A new study in Colorado is trying to answer definitively whether psychedelics help at least some patients dealing with distress over advanced cancer.

Dr. Stacy Fischer, co-leader of cancer prevention and control at the University of Colorado Cancer Center, said several small studies have found that psychedelic drugs may help patients who are experiencing demoralization or despair because of their impending mortality. The study CU is part of will have a larger and more diverse group of people, which hopefully will produce more conclusive evidence of whether there’s a benefit, she said.

“There’s so much science that needs to be done in this space,” Fischer said.

Psilocybin, the active ingredient in magic mushrooms, is still a Schedule 1 drug, meaning the U.S. Drug Enforcement Administration determined it has high potential for misuse and no accepted medical use.

But the U.S. Food and Drug Administration also released guidance earlier this year for trials involving psilocybin and some other psychedelics, and designated it as a “breakthrough” therapy for some mental health conditions, which would ease the path to getting treatments approved.

If the data shows that psilocybin is helpful for at least some people dealing with existential despair, that information could be useful to the FDA, even though no drug companies are asking for the agency’s approval to market it for that condition, Fischer said.

Generally, doctors can prescribe FDA-approved drugs “off label” for any condition where they might be helpful, but the agency also has the option to limit how a drug can be used if it is concerned about risk, said Dr. Brian Anderson, a psychiatrist at University of California San Francisco who is also studying psilocybin.

That means that it’s important to have robust data justifying that it works for people nearing the end of life if patients are going to have that option, he said.

All of the participants in the CU study will receive six hours of therapy before taking the drug and eight hours afterward, spread across multiple sessions. Half will get a dose of psilocybin and the other half will get niacin, a vitamin that causes flushing and some physical symptoms meant to mimic the effects of the psychedelic.

“I think even those receiving the placebo are getting some benefit” from the therapy, Fischer said.

Jim Grisgby, a professor at CU’s Denver and Anschutz campuses and one of the participating therapists, said much of the initial therapy is about preparing for the experience, since people are more likely to benefit if they’re ready to release control and go where the drugs take them. Afterward, they process anything from the experience, as well as patients’ feelings about their cancer and the grief that comes with it, he said.

“Everybody’s got their own sense of loss,” Grisgby said.

Research is still trying to determine how important the drug itself is, versus the therapy to integrate the experience into patients’ lives, Grigsby said. It’s likely both matter, since people who took psychedelics at Phish and Grateful Dead concerts didn’t usually come away changed, he said.

“You’d have a lot more people having these profound experiences” if drugs were all that was needed, he said.

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One weakness in psychedelic research is that most people figure out if they got the active drug or the placebo, Fischer said. They’ll attempt to account for that by asking people about their expectations beforehand, to see if a significant amount of any benefit from psilocybin is because people believe it will help them, she said.

The study is open to people who have stage 3 or 4 cancer and significant anxiety or depression, but no other major medical problems. The participants will have the option to receive psilocybin under a different protocol after they complete the six-month follow-up process in the initial study, Fischer said.

The study leaders also hope to answer whether the experience under psilocybin has to be especially spiritual or mystical to produce a benefit, Fischer said. They think a more mystical experience will prove helpful, and are encouraging participants to bring items that are significant to them to help put them in the right mindset, she said.

Anderson, who is working on a different study to see whether psilocybin reduces demoralization in people with a life expectancy of less than two years, said most research on psilocybin has involved relatively young, physically healthy people, so there’s a need to study how it would affect those who are older and more medically complex.

And of course, there’s no good information about what will happen if people take the drugs in “healing centers” like Colorado is creating, since the conditions may not be as carefully controlled, he said.

“It’s a bit of comparing apples and oranges,” Anderson said.

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