Psilocybin mushrooms that are ready for distribution are shown at a lab in Oregon. With its rules finalized, Colorado will soon follow in offering guided psilocybin therapy.
Craig Mitchelldyer/AP
Colorado’s Department of Revenue recently finalized rules and regulations for psychedelic-assisted therapy, clearing the way for providers to begin offering this new model of therapeutic care in 2025. The new rules provide requirements for businesses entering the field of psilocybin as healing centers, cultivators and manufacturers.
“These therapies will naturally be controversial because they represent a complete paradigm shift in the way mental health services are provided,” said Dr. Brooke Allen, a neurologist at Roaring Fork Neurology. “Using psychedelics as a catalyst to induce meaningful change that is patient-led by their own inner healing ability is very different from the current model of dampening symptoms, and with many fewer side effects and likely better efficacy.”
Pushed ahead by the passage of Proposition 122 by Colorado voters in 2022, the state’s psilocybin therapeutic program will be the second in the nation. Oregon voters passed its program in 2020, with the first state-regulated programs launching in 2022.
While the measure passed with 53% of the statewide votes, in many of Colorado’s High Country counties, it passed by larger margins. In Pitkin County, the initiative passed by the second-highest margin with 76% of voters approving it. Summit, Routt and Eagle counties also had high support with 65%, 63% and 62% of voters approving the measure.
As dictated by a 2023 law on natural medicine regulation and legalization, Colorado’s therapy program will be overseen by two state agencies, both of which have now finalized rules to support the therapeutic framework for psilocybin.
Support Local Journalism
Donate
The Department of Regulatory Agencies approved the first set of regulations in June. This created rules pertaining to the training and licensing for psychedelic therapy facilitators. The Department of Revenue rules approved in August set licensing procedures for businesses that will operate in this space. These include rules for healing centers and businesses around the cultivation, manufacturing, testing and secure storage of psilocybin mushrooms.
With the rules finalized, the two agencies are expected to set licensing fees this fall and begin accepting applications on Dec. 31, 2024. With licenses issued, Colorado could see its first healing centers and providers offering psilocybin treatment by late spring or early summer 2025.
“This is not a dispensary model and we’re not allowing any kind of retail sales. So nobody will be going in, purchasing psilocybin mushrooms, and then just taking them without this therapeutic and supervised structure,” said Tasia Poinsatte, director of the Healing Advocacy Fund in Colorado. “It really is a fundamentally different approach than what we’ve seen with marijuana, and it’s very much geared towards access for mental health.”
With this approach, “anybody who’s going to access the mushrooms has to do so with guidance and support from somebody who’s called a facilitator,” Poinsatte said.
Healing Advocacy Fund is a nonprofit that started in Oregon as the state rolled out its program and opened a second office in Colorado as voters passed the 2022 ballot initiative.
The organization has worked closely with Colorado’s two regulatory agencies as well as the 15-person Natural Medicine Advisory Board, created by the 2023 law to build out the state’s framework. The process included nearly 18 months of public engagement, recommendations from experts and more, Poinsatte said.
What is psychedelic therapy and who does it benefit?
The launch of both Colorado and Oregon’s psilocybin therapy programs follows a growing body of research around the psychedelic’s ability to treat a variety of mental health conditions including anxiety and depression.
“I think what we have done is given therapists another tool in their toolbox with which to help somebody,” said Martha Hammel, an Aspen-based nutritionist and certified integration coach specializing in eating disorders, addiction, traumatic brain injury, anxiety, depression, psychedelic integration.
“I don’t think psychedelics are the be-all-end-all of healing, but they certainly shouldn’t be illegal,” she said. “And it’s really important that they are accessible for anybody who wants to include that in their practice.”
Following the passage of Colorado’s natural medicine ballot initiative, Hammel co-founded the Aspen Psychedelic Resource Center with Laura Betti, a certified psychedelic integration coach.
Hammel described the center as “your local psychedelic librarians,” providing resources and education for the entire community around this emerging type of medicine.
The launch of a psilocybin therapy program in Colorado follows a growing body of research around psychedelics, including magic mushrooms, ability to treat a variety of mental health conditions including anxiety and depression. Jenny Kane/AP
Part of the need for this new treatment modality is that current treatments aren’t working for everyone who suffers from mental health challenges.
“We really need a new model for care,” Allen said. “Only around half of patients who are diagnosed with depression respond to an antidepressant.”
Of those that do respond, it either happens within the first eight weeks of the medication or many receive “second, third or even fourth trials of similar medications, and their rate of response is much lower,” she said.
And still, “as high as 60% of patients with major depressive disorder relapse within two years, even if they are on a medication,” Allen said.
“Medicines such as psilocybin, MDMA, and ketamine and their associated treatment paradigm encourage the client to activate their own inner healing ability rather than relying on an outdated (and often unsubstantiated) theory of neurochemical imbalance,” Allen added. “Psychedelics can open up a window for reflection and growth that other kinds of therapy simply cannot do.”
Integration is also essential to the effectiveness of treatment, Allen said.
“Integration is helping a client find meaning in the experience and find meaning that can integrate into their daily life,” Hammel said.
This practice, she added, helps more people take advantage of the healing properties of psychedelic and natural medicine.
With psychedelic and natural medicine, “some people have what they consider a life-changing healing experience,” Hammel said. “But I would say the vast majority of people take a lot of time to integrate where maybe they didn’t experience a lot of healing in the beginning.”
At Roaring Fork Neurology, its providers already offer psychedelic medicine through ketamine injections to patients as well as provide psilocybin harm reduction services and integration services, Allen said. Its providers are enrolled in the state’s psychedelic medical education programs and working toward meeting the criteria for facilitator and clinical facilitator licensure in 2025 for the new psilocybin program.
“We are learning as much as we can, as fast as we can,” Allen said.
Part of the group’s work includes ensuring proper training of facilitators and integration specialists within its clinic and networking with others in the region as well as addressing issues of access, she said.
“We are also tackling the issue of access with existing financial barriers by getting creative about how to reduce cost,” Allen said. She listed “group psychedelic therapy” as well as offering Spanish-speaking services in the Roaring Fork Valley as examples.
Learning more about psychedelics and mental health
Much of what is currently known about psychedelics in this realm comes from medical and observational research, Poinsatte said.
While studies on the psychedelic’s effectiveness for treating mental health have been conducted at institutions like Johns Hopkins, University of California Los Angeles and New York University, Vail Health’s recently-created Behavioral Health Innovation Center is preparing to conduct its own study into the effects of psilocybin in Colorado. This effort will be led by Dr. Charles Raison, who joined the Vail Health research center as its director in 2023.
Before joining the organization, Raison spent many years studying the efficacy and safety of psilocybin as a treatment for major depressive disorder at the University of Madison Wisconsin and for the nonprofit medical research organization, Usona Institute.
Past research and studies have demonstrated that administering psilocybin in a clinical setting with psychosocial support can benefit individuals with major depression, treatment-resistant depression, generalized anxiety disorder, post-traumatic stress disorder, substance use disorders and more, Raison listed.
However, for all that is already known, there are still unknowns.
Raison said there’s a growing body of research around how psilocybin can help other mental health disorders and health issues like Parkinson’s disease, cognitive impairment, chronic pain, fibromyalgia, certain types of bipolar disorder, and more.
The pending study at Vail Health — which still needs to clear regulatory hurdles with the U.S. Food and Drug Administration before it can start — is designed to answer “some of the key unanswered questions about the use of psilocybin,” Raison said.
According to Raison, this includes: How can we make psilocybin work better, for longer? Does psilocybin influence how people behave in the world and to the people around them? And, can we get a better grasp on the side effect profile of these agents and how to intervene early to try and prevent long-term problematic outcomes?
As the state rolls out its psychedelic therapy program, the goal is the research will help support not only the rollout but have a broader impact as well.
“We are in a remarkable situation with the legalization of psychedelics in Colorado, but really our aim at the Behavioral Health Innovation Center is to impact the larger world and we think we will,” Raison said.
Chris Lindley, the executive director of Vail Health Behavioral Health said “the thing we’re most interested in is the safe and effective use of these agents within our patient population.”
As its behavioral health research arm prepares for its study, Vail Health Behavioral Health’s participation in psilocybin treatment outside of this remains unclear.
“We are absolutely going to be using it on patients in a research setting,” Lindley said. “The question that we don’t have the answer for yet is what will Vail Health’s role be with the new (state) regulations related to healing centers and facilitator training.”
Lindley said that Vail Health is “actively working” with the state to better understand its rules and determine “how that might fit into a future care model that we can operate with.”
Part of the challenge for health care agencies to be in this space is around regulation and compliance, Lindley added.
“As a Medicare-providing hospital in a federally-regulated facility, we as Vail Health can’t open and operate a healing center because it’s against federal law, even though it’s legal within the state,” Lindley said. “However, we can certainly partner with and support other entities that are in this space.”
Why creating a regulatory framework is important
Following the passage of Proposition 122 in 2022, community members gathered at Here House in Aspen to learn more. Kristen Mohammadi/The Aspen Times archive
While current research demonstrates the potential of psilocybin therapy in helping some people, “for this to live up to its promise, it does need to incorporate that robust support so that people are prepared going into this experience,” Poinsatte said.
Part of this includes that the state rules and regulations are “essential for patient safety,” Allen said.
“While the medicines themselves have few significant risks for the right patient, there are risks during the process of taking the medicine,” she said. “Because many of these medicines induce an altered state of awareness, patients are at risk for physical and sexual assault or retraumatization without the proper preparation and integration support.”
One critical example of how the rules built in mechanisms for patient safety is the requirement for an initial safety screen. With this, adults 21 and over who are interested in receiving psychedelic treatment will complete a form about their health history as well as why they’re seeking treatment.
This will form “a determination as to whether or not this is a good fit and then also which type of facilitator they might want to work with,” Poinsatte said. “There might be cases where it’s advisable for them to work with somebody that is, for instance, a licensed psychologist or has deep skills and training in their particular condition.”
With all of the regulations, safety is at the core.
“What we’re doing by legalizing it, by creating this licensed model, is allowing for some oversight and regulation to make the whole system a little safer,” Hammel said.
While Colorado’s program was set up to create statewide access to this new treatment modality, local municipalities will have some authority about what these practices look like in their communities. While local governments do not have the authority to outright ban healing centers, they do have time, place and manner authority — and have control over things like zoning, hours of operation and more.
In Summit County, the towns of Silverthorne and Breckenridge recently discussed what such regulations could look like, with both ultimately determining not to make any rules at this point.
“We’ll see as time goes on how many communities decide to create proactive regulations and what those look like,” Poinsatte said.
Preparing for implementation
As the agencies released their final rules, it’s difficult to tell how many licenses Colorado will ultimately issue, Poinsatte said.
“There’s definitely a lot of interest in general within the mental health community,” she said. “I’ve interacted with hundreds of licensed providers, including nurses, therapists, physicians, social workers who are really interested in participating in this.”
In Oregon, in the program’s first year, it has had 30 licensed service centers obtain licenses, Poinsatte said.
“So I wouldn’t expect more than 10 to 20 in the first year of the program, maybe up to 30,” she added.
Of the licenses, Poinsatte expects the majority at first to be for therapists and professionals integrating psilocybin into their existing practices with fewer issued for healing centers created specifically for this type of treatment.
The state’s regulations are set up to help support this more integrated approach.
“One of the things that we advocated for in the rules was to make it as easy as possible for somebody like a licensed therapist to add this to their existing practice,” Poinsatte said. “(The Department of Revenue) did a really good job of finding ways to do that.”
This included creating separate licensure tiers for “micro-healing centers” or “micro-cultivators” based on the amount of psilocybin they can store on-site. For these micro-sites, while there will still be safety and security requirements, they are intended to be a smaller lift in terms of infrastructure, Poinsatte said.
The license fees are also expected to be lower, she added.
Overcoming stigmas
As Colorado clears the regulatory hurdles and prepares for implementation in 2025, the state may still have one barrier to clear.
“There’s a big ongoing need for education to reach the people that we’re hoping to reach,” Poinsatte said. “There’s a lot of interest, there’s a lot of engagement and still, I think that there’s a need for doctors and other mental health professionals to really understand what this framework is, how it functions, and how their patients can benefit.”
Hammel likened it to backcountry ski education: “We want to make sure that people have full information about what it is that they’re seeking so they can make good decisions for themselves.”
This fits within the goal of the Aspen Psychedelic Resource Center as it provides individuals with resources and information about the services that exist and about psychedelics more generally.
One specific resource Hammel pointed to is the Fireside Project, a nonprofit that has created a psychedelic support line that offers guidance and support before and after psychedelic experiences. This line can be reached by calling or texting 62-Fireside from 11 a.m. to 11 p.m. every day.
With the regulations finalized and education rolling out, all it may take to realize the full potential of the program is time.
“As with all things in medicine, it will take some time for the medical and mental health community to evolve,” Allen said.
