• 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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• 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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• 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.

The post Psychedelics Policy Newsletter: FDA prioritizes drug reform for psychedelics, Texas advances ibogaine research, and more appeared first on Reason Foundation.

• 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.

The post Psychedelics Policy Newsletter: Reforms for Congress, data for rescheduling, and more appeared first on Reason Foundation.

• A policy brief discussing how psychedelic therapy could hold promise for the treatment of neurodegenerative diseases like Alzheimer’s
• A roundup of several states introducing psychedelic bills
• A Republican leader is optimistic about Trump nominee RFK Jr. on psychedelics
• Colorado opens for business
• Commentaries on clinical trial designs for psychedelics and DMT research quotas

Policy brief on psychedelics and neurodegenerative treatments

Reason Foundation has published a policy brief on the use of psychedelics to treat neurodegenerative diseases. Research shows psychedelic substances decrease brain inflammation and increase neuroplasticity, which can allay the onset of these diseases.

Former Texas Gov. Rick Perry praises Trump HHS pick Robert F. Kennedy Jr.

Former Texas Gov. Rick Perry says that President Donald Trump’s nominee to lead the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., is a “gift” for psychedelics reform. Perry appeared on the Joe Rogan podcast with Bryan Hubbard, who advocates for the use of the psychedelic substance ibogaine to treat mental illness and opioid addiction.

States introduce psychedelics bills

A slew of bills have been introduced into state legislatures, from New York to Missouri, aiming to improve access to psychedelics. Multiple competing bills have been introduced in some states, such as Massachusetts. Read more details in Reason Foundation’s state roundup.

Colorado opens license application window

Colorado has begun accepting applications for the first set of licenses within its regulated psychedelic market. Ballot Proposition 122, passed in 2022, tasked state agencies with creating licenses for training schools, service centers, and manufacturers of psilocybin. A commercial market for regulated psilocybin services should become operational later this year.

Psychedelics need alternatives to ‘double-blind’ clinical trials

Reason Foundation analyst Madison Carlino offers commentary on why clinical trials with psychedelics should be able to use alternatives to “double-blind” placebo-controlled methods.

DEA increases 2025 DMT production quotas

In this commentary, Reason Foundation analyst Madison Carlino praises the Drug Enforcement Agency’s increased 2025 production quota for DMT so that more research can be performed with the substance.

The post Psychedelics Policy Newsletter: States propose legalization, optimism for Trump administration nominee, and more appeared first on Reason Foundation.

• Reason’s policy recommendations for the new Trump administration
• The state roundup
• Government funding for addiction study
• Department of Veterans Affairs to fund MDMA research

How the Trump administration can advance psychedelic policy

Senior members of President-elect Donald Trump’s transition team, including Robert F. Kennedy Jr., have promised bold reforms for the Food and Drug Administration (FDA) and have been supportive of psychedelic therapy. Reason Foundation provided the incoming administration with a list of several reforms that could be accomplished through executive order, such as changes to the way clinical trials are administered for psychedelic substances seeking drug approval. Read more about them here.

Massachusetts ballot measure fails and other state reforms

A ballot measure to legalize psychedelics failed to pass in Massachusetts. Despite the setback, other states are still pushing forward, from a regulated market for psilocybin in New Jersey to potential scientific research funding in Missouri. Read more in the state round-up here.

Government funding for addiction research

The National Institute on Drug Abuse (NIDA) has awarded Carey Turnbull’s nonprofit B.More and New York University psychedelics researcher Michael Bogenschutz a $15 million grant to study the effectiveness of psilocybin in treating Opioid Use Disorder. The funds will support a clinical trial that could lead toward FDA approval of psilocybin for this indication.

Veteran’s administration pursues psychedelics

Politico reports that the FDA’s recent rejection of MDMA psychedelic-assisted therapy has not deterred the federal Department of Veterans Affairs (VA). The VA plans to fund more studies on MDMA in the hopes that MDMA can be a safe and effective treatment for post-traumatic stress disorder.

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• State Action Needed in the Wake of FDA’s Rejection of MDMA
• Voter Guide on Massachusetts Ballot
• Costly Proposed Colorado Regulations
• State Roundup
• Profile of Ibogaine Advocate Bryan Hubbard
• DEA Head Worries About Off-Label Use of Ketamine
• Feds Fund Research of Psychedelics to Fight Addiction

Op-Ed in The Hill: Advocating for state-led psychedelic therapy initiatives

Following the Food and Drug Administration’s (FDA) recent rejection of a new drug application for MDMA to be used as post-traumatic stress disorder (PTSD) treatment, Reason Foundation argues in The Hill for states to take the lead in creating commercial access to psychedelics services. Oregon and Colorado have already treated more patients with botanical psychedelics than all U.S. clinical trials combined, and states have the authority to legalize synthetic substances such as MDMA.

Voter guide

Reason Foundation has released its election 2024 voter guide. Read more about our analysis of the Massachusetts psychedelics ballot initiative, Question 4, here.

Colorado’s proposed fees for psychedelic centers would hinder business, increase costs

The Colorado Department of Revenue, which oversees much of the regulation for the state’s upcoming psilocybin services market, has proposed fees for professional licenses. Reason Foundation submitted comments arguing that the thousands of dollars in initial and renewal application fees would hinder small businesses and increase costs for working-class patients.

State roundup

A ballot initiative campaign to legalize psychedelics in Massachusetts has been racking up local endorsements, such as state Sen. Jamie Eldridge (D-Marlborough) and state Rep. Lindsay Sabadosa (D-Northampton). Read more about state-level activity in our round-up here.

Profile of ibogaine advocate Bryan Hubbard

Reason magazine published an in-depth profile of Bryan Hubbard, who is advocating to medicalize the psychedelic ibogaine as a treatment for opioid addiction. Hubbard rose to prominence as the chair and executive director of the Kentucky Opioid Abatement Advisory Commission. Since leaving the commission, he has explored new avenues to state-supported clinical research around the United States.

Reason Foundation recently published an in-depth review of the existing research showing ibogaine offers a more promising treatment for opioid addiction than all existing therapies.

DEA administrator compares ketamine to opioids

In an interview with Face the Nation, Drug Enforcement Administration Administrator Anne Milgram sharply criticized the off-label use of ketamine, drawing parallels to the early stages of the opioid epidemic. Actor Matthew Perry’s death while on ketamine has become a reason for some officials to push for aggressive new regulations and enforced limits on the prescription anesthetic, which can produce psychedelic effects at lower doses. Studies show ketamine can be highly effective as a treatment for depression when administered for this off-label purpose. 

Feds fund psychedelics study

The National Institute on Drug Abuse awarded a $2.4M grant to study how psychedelics could treat addiction to methamphetamine. Recipients include Louisiana State University Health Shreveport, the Medical College of Wisconsin, and the University of California San Diego’s Center for Psychedelic Research.

The post Psychedelics Policy Newsletter: MDMA rejection, advocating for lower state fees in Colorado, and more appeared first on Reason Foundation.

• A field report on the impacts of natural medicine legalization on Colorado
• A presentation at a gathering of conservative legislators
• Commentary on FDA approval of MDMA
• The psychedelic origins of Whole Foods
• Round-up of state-based policies
• A Canadian study of patients

A look at how psychedelic legalization has played out in Colorado

Reason Foundation recently published a glimpse into Colorado’s legal psychedelics scene. The field report assesses the public health impacts of legalizing possession of botanical psychedelics over a year since Proposition 122 was implemented, looks at crime statistics and hospitalization rates, and explores this data with on-the-ground reporting from a variety of psychedelic experiences in Denver. You can the report here.

Reason at ALEC

Reason Foundation hosted a panel discussion of state-level psychedelic reforms at the American Legislative Exchange Council (ALEC) annual meeting, a large gathering of free-market policymakers who debate issues and form model legislative templates for use in states around America.

Reason Foundation Vice President of Government Reform Leonard Gilroy moderated the psychedelics panel, joined by Heroic Hearts Founder Jesse Gould, Utah State Sen. Kirk Cullimore (R-Sandy), Arizona State Senate President Pro Tempore T.J. Shope (R-Pinal County).

After Gould gave background information about the personal experiences of veterans seeking treatment abroad, the lawmakers on the panel spoke about their experiences sponsoring legislation to legalize psychedelic therapies to a full room of attendees.

Arizona’s Shope spoke about his experience passing a bill to legalize professional psilocybin services. The bill was ultimately vetoed by the governor. He took to X (formerly Twitter) after the panel, saying, “I look forward to bringing the bill back to the Legislature next year.”

The FDA can still legalize MDMA

Earlier this month, an advisory panel to the Food and Drug Administration (FDA) recommended that the agency reject Lykos Therapeutic’s new drug application for an MDMA-based treatment, citing many scientific challenges for the research design.

“It’s hard to have a double-blind, placebo-controlled trial” for a psychedelic substance, acknowledged Lykos Board member Rick Doblin on stage at the Aspen Ideas Festival last June.

Reason Foundation penned a commentary highlighting an existing pathway through which the FDA can still safely approve MDMA for the treatment of Post Traumatic Stress Disorder.

It’s worth noting that shortly after the advisory committee opposed approval, a Dutch Agency recommended that MDMA be approved in the Netherlands.

An FDA decision is expected by Aug. 11.

Whole Foods’ psychedelic origins

Whole Foods co-founder John Mackey published a new book, The Whole Story, which relays the history of the iconic grocery store, including how he drew inspiration through his experiences with psychedelics. Reason Editor at Large Nick Gillespie interviewed Mackey in June, discussing his psychedelic inspiration and political philosophy.

Around the 34:30 mark of the video, Mackey describes how LSD inspired him to seek spirituality and, ultimately, set him on an unorthodox path to creating a healthy grocery store.

State roundup

A ballot initiative to legalize botanical psychedelics has qualified for the upcoming election in Massachusetts. If the ballot initiative in Massachusetts passes, the state would undergo a regulatory process similar to what Colorado has seen.

Reason Foundation experts submitted written comments to the Colorado agencies (Colorado’s Department of Revenue and Department of Regulatory Agencies), which have just concluded public hearings before rendering final rules for a regulated psychedelics market. 

More details about state activity are available in the latest state roundup.

Canada psilocybin study

Canada offers a legal pathway for patients to access psilocybin through a special compassionate use program under medical supervision. A new study in Nature finds that patient experiences have been positive so far.

“These preliminary data are amongst the first to suggest that psilocybin-assisted psychotherapy can produce psychiatric benefits in real-world patients akin to those observed in clinical trials,” the authors conclude.

The post Psychedelics Policy Newsletter: A glimpse into Colorado after psychedelics legalization, a gathering of conservative legislators, and more appeared first on Reason Foundation.

• Massachusetts ballot measure worthy of support
• California proposes heavy psychedelic therapy regulation
• State-level psychedelic legislation stalls
• Michigan poll shows support for psychedelic access
• Colorado’s social media censorship bill would target legalized drugs
• NIH funds ibogaine-like compound

Massachusetts initiative would promote safe access

Reason Foundation has published a new opinion piece in favor of a Massachusetts ballot initiative that would legalize personal possession of botanical psychedelics and set up a regulated marketplace for guided psychedelic-assisted therapy sessions. This marketplace would be similar to what is currently happening in Colorado after that state’s passage of Proposition 122. The initiative is likely to be up for a vote this fall.

California legalization bill fails

A Reason Foundation opinion piece syndicated in Southern California newspapers, including the Orange County Register, argued that a California bill, SB 1012, to legalize psychedelic therapy had included too much heavy-handed regulation. For instance, the bill would have required providers to have healthcare licenses to oversee clients. The bill ultimately failed.

Although the bill represented a positive incremental step toward legalization, its proposed regulations, such as requiring a medical license, would have increased costs to consumers and therefore encouraged an illicit market to continue to thrive. The sponsor, State Sen. Scott Wiener (D-San Francisco), has pledged to continue pursuing legalization, and his fellow lawmakers should address these concerns.

Other state legislation stalls

Several states were considering bills to legalize psychedelic medicine earlier this year. However, nearly all of those efforts have either failed or been severely cut back into commissions to report on the possibility of future reform.

Bills in Wisconsin, Rhode Island, and California failed. Maine’s legalization attempt was downgraded to a study and joins Alaska and Vermont in the group of advisory-only reforms. So far, the best outcome is that legislators nationwide seem willing to investigate potential future legalization within their respective states. 

Michigan poll shows majority support for access to psychedelics

As Michigan lawmakers are considering legalization, Reason Foundation conducted an opinion poll to gauge constituent interest. We found that a comfortable majority (65%) support medical access and a slim majority (55%) support retail access to psychedelic products.

Colorado considers bill restricting speech and advertising related to drugs

Reason Foundation published an opinion piece warning against a Colorado bill that would have required social media companies to police content and censor any accounts promoting the use of drugs that are fully legal under state law and provided for other heavy-handed mandates on private industry. The bill narrowly failed and is likely up for a renewed push in the next legislative session.

NIH awards $14 million in grant money for addiction research

The National Institute of Health (NIH) has awarded $14 million to Gilgamesh, a pharmaceutical company developing a compound similar to the psychedelic ibogaine, which can be used to treat opioid addiction. NIH has also opened a grant application to study psychedelic treatment for chronic pain in older adults.

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• A new medical psychedelics model similar to the retail system of medical cannabis
• In-depth look at Ohio’s attempt at ibogaine research
• The state roundup
• LSD drug formulation gets breakthrough status by FDA

Model for direct-to-consumer medical psychedelics

As more states consider legalization, Reason Foundation fellow Greg Ferenstein has outlined a new model of psychedelic legalization that licenses individuals to purchase psychedelic medicines directly rather than licensing professional facilitators who dispense these medicines to patients only for consumption in a supervised facility. This alternative offers policymakers a model that would reduce costs and increase consumer access to psychedelics by reducing the overall regulatory burden.

New Hampshire Rep. Kevin Verville (R-Rockingham County) introduced House Bill 1693, which is based on Reason’s model and would mimic the state’s existing medical cannabis system to set up dispensaries for psilocybin, LSD, and mescaline. The New Hampshire bill “aims to responsibly legalize personal possession of psychedelics. It offers the legalization of both synthetic and botanical psychedelics, flexible qualifying conditions, and legal protections for license holders, providing a unique framework for psychedelic therapy that is cost-effective and accessible.” The paper “A policy framework for personal psychedelics licenses” is here.

Ohio explores ibogaine as a tool to fight opioid addiction

After championing a Kentucky effort to launch clinical trials of ibogaine through a public-private partnership, Bryan Hubbard was dismissed as chair of the Kentucky Opioid Abatement Advisory Commission. Subsequently, Hubbard launched a new ibogaine study project in Ohio with a nonprofit called the REID Foundation, which explores mental health issues through arts and emerging therapies.

Relatedly, Reason Foundation’s Madison Carlino’s new report looks at the safety and efficacy of ibogaine to treat opioid addiction and why policymakers should enable more ibogaine as a potential alternative treatment.

State roundup

There’s been a flurry of bills in multiple states, including Arizona, New Jersey, and California, that would authorize regulated access to professionally facilitated psychedelic experiences and decriminalization. In terms of becoming law, some bills, like New Jersey’s, have the blessing of key political leadership, such as New Jersey state Senate President Nicholas Scutari (D-Union County).

In Massachusetts, a ballot initiative that would decriminalize home cultivation of psychedelic plants and create a regulated framework for professional services is moving forward.

In-depth updates on these and other developments are available in our most recent state roundup of psychedelics policy.

LSD drug formulation given ‘breakthrough’ designation by FDA

MindMed recently received a rare “breakthrough” designation on a unique formulation of LSD for generalized anxiety disorder from the Food and Drug Administration (FDA). This breakthrough status grants manufacturers an accelerated pathway through the approval process. MindMed will now see an accelerated development timeline and perhaps a more favorable probability of approval should phase III trials eventually confirm their compound’s efficacy.

The FDA also granted breakthrough status to drug sponsor Cybin for a modified version of psilocybin for major depressive disorder (two other sponsors, Usona and Compass, have also gotten breakthrough status for a psilocybin formulation).

There is also an effort in the U.S. Senate to automatically reduce penalties and barriers to scientific research for any treatment that receives breakthrough status. If such a bill passes, LSD, along with psilocybin and MDMA, would be covered under the bill.

The post Psychedelics Policy Newsletter: A retail system model, ibogaine research, and legalization updates appeared first on Reason Foundation.

• A new ibogaine study shows the drug’s potential health uses
• Medical psychedelics bill introduced in New Hampshire
• Defense bill includes funding for Republican-led measure for psychedelic studies

A new ibogaine study shows its promise as a treatment

A recent scientific study of ibogaine could address key concerns regarding psychedelics’ safety and encourage new investment into its development as an approved treatment in the United States. Stanford University’s Nolan Williams and his team found that ibogaine dramatically reduced post-traumatic stress disorder and symptoms of traumatic brain injury in veterans. The treatments were administered at a private clinic in Mexico with no serious adverse events. 

Now that there are at least two federal government agencies–the United States Departments of Defense and Veterans Affairs–committed to psychedelics research, this study provides more motivation to allocate dollars to clinical trials if the agencies conclude that ibogaine offers a more cost-effective course of treatment for various conditions afflicting veterans than what currently exists. Ultimately, this research could lead to acceptance by the U.S. Food and Drug Administration of ibogaine as a treatment for brain injury or other mental health conditions. 

This new research should also serve as valuable information for states, such as California, that are considering bills related to the legalization of a range of botanical psychedelics. More information about this study and its implications can be found in this Reason Foundation analysis. 

Medical psychedelics law introduced in New Hampshire

New Hampshire Rep. Kevin Verville (R-Rockingham County) introduced legislation that would establish a medical license framework for psychedelics. The bill would allow eligible residents to legally possess small amounts of LSD, mescaline, or psilocybin after they have demonstrated competency in psychedelic treatment through a medically supervised administration.

New Hampshire’s approach would combine the traditional infrastructure of a medical cannabis card with additional safeguards that require education and regular mental health check-ins. Read our commentary on the bill here. 

State roundup: Jan. 2024

Our regular roundup of state-based psychedelic policy news includes several notable developments, including New Hampshire’s proposed medical psychedelics bill and a proposed pilot program in New York.

The chair of Kentucky’s Opioid Abatement Advisory Commission, Bryan Hubbard, resigned from his post after the state’s newly elected attorney general announced Hubbard would be replaced by Chis Evans, a former administrator at the Drug Enforcement Agency, which is known for its conservative approach to psychedelics. 

Hubbard had championed allocating $42 million toward Food and Drug Administration-supervised clinical trials examining the effectiveness of psychedelic ibogaine as a treatment for opioid addiction. This funding would’ve come from about 5% of the settlement funds received by Kentucky in a lawsuit against manufacturers of prescription opioids in which the state alleged manufacturers had engaged in deceptive marketing practices. Settlement funds are restricted for programs to mitigate the impact of opioid addiction.

For more state news, including a detailed look at considerations from Colorado’s committee that makes recommendations on the state’s upcoming market for professional psychedelic services, please visit our roundup.

Defense bill includes funding for Republican-led measure for psychedelic studies

As part of the $886 billion annual defense spending bill, Congress allocated $10 million in funding toward clinical trials of psychedelics (MDMA, psilocybin, ibogaine, and 5-meo-DMT). An amendment to the National Defense Authorization Act requires the Department of Defense to figure out how service members can participate in the trials, including those to treat post-traumatic stress disorder.

The Texas Tribune reported the idea originated as a bill from Rep. Dan Crenshaw (R-Humble) and was adapted into an amendment by Rep. Morgan Luttrell (R-Houston), both military veterans who have championed psychedelic research aimed at treating active duty service members and veterans.

This month, the Department of Veterans Affairs issued a public call for research grants to study psychedelic therapy. “This is the first time since the 1960s that VA is funding research on such compounds,” reads the announcement.

“This is an important step to explore the efficacy of a potential new set of promising treatments that could improve the health and quality of life for veterans,” said Secretary of Veterans Affairs Denis McDonough in the new release.

Contact Reason Foundation’s experts

Reason Foundation’s experts provide technical assistance for those wishing to pursue psychedelics reform in their states, counties, and cities. Feel free to contact our experts at psychedelics@reason.org.
If you’ve been forwarded this email, you can subscribe here.

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• California’s path forward on psychedelic decriminalization 
• Psychedelics policy roundup from Colorado, Kentucky, and Massachusetts
• Diverse coalition releases Drug Policy Handbook
• Kentucky ibogaine proposal offers an innovative approach to the opioid crisis
• News notes

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California’s Next Steps After Psychedelic Decriminalization Bill Vetoed 

California’s legislature recently became the first in the nation to pass a bill legalizing the personal possession of some botanical psychedelics. Senate Bill 58 would have allowed limited possession of psilocybin, mescaline, and dimethyltryptamine (DMT) but was vetoed by California Gov. Gavin Newsom last month. 

The governor’s veto letter calls on the legislature to send him another bill next year that prioritizes a regulated therapeutic market before the state allows decriminalization. Meanwhile, in response to Gov. Newsom’s veto, a California-based psychedelic church, Ambrosia, started a drive for a ballot proposition that would create a regulated market for a wide variety of psychedelics. You can read the proposition language here. Separately, Treatment, Research, Education, Access, and Therapies (TREAT) California has withdrawn its proposed ballot initiative that attempted to establish an agency to oversee billions in scientific research earmarked for psychedelics. 

To help outline a set of options for the state legislature and other interested stakeholders as they consider the next steps, Reason Foundation recently published a list of promising policy approaches that would create safe, legal access to psychedelics in California. 

November 2023 State Psychedelics Policy Roundup

Reason Foundation’s Psychedelics Policy Project just launched the first in a series of regular reviews of critical state-level activity on psychedelics policy and regulatory action, intended for policy experts who are closely tracking this emerging policy issue. The series will review various activities, including psychedelics policy proposals, public agency and legislative committee hearings, analysis of state legislation, and more. 

The first edition reviews Colorado’s implementation of Proposition 122 and its regulatory rulemaking process, the Kentucky Opioid Abatement Commission’s latest hearings on ibogaine, and a proposed psychedelics ballot measure in Massachusetts.

Diverse Coalition Releases Drug Policy Legalization Handbook

The Law Enforcement Action Partnership, Students for Sensible Drug Policy, the National Coalition for Drug Legalization, the National Survivors Union, and Reason Foundation recently published a new handbook on drug legalization to help guide future drug policy reforms. The handbook, which also features scholars from Harvard University and the Cato Institute, outlines a regulatory pathway for the legalization of all drugs, including psychedelics. Lead author Geoffrey Lawrence points out that a “legal and regulated market for drugs—even hard drugs—could better address the underlying concerns of every relevant party in the drug debate” than prohibition, including concerns about overdose, addiction, and youth access.

Kentucky Ibogaine Proposal Offers Innovative Approach to Opioid Crisis

The Kentucky Opioid Abatement Advisory Commission proposed allocating a small slice of opioid settlement funds toward medical research to evaluate further the effectiveness of ibogaine in treating opioid addiction. The money comes from a legal settlement with pharmaceutical companies convicted of deceptive marketing practices intended to conceal prescription opioids’ addictive potential and would likely be matched by private investors. A new Reason Foundation commentary highlights research on the compound ibogaine showing promise as an opioid addiction treatment and how Kentucky could lead the nation in exploring a promising new solution. 

News Notes

California Congressman Proposes Legislation To Protect State Jurisdiction

U.S. Rep. Robert Garcia (D-CA) introduced the Validating Independence on State Initiatives on Organic Natural Substances (VISIONS) Act to protect states’ constitutional jurisdiction to implement psilocybin laws. It simply says that federal funds cannot be used to contravene states like Colorado or Oregon, which have enacted laws to legalize some psychedelics in limited circumstances. The bill is similar to the Rohrabacher–Farr amendment, a federal budget rider that prohibits the Justice Department from using federal funds to prosecute individuals following state medical cannabis laws. The bill likely has a low probability of passage, given the current political composition of the U.S. House. 

Canadian Senate Committee Report Recommends Researching Psychedelic Therapy for Veterans

The Canadian Senate’s Subcommittee on Veterans Affairs issued a report last week urging federal, provincial, and territorial governments to initiate a large-scale research program on psychedelic-assisted therapy as a means to tackle high rates of post-traumatic stress disorder (PTSD) and suicide among veterans. The subcommittee stopped short of recommending a policy framework for legal, regulated access to psychedelic-assisted therapy, instead suggesting a robust research program to explore the effectiveness of different therapy modalities in improving mental health outcomes among veterans.

Contact Reason Foundation Experts

Reason Foundation’s experts provide technical assistance for those wishing to pursue psychedelics reform in their states, counties, and cities. Feel free to contact our experts at psychedelics@reason.org.

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