Colorado regulators are making final tweaks to a pioneering program overseeing licensed facilitators and manufacturers who will launch the state into the rarified realm of psychedelic-assisted therapies next year.
Following the voter-approved Proposition 122 in 2022 and dozens of public meetings, the 107 pages of regulations around the groundbreaking program were crafted by the 14 members of the Natural Medicine Advisory Board who were appointed by Gov. Jared Polis and include experts in psychedelic medicine and traditional medical care.
Colorado’s rollout will be closely watched as a national model as the federal government navigates the waning years of a more than 50-year drug war and steps back from approving drug-assisted psychotherapy. The Federal Drug Administration in August rejected a nearly 40-year effort to use MDMA as a treatment for post-traumatic stress disorder.
The 22-month planning process has divided oversight of psilocybin-assisted therapies between the Department of Regulatory Agencies, or DORA, and the Department of Revenue. Both those state agencies approved final rules in June and August and the Natural Medicine Division will begin accepting license applications Dec. 31.
“Overall they have been really thoughtful about the rules and I think we have ended up in a really good place,” said Tasia Poinsatte, Colorado director of the Healing Advocacy Fund, a nonprofit formed in 2020 to help Oregon rollout its voter-approved psilocybin therapy program in 2023. “They definitely took their time to bring in the right expertise across a whole spectrum of people in Colorado.”
Colorado’s rules — coming out two years after Oregon opened its first psilocybin service center — allow for two facilitator licensing tracks compared to only one in Oregon. In the first year of the program in Oregon, there are 21 licensed service centers, 10 manufacturing facilities and 329 licensed facilitators.
Poinsatte said it makes sense for states to lead on the implementation of psychotherapy paired with a drug because states already have licensing programs for mental health professionals.
“In Colorado we are in a particularly good position to regulate this therapy paired with a substance and do it well and create a body of evidence that is going to be effective and really help people who are struggling,” she said. “This is a great opportunity for Colorado.”
Poinsatte said her group’s surveys of potential facilitator license applicants in Colorado includes therapists and psychiatrists “who are so frustrated with the limited options that they have for people who are really hurting.”
“The first people who are getting into this are going to do it because they deeply care and they want to make a difference with their patients,” she said.
The state will regulate the use of natural medicines, unlike rules around the sale of marijuana, which is managed by local governments. DORA will oversee the training and licensing program for psychedelic facilitators and the Department of Revenue will license healing centers and businesses involved in the cultivation, manufacture and testing of psychedelic medicines, including psilocybin mushrooms. By June 2026, the Colorado natural medicine program could expand to include other natural psychedelics, including dimethyltryptamine, or DMT, ibogaine and mescaline.
Local communities scrambling to establish rules around a new industry
A survey conducted by state officials of potential participants in the Natural Medicine Program showed about 213 people interested in opening some sort of business. About 146 were interested in opening a healing center, 96 were planning to open a cultivation facility that would grow psilocybin mushrooms, 66 wanted to help process and manufacture psilocybin products and 11 were interested in opening a facility that would test the mushrooms and products to make sure they meet state standards.
At an Oct. 30 meeting between DORA and Department of Revenue officials and municipal planners and staff, a map showed entrepreneurs across the state, with many concentrated along the Front Range.
Of the folks who were interested in opening a healing center, 64 were planning a standard healing center — likely an existing clinical facility — while 112 wanted to open micro-healing centers, which allow some mental health practitioners to add psychedelic-assisted therapies to their offerings.
“That tracks with the purpose of Prop. 122, which was to promote mental health care services and access for Coloradans who are suffering things like treatment-resistant depression, anxiety and PTSD,” Amelia Myers, a senior policy advisor at the Natural Medicine Division, said during the Oct. 30 meeting.
With the state preventing local communities from outright banning licensed natural medicine businesses, a third of the local towns and cities at the Oct. 30 meeting had zoning requirements for licensed healing centers and facilities and many more were contemplating new land use codes.
Without local ordinances addressing where and when natural medicine businesses can operate, the business could locate anywhere in a city or town. And most communities are scrambling to establish new rules before licensed businesses start opening early next year.
Breckenridge, for example, last month approved a new zoning regulation for natural medicine businesses that mirror the town’s marijuana zoning, which prohibits marijuana shops in the downtown core or near schools or child care centers.
In Fountain, south of Colorado Springs, the city council last week met to consider an ordinance that would keep natural medicine businesses in areas zoned for industrial uses and away from schools and homes.
Some communities, like Woodland Park, are considering temporary moratoriums to slow the rollout of natural medicine businesses inside municipal boundaries.
The Colorado Springs city council last week also reviewed similar zoning adjustments to restrict cultivation, manufacturing, testing and clinical businesses in the emerging natural medicine industry to industrially zoned areas of the city.
“If we can take an ancient medicine and perhaps turn it into a modern solution, I would not be opposed to that,” said Colorado Springs Councilman David Leinweber, who asked planning staff to include medical and public health input in the city’s new zoning regulations. “I just feel like it needs to be done right. I feel like we have kind of messed up with THC.”
Two-tracked licensing for facilitators
The DORA facilitator program establishes two tracks for licensing people to administer psychedelic therapies.
A clinical facilitator license allows already licensed medical and mental health providers to include psychedelic-assisted therapy as part of their existing care after completing a 150-hour training program, 40 hours of supervised work with participants and 40 hours of consultation with participants.
A facilitator license allows people who are not trained in medicine or mental health therapy to offer psychedelic-assisted therapy after finishing the same training program required for those seeking a clinical license. Facilitators can work with participants who have been screened in a mandatory initial consultation that shows the participant does not need a higher level of care by medical or mental health providers. For example, a person taking antipsychotic medications will need to see a licensed clinical facilitator.
The DORA licensing program also establishes an educator license that allows facilitators with two years of experience administering natural medicines to train people in psychedelic-assisted therapies. A training license allows students to work with natural medicines under the guidance of licensed facilitators.
The DORA program details specifics of the licensing training, which sets minimum hours of training and standards of practice that include rules around participant safety and privacy. The curriculum includes training in best practices and ethics, including the appropriate use of touch when participants are vulnerable in an altered state of consciousness. The training requires study of compassionate communication, historical and indigenous use of natural medicines, and assessing the risk of suicide. The training program requires hours studying how to initially screen and prepare participants as well as dosing strategies and integrating the insights of a psychedelic medicine session into daily lives.
High fees, costs of licensing
There are eight Colorado training programs in Colorado offering licensure training that often exceeds the state’s minimum requirements. They are also expensive. Most of the programs charge between $10,000 and $13,000 for the training.
Add in the state’s fees licenses — $2,000 for a micro healing center and $5,000 for a standard, for example — and the costs of entry are too high for Laurie Boscaro, a therapist in Gunnison County for 16 years.
She added ketamine-assisted therapy to her practice a few years ago and she’s got a few clients doing that. She’s worried that she will need to charge high prices for psilocybin care to cover her costs.
“As I look forward to the psilocybin rollout, I have to weigh the cost of getting involved against how many folks I can offer this to while making sure the costs for my clients will not be too high,” she said. “All of it is pushing $20,000 to be able to offer this, plus the lost work during training. It’s a process I wholeheartedly believe in, but I’m not sure in my small community that it makes sense for me.”
Dr. Wael Garas hopes to bring psilocybin-assisted therapy to Pagosa Springs. The internal medicine doctor is thinking of opening a micro healing center and working with patients who have chronic medical conditions or end-of-life anxiety.
Like Boscaro, he has concerns about the fees and costs. It takes a lot of energy to host psychedelic-assisted therapy sessions and Garas expects maybe he can host one or two sessions a week. He does not intend for this therapy to replace his full-time job as an internist at medical centers.
“It seems like I will have to see a lot of people and charge them a lot of money to make this work with the cost of training, fees and overhead,” Garas said. “I’m not completely comfortable with the amount we have to charge for the experience with mushrooms, which are legal now.”
Garas is particularly interested in the data that will come from Colorado’s pioneering program of regulating access to psychedelics. The state’s regulations include strict rules about reporting and the documented responses from Colorado participants in psychedelic-assisted therapy could better inform federal regulators as they study new treatments.
“I’m definitely proud of being in Colorado and being in the forefront of trying to get these treatments available to people in a responsible way,” Garas said.