Now that this act has passed, what does it mean in terms of people using these substances?
It looks like it’s going to unfold the same way it did in Oregon. I believe they’re going to roll out their program this January, and that’s going to be a helpful guide for Colorado to see how this could look. It’s going to take some time — months to years — to understand how to develop some infrastructure. This is not designed to roll out like cannabis did, where you have recreational stores. This is about using these substances within a therapeutic environment.
How is that therapeutic environment typically set up?
In the research setting, patients start with preparatory sessions, then they have a dosing session with two “minders,” or guides, to monitor for side effects or adverse events and to help with safety concerns. There’s a lot of transparency there. I do worry about what will happen when these substances are being administered more broadly, because these patients are in a very vulnerable state. It’s important that we’re aware of that and think about how we’re going to keep people safe and keep therapists safe in this very vulnerable setting.
The Natural Medicine Health Act mentions using psilocybin for such conditions as anxiety, depression, substance-use disorder, and post-traumatic stress disorder (PTSD). What does your research show about those uses?
There have been high-quality studies looking at MDMA and PTSD, but there have not been high-quality studies looking at psilocybin and PTSD. I was concerned about this legislation, because I think we’re getting ahead of where the science is on substances.
For our study, we are looking at anxiety, depression, quality of life, and existential distress and demoralization in people with late-stage cancer. The preliminary data that we have right now are very encouraging — they show that a therapeutic process, using psilocybin as a component of that process, can have a profound improvement in symptoms of depression, anxiety, and existential distress. It does look like psilocybin-assisted psychotherapy can improve those things. However, for many of these trials, the sample sizes are very small. At least in the cancer realm, we’re looking at three small studies involving about 20 to 30 patients each. That’s limited data. It’s certainly not enough where we would say, “This definitely has efficacy.” There is more research that needs to be done.
How does this new law compare to the way legal cannabis was rolled out in Colorado? In that case it was legalized for medical use first, then recreational use.
As both a physician and a parent, I have seen firsthand the harm done as we’ve made cannabis so easily available in Colorado. We have some of the highest rates of teens using it. While it may be safe for an adult brain, it is not safe for a teenage developing brain. I think there has been some real harm from the way we legalized cannabis.
I am really hoping with the psychedelics that we can continue to develop and run very high-quality clinical trials and studies to better understand: What are the real benefits? What are the harms of these drugs? In all these clinical trials that have taken part to date, many people are excluded because they are seen as being at higher risk for one reason or another. If they have a family history of schizophrenia or bipolar disorder, they’ve been excluded from these clinical trials. As this opens up more broadly, are we going to have the same ability to screen people? And will we start to see a lot more serious adverse events?
Do you ever see mushrooms being available over the counter in the same way as marijuana? Or are they two different substances in the way that they work on the brain?
I don’t see them ever being available over the counter. They can cause very serious harm to people who are vulnerable, like someone with a history of schizophrenia or bipolar disorder. At very high doses, they can cause hallucinations and a complete dissolution of your ego. I don’t think people should be able to just walk into a store and buy them.
How much of a variance can there be in terms of potency? Is there way to guarantee a standard dose of these active ingredients?
There can be a huge variance in how potent they are. In many of the studies that have taken place to date, the researchers are using a synthesized psilocybin compound that’s synthesized under Current Good Manufacturing Practice standards. We have a very fixed dose, which is very important in these early studies where you want to understand reproducibility. But when they’re found in nature, it’s much more variable.
Will the healing centers use the synthesized version or the real thing? Or is it too early to tell?
Because psilocybin remains a Schedule I drug on the federal level, I can’t imagine any other way than using the natural compounds. The companies that are synthesizing the drug are all working under the regulation of the FDA and the DEA. To use the synthesized product, you must have a Schedule I license in a research environment with an active research protocol. At the healing centers proposed in this new legislation, I have to assume they are going to be using naturally occurring mushrooms.
What is the latest update on your research study using psilocybin?
We have a therapy training session scheduled within the next month, and we’re still on track for starting our enrollment in January. I’m very excited, and we’ve gotten a lot of inquiries and excitement from patients. I think it speaks to the promise of these compounds that people are excited and hoping for some relief from symptoms that we don’t really have any good established therapies for.