COLORADO, USA — Colorado will once again lead the way in building a new drug industry.
As one of the first states to legalize psychedelics and create policy around medicinal use, the state is now figuring out how to build, and regulate, a new industry.
At the same time, the FDA has issued draft guidance for clinical trials involving psychedelic medications.
“While the class itself, psychedelics, hallucinogens, have been used for a very long period of time – millennia in some cases –this is the first situation where they're being approved for a medical use by trained practitioners,” said Joshua Black, senior research scientist at the Rocky Mountain Poison and Drug Safety Division of Denver Health and Hospital Authority.
Researchers are about to get a whole lot of new, post-market data about psychedelic drugs. In a study published last month in Nature Mental Health, Black’s team offered suggestions for how Colorado – and other states – collect and study that data moving forward.
“We want to ensure we’re collecting the right information now, so in the future we can make decisions around safety, around efficacy, around whether individuals need to change the way substances are being used to maximize the benefit, and minimize the harm,” he said. “We want to have evidence-based decisions as these substances become more available, as more people use them, and more… diseases - are being treated with them.”
Broadly, Black’s team’s suggestions include tracking things like:
- Patient’s motivations for using psychedelics
- Whether a patient is using any other drugs at the time of treatment, or if they have any comorbidities
- The experience and training of the provider assisting the patient with treatment
- If the drug has the intendent effect, an adverse effect, or if concerning symptoms show up later – outside of an expected treatment window
Colorado has experience leading the way with a new drug – when the state legalized cannabis.
“The biggest thing we can learn is that rare events in small populations become much more frequent as that population gets bigger,” Black said. “One example we saw was - as cannabis became more and more available a rare, more rare experience called cannabinoid hyperemesis syndrome - cyclical vomiting – suddenly, a lot more people are using cannabis so a lot more people are at risk for that. So when we think about psychedelics and we’re on that same cusp where a few smaller groups of people are using and that group will grow over time – do we see those rarer events? They may stay rare proportionally, but suddenly they become more burdensome on healthcare systems, on people, over time as more people use.”
The Rocky Mountain Poison and Drug Safety Division is trying to gather some of its own data, recruiting for a focus group of people who have used psychedelics to treat a mental health condition.
Oregon is a few steps ahead of Colorado, with psilocybin treatment facilities already legalized and in operation serving patients with mental health diagnoses.
Colorado is still working through making the state's rules, and plans to take applications for natural medicine facilitators by the end of the year.
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