“The state is working really hard to operationalize this program as quickly as possible. People are suffering and they want to address that suffering.”

By Leah Romero, Source NM

New Mexico’s Medical Psilocybin Program recently opened up applications for producers of the psychedelic mushroom, marking a significant step toward the therapeutic program becoming fully operational.

“We’re no longer talking about a piece of legislation and some rulemaking. This is real, this is happening and it’s being operationalized right now,” Santa Fe-based psychedelic attorney Victoria Cvitanovic told Source NM.

The program was created last year with the signing of Senate Bill 219, which created the medical psilocybin program, an advisory board and legalized use of the psychedelic in controlled, therapeutic settings. Qualifying conditions currently include major treatment-resistant depression, post traumatic stress disorder, substance use disorders and end-of-life care.

The New Mexico Department of Health Center for Medical Cannabis and Psilocybin began accepting applications last week from potential producers to grow the mushrooms for future program participants.

Cvitanovic told Source that the application is intended to ensure the psilocybin “produced for this program in New Mexico is both safe and medically beneficial for patients, as well as that this doesn’t cause safety issues for people in New Mexico generally.”

According to the permit requirements, applicants must provide a state business license; proof of registration with the New Mexico Secretary of State and the Taxation and Revenue Department; facility safety documents; proof of ownership of the facility or a signed statement from the landowner; proof of compliance with city and county zoning requirements; and verification that psilocybin products will only be produced and tested in New Mexico.

“I think it’s notable that the application balances both the safety of the patients who will be receiving the end product and the safety of people who may live in areas of the state where someone is granted a license to produce psilocybin,” Cvitanovic said. “These applications are open to anyone, but they are fairly extensive because of the high stakes of producing a controlled substance, specifically for very limited medical use.”

She said she believes that most applicants will have an agricultural and entrepreneurial background, but likely only a small number of “highly qualified” applications will meet the requirements.

A DOH spokesperson told Source NM in an email that there is currently no deadline for applications and that they will be reviewed in order of submission.

Cvitanovic said she recommends those considering applying to be a producer confer with a lawyer and accountant and get documentation together to submit the most complete and compliant application as possible. However, they should also consider whether their plans are operational if a permit is granted.

SB219 set a deadline of December 31, 2027 for the psilocybin program to be implemented; however, the state committed to expediting the timeline by a year, aiming to open the program to its first patients by the end of 2026.

“The state is working really hard to operationalize this program as quickly as possible,” Cvitanovic said. “People are suffering and they want to address that suffering.”

She added that the program’s rulemaking process is not complete and more permit applications will open up down the line for testing and for qualified clinicians. A “buildout and inspection period” will also likely follow before treatment begins with patients. She encouraged people interested in participating in the program to speak with their behavioral health providers about becoming certified to facilitate the treatment.

“Programs like this are only as strong as the clinicians and therapists and other people who choose to participate in them. This is hard work, and it is not risk free, but it has the ability to change the lives of thousands of New Mexicans who are suffering,” Cvitanovic said.

This story was first published by Source NM.

Photo courtesy of Alan Rockefeller.

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The U.S. Department of Veterans Affairs (VA) is launching a new clinical trial to investigate whether psilocybin can help military veterans who are struggling with treatment-resistant depression.

The move follows VA’s recent announcement of a separate trial on MDMA-assisted therapy in treating veterans with severe mental health disorders, including PTSD and alcohol use disorder.

The new psilocybin and depression research announced on Wednesday, titled “Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression,” or PIVOT, will also include veterans concurrent PTSD.

The randomized, controlled trial—which comes on the heels of an executive order President Donald Trump signed in April with the aim of expediting psychedelic therapy access—will be conducted at five separate VA medical centers across Alabama, Oregon, Pennsylvania and Washington State.

“Far too many veterans are living with mental health conditions that don’t respond to available treatments,” VA Secretary Doug Collins said in a press release. “Under President Trump, VA is pursuing all avenues to evaluate new treatments and offer meaningful relief for those who have worn the uniform. This clinical trial reflects another step toward this goal.”

The psilocybin study will compare outcomes between two different dosage levels and will assess levels of depression before and after the psychedelic treatment, as well as tolerability of side effects.

The research “reflects VA’s commitment to pursuing innovative solutions for veterans who have not responded to existing treatments,” the department said in a press release.

Collins, the VA secretary, recently touted psychedelic therapy development at an event in Florida, saying that “we’re making massive progress in how we diagnose things, but also how we do new treatments, which in the past was more of a wait-and-see approach, and now we’re being more cutting-edge.”

Last month, VA and the Department of Health and Human Services (HHS) launchd a new partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.

HHS Secretary Robert F. Kennedy Jr. said recently that the Trump administration is “very anxious” to create a pathway for access to psychedelics therapy and that top officials across federal agencies want to “get it out to the public as quickly as possible.”

In an interview on the Joe Rogan Experience in February, Kennedy said he’s confident “we’re going to get it done,” with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a “very controlled setting.”

“Everybody in my agency…is very anxious to get a rule out there that will allow these kind of studies and will allow access under therapeutic settings, particularly [for] the military soldiers who have suffered these injuries to get access to these products,” the HHS secretary said. “We’re working through that process now. We’re all working on it and trying to make it happen.”

“I think that we’re going to get it done,” he said.

Last June, Kennedy said his agency is “absolutely committed” to expanding research on the benefits of psychedelic therapy and, alongside of the head of FDA, is aiming to provide legal access to such substances for military veterans “within 12 months.”

Collins disclosed last year that he had an “eye-opening” talk with Kennedy about the therapeutic potential of psychedelic medicine. And he said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for access.

Photo courtesy of Mark Groeneveld.

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Another Hawaii House committee has approved a Senate-passed bill that would create a psychedelics task force responsible for studying and making policy recommendations on providing access to breakthrough therapies such as psilocybin and MDMA.

The House Finance Committee advanced the legislation from Sen. Chris Lee (D)  in a 15-0 vote on Tuesday. The measure, which had cleared the Senate in a unanimous vote of 24-0 last month, next heads to the House floor before potentially going back to the Senate for that chamber to consider recent amendments.

The bill would create a Mental Health Emerging Therapies Task Force that would be tasked with spending two years reviewing the current scientific literature, supporting additional clinical research and “developing policy recommendations for safe, ethical, and culturally-informed implementation” of a psychedelics therapy program.

“The legislature finds that addressing the mental health crisis affecting the residents of the State, particularly among veterans, first responders, and trauma survivors, is urgent,” the bill, SB 3199, states. “Suicide continues to be a leading cause of preventable death, and the State must explore all safe and effective treatment options supported by scientific evidence.”

Noting that the federal Food and Drug Administration (FDA) has already designated psilocybin and MDMA as breakthrough therapies in the treatment of serious mental health conditions, which could lend to future rescheduling under the Controlled Substances Act (CSA), the Hawaii legislation says the state “must proactively prepare public health, clinical, and research systems for safe and equitable implementation.”

The state Department of Health said in testimony to the House committee that it supports the bill, noting that in light of FDA’s action on psychedelics, “it is prudent for Hawaii to evaluate research readiness, regulatory implications, workforce development, and culturally informed implementation pathways” in advance of any federal rescheduling of the substances.

The governor’s Office of Wellness and Resilience said the bill “resents an important opportunity to begin to prepare a planful pathway for individuals in need of access to potentially life-saving treatments for trauma and other longstanding mental health challenges.”

“A growing body of research demonstrates that breakthrough therapies (such as MDMA and psilocybin-assisted therapies) show significant efficacy and positive clinical outcomes in treating post-traumatic stress disorder, substance use disorders, end-of-life anxiety in terminally ill patients, eating disorders, treatment-resistant depression, and additional conditions,” it said.

Members of the task force would have to include representatives of the state Department of Health (DOH), the attorney general’s office, the Office of Wellness and Resilience (OWR), the University of Hawaii’s medical school and more.

As drafted, DOH would have overseen the task force, an amendment adopted last month by the House Health Committee makes the John A. Burns School of Medicine (JABSOM) at the University of Hawaii the responsible entity, and designates JABSOM’s appointee as chair of the panel.

The committee additionally adopted amendments suggested by Department of Law Enforcement, to state that its Narcotics Enforcement Division—and not the Board of Pharmacy—would be responsible for changing state scheduling of psychedelics following any federal reclassification, and changing deadline for such action from 90 days to 30 days.

Members also moved to note in the bill report that the State Health Planning & Development Agency has expressed concerns that psychedelics are illegal under federal law and that task force should proceed cautiously.

Finally, the panel made technical amendments for clarity, consistency and style.

If enacted, it appears the bill would build upon prior work conducted by a separate psychedelics task force that convened for the first time in 2023, with a similar goal of exploring pathways for therapeutic access into FDA-approved breakthrough drugs like psilocybin.

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Meanwhile, although Hawaii senators recently approved a bill to legalize low-dose and low-potency marijuana, the legislation didn’t advance through required steps before a key deadline, and so is dead for the year.

A separate marijuana legalization bill that contained provisions making the reform contingent on changes to federal law or the state Constitution, SB 2421, was deferred for action. Both Senate and House panels additionally deferred action on a measure to allow for the sale of certain hemp-derived cannabinoid products.

Those actions comes after key House lawmakers signaled that cannabis legalization proposals would not be advancing in the 2026 session, citing a lack of sufficient support in their chamber.

Earlier this month, a Hawaii Senate committee separately passed legislation to allow patients to immediately access medical cannabis once their registrations are submitted, instead of having to wait until their cards are delivered as is the case under current law.

A Senate committee also approved resolutions calling on Congress to federally legalize marijuana, support state efforts to clear people’s conviction records and take steps to facilitate access to banking services for companies in the cannabis industry.

Another Senate panel advanced separate resolutions  calling on the state attorney general and health department to request an exemption from the Drug Enforcement Administration (DEA) stipulating that Hawaii is permitted to run its medical cannabis program without federal interference.

Photo courtesy of Wikimedia/Mushroom Observer.

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