Colorado doctors highlight patient safety and preparation as key priorities in state’s development of psilocybin therapy rules

By

Shane Ersland

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Colorado is in the process of developing rules for the rollout of its psilocybin therapy program, and mental health experts highlighted some components that will factor into those decisions last week. 

Mental Health Colorado and Healing Advocacy Fund will host a series of webinars about the rollout of psilocybin services in the state over the next couple months, and held the first session on Thursday.  

“We know that natural medicines have been used safely for millennia by cultures for healing, and Colorado can do better to promote health and healing by reducing its focus on criminal punishments for (people) who suffer mental health issues, and by establishing regulated access to natural medicines through a humane, cost-effective and responsible approach,” Mental Health Colorado CEO Vincent Atchity said. 

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Nearly 1.3 million Coloradans voted affirmatively for Proposition 122 in 2022, making Colorado the second state in the nation to approve a state-regulated program for legal access to psilocybin therapies, Healing Advocacy Fund Executive Director Tasia Poinsatte noted.  

“Oregon was the first state to take this step with the passage of their psilocybin services measure in 2020,” Poinsatte said. “Oregon actually launched their program last year. So in the past several months, we’ve seen over 900 people receive access through Oregon’s regulated model. Which is pretty incredible if you think about that in the context that with these state models, we are opening up access a bit more broadly than we’ve seen in clinical trials.”

Colorado continues its rulemaking process for a regulated psilocybin program, which is slated to launch next year. The state figures to benefit from having the option to learn from the implementation process Oregon has undergone in rolling out its program. 

“Our team at Healing Advocacy Fund (is) supporting implementation across both states,” Poinsatte said. “So we are uniquely positioned to make sure the lessons learned from Oregon can be integrated in Colorado in real time.”

Colorado’s psilocybin therapy model will provide access for adults who are 21 or older, and will require support from a trained and licensed facilitator before, during, and after the psychedelic experience, Poinsatte said.

“We have a two-year rulemaking process to set up the regulatory structure—which includes establishing licensing for trained facilitators as well as healing centers—and [the] cultivation, manufacture, and testing of the mushrooms themselves. This program will not require a diagnosis or prescription to receive access. There will be other components in place to support safety.”

— Poinsatte

The program will not allow Coloradans to purchase psilocybin mushrooms and take them home for unsupervised use, Poinsatte said. And anyone participating in therapeutic sessions will need to plan for transportation home after the session that doesn’t involve them driving. 

Those seeking services will need to complete a safety assessment in which the participant must provide information about their physical, mental, and social-emotional health to determine whether to proceed with treatment. Dr. German Ascani, a board-certified psychiatrist in Denver, highlighted some aspects of the screening process. 

“When it comes to screening, the bottom line is you have to keep participants safe,” Ascani said. “You have to keep vulnerable individuals and populations that might not be appropriate to undergo this process [in mind]. In this two-year rulemaking process, there’s a lot of thought and effort that’s going into (screening) individuals that may be at risk appropriately.”

Screens will likely check for cardiovascular conditions, unstable hypertension, neurological conditions, and other things that have been proven to put people at risk based on data that has been compiled around psilocybin use, Ascani said.

“It warrants careful planning and assessment,” he said. “If I’m doing a screening, I would make sure that a psychotic process is not happening, that you don’t have a diagnosis of schizophrenia, (or are in the) manic phases of bipolar (disorder). Active suicidality is one we want to screen for. We know personality disorders exist in a continuum—not that this is exclusionary—but it may be a red flag to further assess and look into this individual’s personality pathology. Lithium (appears) to have an increased risk of adverse reactions, so [I’d be] screening for that.”

A proposed participant and facilitator will review the participant’s goals for a psilocybin therapy session, and develop a safety and support plan. During administration of the drug, participants will remain under the supervision of a trained facilitator for the duration of their experience.

Dr. Jennifer Tippett, a licensed clinical psychologist in Denver, discussed preparation/administration aspects of the process.

“When we talk about preparation, we’re really talking about getting someone to a place where they feel like they know a little bit about what’s about to happen to them. We all do better when we have a bit of a sense of what we’re going to do and what we can expect.

The key thing to remember in the administrative session is that people are extremely impressionable when they’re on a psychedelic. So we want to be careful about what we say or imply. For practitioners, we often want to get someone somewhere or help them have some insight. That usually is about us and not them.”

— Tippett

Facilitators will also want to keep in mind that psilocybin sessions will vary greatly among patients, and that some will undoubtedly have “bad trips,” Tippett said. 

“Not all administration sessions are rainbows and butterflies,” she said. “Sometimes they’re lovely and people have the greatest time. And sometimes really challenging experiences come up. People can really struggle. So having an idea of how you’re going to manage that, what that’s going to look like, (and) what sort of support you need in that space is really important if you’re going to sit and do this work.”

Poinsatte said the Colorado rulemaking process will benefit greatly from having the input of local providers.

“It gives me a lot of reassurance that we’re in a moment in Colorado where people like Dr. Tippett and Dr. Ascani, who are based in Colorado, are informing this process, and bringing this depth of knowledge and experience they have to inform the state regulatory process,” Poinsatte said. “I think we’re going to be so much better off with your efforts.”

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