner, or advanced practice registered nurse who has undergone training specific to psilocybin therapy. Administration of psilocybin may take place only in an approved qualified therapy provider location; patients may never take psilocybin products home.
  • HF978 does not legalize or decriminalize psilocybin and would retain current prohibitions on the possession, manufacturing, and sale of other psychedelic compounds.
  • Similar programs have already been established or approved in Colorado, Oregon, New Mexico, and Utah.

Promise of psilocybin-assisted therapy

  • Over the past decade, the medical and mental health communities have increasingly recognized the potential of psychedelic therapies for the treatment of intractable mental health conditions like post-traumatic stress disorder and others.
    • Psychedelics are demonstrating the potential to be more effective treatments than conventional psychoactive medications
    • Legal and logistical barriers to innovation persist even as the range of potential uses for psychedelic substances has expanded.
  • In 2018 and 2019, the U.S. Food and Drug Administration granted a “breakthrough therapy” designation to psilocybin-based treatment for major depressive disorder and severe treatment-resistant depression, and 14 active FDA Phase II or Phase III clinical trials are underway today.
    • Psilocybin has low physiological toxicity, low risk of abuse or addiction, safe psychological reactions, and no linked persistent harmful physiological or psychological effects during or after use, according to years of anecdotal data as well as modern scientific investigations.
  • A 2024 article in the academic journal Brain Sciences reviewed a dozen high-quality studies on the therapeutic effects of psilocybin administration, concluding: “A quantitative analysis of the studies indicates that psilocybin is highly effective in reducing depressive symptoms severity among patients with primary [Major Depressive Disorder] or [Treatment Resistant Depression]. Both single-dose and two-dose psilocybin treatments significantly reduced depressive symptoms severity, with two-dose administration sometimes yielding more pronounced and lasting effects.”

Takeaway

HF978 creates a regulated, limited program to access psilocybin, which has shown tremendous promise in the therapeutic treatment of a range of neurological and mental health conditions, with minimal risk to both public safety and public health.

Full Backgrounder: Iowa House File 978 would regulate psilocybin access and benefit veterans’ mental health

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Ibogaine offers major promise in treating addiction, mental health https://reason.org/backgrounder/ibogaine-offers-major-promise-in-treating-addiction-mental-health/ Thu, 24 Apr 2025 09:59:00 +0000 https://reason.org/?post_type=backgrounder&p=81972 Ibogaine has the potential to transform the lives of millions of Americans struggling with addiction and mental health challenges.

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What is ibogaine? 
  • Ibogaine is a psychoactive compound derived from the root bark of the Central African shrub Tabernanthe iboga, which has long been used in spiritual practices.  
  • A growing body of scientific research is demonstrating the promise of ibogaine as an unconventional, but effective, treatment option for a wide range of mental health and neurological conditions, including opioid use disorder (OUD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, multiple sclerosis (MS), and more. 
  • Despite such wide-ranging potential, ibogaine’s classification as a Schedule I drug makes it difficult to study and presents a major federal roadblock toward expanding rigorous scientific research into innovative treatment approaches that can improve veterans’ lives and transform state spending on addiction and other mental health conditions. 

The promise of ibogaine treatment for mental health, addiction  

  • Research by Stanford University published in Nature Medicine in 2024 found that ibogaine treatment immediately led to significant improvements in PTSD, depression, and anxiety in a cohort of 30 special operations veterans suffering from TBI.  
  • The results were profound. According to Stanford Medicine, “[o]ne month after treatment participants experienced average reductions of 88% in PTSD symptoms, 87% in depression symptoms and 81% in anxiety symptoms,” relative to their condition prior to treatment.  
  • Cognitive testing also revealed improved concentration, information processing, memory, and impulsivity among the veterans participating in the study.  
  • A consistent theme emerges from clinical studies assessing ibogaine for opioid use disorder: ibogaine and ibogaine analogues are the only known treatments that consistently and immediately reduce both physical withdrawal symptoms from opioid addiction and psychological dependence without the need for ongoing medication.
  • In a small-scale study, 75% of patients remained abstinent from opioids for an entire year following treatment. Ibogaine-assisted therapy has the potential to provide lasting anti-addictive effects after only one or two doses, potentially reducing relapse rates and associated mortality risk. This is particularly beneficial given the shortcomings of traditional treatments for OUD, such as methadone and buprenorphine.  

Emerging state interest in ibogaine’s treatment potential 

  • Colorado voters decriminalized ibogaine in 2022, and the state’s Natural Medicine Advisory Board will consider adding ibogaine to its regulated, facilitated psychedelics access program in 2026. 
  • Policymakers in several states—including Texas, Arizona, Ohio, Washington, and West Virginia—introduced legislation in 2025 to allocate state funds (including those drawn from states’ opioid settlement funds) toward clinical research trials that would demonstrate ibogaine’s potential for treating OUD and other mental health conditions.  

Takeaway: Ibogaine has the potential to transform the lives of millions of Americans struggling with addiction and mental health challenges. States can enact sensible legislation that advances research and development while maintaining a strong commitment to public safety and health. 

Read the full backgrounder:

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Ibogaine offers major promise in treating addiction, mental health

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Texas Senate Bill 2308 could advance ibogaine as a treatment for opioid use disorder https://reason.org/testimony/texas-senate-bill-2308-could-advance-ibogaine-as-a-treatment-for-opioid-use-disorder/ Wed, 23 Apr 2025 17:30:00 +0000 https://reason.org/?post_type=testimony&p=82511 Senate Bill 2308 would allow Texas to administer grants to conduct potentially life-saving research into ibogaine.

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A version of the following public comment was submitted to the Texas Senate Committee on Health and Human Services on April 23, 2025.

We believe that studying ibogaine would be beneficial for mental health and addiction care. If ibogaine demonstrates both safety and efficacy, it could facilitate treatment access to millions of Americans suffering from opioid use disorder (OUD) and other mental health conditions. We believe that Senate Bill 2308 provides a sensible regulatory pathway for the advancement of ibogaine as a potential treatment for OUD, co-occurring substance use disorders (SUD), and other relevant neurological or mental health conditions.

Texas can lead the nation in innovative mental health and addiction care solutions with this bill. Senate Bill 2308 prioritizes patient safety and scientific rigor. There are strict requirements for all applicants wishing to conduct trials. To be eligible for the grant, applicants must be private corporation entities with enough capacity and financial resources to conduct FDA trials, seek FDA approval, and conduct future trials. Applicants must also provide detailed plans on trial design, participant recruitment, safety protocols, post-treatment aftercare, and strategy for FDA-approval.

Senate Bill 2308 does not attempt to legalize ibogaine or ibogaine treatment, nor does it try to bypass existing federal regulations. It would retain current prohibitions on possession, use, manufacture, and sale of psychedelic compounds, as well as provide a framework consistent with the FDA drug-approval process, as ibogaine treatment administration will only apply if FDA approval is granted, requiring licensed physicians to supervise its administration in healthcare facilities.

 Over the past decade, the medical community has increasingly recognized the potential of psychedelic therapies for the treatment of mental health conditions and addiction. However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances. Ibogaine appears to have a unique ability to rapidly reduce withdrawal and craving symptoms associated with opioid addiction, often after just a single dose.

The grant program under SB 3208 offers an opportunity to collect comprehensive safety and efficacy data on ibogaine for treating OUD, SUD, and other mental health disorders, while ensuring alignment with existing federal regulations and FDA drug approval standards.

While not necessarily a major point of concern, we’d like to note that Senate Bill 3208 contains slightly different language regarding funding sources than its companion bill, House Bill 3717.  The House Bill allows for funding from both appropriated money and gifts, grants, or donations, while the Senate Bill only allows for funding from gifts, grants, or donations. The House language may provide additional flexibility for the funding of ibogaine studies, potentially allowing for the use of resources such as opioid settlement funds. This broader funding approach could enhance the program’s impact and success.

Overall, SB 3208 would allow Texas to administer grants to conduct potentially life-saving research into ibogaine, which has shown tremendous promise in the therapeutic treatment of OUD, with minimal risk to both public safety and public health. Thank you for your time and consideration.

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California bill would establish a psilocybin pilot program for veterans, first responders https://reason.org/testimony/california-bill-would-establish-a-psilocybin-pilot-program-for-veterans-first-responders/ Mon, 21 Apr 2025 17:05:00 +0000 https://reason.org/?post_type=testimony&p=81977 Senate Bill 751 proposes the creation of a pilot program to investigate the use of psilocybin services for veterans and inactive first responders.

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A version of the following public comment was submitted to the California Senate Health Committee on April 23, 2025.

Senate Bill 751 proposes the creation of a time-limited, geographically restricted pilot program to investigate the use of psilocybin services for veterans and inactive first responders facing post-traumatic stress disorder (PTSD), end-of-life distress, or related conditions. We believe that SB 751 provides a sensible regulatory framework that prioritizes safety, efficacy, and ethical standards and operates within current federal regulations.

Reason Foundation has comprehensively reviewed the available scientific literature on psilocybin and found that it presents a strong safety profile. Specifically, psilocybin is associated with low physiological toxicity, minimal risk of abuse or addiction, generally well-tolerated psychological effects, and no evidence of lasting harmful physiological or psychological outcomes.

As noted in SB 751’s legislative findings section, “every day, an average of 17.6 veterans commit suicide. … First responders, including law enforcement officers and firefighters, are more likely to die by suicide than in the line of duty.” These stark statistics reflect the inadequacy of existing treatment options for trauma-related mental health conditions and underscore the need to explore promising alternatives.

SB 751 ensures compliance with FDA and DEA regulations

SB 751 does not legalize psilocybin but instead creates a narrowly tailored exception to support federally compliant research. The program would operate in up to five California counties under the oversight of the California Health and Human Services Agency and in partnership with the University of California system. Local pilot sites must also partner with community-based providers already serving veterans and first responders, ensuring the program is embedded within existing support networks.

Importantly, Section 2 requires strict safety protocols aligned with the most current Food and Drug Administration (FDA) and Drug Enforcement Administration guidelines for psychedelic clinical trials. University partners would be responsible for designing research protocols, obtaining Institutional Review Board approvals, training facilitators, and collecting clinical data. This structure prioritizes ethical standards, qualified supervision, and scientific integrity.

SB 751 prioritizes transparency, efficacy, and safety

SB 751 ensures transparent partnerships between local pilot programs and participating universities. Sec. 11315(a) states, “[T]he agency shall enter into an agreement with each university partner approved for participation in the pilot program.” The agreement shall specify “the amount of funding available to the local pilot; the conditions under which payments will be made; data collection and sharing requirements; and reporting requirements.”

This bill also includes a clear framework for monitoring, evaluation, and long-term transparency. Sec. 11316(a) requests university partners to submit mid-year annual reports to the California Health and Human Services Agency. By 2029, university partners must also jointly select an independent third-party evaluator to conduct a peer-reviewed statewide study of the program’s efficacy and community impact. By January 15, 2030, the California Health and Human Services Agency is required to compile a comprehensive report to the legislature, including program outcomes, data analysis, and recommendations.

The promise of psychedelic-assisted therapy

Over the past decade, the medical community has increasingly recognized the potential of psychedelic therapies for the treatment of mental health conditions. In controlled clinical settings, psychedelics have exhibited fewer safety concerns than many standard pharmaceutical drugs. Research suggests that psychedelics are non-addictive and carry a low risk of abuse. 

In 2023, Reason Foundation comprehensively reviewed existing FDA clinical trials examining psilocybin for mental health conditions. Our research concluded that psilocybin offers promise for a range of additional disorders, including PTSD, anxiety due to terminal illness, neurodegenerative disease, obsessive-compulsive disorder, and drug dependency, in addition to its potential therapeutic efficacy in treating depression.

However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances.

Conclusion

SB 751 presents a cautious, evidence-based pathway to study whether psilocybin-assisted therapy can offer a meaningful improvement in the treatment of trauma-related mental health conditions. By centering this work within academic and clinical frameworks—and ensuring strong oversight and federal compliance, California can responsibly contribute to the development of potentially life-saving therapies for some of the most vulnerable populations.

Right now, many veterans and first responders are traveling outside the United States—often to countries like Mexico or Peru—to access psychedelic therapies that they credit with saving their lives. Those who have spent their lives defending our freedoms shouldn’t be forced to cross borders to access healing.

If this pilot program proves successful and psilocybin services are effective and safe, California will be well-positioned to expand access to these therapies to other populations struggling with mental health conditions. States like Colorado, Oregon, and New Mexico have already taken steps in this direction, and California could build on these efforts by developing an evidence-based, compassionate model for broader access.

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Psychedelics Policy Newsletter: Reforms for Congress, data for rescheduling, and more https://reason.org/psychedelics-policy/psychedelics-policy-newsletter-reforms-for-congress-data-for-rescheduling-and-more/ Wed, 09 Apr 2025 20:10:51 +0000 https://reason.org/?post_type=psychedelics-policy&p=81763 Plus: State regulation progress and more.

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Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

  • How Congress can promote access to psychedelic medicine
  • New data dashboard and analysis for rescheduling psychedelics
  • The state roundup

Legislative approaches that could improve access to psychedelic-based medicine

Reason Foundation responded to a request for comment from the Congressional Psychedelics Advancing Therapies Caucus. We recommended that Congress should reform the need for psychedelic pharmaceutical companies to prove “efficacy“ before trial participants are able to purchase treatment, expand the use of observational data in drug approvals, and explore how novel psychedelic treatments could make government healthcare more cost-efficient. Read about these recommendations and more here.

Reason Foundation has produced additional commentaries addressing psychedelics reform proposals in Nevada, Arizona, and Washington.

Exploring new data on the safety of psychedelics

The new leaders of Health and Human Services (HHS) may consider rescheduling certain psychedelics currently listed under Schedule I of the Controlled Substances Act in collaboration with other federal agencies. We have compiled an extensive list of public health data related to psychedelics in a new dashboard and written commentary detailing how this data can help the new administration evaluate the safety of psychedelics.

State roundup

Dozens of state legislative proposals related to psychedelics have been filed across America. Proposals include everything from authorizing facilitated access to psilocybin services within a clinical setting to decriminalization of the personal possession of psychedelics. Our state roundup offers an exhaustive list of bills that have been introduced or have made progress in the last two months.

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