As more states and localities, as well as Congress, see momentum around psychedelics reform, the poll released on February 24 shows that adults in the United States are currently feeling relatively tepid about the prospect of expanding access to hallucinogenic substances. However, there’s reason to believe that could change dramatically in the years to come, if cannabis-related polling is any indication.

For now, just 23 percent of respondents said that psilocybin mushrooms should be legal, and even fewer (around 10 percent) expressed support for legalizing LSD or MDMA. By contrast, RAND’s data reaffirm that there’s strong majority support (65 percent) for the legalization of marijuana.

“Support for the legal use of psilocybin mushrooms is similar to what it was for cannabis in the mid-1990s—just before state medical cannabis laws started to be implemented.”

Of course, it’s relatively early in the push for psychedelics reform. And a look at the public opinion trajectory for cannabis may offer a window into what’s to come.

“Support for the legal use of psilocybin mushrooms is similar to what it was for cannabis in the mid-1990s—just before state medical cannabis laws started to be implemented,” the poll found, with authors adding that it’s “unclear whether psilocybin will follow a similar trajectory in terms of public opinion or policy changes.”

The think tank said there are “some reasons” that could explain the trend. For example, one could better understand the current sentiment toward psychedelics in the context of how opinions shifted around marriage equality.

“From 1995 to 2016, public support for legalizing marijuana rose in tandem with support for same-sex marriage,” it said. “This suggests that both shifts may have been driven by broader, time-specific increases in socially liberal attitudes rather than by issue-specific factors. If that period reflected a unique generational or cultural moment, the same underlying forces might not be present in the near term.”

Support for legalizing psilocybin was high (62 percent) among those who’ve used the psychedelic. Similarly, 80 percent of adults who’ve used marijuana are in favor of the plant’s legalization.

“When respondents were asked about reasons for allowing legal use, addressing a mental or physical health condition is the most endorsed reason.”

Only 42 percent of those who support the legal use of psilocybin say that adults should be able to use it for any reason, while 56 percent say it should be allowed for medical purposes. Overall, just over 10 percent of respondents said psilocybin should be allowed for any use; for LSD and MDMA, that drops to under 10 percent, and support for the medical use of the three psychedelics is all under 30 percent among the general public.

“When respondents were asked about reasons for allowing legal use, addressing a mental or physical health condition is the most endorsed reason for psilocybin, LSD, and MDMA,” the survey found. “When respondents were asked where adults should get psilocybin mushrooms if they were legal, using them at a medical facility under supervision is the most endorsed option (49 percent). About 28 percent endorse getting psilocybin mushrooms from a dispensary, and 23 percent endorse allowing adults to grow or forage for personal use.”

“Among the three psychedelic substances that our policy questions focused on (psilocybin mushrooms, LSD, and MDMA), psilocybin mushrooms had the most support among US adults when asked a simple question about its legality and when asked more-detailed questions about reasons for use and potential sources of supply,” RAND said. “These findings may not be surprising considering that psilocybin mushrooms are the most-used psychedelic substance among US adults.”

“Among the three psychedelic substances that our policy questions focused on, psilocybin mushrooms are also the most commonly included psychedelic substances in state and local policy initiatives in the United States,” it said.

The survey, conducted by the National Opinion Research Center (NORC) at the University of Chicago, involved interviews with 10,122 US adults from September 9 to October 1, 2025. The margin of error was +/-1.33 percentage points.

RAND researchers separately released data in January showing that nearly 10 million US adults microdosed psychedelic substances in 2025.

“To the best of our knowledge, the 2025 RPS is the first probability-based and nationally representative survey to examine policy preferences for individual psychedelic substances rather than asking about the entire class of psychedelics,” RAND said.

Meanwhile, RAND researchers separately released data in January showing that nearly 10 million US adults microdosed psychedelic substances such as psilocybin, LSD or MDMA in 2025.

The results of the RAND Corporation survey indicated that microdosing—which involves ingesting a small amount of a drug to improve mood and well-being without experiencing hallucinations or a full-scale trip—is a popular practice in the US, despite the recent polling that shows limited support for broader legalization of psychedelics.

The latest results are a follow-up to an earlier report RAND issued in 2024 that made the case that “now is the time” for federal policymakers to decide how to regulate psilocybin and other psychedelic substances.

Despite federal prohibition, that report noted, since 2019 more than two dozen localities have deprioritized the enforcement of laws around psychedelics, “generally making it a low or the lowest priority for law enforcement officials.” Voters in Oregon have also legalized supervised use of psilocybin, while Colorado voters legalized not only facilitated psilocybin use but also personal possession and production of psilocybin, DMT, non-peyote mescaline and other psychedelics.

Now is the time for federal policymakers to decide what they want these supply models to look like and to start taking action,” the RAND report said. “Or, if they prefer a patchwork of state policies—possibly including those that allow for commercial supply and promotion—they can do nothing and just watch the industry grow.”

“If that happens,” it added, “it can be difficult to make major changes to supply or regulations, but that will depend on the size and political power of the industry that has taken root.”

The RAND Corporation, which is funded in large part by the US government, is a nonprofit think tank and public consulting firm that’s helped advise policymakers on various issues. In 2021, for example, it released a government-funded report concluding that past cannabis use had relatively little impact on US Army recruits’ overall performance.

Researchers at RAND also contributed to a 2018 report that found that past-month marijuana consumption decreased by a small but statistically significant amount among 8th and 10th grade students in Washington State following legalization there.

Photograph (cropped) by Workman via Wikimedia Commons/Creative Commons 3.0

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on X and Facebook, and sign up for its newsletter.

The post Will Public Support for Legalizing Psychedelics Follow Marijuana’s Path? appeared first on Filter.

But New York City wasn’t too far away, and so by the second semester of my freshman year, I was driving down every weekend and hitting as many clubs as I could. My first year of college also happened to be my last year of college. 

Pretty soon I started selling the nightlife drugs I was using, in order to afford going out that much. By that fall, when classes started up again for what would have been my sophomore year, I was full-on wheeling and dealing. Liquid acid, paper acid, acid gel tabs, ketamine, mescaline microdots. And ecstasy pills.

Ecstasy, or MDMA, all came from the Netherlands in those days. The pure “molly” that you’d hear whispers of—the kind that smells like sassafras, that’s been synthesized properly and will blow any pressed pill you’ve ever taken out of the water—was already over by 1998. But for a short time the pressed MDMA pills were still quality.

There were blue dolphins. Green RNs. Speckled crowns. There were so many kinds of the Mitsubishi-stamp pills it was getting out of hand. Mitsubishi GTs. Mitsubishi GT turbos. Double-stacked Mitsubishi GT turbos. Triple-stacked Mitsubishi GT turbos. They did stop after quadruple-stacked, since most people don’t actually want a pill that’s approaching the dimensions of a Big Mac. 

Everything was advertised as MDMA, but often you’d end up with MDA, or MDEA, or some other amphetamine derivative. There were two kinds in particular—Yellow Sunshines, and the Skull and Crossbones—that were outrageously speedy; one pill could keep you up for three days, reminiscent of a different well-known amphetamine.

Often I distinguished MDMA from the speedier, more hallucinogenic MDA by just taking a pill and figuring the rest of that batch was the same. But for sales purposes I needed something a bit more reliable, because once I started picking up 1,000-packs there were way too many different stamps and color and shapes. I didn’t want to sell something if I couldn’t even tell the buyer what it was.

We’ve just released what is effectively an all-new reagent instruction pamphlet, as well as a fully redesigned heatstroke pamphlet! More info on our website, in the most recent article posted. pic.twitter.com/uKpJ2VLbTv

— DanceSafe (@DanceSafe) May 1, 2024

Nightlife harm reduction nonprofit DanceSafe had just been founded in 1998, and when they started selling drug-testing reagent kits I was all in. When the chemical reagents interact with different drug samples they change to different colors, which you then cross-reference with a corresponding color chart. This gave me a sense of whether a pill was MDMA-based or MDA-based, and allowed me to share the info with people who were buying.

Reagent testing wasn’t something most people were doing, but I wasn’t the only one; people who were really serious about MDMA, whether for personal use or for business purposes, were ordering the kits too. The results didn’t indicate anything about potency, but were still helpful in determining how much to take because we knew MDA was more potent than MDMA.

According to my test results at least, MDMA was fading away while more pills seemed to comprise MDA and things that reagent testing couldn’t identify. And then around 2001, the market shifted toward ecstasy pills people began producing domestically.

The new supply was a lot cheaper than what we’d been getting from Amsterdam—around $1 to $3 per pill when you bought 1,000 at a time, whereas before it had been $7 or $9 per pill. But the quality went way down, to the point that I stopped using them. And because of that, I didn’t feel comfortable selling them anymore.

Image (cropped) via National Science Foundation

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Among respondents who used drugs of all kinds, 70 percent said they used to have fun or get high. That was particularly pronounced among MDMA consumers, with 88 percent reporting that they use it for fun. Some different motivations were apparent depending on the drug, however. About 60 percent of people using heroin, for example, mainly used it to reduce stress or relax. Meanwhile around a third of people using amphetamines, powder cocaine or MDMA did so to socialize.

Delivered across May and June 2024 by the European Drugs Agency, a European Union monitoring body, the survey gathered insights about drug use in the past year from over 67,000 people in 35 countries, including most EU members and nearby places like the Western Balkans, Ukraine, Lebanon and Palestine. Its results were published in late February. 

The multi-national coverage paints a hugely valuable picture, though with some limitations. The self-selecting nature of respondents and variability of countries’ implementation mean the survey is not necessarily representative of national drug prevalence rates. This edition, for example, had a disproportionate number of responses from Sweden and Spain. However, the results have been aggregated with other national measures of drug prevalence to provide more accurate insights.

Almost three-quarters of respondents used drugs at home. This finding is particularly informative for future harm reduction work.

The web-based, time-consuming nature of the survey also means that certain groups of people who use drugs, especially the most marginalized, may be underrepresented.

The last edition was in 2021, and depicted Europe’s post-COVID drug landscape. The latest edition offers more granular insights into people’s habits, and reflects wider recognition of the normality of drug use.

Many of the results uncovered are not groundbreaking: Alcohol and tobacco/nicotine—an aggregation of tobacco with non-tobacco products like vapes and pouches—were consistently the most used drugs across all nations (the survey did not include caffeine). Among the “illegals,” cannabis was by far the most popular, with almost 60 percent of respondents reporting its use. Second came MDMA, with 30 percent of respondents using it, followed by powder or crack cocaine (29 percent).

For many, home is where the drugs are: Almost three-quarters (73 percent) of respondents used drugs at home. This tracked with the 2021 survey, although it was then unclear whether this preference was due to ongoing pandemic restrictions. 

This finding is particularly informative for future harm reduction work. With so many resources and interventions focused on social settings, developing projects or techniques to keep people safe when using in private settings, potentially alone, is increasingly important.

There were some predictable exceptions to the general preference for the home setting. MDMA was primarily used (79 percent) at music festivals or parties, with 45 percent of users opting for clubs or bars. Powder cocaine was primarily used (68 percent) in clubs or bars. Cannabis, crack cocaine and heroin were the drugs most likely to be used in nature or in public spaces like streets and parks.

The most likely combinations of criminalized substances were methamphetamine and cannabis, and heroin and benzodiazepines.  

This edition of the survey also drilled down on the reality of polysubstance use. This should be a given: If you ask people who use drugs whether they use more than one substance, “mono use” is likely to be the exception. 

The results clearly reflected this, with 96 percent of respondents reporting that they used more than two drugs on the same occasion in the past year. 

Alcohol and tobacco/nicotine were consistently the substances most often mixed with other drug groups. The most likely combinations of criminalized substances were methamphetamine and cannabis (mixed by 31 percent of respondents) and heroin and benzodiazepines (30 percent). But powder cocaine was overall the criminalized substance most likely to be mixed with other drugs. Notably, 30 percent of people using cannabis said they would not mix it with other drugs. 

While polysubstance use has long been known as typical, capturing it in the survey represented a big methodological challenge, according to the researchers. 

“I can say that defining [polysubstance use] was one of the things that took the longest and generated the most discussions,” João Matias, scientific analyst at the EUDA and the survey’s lead designer, told Filter. The survey’s format—from what to ask, to which drugs to include or group together—had to be agreed across all 35 participating countries.

As for what “polysubstance use” should be taken to mean, “These are substances you take at the same time, or in a row, or with a few hours in between,” Matias said. “It’s complicated. What’s really a ‘use session’? Methodologically, it’s a challenge.” 

The survey decided to define polysubstance use as “the use of two or more substances on the same occasion,” leaving respondents to interpret that for themselves.  

Alexei Lakhov, the executive director of the European Network of People who Use Drugs (EuroNPUD), was not surprised by the findings—or the researchers’ difficulties.

“I think that poly-drug use accurately reflects real-world trends,” he told Filter. “In addition, some people just don’t perceive certain substances, such as alcohol, benzos or tobacco, as ‘drugs’ per se, and can use them even without wanting to ‘get high.’” 

“In a fatal overdose, it’s rare for just one drug to be in someone’s system. So we need to integrate the concept [of polysubstance use] into all our work.”

Despite the challenges, Matias underscored that it was essential to capture this finding. “We have data for the first time confirming what people have said, that it’s rare for people to just use one drug.”

“We need to work on definitions, as it’s a field with little consensus,” he continued. “We need to apply a poly-use perspective not only in data collection but also in how we interpret drug use and interventions. In a fatal overdose, it’s rare for just one drug to be in someone’s system. So we need to integrate the concept into all our work.”

Studies on polysubstance use are relatively rare, and much of the research that exists has a narrower focus on just two drugs. Only a handful of examples—like a 2006 study looking at alcohol and prescription stimulants, painkillers and sedatives, or a 2022 study examining motivations for poly-drug use—have made broader attempts to widen our understanding.

As British researchers stated almost 20 years ago, polysubstance use is “poorly defined” and “frequently overlooked”—and this partly still holds true. But the benefits of engaging in this work have the potential to be felt across all drug-using communities.

“Recognizing that people who use drugs may seek specific combinations to achieve desired effects, cope with personal issues, or enhance social experiences can inform more empathetic and tailored harm reduction strategies,” Lakhov said.

The survey’s reflection of people’s pleasure in using drugs is also important. It’s another area that research largely ignores—contributing to harmful policies, when drugs are often viewed purely through a pathologizing or negative lens.

Drug use is as messy, complex and diverse as life itself. It is crucial to have a body of research that reflects this reality, so that we can develop more pragmatic and effective support for people who need and want it.

Image (cropped) by Pixabay via Stockvault/Public Domain

The post Latest European Drug Survey Highlights Pleasure, Polysubstance Use appeared first on Filter.

The project, to be conducted by VA researchers affiliated with Brown and Yale universities, will enroll eligible participants and pair them with psychologists for treatment with the drug. The VA had announced in January that it wanted to expand funding opportunities for research around both psilocybin and MDMA.

The new grant award “marks the first time in more than 50 years that psychedelic research will be conducted at VA facilities,” according to Military.com. Treatment will take place at the VA’s medical centers in Providence, Rhode Island, and West Haven, Connecticut. Enrollment in the trials will begin in 2025.

Participants will receive two monthly doses of MDMA, along with counseling before and after taking the drug.

A government summary of the West Haven trial states that it will be the “first open label pilot trial” of veterans suffering both alcohol use disorder and PTSD. Participants will receive two monthly doses of MDMA, along with “preparatory” counseling sessions before taking the drug and “integrative” sessions afterwards. Researchers will evaluate changes over time in patients’ alcohol use and PTSD symptoms, using the Timeline Followback method.

“VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” Under Secretary for Health Dr. Shereef Elnahal said in a press release. “This study will give us better insight into the potential of MDMA-assisted therapy as a treatment for veterans.”

It’s not the first time the federal government has invested in psychedelic research in recent years. In 2023, the Department of Defense awarded Yale researchers a $1 million, three-year grant to study treatment of veterans’ PTSD using MDMA and another synthetic formulation, methylone.

The latest development comes at the end of a disappointing 2024 for proponents of MDMA reform. It was expected to be the year that the Food and Drug Administration (FDA) approved MDMA as a legal treatment for PTSD. Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation, spent over a decade conducting and sponsoring clinical trials with MDMA. But in August, the FDA rejected the company’s application, telling it to conduct an additional Phase 3 trial and resubmit at a later date.

Concern over veterans’ mental health is a rare point of agreement across the political spectrum.

That setback hasn’t stopped psychedelics including MDMA from being increasingly explored and accepted in different settings. The last several years have seen states introduce or pass a wave of legislation to support pilots using the drugs for treatment, often with a specific focus on veterans and first responders like cops or firefighters. Examples include efforts by lawmakers in Wisconsin, Pennsylvania and California; and successful bills in states like Washington and Texas.

Concern over veterans’ mental health is a rare point of agreement across the political spectrum, and the issue has brought some conservative and Republican voices into psychedelic lobbying and lawmaking, including former Texas governor Rick Perry and Texas Congressman Dan Crenshaw.

A 2021 study found that since the 9/11 attacks, active-duty and retired military members were four times more likely to die of suicide than in active combat. The VA estimated that in 2021, an average of 17 veterans died of suicide every single day.

“Some factors linked to suicide in active duty service members include loneliness, relationship issues, workplace difficulties, trauma, disrupted schedules, increased stress, poor sleep, injury and chronic pain,” wrote April Smith, an associate psychology professor and veteran suicide researcher at Auburn University. “On top of these same factors, veterans may also experience difficulties transitioning to civilian life.” Smith also cited veterans’ familiarity with firearms, when research has associated handgun ownership with greatly increased suicide risk.

The VA states that veterans are slightly more likely than civilians to suffer from PTSD at some point in their lives, at a rate of 7 percent; among veterans, certain demographics are at greater risk, with women reportedly twice as likely men to develop PTSD. Earlier in 2024, Yale researchers published findings that veterans are much more likely than the general population to have generalized anxiety disorder (7.9 percent versus 2.9 percent), with certain demographics, such as veterans of color, again more vulnerable. Veterans have also been found to have higher risk of alcohol use disorder.

Such factors have earned psychedelic research for veterans wide political support. In the broader national context, new studies like those the VA is funding could provide compelling evidence on a path toward medical MDMA access for everyone in need.

Photograph of West Haven VA Medical Center by Veterans Health via Flickr/Public Domain

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The meeting featured a panel of representatives from various United States government agencies and research institutions, including the FDA, the Department of Defense, Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA).

“Four percent of men and 10 percent of women in the US will have PTSD in their lifetimes.”  

Dr. Bernard Fischer, the deputy director of the FDA’s division of psychiatry, began the event with a presentation summarizing the history of PTSD andongoing research efforts to address its growing prevalence. He highlighted that roughly “four percent of men and 10 percent of women in the US will have PTSD in their lifetimes.”  

Dr. Fischer noted that there are currently two FDA–approved SSRI medications for treating PTSD (Zoloft and Paxil), but acknowledged that there is still “an unmet need for safe and effective therapies.” He then touted the FDA’s designation of certain psychedelic drugs and compounds as “breakthrough therapies,” and pointed out that “ClinicalTrials.gov shows there are 447 clinical trials [both currently] recruiting [and] not yet recruiting” in this area. 

Dr. Leith States of HHS followed up by referencing the controversy over the FDA’s August rejection of Lykos Therapeutics’ Novel Drug Application for MDMA-assisted therapy to treat PTSD.

“We all feel some type of way about the decision that came out some time ago. And that’s okay,” said Dr. States, who serves as chief medical officer in the HHS Office of the Assistant Secretary for Health. “We’re all big kids,” he added, without sharing his personal opinion on the matter.  

Immediately after the panel discussion, members of the public added lively and passionate commentary, both in person and via video link. Thought leaders with differing perspectives on psychedelics weighed in on the US mental health crisis from a number of angles.

Dr. Neşe Devenot of Johns Hopkins University shared that “as a survivor of complex PTSD … I understand acutely how important it is to find effective treatment options for this life-altering condition.” 

Dr. Devenot, a board member for the Psymposia psychedelic research and education nonprofit, has been a prominent critic of Lykos and the Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit from which the company spun off. Chief among Psymposia’s criticisms are allegations of substantial omissions of adverse events and additional research misconduct during Lykos’s Phase 2 trials.

Dr. Devenot emphasized to the meeting that “the urgency for treatment options is not a license to lower our standards for research, despite the efforts of industry lobbyists to suggest otherwise.”

“All I have heard today is that we are kicking the can down the road.”

Conversely, US Army and Marines veteran Jon Lubecky, a longtime veterans’ mental health advocate, lamented the lack of action by the government officials in attendance. “All I have heard today,” he said, “is that we are kicking the can down the road.”

Lubecky is a former participant in a MAPS clinical trial of MDMA-assisted therapy, and a prominent critic of Psymposia’s conduct. He described to the meeting how he had benefited from his trial participation, stating that  “[my] VA medical record as well as my demonstrated actions show that my PTSD is in full remission following the three-month protocol.”

Lubecky played an instrumental role in the crafting and passage of a historic 2023 bipartisan-backed budgetary amendment, which carved out federal funding for veteran-focused psychedelic research. The deal has become known as the Crenshaw Amendment, after US Representative Dan Crenshaw (R-TX), another veteran, spearheaded its 11th-hour inclusion during an extremely contentious federal budget negotiation process, along with Rep. Alexandra Ocasio-Cortex (D-NY).

Another noteworthy contribution to the public commentary came from Denver-based psychedelic advocate and practitioner Ashley Troxell. Troxell has been a leading voice in Colorado’s grassroots psychedelic community, and an outspoken critic of potential corporatization/pharmaceuticalization of psychedelic care after the state’s adoption of the Natural Medicine Health Act Initiative back in 2022.

Troxell called for the FDA “to recommend the descheduling of psilocybin mushrooms to the DEA, and to propose an evidence-based regulatory framework.”

In her statement, Troxell called for the FDA “to recommend the descheduling of psilocybin mushrooms to the DEA, and to propose an evidence-based regulatory framework that ensures safe, affordable access.”

Troxell also highlighted that “psilocybin has the highest safety profile of any psychedelic, and [psychedelics’] potential for treating PTSD is supported by a growing body of research.” She cited dysfunctional implementation processes in US psychedelic reform efforts as further evidence for the need for a carefully regulated descheduling process, ensuring equitable access to a regulated industry for legacy-market psychedelic professionals and caregivers.

“Oregon and Colorado’s 2025 regulatory framework for facilitation and clinical therapy present significant barriers,” she said. “These models impose excessive fees on providers, driving up the cost of sessions.” Troxell added that a recent CU Denver study “highlights that [Colorado’s] model is set to fail BIPOC communities and low-income individuals.”

While plenty of frustrations and differing opinions were aired, nobody can know exactly how things will turn out for US psychedelic access and PTSD care. What is clear is that both the federal and industry landscapes are rapidly evolving, alongside states’ laws.

Lykos Therapeutics has been restructuring in the wake of its FDA rejection: Longtime CEO Amy Emerson resigned earlier in September, following a 75 percent staff reduction and the departure of MAPS founder Dr. Rick Doblin from the Lykos board.

In August, as Filter previously reported, the Drug Enforcement Administration (DEA) scheduled a 10-day public commentary period around its longstanding attempts to classify two widely-utilized psychedelic research chemicals as Schedule I drugs.

The post Psychedelic Advocates Air FDA Frustrations at Reagan-Udall Meeting appeared first on Filter.

Lykos, formerly known as the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation, is a for-profit pharmaceutical company focused on bringing new mental health treatments to market. The company’s MDMA research led to the FDA’s first formal consideration of a Schedule I psychedelic drug for approval as a medical treatment.

Lykos’ new drug application involved the company’s MDMA capsules, designed to be used during therapy sessions overseen by two trained facilitators, as studied in the Phase 3 trial. The FDA ultimately issued a “complete response letter,” meaning it described specific problems and how Lykos can attempt to remedy them and apply again.

“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones,” Lykos Chief Executive Officer Amy Emerson stated August 9.

“While conducting another Phase 3 study would take several years,” Emerson continued, “we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

With a substance like MDMA, study participants can often tell whether or not they received a placebo.

On June 4, an FDA advisory committee had recommended against approving the application. Some of the concerns prompted by the Lykos Phase 3 trial focused on consent, following a participant’s allegations of sexual assault by facilitators. This intersected concerns about how to balance appropriate training—clinical MDMA sessions often incorporate physical touch—with keeping the treatment affordable for as many patients as possible. There’s no guarantee insurers would cover the sessions, and some estimates for out-of-pocket costs exceed $10,000 per patient.

Another major concern highlighted by the advisory committee was the difficulty in keeping the Phase 3 double-blinded trial unbiased. With a substance like MDMA, participants can often tell whether or not they received a placebo.

“I do think we need a different regulating body to oversee this,” Dr. Genesee Herzberg, a licensed psychologist who was involved in the Phase 3 Lykos trial told Filter ahead of the FDA verdict. She specializes in trauma work and has trained to provide MDMA-assisted therapy for PTSD specifically. “There are so many psychedelic training programs out there and they’re not standardized at all. We need to really get clear on what needs to be incorporated in training, and what credentialing a psychedelic therapist looks like.”

The lead-up to the August 11 deadline for the FDA to issue its decision was marked by a substantial bipartisan push for the agency to go against the advisory committee’s recommendation.

One day after the FDA delivered its verdict, the journal Psychopharmacology retracted three MDMA involving Lykos-affiliated researchers.

Veterans advocacy groups like Healing Breakthrough, which collaborated with Lykos on the trials, held near-constant meetings with legislators. In a letter to FDA Commissioner Robert Califf, 19 senators emphasized the veteran suicide crisis and stated that, should the evidence bear out, “it is our responsibility to ensure that this treatment option is made available to those who could benefit.” A letter signed by 61 House representatives urged President Biden to support the application for the same reasons and warned against listening to outside interest groups.

“It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence,” stated the August 2 letter to Biden. “However, we are aware that … certain groups and individuals have voiced criticism of the application. It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases.”

On August 10, one day after Lykos announced the FDA decision, the journal Psychopharmacology retracted a study analyzing Lykos’ Phase 2 research; another study analyzing long-term followup of that research; and a third MDMA study also affiliated with Lykos. The retraction notes on all three cite “protocol violations amounting to unethical conduct” and allege that the authors had knowingly concealed the violations.

The only other MDMA study currently recruiting for Phase 3 trials is also affiliated with Lykos. Multiple studies on psilocybin, the psychedelic compound in certain mushrooms, are currently recruiting for Phase 3, most of them focused on depression. The FDA has not approved any new treatments for PTSD since 1999. 

Image by HeungSoon via Pixabay

The post FDA Rejects MDMA Treatment for PTSD, Requesting Redo of Key Trial appeared first on Filter.

Many of the Psychopharmacologic Drugs Advisory Committee’s reservations implicate larger isssues with MDMA therapy. But it was also specific shortfalls of the research presented by Lykos Therapeutics that caused members to vote 9-2 against MDMA’s efficacy in helping treat PTSD, and 10-1 against its safety.

Video testimony from members of the public, coupled with a critical Institute for Clinical and Economic Review (ICER) draft report that had been released in March, highlighted concerns about an environment where patients were vulnerable to sexual assault. Among those who testified was a proxy for a trial participant who was inappropriately touched during an MDMA session by her two facilitators, a husband and wife team, and who has also alleged sexual assault by another facilitator who was not a licensed therapist.

“Nurturing touch that occurs when the participant is deeply re-connecting with times in life when they needed and did not get it can provide an important corrective experience,” states the Lykos therapist training manual. “Another kind of touch that can be therapeutic is focused bodywork, usually in the form of giving resistance for the participant to push against.”

To learn more about the complex issues around safety, consent and accessibility, Filter spoke with Dr. Genesee Herzberg, co-founder of Sage Integrative Health, who was one of the licensed therapists involved in the Phase III Lykos trials. Herzberg and eight others who worked on the trials co-authored a response to the ICER draft, acknowledging certain critiques and pushing back on a number of others; another 64 signatories added their names in support. Our interview has been edited for length and clarity.

“When it comes to work with MDMA, touch becomes more important. MDMA can lead to regression to preverbal or young self states, and … often words don’t get through.”

Alexander Lekhtman: What was your first reaction to the FDA advisory committee’s vote?

Dr. Genesee Herzberg: I was disappointed. I have witnessed and been in touch with many people who suffer from PTSD, and I have witnessed the very impactful and efficient change MDMA can bring in psychotherapy. I was concerned this will prolong the time it takes for people to gain access to a modality that can help. There are so few PTSD treatments out there that are effective, those that exist are often too intense for people.

There certainly are risks to the treatment and it’s important we talk about those—the issue of sexual boundary violations that came up was really upsetting. It’s something we need to do our best to make sure does not happen again.

AL: Can you explain the appropriate role of “nurturing touch” and “focused bodywork” in MDMA therapy?

GH: I am trained in Relational Somatic Healing, which is a form of therapeutic touch integrated into psychotherapy, generally without medicine. I think with a therapist well-trained in offering touch, and working with consent, it can be an incredibly supportive approach to deepening the therapy, to helping people drop into preverbal states … that are very hard to access otherwise.

When it comes to work with MDMA, touch becomes more important. MDMA can lead to regression to preverbal or young self states, and all the vulnerability and emotion that comes with them. From those states, often words don’t get through. Physical presence and touch are what’s most helpful in supporting the individual so they feel held and cared for and able to process their trauma. It’s vital the therapist be well trained in holding people in these sensitive states and obtaining informed and ongoing consent. We have seen major breaches to that.

Generally it’s encouraged that you only offer touch at the level you’re experienced in. Nurturing touch is the most simple—just involved holding someone’s hand, or a hand on the shoulder or forehead. Like what a friend might offer.

“Sometimes people say they are not interested in therapeutic touch during the prep session, but then during the MDMA session they ask for it. We will hold the boundary we agreed upon.”

AL: How do you reconcile MDMA’s effects with someone’s ability to give consent?

GH: We have a long discussion around touch and consent in the preparation phase. Getting a history about their relationship to touch, any trauma related to it, and their cultural conditioning. If they’re not open to touch, we just leave it there.

Sometimes people say they are not interested in therapeutic touch during the prep session, but then during the MDMA session they ask for it. We will hold the boundary we agreed upon prior to the MDMA session—if you say “No” before, and ask for it during, we will offer an alternative like placing your own hand on your heart or holding a pillow or pushing against a wall. Then we can circle back after that session … to determine if you do want to incorporate touch in the future.

AL: Does it pose a risk to patients if, as a cost-saving measure, only one of the two facilitators overseeing their treatment has to be a licensed therapist? For example, the facilitator accused of sexually assaulting a patient was not licensed. The provincial board basically told the patient that they couldn’t do anything because the facilitator didn’t have a license to take away.

GH: There are many routes to accessibility. The most important is insurance coverage, [but another is] hiring and training pre-licensed therapists. Not “unlicensed” folks, but people who are on the track to licensure but haven’t yet completed all their hours and taken the exam. Pre-licensed people expect to get paid less, so it would certainly lower the cost. I do think there’s an ethical issue with the tendency to underpay masters- and doctoral-level therapists who are not yet licensed, related to a societal undervaluing of mental health in general.

If less-experienced therapists are in the room with a licensed therapist, I think that is an incredible way to ensure safety and that the pre-licensed person is holding the work in a good way. Live supervision is one of the best forms of training, getting to witness someone doing the work and get direct feedback. Co-therapist teams should be debriefing after each session … It’s a great way for both therapists to learn. 

If someone wanted to file a complaint, they have the same ability to go to the board and if the person acted in a problematic way to have their license, or their potential to be licensed, revoked.

When it comes to people not on licensure tracks at all, I feel torn about this. It’s a complex question—there are many people who, say, were trained in Indigenous traditions, and have been doing this work for decades. To say those people aren’t eligible because they don’t have a license would take away from the potential diversity and depth of experience and knowledge they hold. On the other hand, not having that route of accountability is concerning. That’s why we need better systems of accountability within the field so when something comes up it’s not just a [psychology] board people can go to, but a governing body that regulates psychedelic therapists specifically.

“There’s a giant hype around psychedelics and this idea that if you have one or two experiences you will be cured.”

AL: Opponents of MDMA therapy argue that it will cost a lot of money up front. But it actually reduces health care expenses in the long-run. Are those competing interests?

GH: There is a good chance people with complex PTSD will need more sessions, more MDMA and integration sessions in order to recover. [But] it also appears that MDMA speeds up the therapeutic process—maybe we’re looking at two years of psychotherapy and six MDMA sessions, as opposed to 10 or 20 years of psychotherapy. It’s still likely to [save costs], reducing emergency room visits, intense suicidality, heart disease, all kinds of problems that add to the overall cost of untreated trauma.

The larger issue I think is relevant is what’s been happening in the media the last five years. Michael Pollan’s book [How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence] really brought forward what I call “the myth of the magic pill.” There’s a giant hype around psychedelics and this idea that if you have one or two experiences you will be cured.

That’s the experience of [a few] people. But in general, and for people with complex PTSD, it’s not like that. It’s an intensive process. It requires openness to looking at and working with your trauma, and re-experiencing feelings that are very intense, going back to memories that were dissociated. One of the issues I’ve noticed is that for some people, three MDMA sessions isn’t enough.

There’s all the hype in the media … that I think led some people to feel disappointed when it didn’t work as well for them. Or like they had failed somehow.

Some people who spoke up felt like they were dropped after the study. Unfortunately, that was the nature of the study—it needed to end, so we could collect and analyze the data. It really should be a longer-term treatment for some.

Image via United States Department of Transportation

The post As FDA Weighs MDMA Therapy, Questions of Access and Consent appeared first on Filter.

Senate Bill 266, introduced by Senator Kirk Cullimore (R), will permit two large health care providers— Intermountain Health and the University of Utah Health, as the Salt Lake Tribune reported—to develop a behavioral health treatment program using psilocybin and MDMA. All patients must be at least 18 years old, with psychedelic treatment supervised by licensed hospital staff.

Providers must report to the legislature before July 2026, detailing the drugs used, patient outcomes including any side effects or harms, and other relevant information. The bill includes a “sunset” clause, meaning its provisions only last until July 2027.

“The issue itself of access to care in regulated settings does transcend the political binary.”

“This is one of the clearer examples of bipartisan or ‘multi-partisan’ [support] of this work,” Ismail Ali, policy and advocacy director at the Multidisciplinary Association of Psychedelic Studies (MAPS), told Filter. “The fact a bill like this could pass through a majority-Republican legislature, especially with the ease that it did and a tremendous amount of support, demonstrates that the issue itself of access to care in regulated settings does transcend the political binary.”

The bill’s text prevents smaller hospitals or health care facilities from participating, limiting the program to either “a privately-owned, non-profit, vertically-integrated healthcare system that operates at least 15 licensed hospitals in the state,” or one “closely affiliated with an institution of higher education.”

The scope of treatment with psilocybin or MDMA is also likely to be limited. The bill specifies that hospitals can only use the drugs in forms that have reached at least Phase 3 clinical trials, the final step before potential FDA approval. Only MDMA for post-traumatic stress disorder, and psilocybin for treatment-resistant depression and major depressive disorder, currently meet that standard.

It’s unclear if Utah’s law, which says treatment must be must be “supported by a broad collection of scientific and medical research,” would allow doctors any flexibility in prescribing the drugs for other conditions, like substance use disorder, end-of-life stress and more. In the absence of FDA approval of MDMA or psilocybin for a particular condition, a possible legal mechanism for providers is to offer medicine through “compassionate use” or “expanded access” pathway under FDA rules.

One psychedelic expert is highly skeptical of Utah’s bill.

“It seems like any licensed health care facility will be hesitant … unless it’s through existing federal regulatory channels.”

“It’s a bit of an oddball, I’m not sure what it achieves, if anything at all,” Mason Marks told Filter. Marks is a law professor at Florida State University, specializing in psychedelic law, and the creator of Psychedelic Week.

Dr. Marks has doubts that the hospital systems eligible to offer psychedelic treatment under the law will actually do it, for fear of running afoul of federal drug laws.

“Either of these settings will be very hesitant to get involved in this in any way other than through research or just waiting for FDA approval,” he said. “Unless there’s some actors in Utah that are excited and ready to jump into this, it seems like any licensed health care facility will be hesitant … unless it’s through existing federal regulatory channels.”

Still, it’s noteworthy how Utah’s bill was sponsored by a Republican Senator, passed overwhelmingly by a Republican-dominated House and Senate, and allowed to take effect by a Republican Governor. It indicates a pathway for psychedelic reform in more conservative states—even if the bill is far more limited than the legalization embraced by voters in Oregon and Colorado, for example.

In those states, the law allows any adult to use psilocybin or another psychedelic under the supervision of a trained professional at a licensed facility. There is no requirement for a recipient to have a medical diagnosis, and the facilitators are not medical professionals—even though many people are choosing to pay for these (expensive) services to address mental health needs.

“The trend overall is that psychedelic policy approaches are casting a fairly wide net … They tend to align with what’s politically possible in that jurisdiction.”

Colorado also took it a step further by broadly decriminalizing use, sharing and growing of naturally occurring psychedelics, guaranteeing at least some basic protections for people who use these drugs outside of the regulated system.

“I think the trend overall is that psychedelic policy approaches are casting a fairly wide net,” Ali said. “We’re seeing in some states something limited to a task force or just research for a university … They tend to align with what’s politically possible in that jurisdiction. A bill like Colorado’s may not be able to get passed in most other jurisdictions … In [Utah’s] case, it’s utilizing existing medical infrastructure, which differentiates it from Colorado or Oregon, which are standing up new infrastructure.”

Instead, Utah’s bill more closely resembles those in states including Texas, Washington and Connecticut. They have also authorized some health care providers to give people psychedelic treatment, but as part of conducting clinical research.

“Those [states] are providing funding for clinical trials, and it’s pretty straightforward,” Marks said. “Texas is funding clinical research in Houston, Washington at University of Washington, in Connecticut at Yale.” Washington’s program, for example, will be limited to adults over 21 who are military veterans and first responders, with conditions like PTSD or substance use disorder.

Other states have introduced or considered similar bills, including North Carolina, Wisconsin and Pennsylvania.

For any state that takes steps to liberalize access to psychedelics in therapeutic or health care settings, Marks is concerned that governments are ignoring conflicts with federal law that could risk programs being shut down. As one example, he cited the just-released proposed rules for psychedelic therapy in Colorado, which create a “clinical facilitator” license. These license-holders would have a health care provider role, able to diagnose and treat health conditions.

“That’s going to create some potentially huge liabilities for those clinical facilitators,” Marks said. “I don’t know how many health care professionals will be willing to get involved in that program, because it does pose risks for them. It’s not so much the state but individual practitioners and businesses who could be in trouble when they’re offering non-approved substances as medical treatment … The same would apply in Utah.”

Much remains to be seen, then, about how the state’s new law will play out in practice, even if its adoption is another clear sign of shifting political winds for psychedelics.

Photograph of Utah State Capitol by Ken Lunder via Flickr/Creative Commons 2.0

The post Utah’s New Law to Authorize MDMA and Psilocybin Therapy appeared first on Filter.

On February 9, pharmaceutical company Lykos Therapeutics announced that the FDA has accepted and is reviewing its application, submitted in December, for “[MDMA] capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with [PTSD].” The FDA has now granted the application “priority review” status as requested, meaning it should make a decision by August 11.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” stated Lykos CEO Amy Emerson. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

The company, formerly known as MAPS Public Benefit Corporation, was created by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). The company’s application includes results from its recent clinical research, which builds on nearly 30 years of work. Its “Phase 3” research, the final experimental stage before you gather and submit data to the FDA, was published in the Nature Medicine journal in September 2023.

The future of this MDMA treatment could be impacted by a change in the company seeking to bring it to market. MAPS PBC, as it was then, was a wholly owned subsidiary of MAPS, and raised funds from philanthropic donors. But in January, it announced it had completed an “oversubscribed” stock sale, raising over $100 million from private investors.

“The decisions to be made at Lykos, even though it is a public benefit corporation, will, of necessity, include responsibilities to private stockholders.”

The transformed entity re-branded as Lykos Therapeutics, with CEO Emerson retaining that role. Six members of Lykos’ board of directors are to be appointed by MAPS, with two (including Emerson) representing shareholders. MAPS is the largest shareholder in Lykos, but holds less than half of the total stock.

“The decisions to be made at Lykos, even though it is a public benefit corporation, will, of necessity, include responsibilities to private stockholders,” said Rick Doblin, the founder and former executive director of MAPS, and a Lykos board member. “These decisions will not always be the decisions that the nonprofit MAPS would have made if we had remained the sole owner … responsible only to our donors and to advancing public benefit.”

The company’s Phase 3 research included two studies, one for patients with severe PTSD, the other for people with “moderate to severe” cases. The latter looked at a group of 104 adult patients, who were randomly split into two groups—one given the drug MDMA, the other a placebo—and all received the same psychotherapy. Compared to placebo, MDMA resulted in improved scores for PTSD symptoms and disability over 18 weeks. At the end of the study, over 71 percent of these patients no longer met the diagnostic criteria for PTSD.

“MDMA simultaneously induces prosocial feelings and softens responses to emotionally challenging and fearful stimuli,” the researchers wrote, “potentially enhancing the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotionality.”

No major safety issues came up during the study, the researchers stated. That said, the drug was not risk-free—most participants experienced at least one negative side effect from the treatment, though none life-threatening. Side effects included heart symptoms like palpitations, elevated blood pressure, muscle tightness, nausea, sweating or decreased appetite. Psychiatric side effects included anxiety and insomnia. Some participants also experienced suicidal ideation, but MDMA was not found to increase the risk of it (the study excluded people deemed to be at high suicide risk).

The DEA would have to hold public hearings before making its scheduling decision within 90 days.

The FDA will take the next several months to review these findings, and decide if the drug “[provides] benefits that outweigh its known and potential risks for the intended population.” If the FDA approves the application, the DEA will have to take the important next step of rescheduling MDMA.

Currently, the drug is in Schedule I, the most restrictive of five federal categories for controlled substances—illegal for any use, including medical. The DEA would need to categorize it as Schedule II or lower, making it legal for a doctor to prescribe it.

In that event, the DEA would have to hold public hearings before making its decision within 90 days. This is an important step, because it would determine the level of restrictions and scrutiny to be placed on doctors and pharmacists.  

Schedule II, which includes cocaine, methamphetamine and fentanyl, sets the strictest rules on writing prescriptions, which cannnot be refilled—it’s one and done. Schedule III drugs, including ketamine and anabolic steroids, can be prescribed orally, and can be refilled for up to six months, though no more than five times.

MDMA becoming a legal medicine could be very positive for people with PTSD. They’d be able to receive a regulated dose of known composition—nothing like buying on the unregulated market. They would use it with therapeutic support, and evidence indicates most would benefit.

But making MDMA legal is not the same as making it accessible. When MDMA treatment is projected to cost thousands or even tens of thousands of dollars, large numbers of people will be excluded. A 2022 review estimated that MDMA therapy, as conducted in the trials, costs over $11,000 per patient—although it would generates significant lifetime savings in health care costs.

The price tag is due to a number of factors—all related to the broken US for-profit health care system. Most projected costs relate to the services that would be required to accompany the drug, rather than the drug itself. You’d likely have to visit a clinic, potentially involving an overnight stay, and use MDMA under supervision of one or more trained and licensed psychotherapists, paid to sit with you for hours while you’re under the influence.

Treatment guidelines in the Phase 3 research involved three 90-minute “preparation” sessions before taking the drug, then three eight-hour “dosing” sessions. Finally there was a 90-minute “integration” session, to talk about your feelings on how it went.

If you’ve ever gone to see a counselor, you know it’s not cheap, even with health insurance. And it’s not entirely clear if health insurance companies would pay for MDMA treatment, in full or partially—though that could change.

“There are a variety of different foundations and philanthropic efforts to address the cost of the therapy. You see organizations and clinics working together across the field.”

Much would depend on factors like if the medical establishment embraces MDMA treatment, costs versus demonstrated savings of treatment, and how clinical outcomes compare to existing PTSD treatments. But ultimately, health insurance companies will have a great deal of discretion. And of course none of this would do anything for the estimated 27 million Americans without health insurance. Many people from lower-income and marginalized backgrounds—the very populations that might benefit most from PTSD treatment—will simply not have access, unless large numbers of providers are prepared to eat at least some of the cost of treatment.

“There are so many different ways people are seeking to answer this question, beyond MAPS, [that] I’m really inspired by,” Betty Aldworth, communications director for MAPS, told Filter. “You’ve got nonprofit therapy clinics popping up, perhaps currently providing ketamine therapy but with the intent to provide other psychedelic-assisted therapies as they become available, on a sliding scale or with scholarship programs. There are a variety of different foundations and philanthropic efforts to address the cost of the therapy itself. You see individual organizations and clinics working together across the field to see how we’re going to answer that question.”

Despite that major issue, the rapid progress toward legalization of medical MDMA is a victory for the psychedelic movement. It validates literally decades of work—from activists, underground providers, community organizers, academics and clinicians—to show that a vilified drug has real therapeutic value.

“I do think this is a beacon of hope for people researching the potential benefits of psychedelics to address very serious mental health conditions that have insufficient treatments available,” Aldworth said. “The fact the FDA accepted this application certainly sends a signal that other studies that have similarly careful research methods might lead to more new drug applications for other substances and other conditions.”

Photograph (cropped) by Gustavo Fring via Pexels 

Correction, February 15: This article has been edited to reflect that MAPS PBC, now Lykos Therapeutics, conducted the Phase 3 research referenced, rather than MAPS as originally stated.

The post MDMA Close to Being Legal Medicine, as FDA Grants Priority Review appeared first on Filter.

Members of the Senate Labor and Commerce Committee heard from the bill’s sponsor at the hearing and took public testimony, but did not vote on the measure.

Versions of the bill were introduced in both the House and Senate in January by Rep. Jennie Armstrong (D) and Sen. Forrest Dunbar (D), respectively.

“Crucially, this bill does not legalize anything,” Dunbar, a member of the Senate panel, told colleagues at the hearing. “Rather, it creates a problem-solving task force in anticipation of federal legalization of certain substances in controlled medical settings.”

The legislation would establish the Alaska Mental Health and Psychedelic Medicine Task Force under the state Department of Commerce, Community and Economic Development. The body would comprise government representatives and experts in mental health, psychiatry and more.

Members would be charged with assessing the potential therapeutic uses of psychedelics for mental health treatment, barriers to equitable access and “licensing and insurance requirements” for practitioners if any psychedelics receive federal approval by the Food and Drug Administration (FDA).

Dunbar noted in his comments that Alaska has high rates of veteran suicide and domestic violence, which he said “underscore the urgency of exploring innovative mental health treatments.”

“Research shows the effectiveness of psychedelic-assisted therapies in treating PTSD, depression, anxiety and substance use disorders,” he added, “conditions highly prevalent in Alaska, particularly among veterans.”

 

Under the bills as introduced, the task force would meet at least four times before submitting a report with findings and recommendations to the legislature and governor by December 31, 2024.

“What barriers exist in implementing such therapies in Alaska? What regulations are needed for practitioners to ensure safe integration of psychedelic medicine? These are some of the questions that the task force will explore,” Dunbar explained.

Most speakers during the hearing testified in favor of the proposal, including a psychologist, a military veteran of 34 years, an Alaska native healer and herbalist, a graduate student in mental health counseling and a member of the state’s Marijuana Control Board.

“Currently, psilocybin is in phase three clinical trials, meaning human trials,” said Bailey Stuart, the Marijuana Control Board member, “and I do see the future of mental health medicine encompassing psychedelic therapy as an additional tool.”

“I believe it is important to the public health and safety of our residents that we begin having these discussions about what federal legalization of psychedelics looks like before this event takes place,” Stuart continued, “and discuss the framework on how these substances will be regulated.”

Only one speaker, from the nongovernmental Citizens Commission on Human Rights in Seattle, spoke against the proposal at the hearing, arguing that more information is needed about psychedelics before making them more accessible to patients.

“This bill anticipates that there will be federal action,” Dunbar said. “We want to have the licensing [and] regulatory framework in place.”

One requested change came from the Alaska APRN Alliance, which represents thousand of advanced practice nurses and nurse practitioners in the state. Stephanie Wrightsman-Birch, a nurse practitioner, said the alliance supports Dunbar’s bill but wants to see an amendment that would establish a dedicated seat on the task force for advanced practice nurses.

“We would like the opportunity to speak for our profession and for our patients,” she said, noting that “psychedelic therapy sessions, which can last between two to eight hours, are oftentimes provided by advanced practice registered nurses and licensed therapists.”

Dunbar said he considered the proposal a friendly amendment and that he would support its adoption.

He also pointed out that the bill is beginning its journey not in a healthcare committee, but in the Senate Labor and Commerce Committee.

“That’s intentional. That’s by design,” he said. “We’re not here to debate sort of the efficacy of the medicine itself or which substances should or should not be legalized.”

Instead, he continued, “this bill anticipates that there will be federal action, and then we want to have the licensing in place and the regulatory framework in place. And a lot of the detailed questions that will go into that will be addressed by the task force itself.”

A number of states have moved to enact similar bodies over recent sessions.

Micaela Fowler, deputy commissioner at Alaska’s Department of Commerce, Community and Economic Development, said the agency projects the change would cost about $320,200 in fiscal year 2025, $385,200 in fiscal 2026 and $325,200 in fiscal 2027. That would cover agency staff, travel to six meetings (rather than minimum four in the bill) and costs like legal support, printing and room rentals.

The temporary body would be dissolved at the beginning of Alaska’s 35th Legislature, which would convene in January 2027. The fiscal note anticipates no further costs associated with the bill beyond 2027.

A number of states have moved to enact similar bodies over recent sessions as interest in psychedelic medicines has expanded and researchers push for FDA approval of drugs such as MDMA and psilocybin. Dunbar said that unlike most others, his bill sets aside seats on the task force for Indigenous health care professionals and leaders.

“We want the Indigenous voice to be a part of this task force,” he said.

The Department of Veterans Affairs recently requested applications to research use of psychedelics to treat PTSD and depression.

At the federal level, FDA is actively considering a new drug application for MDMA as a possible treatment option for people with post-traumatic stress disorder (PTSD).

As the agency weighs the application, new standards from the American Medical Association have officially taken effect that assign psychedelics-specific codes to collect data on the novel therapies.

In another milestone, the Department of Veterans Affairs recently issued a request for applications to conduct in-depth research on the use of psychedelics to treat PTSD and depression.

In California, meanwhile, a Republican lawmaker filed legislation in January to create a state workgroup that would be tasked with exploring a regulatory framework to provide therapeutic access to psychedelics like psilocybin and ibogaine and eventually allow health professionals to administer certain psychedelics to military combat veterans.

Massachusetts officials have separately certified that activists submitted enough valid signatures to force legislative consideration of a psychedelics legalization initiative before the measure potentially heads to the state’s 2024 ballot.

Nevada psychedelics activists said in late 2023 that they had a “productive meeting” with the Republican governor’s office about the need to expeditiously form a task force under a law enacted in 2023 in order to inform future reform—including the possible legalization of plant-based medicines.

In January, the Drug Enforcement Administration confirmed that the spores of psychedelic mushrooms are federally legal prior to germination because they do not contain the controlled substances psilocybin or psilocin.

Image via Oregon State

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

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