UCI expert answers questions about future of psychedelic medicine

Chris Cleary is about to become a key player in psychedelic medicine.

He’s a mental health nurse, with a doctorate in nursing, who has been tapped by UC Irvine’s Sue & Bill Gross School of Nursing to lead the creation of new classes in the use of traditional psychedelics – psilocybin, MDMA and the like – as part of a regimen to treat depression, PTSD and other mental health woes.

Cleary’s task is tricky, in part, because the drugs in question remain classified as Schedule 1 drugs under federal law. That means the drugs are illegal to use or possess, and it sets limits on the ways researchers can use the drugs or finance their tests.

That said, Cleary – and UCI – are hardly alone. At least 30 schools are working on classes to teach future health care providers about the potential use(s) of psychedelics.

That’s happening because, for all the lingering stigma and legal hurdles connected to these drugs, research currently is showing that psychedelics might be powerful options for a world of mental health patients who aren’t helped by current medicines.

The research is so promising, in fact, that health experts, Wall Street investors and others widely believe the Food and Drug Administration eventually will approve some hallucinogens as therapies and, when that happens, there will be a huge market for those treatments. At least some on Wall Street believe psychedelic medicine could be a $10 billion-a-year business by the early 2030s.

The public, too, seems interested. Though surveys show people remain leery of legalizing hallucinogens for recreational uses, a 2023 survey from UC Berkeley found that more than 6 in 10 registered voters support legalizing regulated therapeutic access to psychedelics.

So, in that context, the Orange County Register asked Cleary about the future of the industry and UCI’s role in psychedelic medicine. (Questions and answers have been lightly edited for clarity.)

Q: Why is UCI interested in psychedelics?

A: UCI has a strong foundation in scholarship and scientific research. Preliminary research trials have provided compelling evidence that psychedelic-assisted therapies may offer positive outcomes for treatment-resistant depression, PTSD and other mental health disorders.

As a leading research university, UCI supports the fellowship I am participating in, which focuses on preparing the next generation of clinicians for the evolving landscape of mental healthcare.

Q: How big a deal is this? How important might psychedelic medicine become?

A: Early clinical trial data have demonstrated significant therapeutic potential. The FDA has already granted ‘breakthrough therapy’ designation to several psychedelics, marking a shift in how these substances are viewed in medical treatment. This status expedites the development and review process and may shorten the drug approval timeline.

While this is promising, there remains a critical need for rigorous evidence and proper training to ensure safe and effective implementation. Any fundamental shift in treatment practices requires coordinated effort at all levels, including preparing students to meet these evolving challenges.

Q: What’s the timing?

A: Psychedelics such as MDMA and psilocybin are currently in Phase 2 and 3 trials, indicating the possibility of approval in the coming years. While no one can predict the exact timeline, some estimates suggest approval could occur within 3 to 4 years.

Q: What basic issues will the classes explore?

A: Possible module development may include historical background in psychedelics, preconceptions and bias, clinical application and evidence-based care, competency development, and psychopharmacology.

Q: Why aren’t all schools doing this?

A: I am not sure specifically why other schools might not be doing this, but they may be concerned with stigma, regulatory uncertainty, or preferring a wait-and-see model with emerging fields.

Q: How do these drugs work? Can they change the way the brain reacts to past experience or trauma?

A: Psychedelics are more complicated than just impacting serotonin and the site of action (in the brain) on the receptor site. Each drug acts in a distinct way. In summary, a target neurotransmitter is affected, such as glutamate, serotonin, dopamine and/or norepinephrine.

Neuroplasticity is the brain’s ability to rewire itself, meaning forming new connections. Each drug targets different brain systems, eliciting various responses.

Q: If the medicine isn’t yet FDA-approved, and remains illegal under federal law, how come I can go online and find so many guided mushroom therapists?

There is what I describe as the Wild West in psychedelics. … Claims are being made without FDA approval, and that puts vulnerable populations, who may be experiencing serious mental health conditions, at risk.

Cannabis had much longer in the public, with medical marijuana programs, (but) psychedelics have limited legal precedent. My advice is to wait for FDA approval and proper medical oversight.

Q: What are the potential risks?

Psychological; (overwhelming emotions, challenging experiences, adverse reactions). Physical; (heart rate, blood pressure, breathing). Medical; (interactions with medications and drug metabolism).

Q: What pitfalls are you likely to include in the classes?

Potential areas of study should include current regulations and a thorough review, via the literature, about the evidence. There may be unclear guidance on the acceptable settings for care…. With any newly approved drug, a close watch on outcomes, side effects and adverse reactions should be reported to the FDA.

Part of our educational mission is helping students separate science from stigma. These compounds have a complex history, but our focus is on current clinical evidence and future therapeutic applications.

Q: What else should readers should know about?

Psychedelic-assisted therapy is poised to reshape mental healthcare. The real question isn’t whether psychedelic-assisted therapy will enter healthcare, it’s whether our graduates will be ready to engage with it both competently and ethically.

This fellowship helps integrate psychedelic science into curricula using the same rigorous, evidence-based approach we apply to any medical innovation. We’re not advocating for or against these treatments, which will ensure our students can critically evaluate the science.

Also, (if you’re considering using these drugs), educate yourself and connect with experts and your healthcare providers. No treatment is right for everyone. These therapies require careful screening, have contraindications, and aren’t appropriate for all patients. That’s why medical supervision is essential.

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