Interest in the possible mental health benefits of psychedelics is growing as experiments to better understand these substances are moving ahead.
In Fort Collins, researchers at the Wholeness Center are examining the potential therapeutic use of LSD and, in particular, how—and at what dosage—it may impact people with generalized anxiety disorder.
After a lengthy screening process, study participants go to the Wholeness Center for a 12 hour day with two therapists. They are unaware of what they will be swallowing: a placebo or various amounts of LSD.
“Particularly through the second hour or the third hour, people are in a very different frame of mind,” Dr. Scott Shannon, one of the principal study investigators, said of the people who get LSD instead of the placebo. “The trees may be breathing, the couch may be moving. And some people will find this incredibly curious. Other people may be a little intimidated.”
The two therapists are there to reassure participants and calm them down. The experimental sessions taking place in Fort Collins are part of a larger study at 20 sites across the country funded by MindMed, a New York-based biotech company. The company plans to announce topline data from the clinical trials later this year.
“I tell people it's like, if we're living our life every day at street level then psychedelics are kind of like going up into a hot air balloon, or maybe even in a satellite, and you're looking at your life in a very different way, and insights come,” Shannon said. “They can be scary sometimes. They can be terrifying.”
This experiment on LSD and anxiety is part of a much larger push to understand how various psychedelics can be used to treat mental health conditions. The effort involves support from corporations, universities and nonprofits. Earlier this year, the University of Colorado Anschutz Medical Campus announced an upcoming clinical trial to test whether psilocybin can help with treatment-resistant depression.
Past research efforts have indicated that psilocybin—also called magic mushrooms—can ease anxiety, particularly for cancer patients.
“We have some suggestion that psychedelics can be helpful for anxiety, and this is a study to try to test that,” Shannon said.
Much of this research has been on hold for decades. After widespread use in the 1960s, the federal government classified psychedelics as Schedule 1 drugs, meaning they lack an accepted medical use and have a high potential for abuse.
“It really shut down research in this country for a long, long time. And it's now just restarting,” Shannon explained.
Eventually, researchers began requesting licenses from the federal government to study some psychedelics. After encouraging results, the Food and Drug Administration (FDA) has allowed some of this work to move ahead more quickly by granting “breakthrough therapy” status to certain substances.
Luke Niforatos, the CEO of Protect Our Kids, a group that fights for more restrictive drug policies and recently opposed Colorado’s ballot measure to decriminalize magic mushrooms, believes in the importance of following the FDA's process.
“I think the concern that I have is, we're seeing a lot of kind of breathless rhetoric around the...miracle drug potential of psychedelics,” Luke Niforatos, the CEO of Protect Our Kids, a group that fights for more restrictive drug policies and recently opposed Colorado’s ballot measure to decriminalize magic mushrooms, said.
Niforatos points to the risks of other drugs like opioids and cannabis. In MindMed’s LSD trial in Fort Collins, some groups are excluded from participation: pregnant women and people with a history of psychosis. That's because the risks of using psychedelics in these populations are not fully understood.
“That's not to say that these drugs don't do what everyone's really excited about,” Niforatos said. “But what it does mean, though, is it's still early.”
Research into a psychedelic called MDMA could be entering its final phase before possible FDA approval.
Berra Yazar-Klosinski, the chief science officer with the MAPS Public Benefit Corporation, said MDMA is further along in the process than other psychedelics thanks to a growing body of research on using it to treat mental health issues in conjunction with therapy.
She remembers looking over the results from a phase three clinical trial on using MDMA to treat Post-Traumatic Stress Disorder, published in 2021 in the journal Nature Medicine. 88% of the participants experienced a meaningful change in their symptoms. Around two-thirds no longer met the criteria for a PTSD diagnosis.
“Oh, my gosh. It was so exciting,” Yazar-Klosinski said of the results.
Later this year, Yazar-Klosinski will be walking the FDA through the data as part of a larger request to approve MDMA-assisted therapy.
“It was such a huge surprise that everybody was just shocked and very happy for the PTSD patients and what this could mean for them,” Yazar-Klosinski said.
