In 2014, the University of Wisconsin–Madison campus became the site of the first Phase 1 clinical trial for psilocybin. Since that study, which was led by UW–Madison School of Pharmacy Professor Paul Hutson, the campus has steadily become a powerhouse of psychedelic research aimed at treatments for mental health conditions ranging from severe post-traumatic stress disorder (PTSD) to opioid use disorder. “We are one of a handful of academic sites in the U.S. that have a history of doing research with psychedelics,” said Hutson. “And we’re one of even fewer to do it at a quality and caliber high enough to be acceptable by the U.S. Food and Drug Administration for a New Drug Application.”
To provide infrastructure and other resources to stay on the cutting edge of this emerging field, the School of Pharmacy is launching the UW Transdisciplinary Center for Research in Psychoactive Substances. The new center reaches across campus to accelerate scholarly research into the science, history and cultural impact of psychedelic agents, in addition to the potential therapeutic use of psychoactive substances. “From cannabis to psilocybin (magic mushrooms) and MDMA (ecstasy), psychoactive agents are the new frontier for potential new therapies and medications,” said Hutson, the center’s founding director.
“Early studies have showed a dramatic impact on depression from one dose of psilocybin in a structured research setting. Similarly, when combined with psychotherapy for the treatment of PTSD we’re seeing dramatic benefits of the inclusion of MDMA, with a tripling of the response rate or remission rate for PTSD,” Hutson said. Importantly, the MDMA was not used alone, but as part of active, professional psychotherapy. Earlier [in 2021], School of Medicine and Public Health faculty Randall Brown and Christopher Nicholas co-authored a paper published in Nature reporting that MDMA helped 67 percent of study participants drop below the diagnostic criteria for PTSD and 33 percent meet the criteria for remission.
“There appears to be real promise in the treatment of a number of often refractory conditions related to addiction and mental health,” said Brown. “We have a lot to learn yet about possibilities and about optimal implementation and dissemination.” Four clinical trials in phases 1 to 3 are currently underway at UW–Madison to prepare for submitting applications for new drugs to the FDA, such as studying the efficacy of psilocybin as treatment for major depression and opioid addiction.
Cody Wenthur, assistant professor in both the School of Pharmacy’s Pharmaceutical Sciences and Pharmacy Practice Division and a member of the center’s executive committee, is also seeking ways to make ketamine a better therapeutic for depression by blocking some of the drug’s negative impacts. He is collaborating with Hutson and Nicholas to find out if it’s possible to observe therapeutic effects of psilocybin in the absence of memory of the psychedelic experience.
In addition to his findings about MDMA and PTSD, Brown is also working toward the therapeutic use of psilocybin for opioid use disorder and major depressive disorder. Nicholas is applying psychedelic therapy to methamphetamine use disorder. “I anticipate FDA approval of psilocybin and MDMA within the next five years, and the UW Transdisciplinary Center for Research in Psychoactive Substances will help meet the need for more research into these applications, as well as others, that could dramatically improve patients’ lives,” said Hutson.
Infrastructure and Services
Although numerous researchers around campus are already engaging in this work, the center will help provide infrastructure to help them expand their studies and even attract new researchers. “Similar to other types of chemical or biological research that need specific, expensive instrumentation, doing work with psychedelic-assisted psychotherapy requires dedicated infrastructure—trained guides, a study space, proper DEA licensing—all of the things that surround the study design itself,” said Wenthur.
Center members will have access to the School of Pharmacy’s current study space, which is one of few facilities like it in the world. Set up like a living room, it’s equipped with the comforts of home alongside monitoring devices to ensure participant safety and study replicability. Studies involving psychoactive agents require keeping a close eye on participants, both their physical and mental state. For each study, one or two trained guides or therapists protect the space and take care of the patient throughout their dosing session. The center plans to have one trained psychotherapist on staff to serve as a treatment guide and will also offer trainings to members of research groups. “By having these resources available to other investigators, we can potentially increase the number of available grants that are awarded to UW,” said Wenthur.
Another benefit of the center is in the paperwork: Hutson is one of few researchers who hold the necessary investigational new drug exemption and Schedule 1 license for clinical projects that involve drugs like marijuana, psilocybin and LSD. By collaborating with the center, researchers will be able to leverage Hutson’s proven expertise and licensing.